Actimmune (interferon gamma-1b) — Clinical Drug Coverage Criteria
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Clinical drug coverage criteria for Actimmune (interferon gamma-1b) under the member's medical benefit, specifying indications where requests may be approved or denied and applicable coding. Applies to providers seeking prior authorization for members in the plan.
No material clinical or coverage changes in this revision.
Coverage Criteria for Actimmune (interferon gamma-1b)
Initial therapy / Approved indications
Requests for Actimmune (interferon gamma-1b) may be approved if the following criteria are met:
Primary approval path
- Age or qualifying diagnosis: Member is under 19 years of age OR member has a diagnosis of chronic granulomatous disease OR member has a diagnosis of severe malignant osteopetrosis OR member has mycosis fungoides (including Sézary syndrome, NCCN 2A)
Age under 19 is sufficient alone; alternatively any one of the listed diagnoses qualifies.
Restates the policy-approved indications as alternative qualifying conditions.
Requests for Actimmune (interferon gamma-1b) will not be approved for the following explicit indications: advanced ovarian or primary peritoneal cancer; atopic dermatitis; brain tumors; chronic hepatitis C; Friedreich's ataxia; idiopathic pulmonary fibrosis; invasive fungal infection post-transplantation (for example, after hematopoietic stem cell or solid organ transplantation); metastatic renal cell cancer; and pulmonary tuberculosis.
Use of Actimmune for any condition that does not meet the policy's listed approval criteria is considered not medically necessary and will not be approved.
Coding
| J9216 | Injection, interferon, gamma-1b, 3 million units [Actimmune] |
| C84.00-C84.09 | Mycosis fungoides |
| C84.10-C84.19 | Sézary disease |
| D71.8 | Other functional disorders of polymorphonuclear neutrophils [chronic granulomatous disease] |
| D71.9 | Functional disorders of polymorphonuclear neutrophils, unspecified [chronic granulomatous disease] |
| Q78.2 | Osteopetrosis |
| C84.00-C84.09 | Mycosis fungoides |
Provider Actions and Authorization
Prior authorization required for Actimmune
Prior authorization review applies for Actimmune (interferon gamma-1b); requests are reviewed against the policy clinical criteria and may be approved when the member meets those criteria (age under 19 years and/or a qualifying diagnosis).
- Applicable HCPCS: J9216
Include age and specific diagnosis on requests
Provide a clear diagnosis and age information on the prior authorization request; the clinical criteria require either age <19 years or a qualifying diagnosis (chronic granulomatous disease, severe malignant osteopetrosis, or mycosis fungoides/Sezary syndrome) for approval.
- Include member's date of birth to confirm age criterion.
- List specific ICD-10 diagnosis corresponding to the qualifying condition.
Clinical review and required documentation
When Actimmune is reviewed (including for prior authorization), the request will be evaluated against the medical necessity clinical criteria; approvals are granted only when the policy criteria are met.
- Clinical criteria used for review include age <19 years or a qualifying diagnosis (chronic granulomatous disease, severe malignant osteopetrosis, or mycosis fungoides / Sezary syndrome).
Explicit non‑approved indications — high denial risk
Requests for Actimmune may not be approved for several explicit non‑approved indications; requests for these uses or for any indication not meeting the approval criteria are not approved (not medically necessary).
- Advanced ovarian or primary peritoneal cancer
- Atopic dermatitis
- Brain tumors
- Chronic hepatitis C
- Friedreich's ataxia
- Idiopathic pulmonary fibrosis
- Invasive fungal infection post-transplantation
- Metastatic renal cell cancer
- Pulmonary tuberculosis
- Any indication not meeting the listed approval criteria
Background
Actimmune (interferon gamma-1b) is a biologic response modifier with clinical use focused on specific rare immunologic and skeletal disorders. The policy evaluates requests for Actimmune against defined clinical criteria that identify approved indications (see policy criteria for qualifying age and diagnoses).
Definitions
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