Arcalyst (rilonacept) — Medical Mutual

Initial criteria

• Patient is up to date with all vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND
• Patient has been evaluated and screened for latent TB infection prior to initiating treatment and will receive ongoing monitoring for TB during treatment; AND
• Patient does not have an active infection, including clinically important localized infections; AND
• Will not be administered concurrently with live vaccines; AND
• Patient is not on concurrent therapy with other IL-1 blocking agents (For DIRA, anakinra must be discontinued 24 hours prior to starting Arcalyst); AND
• Patient is not on concurrent treatment with another biologic therapy or targeted synthetic therapy; AND
• For Cryopyrin-Associated Periodic Syndromes (CAPS): Patient is at least age ≥ 12 years; AND Used as a single agent; AND Patient has documented baseline serum levels of inflammatory proteins (CRP and/or SAA); AND Patient has documented laboratory evidence of a genetic mutation in CIAS1 (NLRP3); AND Documented diagnosis of Familial Cold Autoinflammatory Syndrome (FCAS) OR Muckle-Wells Syndrome (MWS); AND Patient has two or more CAPS-typical symptoms (urticaria-like rash, cold-triggered episodes, sensorineural hearing loss, musculoskeletal symptoms, chronic aseptic meningitis, skeletal abnormalities)
• For Deficiency of Interleukin-1 Receptor Antagonist (DIRA): Patient weighs at least 10 kg; AND Patient has a confirmed diagnosis as evidenced by mutation in IL1RN gene; AND Used as maintenance of remission in patients who previously experienced benefit from anakinra therapy
• For Recurrent Pericarditis (RP): Patient is at least age ≥ 12 years; AND Used for treatment of recurrent pericarditis and/or reducing recurrence; AND Patient has documented baseline CRP; AND Patient has failed standard therapy (NSAID, colchicine, corticosteroids, etc.)

Reauthorization criteria

• Patient continues to meet universal and indication-specific initial criteria; AND
• Absence of unacceptable toxicity including severe hypersensitivity, serious infections (including TB), lipid profile changes, etc.; AND
• For Cryopyrin-Associated Periodic Syndromes: Disease response as indicated by improvement in symptoms from baseline AND improvement in inflammatory proteins (CRP and/or SAA) from baseline
• For Deficiency of Interleukin-1 Receptor Antagonist (DIRA): Disease response as indicated by improvement in symptoms (fever, rash, bone pain), inflammatory markers (CRP, ESR), and/or radiological evidence of bone lesions compared to baseline
• For Recurrent Pericarditis: Disease response as indicated by improvement in symptoms (pericarditis pain), inflammatory markers (CRP), and/or decreased recurrence rate

Approval duration

6 months initial, 12 months renewal