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Table 1: Immune Globulins


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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

Drug
Notes

antithymocyte globulin, equine Atgam test  
antithymocyte globulin, rabbit Thymoglobulin test  
cytomegalovirus immune globulin IV, human Cytogam test   MB
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-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 IV, human-slra Asceniv 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  
immune globulin subcutaneous injection, human-klhw Xembify PA  
rabies immune globulin IM, human-Hyperrab Hyperrab 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   MB
rho(d) immune globulin IV, human-Winrho SDF Winrho SDF test   MB
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: Gammagard, Gammaked, and Gamunex-C can be administered subcutaneously for primary immunodeficiency disorders (PID), or intravenously for PID as well as other indications.

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 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
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:

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

non-FDA-approved, for example:

  • Antibody mediated rejection (AMR)
  • Autoimmune autonomic ganglionopathy (AAG)
  • Autoimmune encephalitis, including anti-NMDA receptor encephalitis
  • Autoimmune small fiber neuropathy
  • CMV-solid organ transplant
  • Guillain-Barré Syndrome
  • Immune-mediated necrotizing myopathy (IMNM)
  • Immune neutropenia [Autoimmune neutropenia (AIN), Chronic benign neutropenia]
  • Interstitial lung disease (ILD)
  • Multiple myeloma
  • Myasthenia gravis
  • Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS)
  • Pemphigus vulgaris (PV)
  • Polymyositis (PM)
  • Prevention of recurrent infection in pediatric HIV members
  • Specific antibody deficiency (SAD)
  • Stiff person syndrome (SPS)

 

Note: The above lists may not include all FDA-approved and non-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.
  • 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.

 

Antibody mediated rejection (AMR)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one systemic corticosteroid or contraindication to all systemic corticosteroids; and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

   

Autoimmune encephalitis, anti-NMDA receptor encephalitis

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • requested dose is 2 g/kg/day divided over two to five days, followed by 1 g/kg once monthly; and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

    

Autoimmune small fiber neuropathy and autoimmune autonomic ganglionopathy (AAG)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • requested dose is 1 g/kg/monthly, administered in weekly divided doses, up to a maximum of 2 g/kg monthly; and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

    

Chronic inflammatory demyelinating polyneuropathy

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

    

CMV-Solid organ transplant

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member will also receive antiviral therapy with ganciclovir, foscarnet, or cidofovir; and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

     

Dermatomyositis in adults

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response or adverse reaction to one systemic corticosteroid or contraindication to all systemic corticosteroids; and
    • one of the following:
      • member has severe disease; or
      • inadequate response or adverse reaction to one or contraindication to all of the following: azathioprine, chloroquine, hydroxychloroquine, methotrexate, mycophenolate mofetil, rituximab; and 
    • appropriate dosing for member and treatment course; and
    • 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 last 6 days; or
      • use for passive immunization against varicella in immunosuppressed member when Varicella-Zoster Immune Globulin (human) is not available; or
      • use for post-exposure prophylaxis of rubella in a pregnant member; and
    • appropriate dosing for member and diagnosis.

     

Guillain-Barré Syndrome

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • requested dose is ≤ 2 g/kg; and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

      

Immune-mediated necrotizing myopathy (IMNM)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one systemic corticosteroid or contraindication to all systemic corticosteroids; and
    • one of the following:
      • member has severe disease; or
      • inadequate response or adverse reaction to one or contraindication to all of the following: azathioprine, chloroquine, cyclophosphamide, cyclosporin, hydroxychloroquine, methotrexate, mycophenolate mofetil, plasma exchange, rituximab, tacrolimus; and 
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

     

Immune neutropenia (AIN, Chronic benign neutropenia)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • recurrent infections despite prophylactic antibiotics and colony-stimulating factors; and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

      

Immune thrombocytopenia

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

     

Interstitial lung disease (ILD)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one systemic corticosteroid or contraindication to all systemic corticosteroids; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: azathioprine, mycophenolate mofetil; and 
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

     

Kawasaki disease

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

     

Multifocal motor neuropathy

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

      

Multiple myeloma

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • recurrent infections despite prophylactic antibiotics; and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

      

Myasthenia gravis

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • member has severe or rapidly worsening disease, and requested agent will be used as initial therapy followed by longer-acting immunomodulating agents; or
      • inadequate response, adverse reaction, or contraindication to all of the following: pyridostigmine, systemic corticosteroids, one immunomodulating agent (e.g., azathioprine, cyclosporine, mycophenolate); and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

     

Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one antibiotic or contraindication to all antibiotics; and
    • inadequate response or adverse reaction to one systemic corticosteroid or contraindication to all systemic corticosteroids; and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

       

Pemphigus vulgaris (PV)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one systemic corticosteroid or contraindication to all systemic corticosteroids; and
    • inadequate response, adverse reaction, or contraindication to rituximab; and
    • requested dose is ≤ 2 g/kg; and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

      

Polymyositis (PM)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one systemic corticosteroid or contraindication to all systemic corticosteroids; and
    • one of the following:
      • member has severe disease; or
      • inadequate response or adverse reaction to one or contraindication to all of the following: azathioprine, chloroquine, cyclophosphamide, cyclosporin, hydroxychloroquine, methotrexate, mycophenolate mofetil, plasma exchange, rituximab, tacrolimus; and 
    • requested dose is 1 g/kg per day on 2 consecutive days every 4 weeks (total monthly dose: 2 g/kg); and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

     

Prevention of recurrent infection in B-cell chronic lymphocytic leukemia

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

       

Prevention of recurrent infection in pediatric HIV members

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is < 18 years of age; and
    • CD4 count is ≥ 200 cells/microliter (within the last three months); and
    • requested dose is 400 mg/kg every 28 days; and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

       

Primary immunodeficiency disorders

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

      

Specific antibody deficiency (SAD)

  • Documentation of the following is required:
    • appropriate diagnosis with moderate or severe polysaccharide non-responsiveness; and
    • evidence of recurrent infections requiring antibiotic therapy; and
    • requested dose is 400 to 600 mg/kg IV every four weeks or a corresponding subcutaneous dose; and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.

      

Stiff Person Syndrome (SPS)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one benzodiazepine or contraindication to all benzodiazepines; and
    • inadequate response, adverse reaction, or contraindication to baclofen; and
    • requested dose is 2 g/kg, divided over two to three infusions; and
    • for Asceniv, clinical rationale for use instead of other available intravenous immune globulin products.


Original Effective Date: 05/2003

Last Revised Date: 03/2024


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Last updated 05/16/24

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