Note: Gammagard, Gammaplex and Gamunex-C are also subject to Medicare B vs D review

Gammagard, Gammaplex and Gamunex-C will be approved when ONE of the following has been met:

1. The patient has ONE of the following diagnoses: 
   1. Primary immunodeficiency [e.g., congenital agammaglobulinemia, common variable immunodeficiency (CVID), severe combined immunodeficiency, Wiskott-Aldrich Syndrome, X-linked agammaglobulinemia (XLA), humoral immunodeficiency, IgG subclass deficiency with or without IgA deficiency] OR 
   2. B-cell chronic lymphocytic leukemia OR multiple myeloma AND ONE of the following: 
      1. The patient has a history of infections OR 
      2. The patient has evidence of specific antibody deficiency OR 
      3. The patient has hypogammaglobulinemia OR 
   3. Idiopathic thrombocytopenia purpura AND ONE of the following: 
      1. The patient has failed ONE conventional therapy [e.g., corticosteroids (e.g., methylprednisolone), or immunosuppressants (e.g., azathioprine)] OR 
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ONE conventional therapy OR 
   4. Dermatomyositis AND ONE of the following: 
      1. The patient has failed ONE conventional therapy [e.g., corticosteroids (e.g., methylprednisolone) or immunosuppressants (e.g., azathioprine)] OR 
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ONE conventional therapy OR 
   5. Polymyositis AND ONE of the following: 
      1. The patient has failed ONE conventional therapy [e.g., corticosteroids (e.g., methylprednisolone) or immunosuppressants (e.g., azathioprine)] OR 
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ONE conventional therapy OR 
   6. Severe rheumatoid arthritis AND ONE of the following: 
      1. The patient has failed ONE conventional therapy [e.g., tumor necrosis factor antagonists (e.g., Enbrel), DMARDS (e.g., methotrexate)] OR 
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ONE conventional therapy OR 
   7. Myasthenia gravis (MG) AND ONE of the following: 
      1. The patient is in acute myasthenic crisis OR 
      2. The patient has severe refractory MG (e.g., major functional disability/weakness) AND ONE of the following: 
         1. The patient has failed ONE immunomodulator therapy (i.e., corticosteroid, pyridostigmine, or azathioprine) OR 
         2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ONE immunomodulator therapy OR 
   8. Multiple sclerosis (MS) AND BOTH of the following: 
      1. The patient has a diagnosis of relapsing remitting MS (RRMS) AND 
      2. The patient has had an insufficient response, documented failure, or FDA labeled contraindication to TWO MS medications (see below for formulary-specific preferred medications) OR 
   9. Acquired von Willebrand hemophilia AND ONE of the following: 
      1. The patient has failed ONE conventional therapy (e.g., desmopressin, von Willebrand factor replacement therapy, corticosteroids, cyclophosphamide, FEIBA, or recombinant factor VIIa) OR 
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ONE conventional therapy OR 
   10. Refractory pemphigus vulgaris AND ONE of the following: 
       1. The patient has failed ONE conventional immunosuppressive therapy (e.g., azathioprine, cyclophosphamide, mycophenolate, corticosteroids) OR 
       2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ONE conventional immunosuppressive therapy OR 
2. ONE of the following: 
   1. The patient has another FDA labeled indication for the requested medication OR 
   2. The patient has an indication that is supported in CMS approved compendia for the requested medication 

Length of approval: 12 months unless otherwise indicated below.

The preferred medications for MS are as follows (formulary specific): 

MAPD Stars formulary:

Avonex, Betaseron, Copaxone, dimethyl fumarate, fingolimod, glatiramer, Glatopa, Plegridy, Vumerity

Enhanced formulary:

Avonex, Betaseron, Copaxone, dimethyl fumarate, fingolimod, glatiramer, Glatopa, Kesimpta, Plegridy, Vumerity

Basic formulary:

Betaseron, Copaxone, dimethyl fumarate, Kesimpta