FDA-approved, for example:

• Hemophilia A
• Hemophilia B
• Factor deficiencies

Note: The above list may not include all FDA-approved indications.

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.

Beqvez 

• Documentation of the following is required:
  • diagnosis of moderately severe to severe hemophilia B (FIX activity level ≤ 2 IU/dL or 2 %); 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 sex assigned at birth; and
  • copy of test confirming member does not have FIX inhibitor; and
  • copy of FDA-approved test confirming member does not have AAVRh74var NAb; and
  • member does not have active human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) infection; and
  • member has not received any prior gene therapy for hemophilia B; 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
  • baseline annualized bleeding rate (ABR); and
  • FIX activity level; and
  • member does not have any of the following: hepatic fibrosis (stage 3 or 4), cirrhosis, liver related coagulopathy, hypoalbuminemia, persistent jaundice, portal hypertension, splenomegaly, hepatic encephalopathy.

Hemgenix

• Documentation of the following is required:
  • diagnosis of moderately severe to severe hemophilia B (FIX activity level ≤ 2 IU/dL or 2 %); 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 sex assigned at birth; and
  • copy of test confirming member does not have FIX inhibitor; and
  • copy of CLIA-validated test confirming AAV5 NAb titer; and
  • member does not have active human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) infection; and
  • member has not received any prior gene therapy for hemophilia B; 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
  • baseline annualized bleeding rate (ABR); and
  • FIX activity level.

Roctavian

• Documentation of the following is required:
  • diagnosis of severe hemophilia A (FVIII activity level ≤ 1 IU/dL or 1 %); 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 sex assigned at birth; and
  • member does not have active human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) infection; and
  • copy of FDA-approved test confirming member does not have detectable preexisting immunity to AAV5; and
  • copy of test confirming member does not have factor VIII inhibitor; and
  • member currently uses one of the following: FVIII prophylaxis therapy or Hemlibra; and
  • baseline annualized bleeding rate (ABR); and
  • FVIII activity level; and
  • member does not have any of the following: hepatic fibrosis (stage 3 or 4), cirrhosis; and
  • member has not received any prior gene therapy for hemophilia A.