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Table 80: Anti-Hemophilia Agents


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Drug Category: Anti-Hemophilia Agents

Medication Class/Individual Agents: Anti-Hemophilia Agents

I. Prior-Authorization Requirements

 Anti-Hemophilia Agents – Bypassing Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

anti-inhibitor coagulant complex-Feiba NF Feiba NF test  
coagulation factor VIIa, recombinant Novoseven test  
coagulation factor VIIa, recombinant Sevenfact test  

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.

 

etranacogene dezaparvovec-drlb and valoctocogene roxaparvovec-rvox

  • MassHealth Drug Utilization Review will be reaching out to prescribers after PA approval to verify administration date and at ongoing intervals for long-term monitoring of response.


 

 Anti-Hemophilia Agents – Factor VIII Replacement Therapies

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

antihemophilic factor, recombinant pegylated-Adynovate Adynovate test  
antihemophilic factor, recombinant pegylated-aucl-Jivi Jivi PD test  
antihemophilic factor, recombinant, fc-vwf-xten fusion protein-ehtl Altuviiio test  
antihemophilic factor, recombinant, single chain-Afstyla Afstyla test  
antihemophilic factor, recombinant-Advate Advate test  
antihemophilic factor, recombinant-Helixate Helixate test  
antihemophilic factor, recombinant-Hemofil-M Hemofil-M test  
antihemophilic factor, recombinant-Kogenate Kogenate PD test  
antihemophilic factor, recombinant-Kovaltry Kovaltry PD test  
antihemophilic factor, recombinant-Novoeight Novoeight test  
antihemophilic factor, recombinant-Nuwiq Nuwiq test  
antihemophilic factor, recombinant-Recombinate Recombinate test  
antihemophilic factor, recombinant-Xyntha Xyntha PD test  
factor VIII recombinant, Fc fusion protein Eloctate test  
factor VIII recombinant, glycopegylated-exei Esperoct test  

 Anti-Hemophilia Agents – Hemophilia A Gene Therapy

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

valoctocogene roxaparvovec-rvox Roctavian PA   CO, MB

 Anti-Hemophilia Agents – Hemophilia B Gene Therapy

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

etranacogene dezaparvovec-drlb Hemgenix PA   CO, MB

 Anti-Hemophilia Agents – Human Plasma-Derived Factor VIII and Von Willebrand Factor Concentrates

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

antihemophilic factor / von willebrand factor complex, human Alphanate test  
antihemophilic factor, human-Humate-P Humate-P test  
antihemophilic factor, human-Koate-DVI Koate-DVI test  
von willebrand factor / coagulation factor VIII complex Wilate test  

 Anti-Hemophilia Agents – Human Plasma-Derived Factor X Concentrate

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

coagulation factor X, human Coagadex test  

 Anti-Hemophilia Agents – Human Plasma-Derived Factor XIII Concentrate

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

factor XIII concentrate, human Corifact test  

 Anti-Hemophilia Agents – Human Plasma-Derived Fibrinogen Concentrate

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

fibrinogen Fibryga test  
fibrinogen concentrate Riastap test  

 Anti-Hemophilia Agents – Human Plasma-Derived Prothrombin Complex Concentrates

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

factor IX complex human-Profilnine SD Profilnine SD test  

 Anti-Hemophilia Agents – Monoclonal Antibodies

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

emicizumab-kxwh Hemlibra PD test  

 Anti-Hemophilia Agents – Plasma-Derived Factor IX Concentrates

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

factor IX Mononine test  
factor IX, human Alphanine SD test  

 Anti-Hemophilia Agents – Recombinant Factor IX Concentrates

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

coagulation factor IX recombinant, glycopegylated-Rebinyn Rebinyn test  
coagulation factor IX, recombinant Rixubis test  
factor IX human recombinant-Benefix Benefix PD test  
factor IX human recombinant-Ixinity Ixinity test  
factor IX recombinant, albumin fusion protein Idelvion test  
factor IX recombinant, Fc fusion protein Alprolix test  

 Anti-Hemophilia Agents – Recombinant Factor VIII Concentrates for Patients with Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

antihemophilic factor, recombinant, porcine sequence-Obizur Obizur test  

 Anti-Hemophilia Agents – Recombinant Factor XIII-A Subunit

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

factor XIII A-subunit recombinant Tretten test  

 Anti-Hemophilia Agents – Recombinant Von Willebrand Factor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

von willebrand factor, recombinant Vonvendi test  
Table Footnotes
CO Carve-Out. This agent is listed on the Acute Hospital Carve-Out Drugs List and is subject to additional monitoring and billing requirements.
 
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.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Hemophilia A
  • Hemophilia B
  • Factor deficiencies

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.
  • 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.

  

    

Hemgenix

  • Documentation of the following is required:
    • diagnosis of moderately severe to severe hemophilia B (FIX activity level ≤ 2% of normal); and
    • prescriber is a hematologist or consult notes from a hematologist are provided; and
    • appropriate dosing; and
    • member's current weight; and
    • member is ≥ 18 years of age on treatment date; and
    • member is a biologic male/male assigned at birth; and
    • member will be screened for acute infection prior to administration; and
    • member is not currently receiving immunosuppressive therapy; and
    • one of the following:
      • member currently uses FIX prophylaxis therapy; or
      • has current life-threatening hemorrhage; or
      • member has history of life-threatening hemorrhage; or
      • member has repeated, serious spontaneous bleeding episodes; and
    • all of the following:
      • baseline annualized bleeding rate (ABR); and
      • NAb titer (AAV5); and
      • FIX activity level.

Roctavian

  • Documentation of the following is required:
    • diagnosis of severe hemophilia A (FVIII activity level ≤ 1% of normal); and
    • prescriber is a hematologist or consult notes from a hematologist are provided; and
    • appropriate dosing; and
    • member's current weight; and
    • member is ≥ 18 years of age on treatment date; and
    • member is a biologic male/male assigned at birth; and
    • member will be screened for acute infection prior to administration; and
    • member has been assessed for their ability to receive corticosteroids and/or immunosuppressive therapy; and
    • member currently uses FVIII prophylaxis therapy or Hemlibra; and
    • baseline annualized bleeding rate (ABR); and
    • FVIII activity level; and
    • member does not have any of the following: detectable pre-existing immunity to adeno-associated virus serotype 5 (AAV5), history of factor VIII inhibitor, hepatic fibrosis (stage 3 or 4 on the Batts Ludwig scale), cirrhosis, history of thrombosis or thrombophilia, active malignancy.

 


Original Effective Date: 07/2023

Last Revised Date: 01/2024


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Last updated 05/16/24

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