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Table 57: Oncology Agents


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Drug Category: Oncology Agents

Medication Class/Individual Agents: Antineoplastics

I. Prior-Authorization Requirements

 Alkylating Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

bendamustine Belrapzo test   MB IV  

Gleostine for Brain Tumor

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has received surgical and/or radiotherapeutic procedures, as appropriate.


Leukeran for Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • prior therapy with at least two systemic therapies.

Leukeran for Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to rituximab monotherapy.

Zepzelca

  • Documentation of the following is required:
    • diagnosis of metastatic small cell lung cancer (SCLC); and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to platinum-based chemotherapy.

 

 
bendamustine Bendeka test   MB IV  
bendamustine Treanda test   MB IV  
bendamustine Vivimusta test   MB IV  
busulfan injection Busulfex test   MB IV  
busulfan tablet Myleran test   PO  
carboplatin test   MB IV  
carmustine Bicnu test   MB IV/ Implantation  
chlorambucil Leukeran PA   PO  
cisplatin test   MB IV  
cyclophosphamide capsule, tablet test   A90 PO  
cyclophosphamide injection test   MB IV  
dacarbazine test   MB IV  
estramustine Emcyt test   PO  
ifosfamide Ifex test   MB IV  
lomustine Gleostine PA   PO  
lurbinectedin Zepzelca PA   MB IV  
mechlorethamine gel Valchlor test   Topical  
melphalan hydrochloride injection Alkeran test   MB IV  
melphalan injection Evomela test   MB IV  
melphalan tablet Alkeran test   # , A90 PO  
oxaliplatin test   MB IV  
procarbazine Matulane test   PO  
temozolomide Temodar test   # , A90 IV / PO  

 Anthracenediones

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

mitoxantrone test   MB IV  

   

 

 Anthracyclines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

arsenic trioxide Trisenox test   # IV  

      

 
daunorubicin test   MB IV  
doxorubicin Adriamycin test   MB IV  
doxorubicin liposomal injection Doxil test   MB IV  
epirubicin Ellence test   # IV  
idarubicin Idamycin PFS test   MB IV  
streptozocin Zanosar test   MB IV  
teniposide test   IV  
valrubicin Valstar test   MB Intravesically  

 Anti-VEGF

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

bevacizumab Avastin PA   MB IV  

Alymsys, Avastin, Mvasi, Vegzelma, and Zirabev for cervical cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with one of the following:
      • paclitaxel and cisplatin; or
      • paclitaxel and topotecan.

Alymsys, Avastin, Mvasi, Vegzelma, and Zirabev for recurrent glioblastoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Avastin for hepatocellular carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with Tecentriq (atezolizumab); and
    • member has Child-Pugh Class A.

Alymsys, Avastin, Mvasi, Vegzelma, and Zirabev for metastatic colorectal cancer 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with fluoropyrimidine-, capecitabine-, oxaliplatin-, or irinotecan-containing therapy.

Alymsys, Avastin, Mvasi, Vegzelma, and Zirabev for metastatic renal cell carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • if predominant clear cell histology, requested agent will be used in combination with interferon alfa.

Alymsys, Avastin, Mvasi, Vegzelma, and Zirabev for non-squamous non-small cell lung cancer (NSCLC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with both of the following: carboplatin, paclitaxel.

Alymsys, Avastin, Mvasi, Vegzelma, and Zirabev for non-squamous NSCLC with EGFR Mutation Positive

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • requested agent will be used in combination with erlotinib.

Alymsys, Avastin, Mvasi, Vegzelma, and Zirabev for adenocarcinoma, large cell, NSCLC not otherwise specified (NOS) with PD-L1 Expression Positive

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • requested agent will be used in combination with all of the following: carboplatin, paclitaxel, atezolizumab.

Alymsys, Avastin, Mvasi, Vegzelma, and Zirabev for initial therapy of advanced or metastatic adenocarcinoma, large cell, NSCLC NOS (performance status [PS] 0-2)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • member has a contraindication to to PD-1 or PD-L1 inhibitors; and
    • requested agent will be used in combination with one of the following:
      • carboplatin and pemetrexed; or
      • cisplatin and pemetrexed.

Alymsys, Avastin, Mvasi, and Zirabev for maintenance therapy of advanced or metastatic adenocarcinoma, large cell, NSCLC NOS (PS 0-2)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • one of the following:
      • requested agent will be used as monotherapy; or
      • requested agent will be used in combination with one of the following: atezolizumab or pemetrexed.

Alymsys, Avastin, Mvasi, Vegzelma, and Zirabev for ovarian, fallopian, or primary peritoneal cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Avastin for wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, or myopic choroidal neovascularization

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • requested dosing is 1.25 mg intravitreally every four or eight weeks or as needed.

Cyramza for gastric or gastro-esophageal junction (GEJ) adenocarcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: a fluoropyrimidine-containing chemotherapy regimen, a platinum-containing chemotherapy regimen.

Cyramza for HCC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has alpha fetoprotein (AFP) ≥ 400 ng/mL; and
    • inadequate response, adverse reaction, or contraindication to sorafenib.

Cyramza for metastatic colorectal cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with one of the following: FOLFIRI or irinotecan; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: 5-fluorouracil/leucovorin, a capecitabine-based regimen.

Cyramza for NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • both of the following:
        • requested agent will be used in combination with docetaxel; and
        • inadequate response, adverse reaction, or contraindication to a platinum-containing chemotherapy regimen; or
      • all of the following:
        • requested agent will be used in combination with erlotinib; and
        • cancer displays the EGFR exon 19 deletion or exon 21 L858R mutation; and
        • inadequate response or adverse reaction to one of the following used in combination with Tagrisso (osimertinib), or contraindication to both of the following:
          • gefitinib; or 
          • Gilotrif (afatinib).

Zaltrap

  • Documentation of the following is required:
    • diagnosis of metastatic colorectal cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with either irinotecan or FOLFIRI; and
    • inadequate response or adverse reaction to one of the following regimens or a contraindication to all of the following regimens: a fluoropyrimidine (capecitabine or fluorouracil), CAPEOX, FOLFOX, oxaliplatin-based therapy; and
    • inadequate response, adverse reaction, or contraindication to a bevacizumab product.
 
bevacizumab-adcd Vegzelma PA   MB IV  
bevacizumab-awwb Mvasi PA   MB IV  
bevacizumab-bvzr Zirabev PA   MB IV  
bevacizumab-maly Alymsys PA   MB IV  
ramucirumab Cyramza PA   MB IV  
ziv-aflibercept Zaltrap PA   MB IV  

 Antiandrogens

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

abiraterone 125 mg Yonsa PA   PO  

abiraterone 250 mg, 500 mg

  • Documentation of the following is required:
    • diagnosis of metastatic high-risk castration-sensitive prostate cancer or metastatic castration-resistant prostate cancer (mCRPC); and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with prednisone; and 
    • for the 500 mg tablet, medical necessity for use instead of the 250 mg tablet; and
    • one of the following:
      • requested agent will be used in combination with a gonadotropin-releasing hormone (GnRH) analog; or
      • member had a bilateral orchiectomy.

Erleada for metastatic castration-sensitive prostate cancer (mCSPC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to abiraterone; and
    • one of the following:
      • requested agent will be used in combination with a GnRH analog; or
      • member had a bilateral orchiectomy.

Erleada for non-metastatic castration-resistant prostate cancer (NM-CRPC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or urologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to Xtandi (enzalutamide); and
    • one of the following:
      • requested agent will be used in combination with a GnRH analog; or
      • member had a bilateral orchiectomy.

Nubeqa for NM-CRPC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or urologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to Xtandi (enzalutamide); and
    • one of the following:
      • requested agent will be used in combination with a GnRH analog; or
      • member had a bilateral orchiectomy.

Nubeqa for metastatic hormone-sensitive prostate cancer (mHSPC) or mCSPC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or urologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with docetaxel; and
    • one of the following:
      • requested agent will be used in combination with a GnRH analog; or
      • member had a bilateral orchiectomy.

Nubeqa for M1 mCRPC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing; and
    • one of the following:
      • if no prior docetaxel or no novel hormone therapy, inadequate response, adverse reaction, or contraindication to all of the following: abiraterone, docetaxel, and enzalutamide; or
      • if prior docetaxel but no prior novel hormone therapy, inadequate response, adverse reaction, or contraindication to both of the following: abiraterone and enzalutamide; or
      • if prior novel hormone therapy but no prior docetaxel, inadequate response, adverse reaction, or contraindication to docetaxel; or
      • if prior docetaxel and prior novel hormone therapy, inadequate response, adverse reaction, or contraindication to cabazitaxel.

Xtandi for mCSPC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to abiraterone; and
    • one of the following:
      • requested agent will be used in combination with a GnRH analog; or
      • member had a bilateral orchiectomy.

Xtandi for mCRPC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • requested agent will be used in combination with a GnRH analog; or
      • member had a bilateral orchiectomy; and
    • one of the following: 
      • requested agent will be used as monotherapy; or
      • requested agent will be used in combination with Talzenna (talazoparib).

Xtandi for NM-CRPC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or urologist; and
    • appropriate dosing; and
    • one of the following:
      • requested agent will be used in combination with a GnRH analog; or
      • member had a bilateral orchiectomy.

Xtandi for NM-CSPC with high risk biochemical recurrence (BCR)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or urologist; and
    • appropriate dosing.

Yonsa

  • Documentation of the following is required:
    • diagnosis of mCRPC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with methylprednisolone; and
    • one of the following:
      • requested agent will be used in combination with a GnRH analog; or
      • member had a bilateral orchiectomy.
 
abiraterone 250 mg, 500 mg Zytiga PA   A90 PO  
apalutamide Erleada PA   PO  
bicalutamide Casodex test   # , A90 PO  
darolutamide Nubeqa PA   PO  
enzalutamide Xtandi PA   PO  
flutamide test   A90 PO  
nilutamide test   A90 PO  

 Antibiotics

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

bleomycin test   MB IV / IM / SC  

Jelmyto

  • Documentation of the following is required:
    • diagnosis of low-grade upper-tract urothelial cancer; and
    • prescriber is an oncologist or urologist; and
    • appropriate dosing.
  • For recertification, documentation that the member achieved a complete response three months after initiation is required.
 
dactinomycin Cosmegen test   MB IV  
mitomycin injection test   MB IV  
mitomycin pyelocalyceal solution Jelmyto PA   MB Intravesically  

 Antibody-Drug Conjugates

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

ado-trastuzumab Kadcyla PA   MB IV  

Besponsa

  • Documentation of the following is required:
    • diagnosis of ALL; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • both of the following:
        • Philadelphia chromosome-positive; and
        • inadequate response or adverse reaction to one tyrosine kinase inhibitor for the treatment of ALL; or
      • all of the following:
        • Philadelphia chromosome-negative; and
        • B-cell precursor ALL; and
        • prior therapy for the treatment of ALL with one systemic therapy.

Blenrep

  • Documentation of the following is required:
    • diagnosis of multiple myeloma; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member has received at least four prior chemotherapy regimens or contraindication to the use of recommended chemotherapy regimens; and
    • inadequate response or adverse reaction to one or contraindication to all of the following proteasome inhibitors: bortezomib, Kyprolis (carfilzomib), Ninlaro (ixazomib), Velcade (bortezomib); and
    • inadequate response or adverse reaction to one or contraindication to all of the following immunomodulatory agents: Pomalyst (pomalidomide), Revlimid (lenalidomide), Thalomid (thalidomide); and
    • inadequate response or adverse reaction to one or contraindication to all of the following anti-CD38 monoclonal antibodies: Darzalex (daratumumab), Darzalex Faspro (daratumumab-hyaluronidase-fihj), Sarclisa (isatuximab-irfc).

Elahere

  •  Documentation of the following is required:
    • diagnosis of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member is folate receptor-alpha positive; and
    • inadequate response or adverse reaction to at least one systemic therapy, or contraindication to all systemic therapies for the requested indication.

Enhertu for locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma

  •  Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one trastuzumab-based regimen.

Enhertu for unresectable or metastatic HER2-positive breast cancer

  •  Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one anti-HER2-based regimen.

Enhertu for unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer

  •  Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one prior chemotherapy regimen.

Enhertu for unresectable or metastatic NSCLC with activating HER2 (ERBB2) mutations

  •  Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one prior systemic therapy.

Kadcyla 

  • Documentation of the following is required:
    • diagnosis of HER2-positive breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • member has recurrent or metastatic breast cancer and an inadequate response or adverse reaction to trastuzumab and a taxane separately or in combination; or
      • member has early breast cancer and residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

Mylotarg for newly-diagnosed CD33-positive AML in adults and pediatric members one month of age and older 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ one month of age; and
    • prescriber is an oncologist or hematologist, or consult notes from an oncologist or hematologist are provided; and
    • appropriate dosing; and
    • one of the following:
      • requested agent will be used in combination with cytarabine and daunorubicin or fludarabine; or
      • member is ≥ 60 years of age; or
      • clinical rationale why combination therapy with cytarabine and daunorubicin or fludarabine is not appropriate.

Mylotarg for relapsed or refractory CD33-positive AML in adults and pediatric members two years of age and older

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ two years of age; and
    • prescriber is an oncologist or hematologist, or consult notes from an oncologist or hematologist are provided; and
    • appropriate dosing; and
    • one of the following:
      • relapsed or refractory AML; or
      • prior therapy for the treatment of AML with one systemic therapy.

Tivdak for recurrent or metastatic cervical cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member is ≥ 18 years of age; and
    • inadequate response, adverse reaction, or contraindication to one line of platinum-based chemotherapy; and
    • if PD-L1, TMB-H, or MSI-H/dMMR positive, inadequate response, adverse reaction, or contraindication to Keytruda (pembrolizumab).
 
belantamab mafodotin-blmf Blenrep PA   IV  
fam-trastuzumab deruxtecan-nxki Enhertu PA   MB IV  
gemtuzumab ozogamicin Mylotarg PA   MB IV  
inotuzumab ozogamicin Besponsa PA   MB IV  
mirvetuximab soravtansine-gynx Elahere PA   MB IV  
tisotumab vedotin-tftv Tivdak PA   MB IV  

 Antiestrogen

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

tamoxifen solution Soltamox test   PO  
tamoxifen tablet test   M90 PO  

 Antimetabolites

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

allopurinol sodium Aloprim test   # IV  

Infugem

  • Documentation of the following is required:
    • diagnosis of breast cancer, non-small cell lung cancer, ovarian cancer or pancreatic cancer; and
    • prescriber is an oncologist or hematologist; and
    • member is ≥ 18 years of age; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to a gemcitabine product available without PA.

nelarabine

  • Documentation of the following is required:
    • diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL); and
    • prescriber is an oncologist; and
    • appropriate dosing.

Pemfexy

  • Documentation of the following is required:
    • diagnosis of malignant pleural mesothelioma or NSCLC; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to a pemetrexed product available without PA.

Purixan

  • Documentation of the following is required:
    • diagnosis of acute lymphoblastic leukemia (ALL); and
    • one of the following:
      • member is < 13 years of age; or
      • medical necessity for the use of an oral suspension formulation (e.g. swallowing disorder).

SmartPA: Claims for Purixan (mercaptopurine oral suspension) will usually process at the pharmacy without a PA request if the member has a MassHealth history of medical claims for ALL and the member is < 13 years of age.

 
capecitabine Xeloda test   # , A90 PO  
cladribine injection test   MB IV  
clofarabine Clolar test   MB IV  
cytarabine test   MB IV  
floxuridine test   MB Intra-arterial  
fludarabine test   IV  
fluorouracil injection test   MB IV  
gemcitabine premixed infusion Infugem PA   MB IV  
gemcitabine vial test   MB IV  
hydroxyurea capsule Hydrea test   # , A90 PO  
mercaptopurine oral suspension Purixan PA   PO  
mercaptopurine tablet test   A90 PO  
methotrexate injection test   IM / IV / Intra-arterial  
methotrexate tablet test   A90 PO  
nelarabine Arranon PA   MB IV  
pemetrexed test   MB IV  
pemetrexed disodium Alimta test   MB IV  
pemetrexed-Pemfexy Pemfexy PA   MB IV  
pentostatin Nipent test   MB IV  
pralatrexate Folotyn test   MB IV  
thioguanine Tabloid test   PO  

 Antimicrotubulars

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

cabazitaxel Jevtana PA   MB IV  

Jevtana

  • Documentation of the following is required:
    • diagnosis of metastatic castration-resistant prostate cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with prednisone; and
    • inadequate response or adverse reaction to one docetaxel-containing regimen.
 
ixabepilone Ixempra test   MB IV  
paclitaxel injectable suspension Abraxane test   MB IV  
paclitaxel injection test   IV  

 Antineoplastic Combination

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

daunorubicin / cytarabine Vyxeos PA   MB IV  

Kisqali-Femara Co-Pack

  • Documentation of the following is required:
    • diagnosis of HR-positive, HER2-negative advanced or metastatic breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Lonsurf for metastatic colorectal cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to at least one or contraindication to all of the following regimens: CAPEOX, FOLFOX, FOLFIRI, FOLFOXIRI, irinotecan-based therapy, oxaliplatin-based therapy; and
    • if BRAF/KRAS/NRAS wild-type cancer is present, inadequate response or adverse reaction to one or contraindication to both of the following: Erbitux (cetuximab), Vectibix (panitumumab).

Lonsurf for metastatic gastric or GEJ adenocarcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to two prior lines of chemotherapy containing one of the following or contraindication to all appropriate chemotherapy and HER2/neu-targeted therapy: fluoropyrimidine-based therapy, platinum-based therapy, either a taxane- or irinotecan-based therapy, and if appropriate, HER2/neu-targeted therapy.

Phesgo 

  • Documentation of the following is required:
    • diagnosis of HER2-positive breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • for early breast cancer, requested agent will be used in combination with chemotherapy; or
      • for metastatic breast cancer, requested agent will be used in combination with docetaxel.

Vyxeos

  • Documentation of the following is required:  
    • diagnosis of newly diagnosed therapy-related AML or AML with myelodysplasia-related changes (AML-MRC); and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member is ≥ one year of age; and
    • inadequate response, adverse reaction, or contraindication to use of separate daunorubicin and cytarabine chemotherapy agents.
 
pertuzumab / trastuzumab / hyaluronidase-zzxf Phesgo PA   MB SC  
ribociclib / letrozole Kisqali-Femara Co-Pack PA   PO  
trifluridine / tipiracil Lonsurf PA   PO  

 Aromatase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

anastrozole Arimidex test   # , A90 PO  

   

 
exemestane Aromasin test   # , A90 PO  
letrozole Femara test   # , A90 PO  

 Asparaginase

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

asparaginase erwinia chrysanthemi Erwinase PA   MB IV  

Asparlas

  • Documentation of the following is required:
    • diagnosis of ALL; and
    • member is ≥ one month and < 22 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to Oncaspar (pegaspargase); or
    • clinical rationale for use instead of Oncaspar (pegaspargase).
  • For recertification requests that exceed a total treatment duration of 36 weeks, documentation of clinical evidence supporting such an extended duration is required.

 

Erwinase, Rylaze

  • Documentation of the following is required:
    • diagnosis of ALL; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • hypersensitivity to E. coli-derived asparaginase.
  • For recertification requests that exceed a total treatment duration of 36 weeks, documentation of clinical evidence supporting such an extended duration is required.
 
asparaginase erwinia chrysanthemi-rywn Rylaze PA   MB IM  
calaspargase pegol-mknl Asparlas PA   MB IV  
pegaspargase Oncaspar test   MB IM or IV  

 Bruton's Tyrosine Kinase Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

acalabrutinib Calquence PA   PO  

Brukinsa and Calquence for CLL or SLL

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing.

Brukinsa and Calquence for MCL

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • prior therapy with at least one systemic therapy.

Brukinsa for MZL

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • prior therapy with at least one anti-CD20 monoclonal antibody-based regimen.

Brukinsa for Waldenstrom's macroglobulinemia (WM)

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing.

Calquence for MZL

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • prior therapy with at least one systemic therapy.

Imbruvica for cGVHD

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ one year of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all systemic glucocorticoids.

Imbruvica for CLL, SLL, and WM

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing.

Imbruvica for central nervous system (CNS) lymphoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to a methotrexate-based regimen for the treatment of CNS lymphoma.

Jaypirca

  • Documentation of the following is required:
    • diagnosis of MCL; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • prior therapy for the treatment of MCL with at least two lines of systemic therapy, one of which is a Bruton's Tyrosine Kinase Inhibitor; and
    • requested quantity is ≤ 2 units/day.
 
ibrutinib Imbruvica PA   PO  
pirtobrutinib Jaypirca PA   PO  
zanubrutinib Brukinsa PA   PO  

 CD123-Directed Cytotoxins

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

tagraxofusp-erzs Elzonris PA   MB IV  

Elzonris

  • Documentation of the following is required:
    • diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN); and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • first infusion will take place in an inpatient setting, and subsequent infusions may take place in an outpatient setting with appropriate monitoring.
 

 CTLA-4 Blocking Monoclonal Antibodies

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

ipilimumab Yervoy PA   MB IV  

Imjudo for metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with Imfinzi (durvalumab) and platinum-based regimen; and
    • member does not have EGFR or ALK genomic tumor aberrations; and
    • requested quantity is ≤ five doses.

Imjudo for unresectable hepatocellular carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with Imfinzi (durvalumab); and
    • requested quantity is one dose.

Yervoy for hepatocellular carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with Opdivo (nivolumab); and
    • inadequate response, adverse reaction, or contraindication to sorafenib.

Yervoy for malignant pleural mesothelioma (MPM)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with Opdivo (nivolumab).

Yervoy for metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • PD-L1 expression ≥ 1% and requested agent will be used in combination with Opdivo (nivolumab); or
      • requested agent will be used in combination with Opdivo (nivolumab) and two cycles of platinum doublet chemotherapy.

Yervoy for microsatellitle instability-high (MSI-H)/mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: fluoropyrimidine-based therapy, irinotecan-based therapy, oxaliplatin-based therapy.

Yervoy for renal cell carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has clear cell histology; and
    • requested agent will be used in combination with Opdivo (nivolumab).

Yervoy for unresectable advanced or metastatic ESCC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with Opdivo (nivolumab) in the first-line setting.

Yervoy for unresectable or metastatic melanoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to one or contraindication to both of the following: Keytruda (pembrolizumab), Opdivo (nivolumab); or 
      • for treatment of unresectable or metastatic melanoma, requested agent will be used in combination with Opdivo (nivolumab) or Keytruda (pembrolizumab).
 
tremelimumab-actl Imjudo PA   MB IV  

 DNA Methylation Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

azacitidine tablet Onureg PA   PO  

 Onureg

  • Documentation of the following is required:
    • diagnosis of AML; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • achievement of first complete remission (CR) following intensive induction chemotherapy; or
      • complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy; and
    • member is not able to complete intensive curative therapy; and
    • requested quantity is ≤ 14 units/28 days.
 
azacitidine vial Vidaza test   MB IV / SC  
decitabine Dacogen test   MB IV  
decitabine / cedazuridine Inqovi test   PO  

 Estrogen Receptor Antagonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

elacestrant Orserdu PA   PO  

fulvestrant

  • Documentation of the following is required:
    • diagnosis of HR-positive advanced or metastatic breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • member is HER2-positive and one of the following:
        • requested agent will be use as monotherapy; or
        • requested agent will be used in combination with trastuzumab; or
      • member is HER2-negative and one of the following:
        • requested agent will be used as monotherapy; or
        • requested agent will be used in combination with a CDK inhibitor (abemaciclib, palbociclib, or ribociclib); or
        • requested agent will be used in combination with anastrozole or letrozole.

Orserdu

  • Documentation of the following is required:
    • diagnosis of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one line of endocrine therapy containing a CDK4/6 inhibitor; and
    • one of the following:
      • for Orserdu 86 mg tablets, requested quantity is ≤ three units/day; or
      • for Orserdu 345 mg tablets, requested quantity is ≤ one unit/day.
 
fulvestrant Faslodex PA   MB IM  

 Hedgehog Pathway Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

glasdegib Daurismo PA   PO  

 

Daurismo for acute myeloid leukemia (AML)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with low dose cytarabine; and
    • one of the following:
      • member is ≥ 75 years of age; or
      • member is ≥ 60 years of age and one of the following:
        • member is not a candidate for intensive induction chemotherapy; or
        • member has significant comorbidities that preclude the use of intensive induction chemotherapy.

Erivedge for metastatic or locally advanced basal cell carcinoma (BCC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • requested quantity is ≤ one unit/day; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • member has persistent or recurring basal cell carcinoma following surgery and/or radiation therapy; or
      • member is not a candidate for surgery or radiation therapy.

 

Odomzo for locally advanced basal cell carcinoma (BCC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • requested quantity is ≤ one unit/day; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • member has persistent or recurring basal cell carcinoma following surgery and/or radiation therapy; or
      • member is not a candidate for surgery or radiation therapy.
 
sonidegib Odomzo PA   PO  
vismodegib Erivedge PA   PO  

 Histone Deacetylase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

belinostat Beleodaq PA   MB IV  

Beleodaq for peripheral T-cell lymphoma (PTCL)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all second-line treatment options.

Istodax (romidepsin lyophilized) and romidepsin non-lyophilized for cutaneous T-cell lymphoma (CTCL)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist, hematologist, or dermatologist; and
    • appropriate dosing.

Istodax (romidepsin lyophilized) and romidepsin non-lyophilized for PTCL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all second-line treatment options.
 
romidepsin lyophilized Istodax PA   MB IV  
romidepsin non-lyophilized PA   MB IV  
vorinostat Zolinza test   PO  

 Immunomodulator/Immunosuppressant

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

lenalidomide Revlimid PA   BP, A90 PO  

Pomalyst for multiple myeloma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: lenalidomide, Thalomid (thalidomide); and
    • inadequate response or adverse reaction to one or contraindication to all of the following proteasome inhibitors: bortezomib, Kyprolis (carfilzomib), Ninlaro (ixazomib), Velcade (bortezomib).

Pomalyst for Kaposi sarcoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • member has acquired immunodeficiency syndrome (AIDS) and has failed highly active antiretroviral therapy; or
      • member is human immunodeficiency virus (HIV)-negative; and
    • inadequate response, adverse reaction, or contraindication to both of the following: pegylated liposomal doxorubicin, paclitaxel.

lenalidomide 

  • Documentation of the following is required for FL, MZL, myelodysplastic syndrome, or mantle cell lymphoma (MCL):
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • for the 2.5 mg, 5 mg, or 10 mg strength, requested quantity is ≤ one unit/day; or
      • for the 15 mg, 20 mg, or 25 mg strength, requested quantity is ≤ 21 capsules for a 28 day supply; and
    • for previously untreated MZL, clinical rationale for use instead of one of the following:
      • bendamustine + rituximab; or
      • rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (RCHOP); or
      • rituximab, cyclophosphamide, vincristine, and prednisone (RCVP); or
      • rituximab; and
    • for treatment of FL or MZL, the requested agent will be used in combination with rituximab. 
  • Documentation of the following is required for multiple myeloma:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • for the 2.5 mg, 5 mg, or 10 mg strength, requested quantity is ≤ one unit/day; or
      • for the 15 mg strength, one of the following:
        • requested quantity is ≤ 21 capsules/28 day supply; or 
        • requested quantity is ≤ one unit/day and inadequate response to 10 mg daily; or
      • for the 20 mg or 25 mg strength, requested quantity is ≤ 21 capsules/28 day supply.

SmartPA: Claims within quantity limits for lenalidomide will usually process at the pharmacy without a PA request if the member has a MassHealth history of medical claims for multiple myeloma.

 
pomalidomide Pomalyst PA   PO  
thalidomide Thalomid test   BP PO  

 Interferon

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

interferon gamma-1b Actimmune test   SC  

Besremi

  • Documentation of the following is required:
    • diagnosis of polycythemia vera; and
    • prescriber is a hematologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindiation to both of the following: hydroxyurea, Pegasys (peginterferon alfa-2a).
 
ropeginterferon alfa-2b-njft Besremi PA   SC  

 KRAS Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

adagrasib Krazati PA   PO  

Krazati and Lumakras for advanced or mCRC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer has KRAS G12C mutation; and
    • inadequate response or adverse reaction to one or contraindication to all platinum-based chemotherapy; and
    • one of the following:
      • for Krazati, requested quantity is ≤ six units/day; or
      • for Lumakras 120 mg tablet, requested quantity is ≤ eight units/day; or
      • for Lumakras 320 mg tablet, requested quantity is ≤ three units/day.

Krazati and Lumakras for metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer has KRAS G12C mutation; and
    • inadequate response or adverse reaction to one or contraindication to all first-line systemic therapies; and
    • one of the following:
      • for Krazati, requested quantity is ≤ six units/day; or
      • for Lumakras 120 mg tablet, requested quantity is ≤ eight units/day; or
      • for Lumakras 320 mg tablet, requested quantity is ≤ three units/day.
 
sotorasib Lumakras PA   PO  

 Kinase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

abemaciclib Verzenio PA   PO  

Aliqopa

  • Documentation of the following is required:
    • diagnosis of FL; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • prior therapy with at least two systemic therapies.

Balversa

  • Documentation of the following is required:
    • diagnosis of FGFR3- or FGFR2-mutated locally advanced or metastatic urothelial carcinoma; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has received prior treatment with platinum-containing chemotherapy or is not a candidate for platinum-containing chemotherapy.

Braftovi for mCRC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • requested quantity is ≤ four units/day; and
    • positive BRAF V600E mutation; and
    • requested agent will be used in combination with Erbitux (cetuximab) or Vectibix (panitumumab); and
    • inadequate response or adverse reaction to one or a contraindication to all of the following regimens: CAPEOX, FOLFOX, irinotecan-based therapy, oxaliplatin-based therapy.

Braftovi for unresectable or metastatic melanoma

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • requested quantity is ≤ six units/day; and
    • positive BRAF V600E or V600K mutation; and
    • requested agent will be used in combination with Mektovi (binimetinib).

Braftovi for metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • requested quantity is ≤ six units/day; and
    • positive BRAF V600E mutation; and
    • requested agent will be used in combination with Mektovi (binimetinib).

Copiktra for CLL or SLL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • prior therapy with at least two systemic therapies.

Cosela

  • Documentation of the following is required:
    • diagnosis of extensive-stage small cell lung cancer (ES-SCLC); and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member is ≥ 18 years of age; and
    • requested agent will be used in combination with a platinum/etoposide-containing or topotecan-containing regimen.

Cotellic for low-grade or high-grade gliomas

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • positive BRAF V600E mutation; and
    • appropriate dosing; and
    • requested agent will be used in combination with Zelboraf (vemurafenib) ≤ 960 mg every 12 hours.

Cotellic for unresectable or metastatic melanoma

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • requested quantity is ≤ three units/day; and
    • positive BRAF V600E or V600K mutation; and
    • requested agent will be used in combination with Zelboraf (vemurafenib).

Cotellic for histiocytic neoplasms

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • member is ≥ 18 years of age; and
    • requested quantity is ≤ three units/day.

Exkivity for advanced or metastatic NSCLC 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer has EGFR exon 20 insertion mutation; and
    • inadequate response or adverse reaction to at least one platinum-based chemotherapy regimen or contraindication to the use of platinum-based chemotherapy; and
    • requested quantity is ≤ four units/day.

Fruzaqla for mCRC 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all of the following regimens: CAPEOX, FOLFOX, FOLFIRI, FOLFOXIRI, irinotecan-based therapy, oxaliplatin-based therapy; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: Lonsurf (trifluridine/tipiracil), Stivarga (regorafenib); and
    • if BRAF/KRAS/NRAS wild-type cancer is present, inadequate response or adverse reaction to one or contraindication to both of the following: Erbitux (cetuximab), Vectibix (panitumumab); and
    • one of the following: 
      • for 1 mg capsule, requested quantity is ≤ four units/day; or
      • for 5 mg capsule, requested quantity is ≤ one unit/day.

Gavreto and Retevmo for medullary thyroid cancer or thyroid cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member is ≥ 12 years of age; and
    • requested quantity is ≤ four units/day; and
    • one of the following:
      • member has thyroid cancer and one of the following: member refractory to radioactive iodine or radioactive iodine treatment is not appropriate; or
      • member has medullary thyroid cancer.

Gavreto and Retevmo for NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member is ≥ 18 years of age; and
    • requested quantity is ≤ four units/day.

Gilotrif

  • Documentation of the following is required:
    • diagnosis of metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • member has epidermal growth factor receptor (EGFR) mutations; or
      • inadequate response or adverse reaction to one or contraindication to all platinum-based chemotherapy; and
    • requested quantity is ≤ one unit/day.

Ibrance for HER2-negative, HR-positive breast cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • the requested agent will be used in combination with an aromatase inhibitor; or
      • the requested agent will be used in combination with fulvestrant; and
    • requested quantity is ≤ one unit/day.

Inrebic

  • Documentation of the following is required:
    • diagnosis of one of the following: 
      • intermediate or high-risk primary myelofibrosis (PMF); or
      • post-polycythemia vera myelofibrosis (post-PV MF); or
      • post-essential thrombocythemia myelofibrosis (post-ET MF); and
    • member is ≥ 18 years of age; and
    • inadequate response, adverse reaction, or contraindication to Jakafi (ruxolitinib tablet); and
    • requested quantity is ≤ four units/day.

Jakafi for acute graft versus host disease (aGVHD) or chronic graft versus host disease (cGVHD)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 12 years of age; and
    • inadequate response, adverse reaction, or contraindication to systemic glucocorticoids; and
    • requested quantity is ≤ two units/day.

Jakafi for polycythemia vera (PV)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one of the following, or contraindication to both of the following: hydroxyurea, Pegasys (peginterferon alfa-2a); and
    • requested quantity is ≤ two units/day.

Jakafi for intermediate or high-risk PMF, post-PV MF, or post-ET MF

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • requested quantity is ≤ two units/day.

Kisqali

  • Documentation of the following is required:
    • diagnosis of HR-positive, HER2-negative advanced or metastatic breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • requested agent will be used in combination with an aromatase inhibitor; or
      • requested agent will be used in combination with fulvestrant.

Koselugo for plexiform neurofibromas (PN) with neurofibromatosis type 1 (NF1)

  • Documentation of the following is required for members ≥ two years of age and < 18 years of age at the start of therapy:
    • appropriate diagnosis; and
    • prescriber is a neurologist or oncologist; and
    • appropriate dosing; and
    • member is ≥ two years of age and < 18 years of age at the start of therapy; and
    • member has at least one measurable PN and complete resection of PN is not feasible without substanstial risk or morbidity.
  • Documentation of the following is required for members ≥ 18 years of age:
    • appropriate diagnosis; and
    • prescriber is a neurologist or oncologist; and
    • appropriate dosing; and
    • member is ≥ 18 years of age; and
    • member has at least one measurable PN and complete resection of PN is not feasible without substanstial risk or morbidity.

Lorbrena

  • Documentation of the following is required:
    • diagnosis of metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is ALK-positive; and
    • inadequate response, adverse reaction, or contraindication to Alecensa; and
    • requested quantity is ≤ one unit/day.

Lytgobi, Pemazyre and Truseltiq for unresectable locally advanced or metastatic cholangiocarcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • tumor has FGFR2 fusion or other rearrangement; and
    • member is ≥ 18 years of age; and
    • member has received at least one prior treatment; and
    • for Lytgobi, requested quantity is ≤ five units/day; and
    • for Truseltiq, requested quantity is ≤ one blister pack/28 days.

Mekinist for locally advanced or metastatic anaplastic thyroid cancer

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • one of the following:
      • for 0.5 mg tablets, requested quantity is ≤ three units/day; or
      • for 2 mg tablets, requested quantity is ≤ one unit/day; and
    • positive BRAF V600E mutation; and
    • requested agent will be used in combination with Tafinlar (dabrafenib); and
    • member has no satisfactory locoregional treatment options.

Mekinist for low-grade glioma

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • positive BRAF V600E mutation; and
    • requested agent will be used in combination with Tafinlar (dabrafenib); and
    • one of the following: 
      • for 0.5 mg tablets, requested quantity is ≤ three units/day; or 
      • for 2 mg tablets, requested quantity is ≤ one unit/day; or
      • for solution, requested quantity is ≤ 40 mL/day.

Mekinist for adjuvant treatment of melanoma 

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • one of the following:
      • for 0.5 mg tablets, requested quantity is ≤ three units/day; or
      • for 2 mg tablets, requested quantity is ≤ one unit/day; and
    • positive BRAF V600E or V600K mutation; and
    • requested agent will be used in combination with Tafinlar (dabrafenib); and
    • involvement of lymph nodes following complete resection.

Mekinist for unresectable or metastatic melanoma 

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • one of the following:
      • for 0.5 mg tablets, requested quantity is ≤ three units/day; or
      • for 2 mg tablets, requested quantity is ≤ one unit/day; and
    • positive BRAF V600E or V600K mutation; and
    • one of the following:
      • requested agent will be used in combination with Tafinlar (dabrafenib); or
      • all of the following:
        • requested agent will be used as a single agent; and
        • no history of prior therapy with a BRAF inhibitor (i.e., Tafinlar [dabrafenib] or Zelboraf [vemurafenib]); and
        • clinical rationale for bypassing use of a BRAF inhibitor (i.e., Tafinlar [dabrafenib] or Zelboraf [vemurafenib]).

Mekinist for metastatic NSCLC

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • one of the following:
      • for 0.5 mg tablets, requested quantity is ≤ three units/day; or
      • for 2 mg tablets, requested quantity is ≤ one unit/day; and
    • positive BRAF V600E mutation; and
    • requested agent will be used in combination with Tafinlar (dabrafenib).

Mekinist for low-grade serous carcinoma of the ovary, fallopian tube, or primary peritoneum

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • medical records documenting an inadequate response, adverse reaction, or contraindication to one platinum-containing regimen and one hormonal therapy; and 
    • one of the following:
      • for 0.5 mg tablets, requested quantity is ≤ three units/day; or 
      • for 2 mg tablets, requested quantity is ≤ one unit/day.

Mekinist for unresectable or metastatic solid tumors

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • member is ≥ one year of age; and
    • one of the following:
      • for 0.5 mg tablets, requested quantity is ≤ three units/day; or 
      • for 2 mg tablets, requested quantity is ≤ one unit/day; or
      • for solution, requested quantity is ≤ 40 mL/day; and
    • positive BRAF V600E mutation; and
    • requested agent will be used in combination with Tafinlar (dabrafenib).

Mektovi for unresectable or metastatic melanoma

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • requested quantity is ≤ six units/day; and
    • positive BRAF V600E or V600K mutation; and
    • requested agent will be used in combination with Braftovi (encorafenib).

Mektovi for metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • requested quantity is ≤ six units/day; and
    • positive BRAF V600E mutation; and
    • requested agent will be used in combination with Braftovi (encorafenib).

Mektovi for low-grade serous carcinoma of the ovary, fallopian tube, or primary peritoneum

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • requested quantity is ≤ six units/day; and
    • medical records documenting an inadequate response, adverse reaction, or contraindication to one platinum-containing regimen and one hormonal therapy.

Nerlynx for adjuvant therapy for early stage breast cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member received trastuzumab therapy within the last two years; and
    • requested quantity is ≤ six units/day.

Nerlynx for treatment of advanced or metastatic breast cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to two anti-HER2-based regimens; and
    • requested agent will be used in combination with capecitabine; and
    • requested quantity is ≤ six units/day.

Pemazyre for myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member is ≥ 18 years of age.

Piqray 

  • Documentation of the following is required:
    • diagnosis of HR-positive, HER2-negative, PIK3CA-mutated breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • disease has progressed following treatment with endocrine-based therapy; and
    • requested agent will be used in combination with fulvestrant.

Qinlock

  • Documentation of the following is required:
    • diagnosis of gastrointestinal stromal tumor (GIST); and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to at least three prior kinase inhibitor therapies, one of which is imatinib; and
    • requested quantity is ≤ three units/day.

Retevmo for locally advanced or metastatic solid tumor

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member is ≥ 18 years of age; and
    • cancer is RET fusion-positive; and 
    • requested quantity is ≤ four units/day; and
    • one of the following:
      • inadequate response or adverse reaction to at least one prior systemic therapy, or contraindication to the use of systemic therapy; or
      • member has no satisfactory alternative treatment options.

Rezurock

  • Documentation of the following is required:
    • diagnosis of cGVHD; and
    • member is ≥ 12 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to systemic glucocorticoids; and
    • prior therapy for the treatment of cGVHD with at least one prior line of non-steroid systemic therapy; and
    • requested quantity is ≤ one unit/day.

Stivarga for GIST

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to both of the following: imatinib and sunitinib.

Stivarga for HCC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has Child-Pugh Class A; and
    • inadequate response, adverse reaction, or contraindication to sorafenib.

Stivarga for mCRC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all of the following regimens: CAPEOX, FOLFIRI, FOLFOX, FOLFOXIRI, irinotecan-based therapy, oxaliplatin-based therapy; and
    • if BRAF/KRAS/NRAS wild-type cancer is present, inadequate response or adverse reaction to one of the following, or a contraindication to both of the following: Erbitux (cetuximab), Vectibix (panitumumab).

Stivarga for osteosarcoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to both of the following regimens: cisplatin and doxorubicin, high-dose methotrexate, cisplatin, and doxorubicin.

Tabrecta for MET exon 14 skipping metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer has mutation that leads to MET exon 14 skipping; and
    • requested quantity is ≤ four units/day.

Tabrecta for MET positive amplification metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is MET positive amplification; and
    • requested quantity is ≤ four units/day.

Tafinlar for locally advanced or metastatic anaplastic thyroid cancer

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • for 50 mg and 75 mg capsule, requested quantity is ≤ four units/day; and
    • positive BRAF V600E mutation; and
    • requested agent will be used in combination with Mekinist (trametinib); and
    • member has no satisfactory locoregional treatment options.

Tafinlar for low-grade glioma

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • one of the following: 
      • for 50 mg and 75 mg capsule, requested quantity is ≤ four units/day; or 
      • for 10 mg tablet for oral solution, requested quantity is ≤ 30 units/day; and
    • positive BRAF V600E mutation; and
    • requested agent will be used in combination with Mekinist (trametinib).

Tafinlar for adjuvant treatment of melanoma 

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • for 50 mg and 75 mg capsule, requested quantity is ≤ four units/day; and
    • positive BRAF V600E or V600K mutation; and
    • requested agent will be used in combination with Mekinist (trametinib); and
    • involvement of lymph nodes following complete resection.

Tafinlar for unresectable or metastatic melanoma

  •  Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • for 50 mg and 75 mg capsule, requested quantity is ≤ four units/day; and
    • for positive BRAF V600K, requested agent will be used in combination with Mekinist (trametinib); and
    • for positive BRAF V600E, one of the following:
      • requested agent will be used in combination with Mekinist (trametinib); or
      • requested agent will be used as monotherapy.

Tafinlar for metastatic NSCLC

  •  Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • for 50 mg and 75 mg capsule, requested quantity is ≤ four units/day; and
    • positive BRAF V600E mutation; and
    • requested agent will be used in combination with Mekinist (trametinib).

Tafinlar for unresectable or metastatic solid tumors

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • member is ≥ one year of age; and
    • one of the following: 
      • for 50 mg and 75 mg capsule, requested quantity is ≤ four units/day; or 
      • for 10 mg tablet for oral solution, requested quantity is ≤ 30 units/day; and
    • positive BRAF V600E mutation; and
    • requested agent will be used in combination with Mekinist (trametinib).

Tagrisso for advanced or metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested quantity is ≤ one unit/day; and
    • one of the following:
      • cancer displays the EGFR exon 19 deletion or exon 21 L858R mutation; or
      • both of the following:
        • cancer displays the EGFR mutation and the T790M resistance mutation; and
        • inadequate response or adverse reaction to one of the following or contraindication to all of the following: erlotinib, gefitinib, Gilotrif (afatinib), Vizimpro (dacomitinib).

Tagrisso for adjuvant treatment for stage IB to IIIA NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested quantity is ≤ one unit/day; and
    • cancer displays the EGFR exon 19 deletion or exon 21 L858R mutation; and
    • member has completely resected disease; and
    • inadequate response or adverse reaction to at least one platinum-based chemotherapy regimen or contraindication to the use of platinum-based chemotherapy.

Tepmetko for MET exon 14 skipping metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer harbors MET exon 14 skipping alterations; and
    • requested quantity is ≤ two units/day.

Tepmetko for MET positive amplification metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is MET positive amplification; and
    • requested quantity is ≤ two units/day.

Verzenio for HR-positive, HER2-negative early breast cancer (EBC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • the requested agent will be used in combination with an aromatase inhibitor; or
      • the requested agent will be used in combination with tamoxifen; and
    • requested quantity is ≤ two units/day.

Verzenio for HR-positive, HER2-negative advanced or metastatic breast cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • the requested agent will be used in combination with an aromatase inhibitor; or
      • the requested agent will be used in combination with fulvestrant; or
      • the requested agent will be used as monotherapy when disease has progressed after both hormonal therapy and chemotherapy; and
    • requested quantity is ≤ two units/day.

Vizimpro

  • Documentation of the following is required:
    • diagnosis of metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has EGFR mutations; and
    • requested quantity is ≤ one unit/day.

Vonjo

  • Documentation of the following is required:
    • diagnosis of one of the following:
      • intermediate or high-risk PMF; or
      • post-PV MF; or
      • post-ET MF; and
    • member is ≥ 18 years of age; and
    • platelet count is ≤ 50 x 109/L; and
    • requested quantity is ≤ four units/day.

Zydelig

  • Documentation of the following is required:  
    • diagnosis of CLL; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • relapsed or refractory CLL; or
      • prior therapy with at least one systemic therapy.
 
afatinib Gilotrif PA   PO  
alpelisib-Piqray Piqray PA   PO  
belumosudil Rezurock PA   PO  
binimetinib Mektovi PA   PO  
capmatinib Tabrecta PA   PO  
cobimetinib Cotellic PA   PO  
copanlisib Aliqopa PA   MB IV  
dabrafenib Tafinlar PA   PO  
dacomitinib Vizimpro PA   PO  
duvelisib Copiktra PA   PO  
encorafenib Braftovi PA   PO  
erdafitinib Balversa PA   PO  
fedratinib Inrebic PA   PO  
fruquintinib Fruzaqla PA   PO  
futibatinib Lytgobi PA   PO  
idelalisib Zydelig PA   PO  
infigratinib Truseltiq PA   PO  
lorlatinib Lorbrena PA   PO  
mobocertinib Exkivity PA   PO  
neratinib Nerlynx PA   PO  
osimertinib Tagrisso PA   PO  
pacritinib Vonjo PA   PO  
palbociclib Ibrance PD PA   PO  
pemigatinib Pemazyre PA   PO  
pralsetinib Gavreto PA   PO  
regorafenib Stivarga PA   PO  
ribociclib Kisqali PA   PO  
ripretinib Qinlock PA   PO  
ruxolitinib tablet Jakafi PA   PO  
selpercatinib Retevmo PA   PO  
selumetinib Koselugo PA   PO  
tepotinib Tepmetko PA   PO  
trametinib Mekinist PA   PO  
trilaciclib Cosela PA   MB IV  

 LAG-3/PD-1 Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

nivolumab / relatlimab-rmbw Opdualag PA   MB IV  

Opdualag

  • Documentation of the following is required:
    • diagnosis of unresectable or metastatic melanoma; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: 
      • Opdivo (nivolumab) in combination with Yervoy (ipilimumab); or
      • Opdivo (nivolumab); or
      • Keytruda (pembrolizumab); and
    • one of the following:
      • member is negative for the BRAF V600E or V600K mutation; or
      • member is positive for the BRAF V600E or V600K mutation and inadequate response or adverse reaction to one or contraindication to all of the following:
        • Braftovi (encorafenib) and Mektovi (binimetinib); or
        • Tafinlar (dabrafenib) and Mekinist (trametinib); or
        • Zelboraf (vemurafenib) and Cotellic (cobimetinib).

 

 

 Miscellaneous

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

aldesleukin Proleukin PA   PO  

Adstiladrin

  • Documentation of the following is required:  
    • diagnosis of non-muscle-invasive bladder cancer (NMIBC); and
    • disease is high-risk with carcinoma in situ (CIS); and
    • prescriber is an oncologist or urologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to BCG.

Akeega

  • Documentation of the following is required:  
    • diagnosis of mCRPC; and
    • member has deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with prednisone; and
    • requested quantity is ≤ two units/day.

Fusilev, Khapzory, and levoleucovorin injection

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ six years of age; and
    • medical records documenting member is not a candidate for leucovorin therapy due to hypersensitivity to a component of leucovorin; and
    • for Khapzory, clinical rationale for use instead of Fusilev (levoleucovorin powder for injection).

Idhifa

  • Documentation of the following is required:  
    • diagnosis of IDH2-mutated AML; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • requested quantity is ≤ one unit/day; and
    • one of the following: 
      • member is not a candidate for intensive remission induction therapy; or
      • relapsed or refractory IDH2-mutated AML.

Imlygic

  • Documentation of the following is required:
    • diagnosis of unresectable melanoma; and 
    • prescriber is an oncologist; and
    • requested quantity is ≤ four mL/treatment; and
    • unresectable cutaneous, subcutaneous, or nodal lesions; and
    • melanoma is recurrent after initial surgery.

Kimmtrak

  • Documentation of the following is required:
    • diagnosis of unresectable or metastatic uveal melanoma; and 
    • member is positive for HLA-A*02:01 genotype
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member is refractory to radiation therapy or radiation therapy is not appropriate.

Lumoxiti

  • Documentation of the following is required:
    • diagnosis of relapsed or refractory hairy cell leukemia (HCL); and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one purine nucleoside analog (PNA) and one additional systemic therapy.

Proleukin

  • Documentation of the following is required:
    • diagnosis of chronic graft versus host disease (GVHD); and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • disease is refractory to steroid treatment; and
    • for members ≥ 18 years of age, inadequate response or adverse reaction to one or contraindication to both of the following: cyclosporine, tacrolimus.

Please note, requests for all other indications, drug may be subject to additional non-rebate restrictions. Please see MassHealth Pharmacy Operational document for additional information.

Provenge

  • Documentation of the following is required:
    • diagnosis of metastatic castration-resistant prostate cancer; and 
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • ECOG score 0-1 (good performance status); and
    • estimated life expectancy > six months; and
    • no hepatic metastases; and
    • no/minimal symptoms; and
    • requested quantity is ≤ three doses (one completed cycle).

Rezlidhia

  • Documentation of the following is required:  
    • diagnosis of relapsed or refractory IDH1 mutated AML; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • requested quantity is ≤ two units/day.

Synribo

  • Documentation of the following is required:
    • diagnosis of chronic myelogenous leukemia (CML); and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to two or contraindication to all of the following: Bosulif (bosutinib), Iclusig (ponatinib), imatinib, Sprycel (dasatinib), Tasigna (nilotinib).

Tazverik for FL

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • requested quantity is ≤ eight units/day; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • both of the following:
        • member has FL with an EZH2 mutation (as detected by an FDA-approved test); and
        • prior therapy for the treatment of FL with at least two systemic therapies; or
      • both of the following:
        • member has relapsed or refractory FL; and
        • member has no satisfactory alternative treatment options.

Tazverik for metastatic or locally advanced epithelioid sarcoma

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested quantity is ≤ eight units/day; and
    • member is ≥ 16 years of age. 

Tibsovo for IDH1-mutated AML

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • requested quantity is ≤ two units/day; and
    • one of the following: 
      • member is not a candidate for chemotherapy; or
      • relapsed or refractory IDH1-mutated AML.

Tibsovo for IDH1-mutated cholangiocarcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • requested quantity is ≤ two units/day; and
    • prior treatment of IDH1-mutated cholangiocarcinoma with at least one of the following systemic therapies: 
      • cisplatin and gemcitabine; or
      • cisplatin, durvalumab, and gemcitabine; or
      • single agent and combination chemotherapies involving 5-fluorouracil, capecitabine, cisplatin, gemcitabine, oxaliplatin, or paclitaxel; or
      • entrectinib or larotrectinib (for NTRK gene fusion positive); or
      • pembrolizumab (for MSI-H/dMMR tumors); or
      • pralsetinib or selpercatinib (for RET gene fusion-positive).

Venclexta for AML

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • member is not a candidate for intensive induction therapy; or
      • member has poor-risk AML; or
      • clinical rationale for use of requested agent instead of intensive induction chemotherapy; and
    • requested agent will be used in combination with one of the following: azacitidine, decitabine, low-dose cytarabine.

Venclexta for CLL or SLL

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • member has not received treatment for CLL or SLL and requested agent will be used in combination with Gazyva (obinutuzumab); or
      • prior therapy with at least one systemic therapy.

Venclexta for multiple myeloma

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member has t(11;14) mutation; and
    • prior therapy with at least one prior chemotherapy regimen.

Welireg

  • Documentation of the following is required:  
    • diagnosis of von Hippel-Lindau (VHL) disease as confirmed by germline VHL alteration; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested quantity is ≤ three units/day; and
    • member has renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors; and
    • member is not a candidate for or does not require immediate surgery.

Xpovio

  • Documentation of the following is required for monotherapy:
    • diagnosis of multiple myeloma; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member has received at least four prior chemotherapy regimens or contraindication to the use of recommended chemotherapy regimens; and
    • inadequate response or adverse reaction to two or contraindication to all of the following proteasome inhibitors: bortezomib, Kyprolis (carfilzomib), Ninlaro (ixazomib), Velcade (bortezomib); and
    • inadequate response or adverse reaction to two or contraindication to all of the following immunomodulatory agents: Pomalyst (pomalidomide), Revlimid (lenalidomide), Thalomid (thalidomide); and
    • inadequate response or adverse reaction to one or contraindication to all of the following anti-CD38 monoclonal antibodies: Darzalex (daratumumab), Darzalex Faspro (daratumumab-hyaluronidase-fihj), Sarclisa (isatuximab-irfc); and
    • requested medication will be used in combination with dexamethasone.
  • Documentation of the following is required for combination therapy:
    • diagnosis of multiple myeloma; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one prior chemotherapy regimen for the requested indication; and
    • requested medication will be used in combination with Velcade (bortezomib) or bortezomib and dexamethasone.
  • Documentation of the following is required for diagnosis of diffuse large B-cell lymphoma (DLBCL):
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member has received at least two prior chemotherapy regimens or contraindication to the use of recommended chemotherapy regimens.

Zelboraf for Erdheim-Chester Disease

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • requested quantity is ≤ eight units/day; and
    • positive BRAF V600 mutation.

Zelboraf for low-grade or high-grade gliomas

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • positive BRAF V600E mutation; and
    • appropriate dosing; and
    • requested agent will be used in combination with Cotellic (cobimetinib) ≤ 60 mg/day.

Zelboraf for unresectable or metastatic melanoma

  • Documentation of the following is required:
    • appropriate diagnosis; and 
    • prescriber is an oncologist; and
    • requested quantity is ≤ eight units/day; and
    • positive BRAF V600E mutation.
 
belzutifan Welireg PA   PO  
enasidenib Idhifa PA   PO  
iobenguane I 131 Azedra test   MB IV  
ivosidenib Tibsovo PA   PO  
leucovorin test   A90 IV / PO  
levoleucovorin injection PA   IV  
levoleucovorin powder for injection Fusilev PA   IV  
levoleucovorin powder for injection Khapzory PA   IV  
mitotane Lysodren test   PO  
moxetumomab pasudotox-tdfk Lumoxiti PA   MB IV  
nadofaragene firadenovec-vncg Adstiladrin PA   MB Intravesicular  
niraparib/abiraterone Akeega PA   PO  
olutasidenib Rezlidhia PA   PO  
omacetaxine mepesuccinate Synribo PA   SC  
selinexor Xpovio PA   PO  
sipuleucel-T Provenge PA   MB IV  
talimogene laherparepvec Imlygic PA   MB Intralesional  
tazemetostat Tazverik PA   PO  
tebentafusp-tebn Kimmtrak PA   MB IV  
vemurafenib Zelboraf PA   PO  
venetoclax Venclexta PA   PO  

 Mitotic Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

brentuximab Adcetris PA   MB IV  

Adcetris for relapsed or refractory Hodgkin Lymphoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • member is at high risk of relapse as post autologous hematopoietic stem cell transplantation (auto-HSCT); or
      • inadequate response to auto-HSCT; or
      • member is not a candidate for auto-HSCT and inadequate response or adverse reaction to two prior multi-agent chemotherapy regimens; or
      • clinical rationale as to why the other available treatment regimens cannot be used.

Adcetris for treatment-naïve Hodgkin Lymphoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with doxorubicin, vinblastine, and dacarbazine.

Adcetris for primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing.

Adcetris for previously untreated CD-30 expressing PTCL, including systemic anaplastic large cell lymphoma (sALCL) used in combination with chemotherapy

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with cyclophosphamide, doxorubicin, and prednisone.

Adcetris for sALCL after failure of at least one prior multiagent chemotherapy regimen, used as monotherapy

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to one prior chemotherapy regimen or agent; or
      • clinical rationale as to why the other available treatment regimens cannot be used.

Halaven for metastatic or recurrent breast cancer 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to two prior chemotherapy regimens that included an anthracycline and a taxane; and
    • inadequate response, adverse reaction, or contraindication to vinorelbine (may have been part of prior chemotherapy regimens).

Halaven for unresectable or metastatic liposarcoma 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to an anthracycline-containing regimen.

Polivy

  • Documentation of the following is required:
    • diagnosis of diffuse large B-cell lymphoma (DLBCL); and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to at least one or contraindication to all systemic therapies.
 
docetaxel Docefrez test   MB IV  
docetaxel test   MB IV  
eribulin Halaven PA   MB IV  
polatuzumab vedotin-piiq Polivy PA   MB IV  

 Monoclonal Antibodies

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

alemtuzumab 30 mg Campath test   IV  

Arzerra for relapsed or refractory CLL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to both of the following: alemtuzumab, fludarabine.

Arzerra for untreated CLL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • contraindication to fludarabine; and
    • one of the following:
      • requested agent will be used in combination with chlorambucil; or
      • clinical rationale as to why the agent will not be used with chlorambucil.

Blincyto

  • Documentation of the following is required:
    • diagnosis of ALL; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • member with complete remission following initial treatment; or 
      • both of the following:
        • Philadelphia chromosome-positive; and
        • inadequate response or adverse reaction to one tyrosine kinase inhibitor for the treatment of ALL; or
      • all of the following:
        • Philadelphia chromosome-negative; and
        • B-cell precursor ALL; and
        • prior therapy for the treatment of ALL with one systemic therapy.

Danyelza

  • Documentation of the following is required: 
    • diagnosis of neuroblastoma of bone or bone marrow; and
    • member is ≥ one year of age; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • tumor is high-risk; and
    • member had had partial response, minor response, or stable disease to prior treatment; and
    • requested agent will be used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) agent.

Darzalex and Darzalex Faspro for multiple myeloma

  • Documenation of the following is required for monotherapy:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and 
    • inadequate response or adverse reaction to one or contraindication to all of the following proteasome inhibitors: bortezomib, Kyprolis (carfilzomib), Ninlaro (ixazomib), Velcade (bortezomib); and
    • inadequate response or adverse reaction to one or contraindication to all of the following immunomodulatory agents; Pomalyst (pomalidomide), Revlimid (lenalidomide), Thalomid (thalidomide); and
    • one of the following:
      • inadequate response or adverse reaction to one proteasome inhibitor and one immunomodulatory agent noted above; or
      • history of a total of three trials with chemotherapy regimens for the requested indication.
  • Documentation of the following is required for combination therapy:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • both of the following:
        • member is newly diagnosed and eligible for transplant; and
        • requested agent will be used in combination with Velcade (bortezomib) or bortezomib and thalidomide and dexamethasone; or
      • both of the following;
        • inadequate response or adverse reaction to at least one prior line of systemic therapy; and
        • requested agent will be used in combination with dexamethasone and at least one other agent for treatment of multiple myeloma (excluding anti-CD38 agents); or
      • all of the following:
        • member is newly diagnosed and ineligible for transplant; and
        • one of the following:
          • requested agent will be used in combination with Revlimid (lenalidomide) and dexamethasone; or
          • requested agent will be used in combination with Velcade (bortezomib) or bortezomib and melphalan and prednisone; or
          • clinical rationale for the use of the requested combination instead of Velcade (bortezomib) or bortezomib and Revlimid (lenalidomide) and dexamethasone.

Darzalex Faspro for light chain amyloidosis

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • concurrent therapy with Velcade (bortezomib) or bortezomib and cyclophosphamide and dexamethasone.

Empliciti

  • Documentation of the following is required:
    • diagnosis of multiple myeloma; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • both of the following:
        • inadequate response or adverse reaction to at least one prior chemotherapy regimen for the requested indication; and
        • requested agent will be used in combination with Revlimid (lenalidomide) and dexamethasone; or
      • all of the following:
        • inadequate response or adverse reaction to at least two prior chemotherapy regimens for the requested indication; and
        • inadequate response or adverse reaction to one or contraindication to all of the following proteasome inhibitors: bortezomib, Kyprolis (carfilzomib), Ninlaro (ixazomib), Velcade (bortezomib); and
        • inadequate response, adverse reaction, or contraindication to Revlimid (lenalidomide); and
        • requested medication will be used in combination with Pomalyst (pomalidomide) and dexamethasone.

Gazyva for CLL or SLL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • member has CLL or SLL without del(17p)/TP53 mutation; or
      • member has CLL or SLL with del(17p)/TP53 mutation AND is treatment naive.

Gazyva for FL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • relapsed or refractory FL after treatment with a rituximab-containing regimen; or
      • concurrent therapy with first-line chemotherapy agent.

Herceptin, Herceptin Hylecta, Herzuma, Kanjinti, Ogivri, Ontruzant, and Trazimera for HER2-overexpressing breast cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Herceptin, Herzuma, Kanjinti, Ogivri, Ontruzant, and Trazimera for RAS wild-type (WT), HER2-positive unresectable or metastatic colorectal cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to at least one or contraindication to all of the following regimens: CAPEOX, FOLFOX, FOLFIRI, FOLFOXIRI, FOLFIRINOX, irinotecan-based therapy, oxaliplatin-based therapy; and
    • requested agent will be used in combination with Tukysa.

Herceptin, Herzuma, Kanjinti, Ogivri, Ontruzant, and Trazimera for HER2-overexpessing metastatic gastric or gastroesophageal adenocarcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with chemotherapy.

Margenza

  • Documentation of the following is required: 
    • diagnosis of metastatic HER-2 positive breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine); and
    • inadequate response or adverse reaction to two anti-HER-2 based regimens.

Monjuvi for diffuse large B cell lymphoma (DLBCL)

  • Documentation of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all systemic therapies. 

Perjeta 

  • Documentation of the following is required:
    • diagnosis of HER-2 positive breast cancer; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • for recurrent or stage IV disease, requested agent will be used in combination with Herceptin (trastuzumab) and docetaxel or paclitaxel; or
      • for adjuvant or neoadjuvant chemotherapy, requested agent will be used in combination with trastuzumab and chemotherapy.

Portrazza 

  • Documentation of the following is required:
    • diagnosis of advanced or metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer of squamous cell histology; and
    • requested agent will be used in combination with gemcitabine and cisplatin; and
    • medical necessity for use of the requested agent instead of all other clinically appropriate alternatives.

Poteligeo for mycosis fungoides

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • Stage IA disease and member is refractory to skin-directed therapy; or
      • Stage IB to III disease.

Poteligeo for Sézary syndrome

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing.

Riabni, Rituxan, Ruxience, and Truxima 

  • Documentation of the following is required for autoimmune encephalitis:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: intravenous glucocorticoids, intravenous immune globulin, plasma exchange; and
    • inadequate response, adverse reaction, or contraindication to cyclophosphamide.
  • Documentation of the following is required for autoimmune epilepsy:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: intravenous glucocorticoids, intravenous immune globulin, plasma exchange; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: azathioprine, cyclophosphamide, mycophenolate.
  • Documentation of the following is required for autoimmune hemolytic anemia (AIHA) or IgG-related disease:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to all corticosteroids.
  • Documentation of the following is required for CLL:
    • appropriate diagnosis; and
    • appropriate dosing.
  • Documentation of the following is required for moderate-to-severe cryoglobulinemia syndrome:
    • appropriate diagnosis; and
    • requested agent will be used in combination with systemic glucocorticoids.
  • Documentation of the following is required for graft versus host disease (GVHD):
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to all corticosteroids; and
    • inadequate response or adverse reaction to two or contraindication to all of the following: abatacept, alemtuzumab, belumosudil, cyclosporine, etanercept, everolimus, hydroxychloroquine, ibrutinib, imatinib, methotrexate, mycophenolate mofetil, ruxolitinib, sirolimus, tacrolimus, temsirolimus.
  • Documentation of the following is required for granulomatosis with polyangitis (GPA) or microscopic polyangitis (MPA):
    • For induction (initial) therapy, documentation of the following is required:
      • appropriate diagnosis; and
      • appropriate dosing; and
      • inadequate response, adverse reaction, or contraindication to cyclophosphamide; and
      • one of the following:
        • requested agent will be used in combination with a glucocorticoid; or
        • adverse reaction or contraindication to glucocorticoids.
    • For maintenance (subsequent) therapy, documentation of the following is required:
      • appropriate diagnosis; and
      • appropriate dosing.
  • Documentation of the following is required for idiopathic membranous nephropathy (IMN):
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: chlorambucil, cyclophosphamide; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: cyclosporine, tacrolimus.
  • Documentation of the following is required for idiopathic thrombocytopenia purpura (ITP):
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to all corticosteroids.
  • Documentation of the following is required for lupus nephritis (LN):
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to both of the following: cyclophosphamide, mycophenolate.
  • Documentation of the following is required for minimal change disease:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to both of the following: cyclophosphamide, cyclosporine.
  • Documentation of the following is required for multiple sclerosis:
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurologist are provided.
  • Documentation of the following is required for generalized myasthenia gravis (MG):
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to pyridostigmine; and
    • inadequate response or adverse reaction to one or contraindication to all corticosteroids; and
    • one of the following:
      • member has muscle-specific tyrosine kinase (MuSK)-positive MG; or
      • inadequate response or adverse reaction to one or contraindication to all of the following: azathioprine, cyclophosphamide, cyclosporine, eculizumab, efgartigimod, intravenous immune globulin, mycophenolate, ravulizumab, tacrolimus.
  • Documentation of the following is required for neuromyelitis optica spectrum disorder (NMOSD) maintenance therapy:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: azathioprine, mycophenolate.
  • Documentation of the following is required for Non-Hodgkin's Lymphoma (NHL):
    • appropriate diagnosis; and
    • appropriate dosing.
  • Documentation of the following is required for pemphigus foliaceus (PF):
    • appropriate diagnosis; and
    • one of the following:
      • requested agent will be used in combination with systemic glucocorticoids; or
      • inadequate response or adverse reaction to one or contraindication to all systemic corticosteroids; and
    • appropriate dosing.
  • Documentation of the following is required for Polymyositis (PM) or Dermatomyositis (DM):
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one or contraindication to all corticosteroids; and
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclophosphamide, cyclosporine, methotrexate.
  • Documentation of the following is required for Post-Transplantation Lymphoproliferative Disease (PTLD) or Waldenström’s macroglobulinemia:
    • appropriate diagnosis.
  • Documentation of the following is required for rheumatoid arthritis (RA):
    • appropriate diagnosis; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to one TNF antagonist; and
    • one of the following:
      • requested agent will be used in combination with methotrexate; or
      • adverse reaction or contraindication to methotrexate.
  • Documentation of the following is required for Systemic Lupus Erythematosus (SLE):
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclophosphamide, cyclosporine, leflunomide, methotrexate, mycophenolate.
  • Documentation of the following is required for Thrombotic Thrombocytopenia Purpura (TTP):
    • appropriate diagnosis; and
    • one of the following:
      • member underwent plasma exchange; or
      • clinical rationale as to why plasma exchange was not performed; and
    • inadequate response or adverse reaction to one or contraindication to all corticosteroids.

Rituxan for pediatric members with mature B-cell NHL or mature B-cell acute leukemia (B-AL) 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing; and
    • member is ≥ six months and < 18 years of age; and
    • requested agent will be used in combination with systemic Lymphome Malin B (LMB) chemotherapy.

Rituxan for Pemphigus Vulgaris (PV)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing; and
    • one of the following:
      • requested agent will be used in combination with systemic glucocorticoids; or
      • inadequate response or adverse reaction to one or contraindication to all systemic corticosteroids.

Rituxan Hycela for CLL, diffuse large B-cell lymphoma, or FL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing.

Sarclisa

  • Documentation of the following is required:
    • diagnosis of multiple myeloma; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • both of the following:
        • inadequate response or adverse reaction to one chemotherapy regimen for the requested indication; and
        • requested agent will be used in combination with Kyprolis (carfilzomib) and dexamethasone; or
      • all of the following:
        • inadequate response, adverse reaction, or contraindication to Revlimid (lenalidomide); and
        • history of a total of at least two trials with appropriate regimens for the requested indication; and
        • requested agent will be used in combination with Pomalyst (pomalidomide) and dexamethasone; and
        • inadequate response or adverse reaction to one or contraindication to all of the following proteasome inhibitorsbortezomib, Kyprolis (carfilzomib), Ninlaro (ixazomib), Velcade (bortezomib).

Zynlonta

  • Documentation of the following is required: 
    • diagnosis of relapsed or refractory large B cell lymphoma; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • prior therapy with at least two or contraindication to all recommended chemotherapy regimens.
 
blinatumomab Blincyto PA   MB IV  
cetuximab Erbitux test   MB IV  
daratumumab Darzalex PA   MB IV  
daratumumab / hyaluronidase-fihj Darzalex Faspro PA   MB SC  
elotuzumab Empliciti PA   MB IV  
isatuximab-irfc Sarclisa PA   MB IV  
loncastuximab tesirine-lpyl Zynlonta PA   IV  
margetuximab-cmkb Margenza PA   MB IV  
mogamulizumab-kpkc Poteligeo PA   MB IV  
naxitamab-gqgk Danyelza PA   MB IV  
necitumumab Portrazza PA   MB IV  
obinutuzumab Gazyva PA   MB IV  
ofatumumab vial Arzerra PA   MB IV  
panitumumab Vectibix test   MB IV  
pertuzumab Perjeta PA   MB IV  
rituximab Rituxan PA   MB IV  
rituximab / hyaluronidase human Rituxan Hycela PA   MB SC  
rituximab-abbs Truxima PA   MB IV  
rituximab-arrx Riabni PA   MB IV  
rituximab-pvvr Ruxience PA   MB IV  
tafasitamab-cxix Monjuvi PA   IV  
trastuzumab Herceptin PA   MB IV  
trastuzumab / hyaluronidase-oysk Herceptin Hylecta PA   MB SC  
trastuzumab-anns Kanjinti PA   MB IV  
trastuzumab-dkst Ogivri PA   MB IV  
trastuzumab-dttb Ontruzant PA   MB IV  
trastuzumab-pkrb Herzuma PA   MB IV  
trastuzumab-qyyp Trazimera PA   MB IV  

 Multiple Receptor Antibodies

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

amivantamab-vmjw Rybrevant PA   MB IV  

Rybrevant for advanced or metastatic non-small cell lung cancer 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer has EGFR exon 20 insertion mutation; and
    • inadequate response or adverse reaction to at least one
      platinum-based chemotherapy regimen or contraindication
      to the use of platinum-based chemotherapy.
 

 Nectin-4 Directed Antibody

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

enfortumab vedotin-ejfv Padcev PA   MB IV  

Padcev

  • Documentation of the following is required:
    • diagnosis of locally advanced or metastatic urothelial cancer; and
    • prescriber is an oncologist or consult notes from an oncologist are provided; and
    • appropriate dosing; and
    • one of the following:
      • all of the following: 
        • inadequate response or adverse reaction to a platinum-based chemotherapy; and
        • inadequate response or adverse reaction to a PD-1 inhibitor or PD-L1 inhibitor therapy; and
        • requested agent will be used as monotherapy; or
      • all of the following:
        • contraindication to all cisplatin-containing chemotherapy; and
        • member has received at least one prior line of therapy for requested indication; and
        • requested agent will be used as monotherapy; or
      • both of the following:
        • contraindication to all cisplatin-containing chemotherapy; and 
        • requested agent will be used in combination with Keytruda.
 

 PD-1/PD-L1 Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

atezolizumab Tecentriq PA   MB IV  

Bavencio, Keytruda, and Zynyz for metastatic Merkel cell carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • for Bavencio and Zynyz, an inadequate response, adverse reaction, or contraindication to Keytruda.

Bavencio for first-line treatment of RCC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • tumor is clear cell histology; and
    • requested agent will be used in combination with Inlyta (axitinib).

Bavencio for locally advanced or metastatic urothelial carcinoma (UC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to one or contraindication to all platinum-containing regimens; or
      • disease has not progressed following treatment with four-to-six cycles of first-line platinum-containing regimen.

Imfinzi for extensive-stage (ES) SCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has extensive stage disease; and
    • requested agent will be used in combination with etoposide and either carboplatin or cisplatin.

Imfinzi and Keytruda for locally advanced or metastatic biliary tract cancer (BTC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with cisplatin and gemcitabine.

Imfinzi for metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with Imjudo (tremelimumab-actl) and platinum-based regimen; and
    • member does not have EGFR or ALK genomic tumor aberrations.

Imfinzi for unresectable hepatocellular carcinoma (HCC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with Imjudo (tremelimumab-actl).

Imfinzi for stage III NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • disease has not progressed following combination therapy with platinum-based chemotherapy and radiation therapy.

Jemperli for dMMR recurrent or advanced solid tumors

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member is ≥ 18 years of age; and
    • cancer is dMMR; and
    • inadequate response or adverse reaction to one or contraindication to all other treatments for dMMR.

Jemperli for recurrent or advanced dMMR or MSI-H endometrial cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • cancer is MSI-H and requested agent will be used in combination with carboplatin and paclitaxel every three weeks for six doses followed by monotherapy of Jemperli every six weeks; or
      • cancer is dMMR and one of the following: 
        • requested agent will be used as monotherapy and an inadequate response or adverse reaction to one or contraindication to all lines of platinum-based regimens; or
        • requested agent will be used in combination with carboplatin and paclitaxel every three weeks for six doses followed by monotherapy of Jemperli every six weeks.

Keytruda for non-muscle invasive bladder cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or urologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to BCG; and
    • disease is high-risk with carcinoma in situ.  

Keytruda for high-risk early stage TNBC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with chemotherapy and then continued as a single agent following surgery.

Keytruda for cervical cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • PD-L1 expression [combined positive score (CPS) ≥ 1]; and
    • one of the following:
      • requested agent will be used in combination with chemotherapy, with or without bevacizumab; or
      • requested agent will be used as monotherapy in the setting of disease progression following one systemic chemotherapy regimen.

Keytruda for MSI-H/dMMR solid tumors or mCRC 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Keytruda for advanced endometrial carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one prior line of systemic therapy or contraindication to all systemic therapies; and
    • member is not a candidate for surgery or radiation; and
    • one of the following:
      • for advanced endometrial carcinoma that is not MSI-H or dMMR, requested agent will be used in combination with Lenvima (lenvatinib); or
      • for advanced endometrial carcinoma that is MSI-H or dMMR, requested agent will be used as monotherapy.

Keytruda for advanced, recurrent or metastatic esophageal or EGJ cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following: 
      • if previously untreated, requested agent will be used in combination with a fluoropyrimidine- and platinum-containing regimen; or
      • requested agent will be used as monotherapy and member had at least one prior line of systemic therapy for squamous cell tumor with PD-L1 (CPS ≥ 10).

Keytruda for recurrent locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with trastuzumab, fluoropyrimidine-, and platinum-containing regimen.

Keytruda for locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with a fluoropyrimidine- and platinum-containing regimen.

Keytruda for HCC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member has Child-Pugh Class A; and
    • inadequate response, adverse reaction, or contraindication to sorafenib.

Keytruda and Opdivo for Hodgkin Lymphoma in adult members

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • member has progressed after autologous hematopoietic stem cell transplant with or without brentuximab; or
      • member is ineligible for transplant or inadequate response to two lines of prior chemotherapy; or
      • member has received allogeneic transplant.

Keytruda and Opdivo for Hodgkin Lymphoma in pediatric members

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member is < 18 years of age; and
    • inadequate response or adverse reaction to two or more lines of prior chemotherapy.

Keytruda for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all platinum-containing regimens; or
    • cancer is non-nasopharyngeal and one of the following:
      • requested agent is used in combination with a platinum agent (cisplatin, carboplatin) and fluorouracil; or 
      • tumor is PD-L1 positive (CPS ≥ 1).

Keytruda and Opdivo for stage IIB, IIC, or III melanoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used as adjuvant treatment following complete resection.

Keytruda and Opdivo for unresectable or metastatic melanoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Keytruda for resectable NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in the neoadjuvant setting in combination with one of the following:
      • carboplatin and paclitaxel; or
      • cisplatin and gemcitabine; or
      • cisplatin and paclitaxel; or
      • cisplatin and pemetrexed; and
    • requested agent will be continued as monotherapy as adjuvant treatment after surgery.

Keytruda for stage IB (T2a ≥4 cm), II, or IIIA NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used as adjuvant treatment following resection and platinum-based regimen.

Keytruda for stage III NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • PD-L1 expression [tumor proportion score (TPS) ≥ 1%]; and
    • requested agent will be used in combination with carboplatin and one of the following: paclitaxel, pemetrexed.

Keytruda for unresectable or metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • for nonsquamous NSCLC in the first-line setting, requested agent will be used in combination with pemetrexed and one of the following: carboplatin, cisplatin; or
      • for squamous NSCLC in the first-line setting, requested agent will be used in combination with carboplatin and one of the following: paclitaxel, albumin-bound paclitaxel ; or
      • PD-L1 expression and one of the following:
        • both of the following:
          • inadequate response or adverse reaction to one or containdication to all platinum-containing regimens; and
          • requested agent will be used as monotherapy; or
        • both of the following:
          • member does not have EGFR or ALK genomic tumor aberrations; and
          • requested agent will be used as monotherapy in the first-line setting.

Keytruda for primary mediastinal B-cell lymphoma (PMBCL)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to two or contraindication to all systemic chemotherapies.

Keytruda for advanced RCC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • tumor is clear cell histology and one of the following:
        • requested agent will be used in combination with Inlyta (axitinib); or
        • requested agent will be used in combination with Lenvima (lenvatinib); or
        • requested agent will be used as adjuvant treatment following nephrectomy; or
      • tumor is non-clear cell histology and inadequate response or adverse reaction to one of the following, or contraindication to both of the following: Cabometyx (cabozantinib), sunitinib.

Keytruda for metastatic squamous cell carcinoma of the esophagus (ESCC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • tumor expresses PD-L1 (CPS ≥ 10); and
    • inadequate response or adverse reaction to one or contraindication to all other lines of systemic therapy.

Keytruda and Libtayo for metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing;  and
    • member is ≥ 18 years of age; and
    • member is not a candidate for surgery and/or radiation therapy.

Keytruda for tumor mutational burden-high (TMB-H) cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing;  and
    • tumor has ≥ 10 mutations/megabase.

Keytruda for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member is PD-L1 positive (CPS ≥ 10); and
    • requested agent will be used in combination with one of the following: paclitaxel protein-bound, paclitaxel, or gemcitabine plus carboplatin.

Keytruda for locally advanced or metastatic UC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • requested agent will be used as monotherapy and an inadequate response or adverse reaction to one or contraindication to all platinum-containing regimens; or
      • requested agent will be used in combination with Padcev (enfortumab vedotin-ejfv) and contraindication to all cisplatin-containing regimens.

Libtayo for basal cell carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all hedgehog pathway inhibitors.

Libtayo for NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • member has locally advanced cancer and is not a candidate for surgical resection or definitive chemoradiation; or
      • member has metastatic disease; and
    • member does not have EGFR, ALK, or ROS1 tumor aberrations; and
    • one of the following:
      • requested agent will be used in combination with platinum-based regimen; or
      • requested agent will be used as monotherapy in the first-line setting and the tumor has PD-L1 expession ≥ 50%.

Opdivo for RCC 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • tumor is clear cell histology and requested agent will be used in combination with Yervoy (ipilimumab); or
      • tumor is clear cell histology and requested agent will be used in combination with Cabometyx (cabozantinib); or
      • tumor is clear cell histology and member has received prior anti-angiogenic therapy and requested agent will be used as monotherapy; or
      • tumor is non-clear cell histology and inadequate response or adverse reaction to one of the following, or contraindication to both of the following: Cabometyx (cabozantinib), sunitinib.

Opdivo for completely resected esophageal or gastroesophageal junction (GEJ) cancer 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has residual pathologic disease; and
    • member has received neoadjuvant chemoradiotherapy (CRT).

Opdivo for advanced or metastatic gastric cancer, GEJ cancer or esophageal adenocarcinoma 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is HER-2 negative; and
    • requested agent is to be used in combination with a fluoropyrimidine- and platinum-containing regimen.

Opdivo for HCC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member has Child-Pugh Class A or B; and
    • inadequate response, adverse reaction, or contraindication to sorafenib.

Opdivo for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all platinum-containing regimens.

Opdivo for MPM

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with Yervoy (ipilimumab).

Opdivo for MSI-H/dMMR mCRC 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: fluoropyrimidine-containing regimen, irinotecan-containing regimen, oxaliplatin-containing regimen.

Opdivo for resectable NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in the neoadjuvant setting in combination with one of the following:
      • carboplatin and paclitaxel; or
      • cisplatin and gemcitabine; or
      • cisplatin and paclitaxel; or
      • cisplatin and pemetrexed.

Opdivo for unresectable or metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to one or contraindication to all platinum-containing regimens; or
      • requested agent will be used in combination with ipilimumab and either: pemetrexed and carboplatin, pemetrexed and cisplatin, or paclitaxel and carboplatin; or
      • tumor has PD-L1 expression ≥ 1% and the requested agent is used in combination with ipilimumab.

Opdivo for unresectable advanced, recurrent, or metastatic squamous cell carcinoma of the esophagus (ESCC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • member has received prior fluoropyrimidine-based and platinum-based regimen; or
      • requested agent will be used in combination with a fluoropyrimidine- and platinum-based regimen in the first-line setting; or
      • requested agent will be used in combination with Yervoy (ipilimumab) in the first-line setting.

Opdivo for UC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • disease progression during or following a platinum-containing regimen; or
      • requested agent will be used as adjuvant treatment following radical resection of the bladder or parts of the urinary tract.

Tecentriq for extensive-stage (ES) SCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has extensive stage disease; and
    • requested agent will be used in combination with carboplatin and etoposide.

Tecentriq for hepatocellular carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with bevacizumab; and
    • member has Child-Pugh Class A.

Tecentriq for stage II to IIIA NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • tumor has PD-L1 expression ≥ 1%; and
    • requested agent will be used as adjuvant treatment following complete resection and platinum-based regimen. 

Tecentriq for unresectable or metastatic alveolar soft part sarcoma (ASPS)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Tecentriq for unresectable or metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to one or contraindication to all platinum-containing regimens; or
      • first-line setting for nonsquamous NSCLC and requested agent will be used in combination with all of the following: Avastin (bevacizumab), carboplatin, paclitaxel; or 
      • tumor has PD-L1 expression ≥ 50%; or
      • first-line setting for nonsquamous NSCLC and requested agent will be used in combination with both of the following: albumin-bound paclitaxel and carboplatin.

Tecentriq for unresectable or metastatic melanoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • positive BRAF V600E or V600K mutation; and
    • documentation that the requested agent will be used in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib); and
    • inadequate response or adverse reaction to one of the following or contraindication to all of the following: 
      • Tafinlar (dabrafenib) + Mekinist (trametinib); or
      • Cotellic (cobimetinib) + Zelboraf (vemurafenib); or
      • Braftovi (encorafenib) + Mektovi (binimetinib).

 

 
avelumab Bavencio PA   MB IV  
cemiplimab-rwlc Libtayo PA   MB IV  
dostarlimab-gxly Jemperli PA   MB IV  
durvalumab Imfinzi PA   MB IV  
nivolumab Opdivo PA   MB IV  
pembrolizumab Keytruda PA   MB IV  
retifanlimab-dlwr Zynyz PA   MB IV  

 Poly-Adenosine Diphosphate Ribose Polymerase (PARP) Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

niraparib Zejula PA   PO  

Lynparza for BRCA-mutated breast cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer has deleterious or suspected deleterious gBRCAm; and
    • member has completed neoadjuvant or adjuvant chemotherapy; and
    • requested quantity is ≤ four tablets/day.

Lynparza for BRCA-mutated mCRPC

  • Documentation of the following is required: 
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer has a deleterious or suspected deleterious germline or somatic mutation in BRCA1 or BRCA2; and
    • requested agent will be used in combination with both of the following: 
      • abiraterone; and
      • prednisone or prednisolone; and
    • requested quantity is ≤ four tablets/day.

Lynparza for homologous recombination repair (HRR) gene-mutated mCRPC

  • Documentation of the following is required: 
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer has deleterious or suspected deleterious germline or somatic HRR gene mutation; and
    • inadequate response or adverse reaction to one of the following or contraindication to all of the following: 
      • Xtandi (enzalutamide); or
      • Yonsa (abiraterone); or
      • Zytiga (abiraterone); and
    • requested quantity is ≤ four tablets/day.

Lynparza for advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer

  • For first-line maintenance therapy as monotherapy, documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has deleterious or suspected deleterious gBRCAm or sBRCAm cancer; and
    • member has achieved a partial or complete response to first-line platinum-based chemotherapy; and
    • requested quantity is ≤ four tablets/day.
  • For first-line maintenance therapy as combination therapy, documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following: 
      • cancer has a deleterious germline or somatic mutation in BRCA1 or BRCA2; or
      • cancer is homologous recombination deficiency (HRD) positive status; and 
    • member has achieved a partial or complete response to first-line platinum-based chemotherapy; and
    • requested agent will be used in combination with bevacizumab; and
    • requested quantity is ≤ four tablets/day.
  • For recurrent disease, documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member achieved a partial or complete response to platinum-based chemotherapy; and
    • requested quantity is ≤ four tablets/day.

Lynparza for metastatic pancreatic adenocarcinoma (first-line maintenance therapy)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has deleterious or suspected deleterious gBRCAm; and
    • member has disease which has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen; and
    • requested quantity is ≤ four tablets/day.

Rubraca for BRCA-mutated mCRPC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer has deleterious gBRCAm or sBRCAm; and 
    • inadequate response or adverse reaction to one of the following or contraindication to all of the following:
      • Xtandi (enzalutamide); or
      • Yonsa (abiraterone); or
      • Zytiga (abiraterone); and
    • inadequate response, adverse reaction, or contraindication to taxane-based chemotherapy; and
    • requested quantity is ≤ four units/day.

Rubraca for advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (maintenance therapy)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has deleterious gBRCAm or sBRCAm cancer; and
    • member has achieved a partial or complete response to platinum-based chemotherapy; and
    • requested quantity is ≤ four tablets/day.

Talzenna for locally advanced or metastatic breast cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer has deleterious or suspected deleterious gBRCAm; and
    • one of the following:
      • for the 0.5 mg, 0.75 mg, or 1 mg capsule, requested quantity is ≤ one unit/day; or
      • for the 0.25 mg capsule, requested quantity is ≤ three units/day.

Talzenna for HRR gene-mutated mCRPC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with enzalutamide; and
    • requested quantity is ≤ one unit/day.

Zejula for advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer

  • For first-line maintenance therapy, documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has achieved a partial or complete response to platinum-based chemotherapy; and
    • requested quantity is ≤ one unit/day.
  • For maintenance therapy, documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has deleterious or suspected deleterious gBRCAm cancer; and
    • member has achieved a partial or complete response to platinum-based chemotherapy; and
    • requested quantity is ≤ one unit/day.
 
olaparib Lynparza PA   PO  
rucaparib Rubraca PA   PO  
talazoparib Talzenna PA   PO  

 Proteasome Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

bortezomib Velcade test   MB IV / SC  

Kyprolis

  • Documentation of the following is required for monotherapy:
    • diagnosis of multiple myeloma; and
    • appropriate dosing; and
    • prescriber is an oncologist or hematologist; and
    • inadequate response or adverse reaction to at least one prior chemotherapy regimen for the requested indication.

 

  • Documentation of the following is required for combination therapy:
    • diagnosis of multiple myeloma; and
    • appropriate dosing; and
    • prescriber is an oncologist or hematologist; and
    • inadequate response or adverse reaction to at least one prior chemotherapy regimen for the requested indication; and
    • requested agent will be used in combination with dexamethasone with or without additional agents for the treatment of multiple myeloma (excluding proteasome inhibitors).

Ninlaro

  • Documentation of the following is required:
    • diagnosis of multiple myeloma; and
    • appropriate dosing; and
    • prescriber is an oncologist or hematologist; and
    • inadequate response or adverse reaction to at least one prior chemotherapy regimen for the requested indication; and
    • requested agent will be used in combination with dexamethasone with or without additional agents for the treatment of multiple myeloma (excluding proteasome inhibitors); and
    • requested quantity is ≤ three capsules/28 days.
 
bortezomib test   MB IV  
carfilzomib Kyprolis PA   MB IV  
ixazomib Ninlaro PA   PO  

 Retinoids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

bexarotene Targretin test   BP, A90 PO / Topical  

    

 
tretinoin capsule test   A90 PO  

 Selective Estrogen Receptor Modulator (SERM)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

toremifene Fareston test   # , A90 PO  

       

 

 Topoisomerase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

etoposide capsule test   A90 PO  

Etopophos

  • Documentation of the following is required:
    • diagnosis of small cell lung cancer or testicular cancer; and
    • prescriber is an oncologist or hematologist; and
    • member is ≥ 18 years of age; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to an etoposide product available without PA.

Onivyde

  • Documentation of the following is required:
    • diagnosis of metastatic adenocarcinoma of the pancreas; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member is ≥ 18 years of age; and
    • requested agent will be used in combination with fluorouracil and leucovorin; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: a fluoropyrimidine-based chemotherapy regimen, a gemcitabine-based chemotherapy regimen.

Trodelvy for HR-positive, HER2-negative unresectable locally advanced or metastatic breast cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one or contraindication to all endocrine-based therapies; and
    • inadequate response or adverse reaction to at least two prior non-endocrine-based systemic therapies in the metastatic setting; and
    • if HER2 IHC 1+ or 2+/ISH negative (HER2-low) breast cancer, inadequate response, adverse reaction, or contraindication to Enhertu.

Trodelvy for unresectable locally advanced or metastatic triple negative breast cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to at least two prior systemic therapies, at least one for metastatic disease.

Trodelvy for locally advanced or metastatic urothelial cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to both of the following: a platinum-containing regimen, a PD-1 or PD-L1 inhibitor.
 
etoposide injection test   MB IV  
etoposide phosphate Etopophos PA   MB IV  
irinotecan Camptosar test   MB IV  
irinotecan liposome Onivyde PA   MB IV  
sacituzumab govitecan-hziy Trodelvy PA   MB IV  
topotecan capsule Hycamtin test   PO  
topotecan injection Hycamtin test   MB IV  

 Tropomyosin Receptor Kinase (TRK) Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

entrectinib Rozlytrek PA   PO  

Rozlytrek for solid tumors with neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • for Rozlytrek oral pellet, medical necessity for the use of the oral pellet formulation instead of the oral capsule compounded into a suspension; and
    • one of the following:
      • tumor is metastatic; or
      • member is not a candidate for surgical resection; and
    • one of the following:
      • for the 50 mg oral pellet, requested quantity is ≤ 12 units/day; or
      • for the 100 mg capsule, requested quantity is ≤ one unit/day; or
      • for the 200 mg capsule, requested quantity is ≤ three units/day; and
    • one of the following:
      • requested agent is first-line for the requested indication; or
      • member has no satisfactory alternative treatment options; or
      • disease has progressed following at least one first-line treatment for the requested indication (e.g., chemotherapy, radiation, surgical intervention).

Rozlytrek for ROS1-positive metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is ROS1 positive; and
    • for Rozlytrek oral pellet, medical necessity for the use of the oral pellet formulation instead of the oral capsule compounded into a suspension; and
    • one of the following:
      • for the 50 mg oral pellet, requested quantity is ≤ 12 units/day; or
      • for the 100 mg capsule, requested quantity is ≤ one unit/day; or
      • for the 200 mg capsule, requested quantity is ≤ three units/day.

Vitrakvi

  • Documentation of the following is required:
    • diagnosis of solid tumors with NTRK gene fusion without a known acquired resistance mutation; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • tumor is metastatic; or
      • member is not a candidate for surgical resection; and
    • one of the following:
      • requested agent is first-line for the requested indication; or
      • member has no satisfactory alternative treatment options; or
      • disease has progressed following at least one first-line treatment for the requested indication (e.g., chemotherapy, radiation, surgical intervention); and
    • one of the following:
      • for the 100 mg capsule, requested quantity is ≤ two units/day; or
      • for the 25 mg capsule, requested quantity is ≤ six units/day; or
      • for the oral solution, requested quantity is ≤ ten mL/day; and
    • if the request is for oral solution formulation, medical necessity for the use of an oral solution formulation (e.g., swallowing disorder) must be provided.

MassHealth Drug Utilization Review will be reaching out to prescribers after Vitrakvi PA approval to verify clinical effectiveness.

 
larotrectinib Vitrakvi PA   PO  

 Tyrosine Kinase Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

alectinib Alecensa PA   PO  

Alecensa

  • Documentation of the following is required:
    • diagnosis of metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is anaplastic lymphoma kinase (ALK)-positive; and
    • requested quantity is ≤ eight units/day.

Alunbrig

  • Documentation of the following is required:
    • diagnosis of metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is ALK-positive; and
    • one of the following:
      • for 30 mg tablets, requested quantity is ≤ two units/day; or
      • for 90 mg or 180 mg tablets, or the 90 mg-180 mg tablet pack, requested quantity is ≤ one unit/day.

Ayvakit for unresectable or metastatic GIST

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has disease harboring a PDGFRA exon 18 mutation (including PDGFRA D842V mutations); and
    • requested quantity is ≤ one unit/day.

Ayvakit for advanced systemic mastocytosis (AdvSM), systemic mastocytosis (SM) with associated hematological neoplasm, mast cell leukemia

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • requested quantity is ≤ one unit/day; and
    • one of the following:
      • D816V c-Kit mutation positive (as determined by an FDA-approved test); or
      • both of the following:
        • member has aggressive SM without the D816V c-Kit mutation (as determined by an FDA-approved test) or with c-Kit mutation status unknown; and
        • inadequate response, adverse reaction, or contraindication to imatinib.

Ayvakit for indolent systemic mastocytosis (ISM)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is a specialist (e.g., hematologist, oncologist, allergist/immunologist) or consult notes from a specialist are provided; and
    • appropriate dosing; and
    • requested quantity is ≤ one unit/day; and
    • inadequate response, adverse reaction, or contraindication to all of the following: histamine1 antihistamine, histamine2 antihistamine, leukotriene inhibitor, Xolair.

Bosulif

  • Documentation of the following is required:
    • diagnosis of CML; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • member has chronic phase Philadelphia chromosome-positive (Ph+) CML; or
      • inadequate response or adverse reaction to one prior therapy for CML or contraindication to all other therapies for CML.

Cabometyx for advanced renal cell carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • both of the following:
        • member has clear cell histology; and
        • requested agent will be used in combination with Opdivo; or
      • all of the following: 
        • member has clear cell histology; and 
        • member has received a previous treatment in the metastatic setting; and 
        • requested agent will be used as monotherapy; or
      • member has non-clear cell histology; and
    • requested quantity is ≤ one unit/day.

Cabometyx for locally recurrent, advanced, and/or metastatic differentiated thyroid carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one of the following, or contraindication to both of the following: Lenvima (lenvatinib), sorafenib; and
    • requested quantity is ≤ one unit/day; and
    • one of the following:
      • member is refractory to radioactive iodine; or
      • radioactive iodine treatment is not appropriate.

Cabometyx for unresectable HCC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to sorafenib; and
    • requested quantity is ≤ one unit/day.

Caprelsa

  • Documentation of the following is required:
    • diagnosis of symptomatic or progressive medullary thyroid cancer; and
    • one of the following:
      • for 100 mg tablets, requested quantity is ≤ two units/day; or
      • for 300 mg tablets, requested quantity is ≤ one unit/day; or
      • medical necessity for exceeding quantity limit of two units/day for 100 mg tablets or one unit/day for 300 mg tablets.

Cometriq

  • Documentation of the following is required:
    • diagnosis of symptomatic or progressive medullary thyroid cancer; and
    • one of the following:
      • requested dose is ≤ 140 mg/day; or
      • medical necessity for exceeding the 140 mg/day dose.

erlotinib for advanced or metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations; and
    • requested quantity is ≤ one unit/day.

erlotinib for advanced or metastatic pancreatic cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member will be using the requested agent in combination with gemcitabine; and
    • requested quantity is ≤ one unit/day.

Fotivda 

  • Documentation of the following is required:
    • diagnosis of advanced renal cell carcinoma; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • tumor is clear cell histology; and
    • inadequate response or adverse reaction to two or contraindication to all systemic therapies; and
    • requested quantity is ≤ one unit/day.

gefitinib

  • Documentation of the following is required:
    • diagnosis of metastatic NSCLC; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • member has EGFR mutations; and
    • requested quantity is ≤ one unit/day.

Iclusig for Ph+ ALL

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following: 
      • inadequate response or adverse reaction to one or contraindication to all of the following: imatinib, Sprycel (dasatinib), Tasigna (nilotinib); or
      • confirmed T315I mutation.

Iclusig for CML

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to two or contraindication to all of the following: Bosulif (bosutinib), imatinib, Sprycel (dasatinib), Tasigna (nilotinib); or
      • confirmed T315I mutation.

Inlyta

  • Documentation of the following is required:
    • diagnosis of advanced renal cell carcinoma; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • both of the following:
        • tumor is clear cell histology; and
        • requested agent will be used in combination with Bavencio (avelumab) or Keytruda (pembrolizumab); or
      • both of the following:
        • requested agent will be used as monotherapy; and
        • member has failed one prior line of systemic therapy.

Lenvima for advanced renal cell carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • all of the following: 
        • tumor is clear cell histology; and
        • requested agent will be used in combination with everolimus; and
        • member has failed one first-line therapy for advanced renal cell carcinoma; or
      • both of the following: 
        • tumor is clear cell histology; and
        • requested agent will be used in combination with Keytruda (pembrolizumab); or
      • tumor is non-clear cell histology and inadequate response or adverse reaction to one or contraindication to both of the following: Cabometyx, sunitinib.

Lenvima for differentiated thyroid cancer (DTC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing.

Lenvima for endometrial carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response or adverse reaction to one prior line of systemic therapy or contraindication to systemic therapy; and 
    • requested agent will be used in combination with Keytruda (pembrolizumab).

Lenvima for unresectable hepatocellular carcinoma (HCC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing.

pazopanib for advanced renal cell carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested quantity is ≤ four units/day.

pazopanib for soft tissue sarcoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to prior chemotherapy; and
    • requested quantity is ≤ four units/day.

pazopanib for GIST

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to all of the following: imatinib, Qinlock (ripretinib), sunitinib, Stivarga (regorafenib); and
    • requested quantity is ≤ four units/day.

Rydapt for FLT3-mutated acute myeloid leukemia (AML)

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • for induction therapy, requested agent will be used in combination with cytarabine and daunorubicin; or
      • for consolidation therapy, requested agent will be used in combination with cytarabine.

Rydapt for aggressive systemic mastocytosis (SM), SM with associated hematological neoplasm, and mast cell leukemia

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • both of the following:
        • member has aggressive SM without the D816V c-Kit mutation (as determined by an FDA-approved test) or with c-Kit mutation status unknown; and
        • inadequate response, adverse reaction, or contraindication to imatinib; or
      • D816V c-Kit mutation positive (as determined by an FDA-approved test).

Scemblix

  • Documentation of the following is required:
    • diagnosis of CML; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • confirmed T315I mutation; or
      • inadequate response or adverse reaction to two or contraindication to all of the following: Bosulif (bosutinib), Iclusig (ponatinib), imatinib, Sprycel (dasatinib), Tasigna (nilotinib).

sorafenib for advanced renal cell carcinoma, DTC, or unresectable HCC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested quantity is ≤ four units/day.

sorafenib for FLT3-ITD mutated AML

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • member has relapsed/refractory disease; and
    • requested agent will be used in combination with a hypomethylating agent (5-azacytidine or decitabine); and
    • requested quantity is ≤ four units/day.

sunitinib for advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors (PNET)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested quantity is ≤ one unit/day.
    •  

sunitinib for GIST

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • inadequate response, adverse reaction, or contraindication to imatinib; and
    • requested quantity is ≤ one unit/day.

sunitinib for renal cell carcinoma (adjuvant setting)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • tumor is clear cell histology; and
    • requested quantity is ≤ one unit/day.
    •  

Tukysa for advanced unresectable or metastatic HER2-positive breast cancer 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with trastuzumab and capecitabine; and
    • inadequate response or adverse reaction to one anti-HER2-based regimen; and
    • requested quantity is ≤ four units/day.

Tukysa for RAS wild-type (WT), HER2-positive unresectable or metastatic colorectal cancer 

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested agent will be used in combination with trastuzumab; and
    • inadequate response or adverse reaction to at least one or contraindication to all of the following regimens: CAPEOX, FOLFOX, FOLFIRI, FOLFOXIRI, FOLFIRINOX, irinotecan-based therapy, oxaliplatin-based therapy; and
    • requested quantity is ≤ four units/day.

Turalio

  • Documentation of the following is required:
    • diagnosis of tenosynovial giant cell tumor; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or consult notes from an oncologist are provided; and
    • appropriate dosing; and
    • member is not a candidate for surgery.

Vanflyta for FLT3-ITD mutated AML

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • requested quantity is ≤ two units/day; and
    • one of the following:
      • for relapsed or refractory disease, requested agent will be used as monotherapy; or 
      • for induction therapy, clinical rationale for use of requested agent instead of Rydapt and requested agent will be used in combination with cytarabine and daunorubicin or idarubicin; or
      • for consolidation therapy, clinical rationale for use of requested agent instead of Rydapt and requested agent will be used in combination with cytarabine; or
      • for maintenance therapy, requested agent will be used as monotherapy and one of the following:
        • member received the requested agent as part of induction and/or consolidation therapy; or
        • clinical rationale for use of the requested agent instead of both Rydapt and sorafenib.

Xalkori for systemic anaplastic large cell lymphoma (ALCL)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is ALK-positive; and
    • one of the following:
      • member has relapsed or refractory disease to one prior agent or regimen; or 
      • clinical rationale as to why the other available treatment regimens cannot be used; and
    • for Xalkori (crizotinib) oral pellets, medical necessity for the use of the oral pellet formulation instead of the capsule as noted by one of the following:
      • member is < 13 years of age; or
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • requested dose cannot be obtained from capsule formulation.

Xalkori for unresectable, recurrent, or refractory inflammatory myofibroblastic tumors (IMT)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • member is ≥ one year of age; and
    • appropriate dosing; and
    • cancer is ALK-positive; and
    • for Xalkori (crizotinib) oral pellets, medical necessity for the use of the oral pellet formulation instead of the capsule as noted by one of the following:
      • member is < 13 years of age; or
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • requested dose cannot be obtained from capsule formulation.

Xalkori for ALK-positive or ROS1 positive metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is ALK-positive or ROS1 positive; and
    • for Xalkori (crizotinib) oral pellets, medical necessity for the use of the oral pellet formulation instead of the capsule as noted by one of the following:
      • member is < 13 years of age; or
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • requested dose cannot be obtained from capsule formulation.

Xalkori for MET positive amplification metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is MET positive amplification; and
    • for Xalkori (crizotinib) oral pellets, medical necessity for the use of the oral pellet formulation instead of the capsule as noted by one of the following:
      • member is < 13 years of age; or
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • requested dose cannot be obtained from capsule formulation.

Xospata

  • Documentation of the following is required:  
    • diagnosis of FLT3-mutated AML; and
    • member is ≥ 18 years of age; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • one of the following:
      • member has received at least one line of treatment; or
      • member has relapsed or refractory disease; and
    • requested quantity is ≤ three units/day.

Zykadia for ALK-positive metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • cancer is ALK-positive; and
    • requested quantity is ≤ three units/day.

Zykadia for ROS1-rearrangement metastatic NSCLC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • cancer is ROS1-rearrangement; and
    • requested quantity is ≤ three units/day.
 
asciminib Scemblix PA   PO  
avapritinib Ayvakit PA   PO  
axitinib Inlyta PA   PO  
bosutinib Bosulif PA   PO  
brigatinib Alunbrig PA   PO  
cabozantinib capsule Cometriq PA   PO  
cabozantinib tablet Cabometyx PA   PO  
ceritinib Zykadia PA   PO  
crizotinib Xalkori PA   PO  
dasatinib Sprycel test   BP PO  
erlotinib Tarceva PA   A90 PO  
gefitinib Iressa PA   A90 PO  
gilteritinib Xospata PA   PO  
imatinib Gleevec test   # , A90 PO  
lapatinib Tykerb test   BP, A90 PO  
lenvatinib Lenvima PA   PO  
midostaurin Rydapt PA   PO  
nilotinib Tasigna test   PO  
pazopanib Votrient PA   BP, A90 PO  
pexidartinib Turalio PA   PO  
ponatinib Iclusig PA   PO  
quizartinib Vanflyta PA   PO  
sorafenib Nexavar PA   BP, A90 PO  
sunitinib Sutent PA   BP, A90 PO  
tivozanib Fotivda PA   PO  
tucatinib Tukysa PA   PO  
vandetanib Caprelsa PA   PO  

 Vinca Alkaloid

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

vinblastine test   MB IV  

Marqibo

  • Documentation of the following is required:
    • diagnosis of Philadelphia chromosome negative ALL; and
    • prescriber is an oncologist or hematologist; and
    • appropriate dosing; and
    • member is ≥ 18 years of age; and
    • medical records documenting trials with two previous chemotherapy regimens.      
 
vincristine test   MB IV  
vincristine liposome Marqibo PA   MB IV  
vinorelbine test   IV  

 mTOR Kinase Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Route of Administration

Clinical Notes

everolimus 2.5 mg, 5 mg, 7.5 mg, 10 mg Afinitor PA   BP, A90 PO  

everolimus 2.5 mg, 5 mg, 7.5 mg, 10 mg and everolimus tablets for oral suspension for treatment-resistant epilepsy associated with tuberous sclerosis complex (TSC)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is a neurologist or consult notes from a neurologist are provided; and
    • inadequate response to combination therapy with at least two anticonvulsants or contraindication to all other anticonvulsants; and
    • requested agent will be used as adjunctive therapy with at least one anticonvulsant agent; and
    • requested quantity is ≤ one unit/day.

everolimus tablets for oral suspension for subependymal giant cell astrocytoma (SEGA) with TSC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested quantity is ≤ one unit/day.

everolimus 2.5 mg, 5 mg, 7.5 mg, 10 mg for advanced hormone receptor-positive, HER2-negative breast cancer

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • requested regimen includes exemestane, fulvestrant, or tamoxifen; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: anastrozole, letrozole, tamoxifen, toremifene, exemestane; and
    • requested quantity is ≤ one unit/day.

everolimus 2.5 mg, 5 mg, 7.5 mg, 10 mg for advanced renal cell carcinoma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is an oncologist; and
    • appropriate dosing; and
    • one of the following:
      • tumor is clear cell histology and requested agent will be used as monotherapy or in combination with Lenvima; or
      • tumor is non-clear cell histology and inadequate response or adverse reaction to one or contraindication to both of the following: Cabometyx, sunitinib; and
    • requested quantity is ≤ one unit/day.

everolimus 2.5 mg, 5 mg, 7.5 mg, 10 mg for renal angiomyolipoma with TSC, advanced PNET, advanced neuroendocrine tumors (NET) of gastrointestinal or lung origin, and SEGA with TSC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is a specialist (e.g., oncologist or nephrologist) or consult notes from a specialist are provided; and
    • appropriate dosing; and
    • requested quantity is ≤ one unit/day.

Fyarro

  • Documentation of the following is required:
    • diagnosis of locally advanced or metastatic malignant perivascular epithelioid cell tumor (PEComa); and
    • appropriate dosing.

Hyftor

  • Documentation of the following is required:
    • diagnosis of facial angiofibroma; and
    • member is ≥ six years of age; and
    • prescriber is a neurologist or dermatologist or consult notes from a neurologist or dermatologist are provided; and
    • one of the following:
      • for members < 12 years of age, requested quantity is ≤ 20 grams/30 days (2 tubes/30 days); or
      • for members ≥ 12 years of age,  requested quantity is ≤ 30 grams/30 days (3 tubes/30 days).
 
everolimus tablets for oral suspension Afinitor Disperz PA   BP, A90 PO  
sirolimus gel Hyftor PA   Topical  
sirolimus injection Fyarro PA   IV  
temsirolimus Torisel test   # IV  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
PD Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class.
 
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 
M90 Mandatory 90-day supply. After dispensing up to a 30-day supply initial fill, dispensing in a 90-day supply is required. May not include all strengths or formulations. Quantity limits and other restrictions may also apply.
 

II. Therapeutic Uses

 FDA-approved, for example:

  • Cancer

 Non-FDA-approved, for example:

  • Cancer

Note: The above lists may not include all FDA-approved and non-FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

 

Please see clinical criteria for agents requiring PA in the table above under the Clinical Notes section. 

 

Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 07/2011

Last Revised Date: 03/2024


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Last updated 06/24/24

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