FDA-approved, for example:

• Primary immunodeficiency disorder (e.g., primary/congenital agammaglobulinemia, severe combined immunodeficiency (SCID), Wiskott-Aldrich Syndrome, common variable immunodeficiency (CVID), hypogammaglobulinemia, X-linked agammaglobulinemia)
• Immune thrombocytopenia (ITP)
• Kawasaki disease (mucocutaneous lymph node syndrome)
• B-cell chronic lymphocytic leukemia (CLL)
• Chronic inflammatory demyelinating polyneuropathy (CIDP)
• Multifocal Motor Neuropathy (MMN)
• Dermatomyositis in adults (DM)

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 prior-authorization 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).

Primary immunodeficiency disorders (Asceniv, Bivigam, Cutaquig, Cuvitru, Flebogamma, Gammagard, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Hizentra SC, Hyqvia, Octagam, Panzyga, Privigen, and Xembify)

• Documentation of the following is required:
  • laboratory documentation supporting diagnosis (e.g., deficient serum IgG [or subclasses IgG1, IgG2, IgG3, and IgG4], IgM, and/or IgA levels, assessment of functional antibody production, immunophenotype of B cells [flow cytometry] or genetic testing); and
  • Serum IgG (or subclasses IgG1, IgG2, IgG3, and IgG4), IgM, and/or IgA levels are provided via medical records or written on PA with dates drawn and reference ranges; and
  • dose is appropriate for the member and treatment course; and
  • for requests for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

Immune thrombocytopenia (Flebogamma, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, and Privigen)

• Documentation of the following is required:
  • one of the following:
    • platelets < 30,000 /µL; or
    • clinically significant bleeding; or
    • history of significant bleeding; or
    • risk of significant bleeding; or
    • medical necessity to raise platelet count within 12 to 24 hours; and
  • dose is appropriate for member and treatment course; and
  • for requests for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

Kawasaki disease (Gammagard S/D)

• Documentation of the following is required:
  • one of the following:
    • onset of illness occurred within previous 10 days; or
    • member has unexplained persistent fever; or
    • member has evidence of aneurysm; or
    • member exhibits signs of persistent inflammation; and
  • drug and dose are appropriate for the member and treatment course; and
  • for requests for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

Multifocal Motor Neuropathy (Gammagard)

• Documentation of the following is required:
  • appropriate diagnosis; and
  • dose is appropriate for the member and treatment course; and
  • for requests for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

Prevention of recurrent infection in B-cell chronic lymphocytic leukemia (Gammagard S/D)

• Documentation of the following is required:
  • appropriate diagnosis; and
  • dose is appropriate for member and treatment course; and
  • for requests for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

Chronic inflammatory demyelinating polyneuropathy (Gammaked, Gamunex-C, Hizentra, Panzyga, and Privigen)

• Documentation of the following is requied:
  • appropriate diagnosis; and
  • dose is appropriate for member and treatment course; and
  • for requests for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

Dermatomyositis in adults (Octagam)

• Documentation of the following is required:
  • member is ≥ 18 years of age; and
  • inadequate response, adverse drug reaction or contraindication to one systemic corticosteroid; and
  • one of the following:
    • documentation of severe disease; or
    • an inadequate response or adverse reaction to one of the following, or contraindication to all of the following: azathioprine, chloroquine, hydroxychloroquine, methotrexate, mycophenolate mofetil, rituximab; and 
  • dose is appropriate for member and treatment course; and
  • for requests for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

Gamastan S/D

• Documentation of the following is required:
  • one of the following:
    • use for protection against Hepatitis A virus in unvaccinated member who has been exposed to the virus in the previous 2 weeks OR cannot receive hepatitis A vaccine (i.e., hypersensitivity or child less than one year of age); or
    • use to prevent or modify symptoms of measles if exposed within the past 6 days; or
    • use for passive immunization against varicella in immunosuppressed member when Varicella-Zoster Immune Globulin (human) is not available; or
    • use for postexposure prophylaxis of rubella in a pregnant member; and
  • dose is appropriate for member and diagnosis.