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Table 5: Immunological Agents


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Drug Category: Immunological Agents

Medication Class/Individual Agents: Anti-TNF-Alpha, Corticosteroid, Immunosuppressant, Interleukin Antagonist, Miscellaneous, Topical

I. Prior-Authorization Requirements

 Immunological Agents – Anti-TNF-Alpha

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

adalimumab Humira PD PA  
certolizumab Cimzia PA  
etanercept Enbrel PD PA  
golimumab Simponi PA  
golimumab for infusion Simponi Aria PA  
infliximab Remicade PA  
infliximab-abda Renflexis PA  
infliximab-axxq Avsola PA  
infliximab-dyyb Inflectra PA  

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.

For PA drugs, one of the following FDA-approved indications must be met. For unlabeled uses, approval is considered based on current medical evidence.

Immunological agents warnings and precautions:

  • Chronic obstructive pulmonary disease, concomitant use of biologic therapy, use of live vaccines in previous three months, viral hepatitis, hypersensitivity reactions, tuberculosis, injection site reactions, infusion reactions, infections, demyelinating disease, heart failure, malignancy, induction of autoimmunity. See manufacturers’ information for full details on each agent.

Monoclonal antibodies warning and precautions:

  • History of malignancy, patients with human immunodeficiency virus (HIV) infection, lymphopenia, malignancy, serious infections, immunosuppression, allergic reactions, hepatic injury, immune-mediated thrombocytopenia or hemolytic anemia, psoriasis worsening and variants; see manufacturers’ information for full details.

Oral Corticosteroids:

  • Due to their anti-inflammatory and immunosuppressive effects, glucocorticosteroids are widely used in the treatment of various inflammatory conditions including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease.1,2
  1. Rayos [package insert on the internet]. Deerfield (IL): Horizon Pharma USA, Inc.; 2012 July [cited 2012 Sept 14]. Available from: https://hznp.azureedge.net/public/rayos-prescribing-information.pdf.
  2. Buttgereit F, Doering G, Schaeffler A, Witte S, Sierakowski S, Gromnica-Ihle E, et al. Efficacy of modified-release versus standard prednisone to reduce duration of morning stiffness of the joints in rheumatoid arthritis (CAPRA-1): a double-blind, randomized controlled trial. Lancet. 2008 Jan 19;371(9608):205-14.
 

 Immunological Agents – Corticosteroids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

betamethasone injection Celestone test   #
cortisone test  
deflazacort Emflaza PA  
dexamethasone injection test  
dexamethasone solution, tablet Decadron test   #
dexamethasone tablet pack PA  
hydrocortisone injection A-Hydrocort test   #
hydrocortisone injection-Solu-Cortef Solu-Cortef test   #
hydrocortisone sprinkle capsule Alkindi PA  
hydrocortisone tablet Cortef test   #
methylprednisolone Medrol test   #
methylprednisolone acetate Depo-Medrol test   #
methylprednisolone sodium succinate Solu-Medrol test   #
prednisolone 10 mg/5 mL oral solution PA  
prednisolone 15 mg/5 mL, 25 mg/5 mL oral solution test  
prednisolone 20 mg/5 mL oral solution PA  
prednisolone 5 mg/5 mL oral solution Pediapred test   #
prednisolone orally disintegrating tablet PA  
prednisolone tablet test  
prednisone test  
prednisone delayed-release Rayos PA  
triamcinolone extended-release injectable suspension Zilretta PA  
triamcinolone injection Aristospan test  
triamcinolone injection Kenalog test   #

 Immunological Agents – Immunosuppressants

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

azathioprine 50 mg tablet Imuran test   #
azathioprine 75 mg, 100 mg tablet PA  
azathioprine injection test  
belatacept Nulojix PA  
cyclosporine Sandimmune test   #
cyclosporine modified Neoral test   #
everolimus 0.25 mg, 0.5 mg, 0.75 mg, 1 mg Zortress test   #
mycophenolate mofetil Cellcept test   #
mycophenolic acid Myfortic PA  
sirolimus powder PA  
sirolimus solution Rapamune test   BP
sirolimus tablet Rapamune test   #
tacrolimus extended-release capsule Astagraf XL test  
tacrolimus extended-release tablet Envarsus XR PA  
tacrolimus granules Prograf PA  
tacrolimus immediate-release capsule Prograf test   #
tacrolimus injection Prograf test   ^
voclosporin Lupkynis PA  

 Immunological Agents – Interleukin (IL)-1 Antagonist

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

anakinra Kineret PA  

 Immunological Agents – Interleukin (IL)-12/23 Antagonist

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

ustekinumab Stelara PD PA  

 Immunological Agents – Interleukin (IL)-17A Antagonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

brodalumab Siliq PA  
ixekizumab Taltz PD PA  
secukinumab Cosentyx PA  

 Immunological Agents – Interleukin (IL)-23 Antagonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

guselkumab Tremfya PA  
risankizumab-rzaa Skyrizi PA  
tildrakizumab-asmn Ilumya PA  

 Immunological Agents – Interleukin (IL)-6 Antagonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

sarilumab Kevzara PA  
tocilizumab Actemra PA  

 Immunological Agents – Janus Kinase (JAK) Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

baricitinib Olumiant PA  
tofacitinib Xeljanz PD PA  
tofacitinib extended-release Xeljanz XR PD PA  
upadacitinib Rinvoq PA  

 Immunological Agents – Miscellaneous Interleukin Antagonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

basiliximab Simulect test  
canakinumab Ilaris PA  
rilonacept Arcalyst PA  
siltuximab Sylvant PA  

 Immunological Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

apremilast Otezla PA  
methotrexate oral solution Xatmep PA  
methotrexate subcutaneous injection-Otrexup Otrexup PA  
methotrexate subcutaneous injection-Rasuvo Rasuvo PA  
methotrexate subcutaneous injection-Reditrex Reditrex PA  
methotrexate tablet test  
ozanimod for ulcerative colitis Zeposia PA  
vedolizumab Entyvio PA  

 Immunological Agents – Selective T-Cell Costimulation Blocker

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

abatacept Orencia PA  

 Immunological Agents – Topical Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

calcipotriene cream Dovonex PA   - > 60 grams/month #
calcipotriene foam Sorilux PA   BP
calcipotriene ointment PA   - > 60 grams/month
calcipotriene scalp solution test  
calcitriol ointment Vectical PA  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization 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.
 
^ This drug is available through the health care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Acute lymphoblastic leukemia – Xatmep
  • Adult Onset Still's Disease – Ilaris
  • Adrenocortical Insufficiency – Alkindi
  • Ankylosing spondylitis – Avsola, Cimzia, Cosentyx, Enbrel, Humira, Inflectra, Remicade, Renflexis, Simponi, Simponi Aria, Taltz 
  • Crohn’s disease, moderate-to-severe – Avsola, Cimzia, Entyvio, Humira, Inflectra, Remicade, Renflexis, Stelara
  • Crohn’s disease (including fistulizing disease), moderate-to-severe – Avsola, Inflectra, Remicade, Renflexis
  • Cytokine release syndrome – Actemra
  • Deficiency of Interleukin-1 Receptor Antagonist (DIRA) – Arcalyst, Kineret 
  • Duchenne muscular dystrophy (DMD) – Emflaza
  • Familial cold autoinflammatory syndrome – Arcalyst, Ilaris
  • Familial Mediterranean fever – Ilaris
  • Giant cell arteritis – Actemra
  • Hidradenitis Suppurativa, moderate-to-severe – Humira
  • Hyperimmunoglobulin D syndrome/Mevalonate kinase deficiency – Ilaris
  • Inflammatory, allergic, or immunological disorders – dexamethasone tablet pack, prednisolone ODT, prednisolone oral solution, Rayos
  • Lupus Nephritis – Lupkynis
  • Muckle-Wells syndrome – Arcalyst, Ilaris
  • Multicentric Castleman's Disease – Sylvant
  • Neonatal-onset multisystem inflammatory disease – Kineret
  • Non-infectious uveitis – Humira
  • Non-radiographic axial spondyloarthritis – Cimzia, Cosentyx, Taltz
  • Oral ulcers associated with Behçet’s Disease – Otezla
  • Osteoarthritis pain of the knee – Zilretta
  • Plaque psoriasis – calcipotriene cream, ointment, calcipotriene foam, calcitriol ointment
  • Plaque psoriasis, moderate-to-severe – Avsola, Cimzia, Cosentyx, Enbrel, Humira, Ilumya, Inflectra, Otezla, Otrexup, Rasuvo, Reditrex, Remicade, Renflexis, Siliq, Skyrizi, Stelara, Taltz, Tremfya 
  • Polyarticular juvenile idiopathic arthritis – Otrexup, Rasuvo, Reditrex, Xatmep
  • Polyarticular juvenile idiopathic arthritis, moderate-to-severe – Actemra, Enbrel, Humira, Orencia, Simponi Aria, Xeljanz
  • Prevention of rejection of kidney allografts – Envarsus XR, Nulojix
  • Prevention of rejection of kidney, heart, or liver allografts – azathioprine 75 mg and 100 mg tablet, mycophenolic acid, Prograf granules
  • Psoriasis, severe, recalcitrant, disabling – Otrexup, Rasuvo
  • Psoriatic arthritis – Avsola, Cimzia, Cosentyx, Enbrel, Humira, Inflectra, Orencia, Otezla, Remicade, Renflexis, Simponi, Simponi Aria, Stelara, Taltz, Tremfya, Xeljanz, Xeljanz XR 
  • Recurrent pericarditis - Arcalyst
  • Rheumatoid arthritis, moderate-to-severe – Actemra, Avsola, Cimzia, Enbrel, Humira, Inflectra, Kevzara, Kineret, Olumiant, Orencia, Otrexup, Rasuvo, Remicade, Reditrex, Renflexis, Rinvoq, Simponi, Simponi Aria, Xeljanz, Xeljanz XR 
  • Systemic juvenile idiopathic arthritis – Actemra, Ilaris
  • Systemic sclerosis-associated interstitial lung disease - Actemra
  • Tumor necrosis factor receptor associated periodic syndrome – Ilaris
  • Ulcerative colitis, moderate-to-severe – Avsola, Entyvio, Humira, Inflectra, Remicade, Renflexis, Simponi, Stelara, Xeljanz, Xeljanz XR, Zeposia

Note: The above list may not include all 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.
  • 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 the member’s condition and requested medication (see below).

   

Actemra for cytokine release syndrome

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • concurrent therapy with CAR T-cell therapies (request must include anticipated date of administration); and
    • appropriate dosing.

 

Actemra for giant cell arteritis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • an inadequate response or adverse reaction to one systemic glucocorticoid or contraindication to all systemic glucocorticoids.

 

Actemra for moderate-to-severe polyarticular juvenile idiopathic arthritis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • one of the following:
      • an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; or
      • an inadequate response, adverse reaction, or contraindication to Humira.

   

Actemra for systemic juvenile idiopathic arthritis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • one of the following:
      • an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; or
      • an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for systemic juvenile idiopathic arthritis.

  

Actemra for systemic sclerosis-associated interstitial lung disease

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • one of the following:
      • an inadequate response or adverse reaction to cyclophosphamide; or
      • an inadequate response or adverse reaction to mycophenolate; or
      • contraindication to cyclophosphamide and mycophenolate.

   

Actemra, Avsola, Cimzia, Enbrel, Humira, Inflectra, Kevzara, Orencia, Remicade, Renflexis, Simponi, and Simponi Aria for moderate-to-severe rheumatoid arthritis (RA)

  • Documentation of the following is required:
    • an appropriate diagnosis; and 
    • appropriate dosing; and
    • one of the following:
      • an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; or
      • an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for RA; and
    • for all anti-TNF agents other than Enbrel and Humira, both of the following:
      • clinical rationale for the use of the requested agent instead of Enbrel; and 
      • clinical rationale for the use of the requested agent instead of Humira.

 

Alkindi

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is < 18 years of age; and
    • one of the following:
      • medical necessity for the granule formulation; or
      • medical records documenting inadequate response or adverse reaction to hydrocortisone immediate-release tablets.

 

Arcalyst and Ilaris for familial cold autoinflammatory syndrome (FCAS) or Muckle-Wells syndrome (MWS)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate age (for Arcalyst member is ≥ 12 years of age, for Ilaris member is ≥ four years of age); and
    • appropriate dosing; and
    • one of the following:
      • evidence of symptoms indicative of the disease; or
      • confirmation of diagnosis through genetic testing; and
    • for Arcalyst, an inadequate response, adverse reaction, or contraindication to Ilaris.

 

Arcalyst and Kineret for Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • confirmation of diagnosis through genetic testing; and
    • appropriate dosing; and
    • for Arcalyst, an inadequate response, adverse reaction, or contraindication to Kineret.

   

Arcalyst for recurrent pericarditis  

  • Documentation of the following is required: 
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • member is ≥ 12 years of age; and
    • one of the following: 
      • an inadequate response or adverse reaction to one NSAID; or
      • an inadequate response or adverse reaction to aspirin; or
      • contraindication to all NSAIDs and aspirin; and
    • an inadequate response, adverse reaction, or contraindication to one corticosteroid; and
    • an inadequate response, adverse reaction, or contraindication to colchicine; and
    • an inadequate response, adverse reaction, or contraindication to Kineret.

   

Avsola, Enbrel, Humira, Inflectra, Remicade, Renflexis, Simponi, and Simponi Aria for ankylosing spondylitis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • an inadequate response or adverse reaction to two NSAIDs or contraindication to all NSAIDs; and
    • for all anti-TNF agents other than Enbrel and Humira, both of the following:
      • clinical rationale for the use of the requested agent instead of Enbrel; and 
      • clinical rationale for the use of the requested agent instead of Humira.


Avsola, Cimzia, Entyvio, Humira, Inflectra, Remicade, Renflexis, and Stelara for Crohn’s disease

  • Documentation of the following is required for moderate-to-severe Crohn's disease (see below for fistulizing Crohn's disease):
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • for all anti-TNF agents other than Humira, clinical rationale for the use of the requested agent instead of Humira; and
    • for Stelara, one of the following:
      • an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for Crohn's disease; or
      • contraindication to all biologic DMARDs that are FDA-approved for Crohn's disease.
  • For Avsola, Inflectra, Remicade, and Renflexis for fistulizing Crohn's disease, documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing.

 

Avsola, Cimzia, Cosentyx, Enbrel, Humira, Ilumya, Inflectra, Otezla, Remicade, Renflexis, Siliq, Skyrizi, Stelara, Taltz, and Tremfya for moderate-to-severe plaque psoriasis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • one of the following:
      • an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for plaque psoriasis; or
      • an inadequate response or adverse reaction to one conventional therapy (as defined in appendix below); or
      • a contraindication to all conventional therapies (topical agents, phototherapy, and systemic agents); and
    • for all anti-TNF agents other than Enbrel and Humira, both of the following:
      • clinical rationale for the use of the requested agent instead of Enbrel; and
      • clinical rationale for the use of the requested agent instead of Humira; and
    • for Cosentyx, Iluymya, Siliq, Skyrizi, Taltz, and Tremfya, clinical rationale for the use of the requested agent instead of Stelara; and
    • for Otezla, quantity requested is ≤ two tablets/day

 

Avsola, Cimzia, Cosentyx, Enbrel, Humira, Inflectra, Orencia, Otezla, Remicade, Renflexis, Simponi, Simponi Aria, Stelara, Taltz, and Tremfya for psoriatic arthritis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • for all anti-TNF agents other than Enbrel and Humira, both of the following:
      • clinical rationale for the use of the requested agent instead of Enbrel; and
      • clinical rationale for the use of the requested agent instead of Humira; and
    • for Orencia, Otezla, and Stelara, one of the following:
      • an inadequate response or adverse reaction to one anti-TNF agent that is FDA-approved for psoriatic arthritis; or
      • contraindication to all anti-TNF agents that are FDA-approved for psoriatic arthritis; and
    • for Otezla, quantity requested is ≤ two tablets/day; and
    • for Cosentyx, Taltz, and Tremfya, both of the following:
      • an inadequate response, adverse reaction, or contraindication to Stelara; and
      • one of the following:
        • an inadequate response or adverse reaction to one anti-TNF agent that is FDA-approved for psoriatic arthritis; or
        • a contraindication to all anti-TNF agents that are FDA-approved for psoriatic arthritis.

 

Avsola, Entyvio, Humira, Inflectra, Remicade, Renflexis, Simponi, and Stelara for moderate-to-severe ulcerative colitis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • for all anti-TNF agents other than Humira, clinical rationale for use of the requested agent instead of Humira; and
    • for Stelara, one of the following:
      • an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for ulcerative colitis; or
      • contraindication to all biologic DMARDs that are FDA-approved for ulcerative colitis.


azathioprine 75 mg, 100 mg tablet

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • medical necessity for the use of the 75 mg or 100 mg tablets over the 50 mg tablets.

SmartPA: Claims for azathioprine 75 mg and 100 mg tablets will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for the requested agent and the member has a history of MassHealth medical claims for organ transplant, complications of transplanted organs, or paid MassHealth pharmacy claims for sirolimus in the past 365 days.

 

calcipotriene cream, ointment > 60 grams/month

  • Documentation of the following is required:
    • diagnosis of plaque psoriasis; and 
    • member is ≥ 18 years of age; and
    • clinical rationale for the use of > 60 grams/month.

 

calcipotriene foam and calcitriol ointment

  • Documentation of the following is required: 
    • diagnosis of plaque psoriasis; and
    • one of the following:
      • for calcitriol ointment, member is ≥ two years of age; or
      • for calcipotriene foam, member is ≥ four years of age; and
    • an inadequate response or adverse reaction to one topical corticosteroid, or a contraindication to all topical corticosteroids; and
    • an inadequate response or adverse reaction to calcipotriene cream, ointment, or scalp solution, or a contraindication to calcipotriene cream, ointment, and scalp solution; and
    • for calcipotriene foam, one of the following:
      • request is for the 60 gram tube; or
      • clinical rationale for the use of > 60 grams/month.

  

Cimzia, Cosentyx, and Taltz for ankylosing spondylitis and non-radiographic axial spondyloarthritis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • an inadequate response or adverse reaction to two NSAIDs or contraindication to all NSAIDs; and
    • for Cosentyx and Taltz, one of the following:
      • an inadequate response or adverse reaction to one anti-TNF agent that is FDA-approved for the requested indication; or
      • a contraindication to all anti-TNF agents that are FDA-approved for the requested indication.

 

dexamethasone tablet pack

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • one of the following:
      • clinical rationale for requested medication; or
      • requested medication provides a significant or unique therapeutic advantage over the conventionally packaged formulation.

 

Emflaza

  • Documentation of the following is required:
    • genetically confirmed mutation in the dystrophin gene representative of DMD; and
    • member is ≥ two years of age; and
    • one of the following:
      • prescriber is a neuromuscular neurologist; or
      • consult notes from a neuromuscular neurology office are provided; and
    • trial of prednisone and experienced significant weight gain [e.g., crossing two major percentiles and/or reaching the 98th percentile for body mass index (BMI) for age and gender] that was not alleviated with at least a 25% dose reduction (~0.56 mg/kg/day); and
    • dose is appropriate for weight (~0.9 mg/kg/day) (current dose and current weight must be provided); and
    • for suspension formulation, medical necessity for use of the suspension formulation instead of the tablet formulation.
  • For recertification, documentation of the following is required:
    • genetically confirmed mutation in the dystrophin gene representative of DMD; and
    • member is ≥ two years of age; and
    • one of the following:
      • prescriber is a neuromuscular neurologist; or
      • consult notes from a neuromuscular neurology office are provided; and
    • dose is appropriate for weight (~0.9 mg/kg/day) (current dose and current weight must be provided); and
    • medical records to support improvement from baseline in steroid-specific side-effects after treatment with the requested agent.

 

Enbrel, Humira, Orencia, Simponi Aria, and Xeljanz for moderate-to-severe polyarticular juvenile idiopathic arthritis (PJIA)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • one of the following:
      • an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; or
      • an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for polyarticular juvenile idiopathic arthritis; and
    • for all anti-TNF agents other than Enbrel and Humira, both of the following:
      • clinical rationale for the use of the requested agent instead of Enbrel; and 
      • clinical rationale for the use of the requested agent instead of Humira; and
    • for Xeljanz, quantity requested is ≤ two tablets/day. 

 

Envarsus XR

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • clinical rationale why tacrolimus capsules may not be appropriate.

SmartPA: Claims for Envarsus XR will usually process and pay at the pharmacy without a prior authorization if the member has paid claims for at least 90 days of therapy out of the last 120 days.

 

Humira for moderate-to-severe hidradenitis suppurativa

  • Documentation of the following is required:
    • diagnosis of moderate-to-severe hidradenitis suppurativa (Hurley Stage II or Hurley Stage III disease); and
    • appropriate dosing.

 

Humira for non-infectious uveitis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and 
    • an inadequate response or adverse reaction to one topical or systemic glucocorticoid, or a contraindication to all topical and systemic glucocorticoids; and
    • an inadequate response or adverse reaction to one systemic immunosuppressive therapy, or a contraindication to all systemic immunosuppressive therapies (e.g., methotrexate, azathioprine, mycophenolate, cyclosporine, tacrolimus, cyclophosphamide).

  

Ilaris for familial Mediterranean fever (FMF), Hyperimmunoglobulin D syndrome (HIDS)/Mevalonate kinase deficiency (MKD), or Tumor necrosis factor receptor associated periodic syndrome (TRAPS)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • one of the following:
      • evidence of symptoms indicative of the disease; or
      • confirmation of diagnosis through genetic testing; and
    • for diagnosis of FMF, an inadequate response, adverse reaction, or contraindication to colchicine.

  

Ilaris for Adult Onset Still's Disease (AOSD) and sJIA

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ two years of age; and
    • an inadequate response, adverse reaction, or contraindication to one corticosteroid; and
    • an inadequate response, adverse reaction, or contraindication to Kineret; and
    • appropriate dosing.

 

Kineret for neonatal-onset multisystem inflammatory disease (NOMID)

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

 

Kineret for moderate-to-severe RA

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • appropriate dosing; and
    • an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; and
    • an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for RA, or a contraindication to all biologic DMARDs that are FDA-approved for RA.

 

Lupkynis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • member is receiving concurrent immunosuppressive therapy, excluding cyclophosphamide and biologics; and 
    • appropriate dosing.

 

mycophenolic acid

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to mycophenolate mofetil.

SmartPA: Claims for mycophenolic acid will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for the requested agent and the member has a history of MassHealth medical claims for organ transplant, complications of transplanted organs, or paid MassHealth pharmacy claims for sirolimus in the past 365 days.

  

Nulojix

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

     

Olumiant and Rinvoq for moderate-to-severe RA

  • Documentation of the following is required:
    • an appropriate diagnosis; and 
    • an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; and
    • an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for RA, or a contraindication to all biologic DMARDs that are FDA-approved for RA; and
    • an inadequate response, adverse reaction, or contraindication to Xeljanz or Xeljanz XR; and
    • quantity requested is ≤ one tablet/day.

   

Otezla for oral ulcers associated with Behçet’s disease

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

 

Otrexup

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to oral methotrexate; and
    • an inadequate response or adverse reaction to Rasuvo or Reditrex; and
    • one of the following:
      • an inadequate response, adverse reaction, or contraindication to intramuscular methotrexate; or
      • medical necessity for prefilled methotrexate injector as noted by one of the following:
        • physical disability; or
        • visual impairment; or
        • cognitive impairment.

 

prednisolone 10 mg/5 mL oral solution, prednisolone 20 mg/5 mL oral solution, and prednisolone orally disintegrating tablet

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • compelling clinical rationale why the requested prednisolone product would offer a therapeutic advantage over generically available, less costly alternatives.

 

Prograf granules

  • Documentation of the following is required:
    • an appropriate diagnosis; and 
    • clinical rationale why tacrolimus capsules may not be appropriate.
  • For recertification, documentation of continued medical necessity of dosage form is required.

 

Rasuvo and Reditrex

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to oral methotrexate; and
    • one of the following:
      • an inadequate response, adverse reaction, or contraindication to intramuscular methotrexate; or
      • medical necessity for prefilled methotrexate injector as noted by one of the following:
        • physical disability; or
        • visual impairment; or
        • cognitive impairment.

 

Rayos

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • medical records documenting inadequate response or adverse reaction to generic prednisone immediate-release tablets.

 

sirolimus powder

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • clinical rationale why other commercially available alternatives cannot be used.

 

Sylvant

  • Documentation of the following is required:
    • diagnosis of multicentric Castleman's disease (MCD); and
    • member is ≥ 18 years of age; and
    • member is HIV negative and HHV-8 negative; and
    • member's current weight; and
    • results from hematological laboratory tests at baseline showing all of the following:
      • absolute neutrophil count ≥ 1.0x109/L; and
      • platelet count ≥75x109/L; and
      • hemoglobin <17 g/dL.

 

Xatmep

  • Documentation of the following is required:
    • an appropriate diagnosis; and 
    • member is < 13 years of age; and
    • member's current body surface area; and
    • clinical rationale why intramuscular methotrexate may not be appropriate; and
    • clinical rationale why methotrexate tablets may not be appropriate.

 

Xeljanz and Xeljanz XR for moderate-to-severe RA, psoriatic arthritis, and moderate-to-severe UC

  • Documentation of the following is required:
    • an appropriate diagnosis; and 
    • one of the following:
      • an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; or
      • an inadequate response of adverse reaction to one biologic DMARD that is FDA-approved for the requested indication; and
    • one of the following:
      • for Xeljanz, quantity requested is ≤ two tablets/day; or
      • for Xeljanz XR, quantity requested is ≤ one tablet/day.

 

Zeposia for moderate-to-severe ulcerative colitis

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • prescriber is a gastroenterologist or consult notes from a gastroenterology office are provided; and
    • one of the following:
      • an inadequate response or adverse reaction to one anti-TNF agent that is FDA-approved for ulcerative colitis; or
      • a contraindication to all anti-TNF agents that are FDA-approved for ulcerative colitis; and
    • an inadequate response, adverse reaction, or contraindication to Entyvio; and
    • appropriate dosing; and
    • member is not currently receiving concomitant therapy with immunomodulators or biologic agents; and
    • quantity requested is ≤ one capsule/day.

  

Zilretta

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • one of the following:
      • an inadequate response or adverse reaction to two different intra-articular corticosteroid injection preparations; or
      • a contraindication to all other intra-articular corticosteroid injection preparations; and
    • appropriate dosing.

  

Appendix:

Conventional Therapies for Plaque Psoriasis

Phototherapy

Topical Agents

Systemic Agents

ultraviolet A and topical psoralens (topical PUVA)

  emollients

Traditional DMARDs:

ultraviolet A and oral psoralens (systemic PUVA)

  keratolytics

    methotrexate

narrow band UV-B (NUVB)

  corticosteroids

    sulfasalazine

 

  calcipotriene

    cyclosporine

 

  tazarotene

    tacrolimus

 

 

    acitretin

 

 

    mycophenolate mofetil

 

 

    azathioprine

 

 

    hydroxyurea

 

 

    leflunomide

 

 

    6-thioguanine

 

 

  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: 09/2003

Last Revised Date: 11/2021


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Last updated 11/19/21