ACTIMMUNE, Interferon Gamma-1B Form

Interferon gamma-1b (Actimmune®) is a recombinant form of gamma interferon. FDA Approved Indication(s) Actimmune is indicated for: • Reducing the frequency and severity of serious infections associated with chronic granulomatous disease (CGD) • Delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO) Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Actimmune is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Chronic Granulomatous Disease (must meet all):

1. Diagnosis of CGD;
   2. Age ≥ 1 year;
   3. Prescribed by or in consultation with a hematologist or infectious disease specialist;
   4. Dose does not exceed one of the following (a or b): a. Body surface area (BSA) > 0.5 m2: 50 mcg/m2 three times weekly; b. BSA ≤ 0.5 m2: 1.5 mcg/kg three times weekly. Approval duration:
      Medicaid/HIM – 6 months Commercial – 6 months or member’s renewal period, whichever is longer
      B. Severe Malignant Osteopetrosis (must meet all):

2. Diagnosis of SMO (also known as autosomal recessive osteopetrosis);

   2. Prescribed by or in consultation with an endocrinologist or rheumatologist;
   3. Age ≥ 1 month;
   4. Dose does not exceed one of the following (a or b): a. BSA > 0.5 m2: 50 mcg/m2 three times weekly; b. BSA ≤ 0.5 m2: 1.5 mcg/kg three times weekly. Approval duration:
      Medicaid/HIM – 6 months Page 1 of 6

   CLINICAL POLICY Interferon Gamma-1b Commercial – 6 months or member’s renewal period, whichever is longer
   C. Mycosis Fungoides, Sezary Syndrome (off-label) (must meet all):

3. Diagnosis of mycosis fungoides or Sezary syndrome;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Request meets one of the following (a, b, or c): a. BSA > 0.5 m2: Dose does not exceed 50 mcg/m2 three times weekly; b. BSA ≤ 0.5 m2: Dose does not exceed 1.5 mcg/kg three times weekly; c. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.
      Approval duration:
      Medicaid/HIM – 6 months Commercial – 6 months or member’s renewal period, whichever is longer
      D. Other diagnoses/indications (must meet 1 or 2):
4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. All Indications in Section I (must meet all):
6. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Documentation supports that member is currently receiving Actimmune for mycosis fungoides or Sezary syndrome and has received this medication for at least 30 days;

7. Member is responding positively to therapy;

   3. If request is for a dose increase, request meets one of the following (a, b, or c):* a. BSA > 0.5 m2: New dose does not exceed 50 mcg/m2 three times weekly; b. BSA ≤ 0.5 m2: New dose does not exceed 1.5 mcg/kg three times weekly;
      Page 2 of 6

   CLINICAL POLICY Interferon Gamma-1b c. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN. Approval duration:
   Medicaid/HIM – 6 months Commercial – 6 months or member’s renewal period, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):

8. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

9. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key BSA: body surface area
   CGD: chronic granulomatous disease
   Appendix B: Therapeutic Alternatives Not applicable FDA: Food and Drug Administration
   SMO: severe, malignant osteopetrosis
   Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to interferon gamma, E. coli derived products, or any component of the product • Boxed warning(s): none reported Page 3 of 6

   CLINICAL POLICY Interferon Gamma-1b V. Dosage and Administration
   Indication CGD, SMO Dosing Regimen BSA > 0.5 m2: 50 mcg/m2 SC TIW BSA ≤ 0.5 m2: 1.5 mcg/kg/dose SC TIW VI. Product Availability
   Single-use vial for injection: 100 mcg (2 million IU)/0.5 mL Maximum Dose See dosing regimen VII.