Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Canakinumab (Ilaris) may be approved when ALL of the following are met:
- The individual must meet criteria as outlined in prescribing information (PI) including recommendations for diagnosis and age; and
- The prescriber is a specialist, or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- One of the following criteria is met:
- The individual has failed a 3-month trial of an interleukin-1 inhibitor (e.g. Kineret), interleukin-6 inhibitor (e.g. Actemra), or tumor necrosis factor (TNF)-blocker (e.g., Enbrel, Humira, Cimzia, and Simponi), as evidenced by paid claims or pharmacy print outs; or
- Clinical justification must be provided explaining why the individual is unable to use the preferred agents (subject to clinical review); and
- ONE of the following:
- A diagnosis of Cryopyrin Associated Periodic Syndrome (CAPS) and ALL of the following:
- The individual has elevated pretreatment serum inflammatory markers (e.g. C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) serum amyloid A(SAA)); and
- The individual has at least two of the following symptoms (as evidenced by documentation):
- Urticaria-like rash
- Cold/stress triggered episodes
- Sensorineural hearing loss
- Musculoskeletal symptoms of arthralgia/arthritis/myalgia
- Chronic aseptic meningitis
- Skeletal abnormalities of epiphyseal overgrowth/frontal bossing; or
- A diagnosis of Familial Mediterranean Fever (FMF) and the individual experiences one or more attacks each month despite receiving maximally tolerated dose of colchicine for at least 6 months, as evidenced by paid claims or pharmacy print outs and clinical documentation; or
- A diagnosis of Hyperimmunoglobulin D Syndrome/Mevalonate Kinase (MVK) Deficiency and ONE of the following in addition to clinical features of the disease:
- Immunoglobulin D (IgD) is elevated (>14 mg/dL); or
- Immunoglobulin A (IgA) level is elevated (>260 mg/dL); or
- Mutations in the MVK gene or decreased MVK activity; or
- Recurrent attacks with elevated serum inflammatory markers (e.g. C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) serum amyloid A(SAA)); or
- A diagnosis of Still's Disease* and at least TWO of the following symptoms (as evidenced by documentation):
- Fever lasting for at least 2 weeks
- Evanescent erythematous rash
- Lymphadenopathy
- Splenomegaly
- Arthritis or arthralgia; or
- A diagnosis of Tumor Necrosis Factor Receptor Associated Periodic Syndrome and ONE of the following (as evidenced by documentation):
- Genetic testing confirming pathogenic variants in the tumor necrosis factor receptor 1 (TNFR1) gene (TNF receptor superfamily individual 1A, TNFRSF1A); or
- BOTH of the following:
- Elevated serum inflammatory markers (e.g. C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) serum amyloid A(SAA)); and
- History of recurrent fever, prominent myalgias, migratory rash, and periorbital edema.
- Includes: Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA)
Initial Authorization: 6 months
Reauthorization Criteria
Continuation of therapy with canakinumab (Ilaris) may be considered medically necessary when the following is met:
- The individual must have experienced and maintained clinical benefit since starting treatment with the requested medication, as evidenced by medical documentation (e.g. chart notes) attached to the request (subject to clinical review.
Continuation Authorization: 12 months
The use of canakinumab (Ilaris) for any other indication is considered experimental/investigational and therefore, not covered. Scientific evidence does not support its efficacy or safety for any other indications.
Procedure Codes
