Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Canakinumab (Ilaris) may be approved if:
- Information has been provided that indicates the individual has been treated with canakinumab (Ilaris) (starting on samples is not approvable) within the last 90 days; or
- The prescriber states that the individual has been treated with canakinumab (Ilaris) (starting on samples is not approvable) within the past 90 days and is at risk if therapy is changed; or
Canakinumab (Ilaris) may be approved when ALL of the following are met:
- ONE of the following:
- The individual’s age is within FDA labeling for the requested indication for canakinumab (Ilaris); or
- The prescriber has provided information in support of using canakinumab (Ilaris) for the individual’s age; and
- ONE of the following:
- BOTH of the following:
- The individual has one of the following indications:
- Cryopyrin Associated Periodic Syndrome (CAPS); or
- Familial Cold Auto-Inflammatory Syndrome (FCAS); or
- Muckle-Wells Syndrome (MWS); and
- BOTH of the following:
- The individual has elevated pretreatment serum inflammatory markers (C-reactive protein/serum amyloid A); and
- The individual has at least TWO of the following symptoms typical for CAPS:
- 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
- The individual has a diagnosis of Familial Mediterranean Fever (FMF) AND ONE of the following:
- The individual has tried and had an inadequate response to colchicine for at least 6 months; or
- The individual has an intolerance or hypersensitivity to colchicine; or
- The individual has an FDA labeled contraindication to colchicine; or
- The individual has a diagnosis of Hyperimmunoglobulin D Syndrome (HIDS) or Mevalonate Kinase Deficiency (MKD); or
- The individual has a diagnosis of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS); or
- The individual has a diagnosis of Active systemic juvenile idiopathic arthritis (SJIA) AND BOTH of the following:
- The individual has documented active systemic features (e.g., ongoing fever for at least 2 weeks, evanescent erythematous rash, generalized lymphadenopathy, ≥1 joint with active arthritis, hepatomegaly, splenomegaly, serositis); and
- ONE of the following:
- The individual has tried and had an inadequate response to TWO of the following drug classes:
- DMARDs (i.e., methotrexate, leflunomide) for at least a 3-month trial; or
- Systemic glucocorticoids (oral or IV) for at least a 3-month trial; or
- NSAIDs for at least a 1-month trial; or
- The individual has an intolerance or hypersensitivity to TWO of the prerequisite drug classes; or
- The individual has an FDA labeled contraindication to ALL prerequisite agents; or
- The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex for the treatment of SJIA; or
- The individual has a diagnosis of Adult onset Still’s disease and BOTH of the following:
- ONE of the following:
- The individual has tried and had an inadequate response to at least ONE corticosteroid; or
- The individual has an intolerance or hypersensitivity to ONE corticosteroid; or
- The individual has an FDA labeled contraindication to ALL corticosteroids; and
- ONE of the following:
- The individual has tried and had an inadequate response to methotrexate; or
- The individual has an intolerance or hypersensitivity to methotrexate; or
- The individual has an FDA labeled contraindication to methotrexate; or
- The individual has another FDA approved indication for canakinumab (Ilaris); or
- The individual has another indication that is supported in compendia for canakinumab (Ilaris); and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., allergist, immunologist, pediatrician, rheumatologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual will NOT be using canakinumab (Ilaris) in combination with another biologic immunomodulator agent or Zeposia; and
- The individual does NOT have any FDA labeled contraindications to canakinumab (Ilaris).
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