Interferon alpha is a family of highly homologous, species-specific proteins that possess antiviral, antineoplastic, and immunomodulating activities. Human interferon alpha is commercially available in the United States as interferon alpha-N3 which is a mixture of naturally occurring human interferon alpha proteins, and as interferon alpha-2a and interferon alpha-2b which are of recombinant DNA origin and exist as single interferon subtype preparations.

Interferon may be medically necessary for the treatment of ANY of the following conditions for individuals 18 years or older.

• AIDS-related Kaposi's sarcoma; or 
• Chronic hepatitis B, has compensated disease; or
• Condyloma acuminata (genital warts, intralesional); or
• Hairy cell leukemia, relapsed or refractory; or
• Malignant melanoma; or
• Multiple myeloma; or
• Mycosis fungoides; or
• Non-Hodgkin's lymphoma (follicular); or
• Papillomatosis, laryngeal; or
• Renal cell cancer as a debulking agent; or
• Polycythemia vera (when other treatments have failed); or
  • Oral therapy with hydroxyurea or other myelosuppressive agents are not effective, not tolerated, or is contraindicated; and
  • Phlebotomy is not effective, not tolerated, or contraindicated
    Note: Failure of phlebotomy and or myelosuppresssive agents may be defined as ANY of the following:
    • Lack of hematological control (e.g., hematocrit greater than 45 or platelet count greater than 600 x 10 (9)/L); or
    • Occurrence of intractable symptoms (e.g., headaches, pruitis); or
    • Occurrence of symptoms related to hepatosplenomegaly; or
    • Occurrence of thrombotic of hemorrhagic complications; or
    • Phlebotomy required more often than every 2 months.
• Chronic phase, Philadelphia chromosome-positive chronic myelogenous leukemia. 

Chronic Hepatitis C

Initial therapy with Interferon Alpha may be considered medically necessary in individuals with diagnosis of chronic hepatitis C infection. The prescribing clinician must be a gastroenterologist, hepatologist, infectious diseases physician or a liver transplant physician.

• For individuals with Genotype 1, Interferon alpha may be considered medically necessary if ANY of the following criteria is met:
  • Interferon alpha is being used in combination with sofosbuvir (Sovaldi) and ribavirin; or
  • Interferon alpha is being used in combination with telaprevir (Incivek) and ribavirin; or
  • Interferon alpha is being used in combination with boceprevir (Victrelis) and ribavirin; or
  • Interferon alpha is being used in combination with simeprevir (Olysio) and ribavirin. If the individual is genotype 1a, coverage will be limited to individuals without Q80K polymorphism.
• For individuals with Genotypes 2, 3, 4, 5, Interferon alpha may be considered medically necessary if ANY of the following criteria is met:
  • Interferon alpha is being used in combination with sofosbuvir (Sovaldi) and ribavirin in treatment naïve individuals or individuals who have previously failed a regimen containing interferon alpha and ribavirin. 

NOTE: Dosage recommendations per the FDA label.

NOTE:  Interferon alpha is not to be used with ledipasvir/sofosbuvir (Harvoni) or paritaprevir/ritonavir/ombitasvir + dasabuvir (Viekira Pak).

Interferon alpha is not to be used in members with Genotype 1 infection and previous failure of an interferon alpha-containing regimen.

Bone Cancer – Giant Cell Tumor of the Bone

• Used as therapy for ANY of the following:
  • a single agent or combined with denosumab or radiation therapy for localized disease; or
  • a single agent for metastatic disease. 

Central nervous system Cancers, e.g. leptomeningeal metastases: intracerebrospinal fluid (CSF) treatment

• as induction therapy for primary treatment of good-risk individuals with normal CSF flow; or
• as maintenance therapy for individuals with negative CSF cytology or for clinically stable individuals with persistently positive CSF cytology; or
• as post induction therapy for individuals with positive CSF cytology.

Central Nervous System Cancer, Meningiomas

• treatment for surgically inaccessible recurrent or progressive meningiomas when further radiation is not possible. 

Chronic Myelogenous Leukemia (CML)

• Chronic Myelogenous Leukemia (CML) – follow-up therapy in rare individuals unable to tolerate imatinib, dasatinib, niltinib or bosutinib with ANY of the following:
  • BCR-ABL1 transcript levels >10% at 3 or 6 months; or 
  • partial, minor, or no cytogenetic response or cytogenetic relapse at 12 months; or
  • less than complete cytogenetic response or cytogenetic relapse at 18 months.
• CML Post transplant follow-up treatment in individuals with ANY of the following:
  • molecular relapse (polymerase chain reaction positive) following complete cytogenetic response; or
  • cytogenetic relapse or those who do not achieve complete cytogenetic response. 

Kidney Cancer

• First-line therapy in combination with bevacizumab for relapse or for surgically unresectable stage IV disease with predominant clear cell histology. 

Melanoma

• Intralesional therapy for ANY of the following:
  • unresectable stage III in-transit metastases, particularly superficial cutaneous or dermal lesions; or
  • local/satellite and/or in-transit unresectable recurrence.
• Adjuvant treatment for ANY of the following:
  • stage IIB or C disease following wide excision; or
  • stage III disease with nodal metastases following wide excision and/or lymph node dissection; or
  • stage III in-transit disease following primary treatment; or
  • local/satellite and/or in-transit recurrence following initial treatment; or
  • nodal recurrence following complete lymph node dissection.
• Therapy for metastatic or unresectable disease in combination with cisplatin and vinblastine with either dacarbazine or temozolomide and with interleukin-2 for ANY of the folloiwng:
  • first-line therapy for BRAF V600 wild type disease if clinical deterioration is anticipated in ≤12 week; or
  • second-line or subsequent therapy for disease progression of BRAF V600 wild type disease for individuals with performance status (PS) 0-2; or
  • second-line or subsequent therapy for BRAF V600 mutant disease if clinical deterioration is anticipated in ≤12 weeks for disease progression or following maximum clinical benefit from BRAF targeted therapy for individuals with PS 0-2. 

Multiple myeloma              

• Maintenance therapy as a single agent for ANY of the following:
  • for active (symptomatic) myeloma responding to primary myeloma therapy; or
  • for stable or responsive disease following stem cell transplant; or
  • with second tandem transplant for stable or responsive disease following autologous stem cell transplant.         
• Multiple Myeloma - Systemic Light Chain Amyloidosis
  • primary treatment in combination with dexamethasone
    

NHL - Adult T-Cell Leukemia/Lymphoma

• Used in combination with zidovudine for chronic, smoldering, or acute disease for ANY of the following:
  • first-line therapy; or
  • additional therapy following response to first-line therapy; or
  • additional therapy for acute disease in nonresponders if not previously received.

NHL - Hairy Cell Leukemia

• Single-agent therapy in individuals with the indication  for treatment for ANY of the following: 
  • refractory disease; or
  • relapse within one year of complete response.

NHL - Mycosis Fungoides (MF)/Sezary Syndrome (SS)

• Systemic biologic therapy for ANY of the following:
  • single agent or in combination with skin-directed therapy for stage I-IIA and stage III MF with blood involvement; or
  • single agent or in combination with skin-directed therapies for stage I-IIA MF with histologic evidence of folliculotropic or large cell transformation or stage IIB MF with limited extent tumor disease; or
  • single agent or in combination with systemic retinoids, phototherapy, or photopheresis (with or without systemic retinoids) for stage IA-IIB MF with histologic evidence of folliculotropic or large cell transformation, or stage IIB MF with generalized extent tumor, transformed, and/or folliculotropic disease, with or without skin-directed therapy; or
  • as a single agent or in combination with systemic retinoids, phototherapy, or photopheresis (with or without systemic retinoids) for SS; or
  • May be used as adjuvant systemic biologic therapy after total skin electron beam therapy for stage IIB MF generalized extent tumor, transformed, and/or folliculotropic disease or after chemotherapy for stage IV non-Sezary or visceral disease; or
    o Systemic biologic therapy as a single agent or in combination with systemic retinoids, phototherapy, or photopheresis (with or without systemic retinoids), with or without skin-directed therapy for refractory or progressive stage I-III MF.

 NHL - Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders

• Single-agent therapy for primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions for ANY of the following:
  • primary treatment; or

Soft Tissue Sarcoma - Desmoid Tumors (Aggressive Fibromatosis)

• Low-dose single agent for primary, recurrent, or progressive disease for ANY of the following:
  • initial treatment for resectable disease; or
  • adjuvant treatment for gross residual disease; or
  • initial treatment for unresectable disease or for disease for which surgery would be unacceptably morbid.