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Drug Category: Vaccines and Immune Serums

Medication Class/Individual Agents: Immune Serums

I. Prior-Authorization Requirements

 Immune Globulins

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

antithymocyte globulin, equine Atgam test  
antithymocyte globulin, rabbit Thymoglobulin test  
cytomegalovirus immune globulin IV, human Cytogam test  
hepatitis B immune globulin IM, human-Hyperhep B Hyperhep B test  
hepatitis B immune globulin IM, human-Nabi-HB Nabi-HB test  
hepatitis B immune globulin IV, human-Hepagam B Hepagam B test  
immune globulin IM, human-Gamastan S/D Gamastan S/D PA  
immune globulin injection, human-Gammagard Gammagard PA  
immune globulin injection, human-Gammaked Gammaked PA  
immune globulin injection, human-Gamunex-C Gamunex-C PA  
immune globulin IV, human-Bivigam Bivigam PA  
immune globulin IV, human-Carimune NF Carimune NF PA  
immune globulin IV, human-Flebogamma Flebogamma PA  
immune globulin IV, human-Gammagard S/D Gammagard S/D PA  
immune globulin IV, human-Gammaplex Gammaplex PA  
immune globulin IV, human-ifas Panzyga PA  
immune globulin IV, human-Octagam Octagam PA  
immune globulin IV, human-Privigen Privigen PA  
immune globulin subcutaneous injection, human / hyaluronidase human recombinant Hyqvia PA  
immune globulin subcutaneous injection, human-Cuvitru Cuvitru PA  
immune globulin subcutaneous injection, human-hipp Cutaquig PA  
immune globulin subcutaneous injection, human-Hizentra Hizentra PA  
rabies immune globulin IM, human-Hyperrab Hyperrab test  
rabies immune globulin IM, human-Imogam Rabies-HT Imogam Rabies-HT test  
rabies immune globulin IM, human-Kedrab Kedrab test  
rho(d) immune globulin IM, human-Hyperrho Hyperrho test  
rho(d) immune globulin IM, human-Micrhogam Micrhogam test  
rho(d) immune globulin IM, human-Rhogam Rhogam test  
rho(d) immune globulin IV, human-Rhophylac Rhophylac test  
rho(d) immune globulin IV, human-Winrho SDF Winrho SDF test  
tetanus immune globulin IM, human Hypertet 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.

 

Please note: Gammaked and Gamunex-C can be administered subcutaneously or intravenously.

Rate and Route of Administration:

  • Administer only at rate, route, and concentration indicated for product; an IV administration rate that is too rapid may lead to a precipitous drop in blood pressure, fluid overload, and a possible thrombotic event. Cautious use in patients with history of cardiovascular disease or thrombotic episodes.

Renal Risk:

  • IGIV (human) products have been associated with renal dysfunction, acute renal failure, and osmotic nephrosis. Risk factors include age >/= 66 years, pre-existing renal dysfunction, volume depletion, concurrent use of nephrotoxic drugs, diabetes, and sepsis.

Hypersensitivity Reactions:

  • Reportedly rare, however incidence may increase with use of large IM doses or repeated injections of immune globulins.

Live Virus Vaccines (measles, mumps, rubella, varicella):

  • Antibodies present in immune globulin preparations may interfere with the immune response of live virus vaccines, especially when large doses of immunoglobulins are given. For many immune globulins, a live virus vaccine should not be administered within 3 months of immune globulin administration. A a few immune globulins require an even longer period (5-11 months) before a live virus vaccine should be given. Check individual manufacturer's recommendations for each product.
 
Table Footnotes

II. Therapeutic Uses

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)

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 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 (Bivigam, Carimune NF, Cutaquig, Cuvitru, Flebogamma, Gammagard, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Hizentra SC, Hyqvia, Octagam, Panzyga, and Privigen)

  • Documentation of the following is required:
    • laboratory documentation supporting diagnosis (e.g., serum IgG, IgM, and/or IgA levels are deficient); and
    • dose is appropriate for the member and treatment course.

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

  • Documentation of the following is required:
    • documentation supporting diagnosis with appropriateness for IVIG treatment (e.g., platelets < 30,000 /mcL, and/or has clinically significant bleeding, history or risk of significant bleeding); and
    • dose is appropriate for member and treatment course.

Kawasaki disease (Gammagard S/D)

  • Documentation of the following is required:
    • documentation that the onset of illness occurred within the previous 10 days or the member exhibits signs of persistent inflammation; and
    • drug and dose are appropriate for the member and treatment course.

Multifocal Motor Neuropathy (Gammagard)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • dose is appropriate for the member and treatment course.

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.

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

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • dose is appropriate for member and treatment course.

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.


Original Effective Date: 05/2003

Last Revised Date: 08/2019


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Last updated 10/09/19