CurrentAvMedPolicy N/A

Arcalyst (rilonacept) — Pharmacy Prior Authorization / Coverage Criteria

Prior authorization and step-edit requirements for coverage of Arcalyst (rilonacept) for AvMed members, including initial and reauthorization clinical criteria, dosing, and documentation requirements for multiple inflammatory indications.

Policy Summary

PayerAvMed

PolicyArcalyst (rilonacept) — Pharmacy Prior Authorization / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and fax the prior authorization form with required documentation (labs, chart notes, prior therapy verification) to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial approval duration

1 yearReauthorization approval duration

320→160 mgDose limits

PropriumRxDispensed by

Coverage Criteria for Arcalyst (rilonacept)

Initial Therapy - SJIA

Policy Summary

PayerAvMed

PolicyArcalyst (rilonacept) — Pharmacy Prior Authorization / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and fax the prior authorization form with required documentation (labs, chart notes, prior therapy verification) to 1-305-671-0200.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

SJIA initial therapy: Member is not on concurrent treatment with a TNF inhibitor or other biologic response modifier; member's current weight documented; reference labs (CRP, SAA) submitted; date of diagnosis noted; member must have had trial and failure of NSAIDs and corticosteroids for >3 months consecutively within the last 4 months (paid claims will be reviewed for verification); member must have had ≥2 active joints with concomitant fever for at least 5 days and trial of prednisone or equivalent dosed at 0.5 mg/kg/day or 30 mg/day within the last 3 months of this request; member must have had fever >38°C (100.4°F) for at least 2 weeks within the last 2 months of this request; member must have had one of the following measurements of active disease: CRP >15 mg/L OR ESR >45 mm/hr within the last 2 months of this request

Dosage: 160 mg once weekly

Initial Therapy - AOSD

Covered when ALL of the following are met for Adult Onset Still Disease (AOSD):

AOSD initial therapy: Member is ≥18 years of age; member must meet at least two of the following clinical features: fever >39°C lasting ≥1 week, arthralgia or arthritis lasting ≥2 weeks, typical rash, leukocytosis >10,000/mm3 with >80% neutrophils; disease activity based on DAS28 ≥3.2 at screening; member must have one of the following measurements of active disease: CRP >15 mg/L OR ESR >45 mm/hr within the last 2 months of this request; member must have had ≥2 painful/swollen joints for at least 2 weeks within the last 3 months of this request; trial and failure of at least 1 week of glucocorticoids (≤10 mg/day prednisone equivalent) AND at least 4 weeks of NSAIDs within the last 3 months of this request; member has had trial and failure of Kineret (anakinra)

Dosage: 160 mg once weekly

Initial Therapy - CAPS (FCAS, MWS, NOMID)

Covered when ALL of the following are met for CAPS spectrum disorders (FCAS, MWS, NOMID):

CAPS initial therapy: Prescribed by or in consultation with a Rheumatologist or Immunologist with expertise in CAPS; member has two or more CAPS-typical symptoms (urticaria-like rash, cold-triggered episodes, sensorineural hearing loss, musculoskeletal symptoms, chronic aseptic meningitis, skeletal abnormalities); member has elevated serum markers indicating active disease (CRP and SAA) with labs collected within the last 30 days; member has documented laboratory evidence of a genetic mutation in CIAS1/NLRP3 (examples: R26OW, T348M, D303N, E311K, M662T, A439V, D305N, T436N, T4361) with genetic testing results submitted; member has diagnosis of FCAS, MWS, or NOMID; member has had trial and failure of Kineret (anakinra)

Dosage (children ≥12 years and adolescents ≤17): loading SubQ 4.4 mg/kg (max 320 mg), maintenance begin 1 week after loading SubQ 2.2 mg/kg once weekly (max 160 mg). Adolescents ≥18 years: loading 320 mg as two 160 mg injections same day; maintenance 160 mg once weekly

Initial Therapy - DIRA

Covered when ALL of the following are met for Deficiency of interleukin 1 receptor antagonist (DIRA):

DIRA initial therapy: Prescribed by or in consultation with a Rheumatologist or Immunologist with expertise in DIRA; member must weigh ≥10 kg; member must not be receiving another IL-1 antagonist medication (example: Ilaris or Kineret); member must have one of the following clinical findings documented in chart notes: pustular dermatitis, osteomyelitis, or vertebral destruction; member must have elevated serum markers indicating active disease (CRP or ESR) with labs collected within the last 30 days; member must have documented laboratory evidence of a genetic mutation in IL1RN (DIRA) with genetic testing results submitted; member has had trial and failure of Kineret (anakinra)

Dosage for children ≥10 kg and adolescents: 4.4 mg/kg once weekly (max 320 mg/dose)

Initial Therapy - Recurrent Pericarditis

Covered when ALL of the following are met for Recurrent Pericarditis:

Pericarditis initial therapy: Member is >12 years old; treatment is for recurrent pericarditis defined as two recurrent episodes with symptoms such as pericarditic chest pain, pericardial rub, pericardial effusion, or ST-segment elevation/PR depression; member has failed one of the following within the last 6 months (verified by pharmacy paid claims): aspirin (750–1000 mg every 8 hours for 30 days), ibuprofen (600–800 mg every 8 hours for 30 days), or indomethacin (25–50 mg every 8 hours for 30 days), or failed prednisone (0.2–0.5 mg/kg daily) for 90 days, and member has failed colchicine (0.5–1.2 mg) for 90 days; member has at least one elevated serum marker indicating active disease: CRP >10 mg/L OR ESR >20 mm/hr (labs collected within the last 30 days)

Initial dose 320 mg; maintenance 160 mg once weekly

Reauthorization

Reauthorization criteria (applies across indications):

Reauthorization: Provide current progress notes documenting CRP and/or SAA levels and symptoms; absence of unacceptable toxicity from the drug (examples include severe hypersensitivity reactions, serious infections including tuberculosis, and macrophage activation syndrome); member is receiving ongoing monitoring for presence of TB or other active infections; demonstration of disease response as indicated by improvement in patient's symptoms from baseline AND improvement in serum levels (CRP/ESR and/or SAA) to within normal range

Reauthorization approval: 1 year

Concurrent use of another interleukin-1 antagonist or other biologic response modifier is not permitted. The form explicitly requires that the member is not on concurrent treatment with a TNF inhibitor or other biologic response modifier (examples listed) for initial approval and, for DIRA, specifies the member is not receiving another IL‑1 antagonist medication (example Ilaris® or Kineret®). Documentation (chart notes or paid pharmacy claims) will be reviewed to verify absence of overlapping biologic therapy.

Requests that indicate concurrent biologic therapy should be denied or returned for clarification unless clear documentation supports an appropriate washout or discontinuation of the other agent. Providers must submit supporting records showing the other biologic was stopped and appropriate timing relative to the requested rilonacept start date.

Initial Dosing and Administration

Initial dosing

Initial dosing — dosing instructions by age/weight and loading/maintenance schedule:

Pediatric/adolescent dosing: Children ≥12 years and adolescents ≤17 years: loading SubQ 4.4 mg/kg (maximum 320 mg/dose; max injection volume 2 mL per injection) and begin maintenance 1 week after loading with SubQ 2.2 mg/kg once weekly (maximum 160 mg/dose)

Prescribed by or in consultation with a Rheumatologist or Immunologist

Adult dosing: Adolescents ≥18 years and adults: loading 320 mg administered as two separate 160 mg injections on the same day at different sites; begin maintenance 1 week after loading with 160 mg once weekly

Arcalyst (rilonacept) — Maximum loading and maintenance doses (inv-19)

Maximum loading dose320 mg on day 1 (single-day loading dose)

Maintenance dose160 mg subcutaneously once weekly starting 1 week after loading dose

Injection detailsLoading dose may be given as two 160 mg injections at different sites for adults if needed to reach 320 mg

Reauthorization / Continuation Requirements

Reauthorization / Continuation Therapy

Requirements for continued approval (applies across indications):

Continuation therapy: Provide progress notes documenting CRP and/or SAA levels and symptom improvement; absence of unacceptable toxicity (severe hypersensitivity, serious infections including tuberculosis, macrophage activation syndrome); ongoing monitoring for TB or other active infections; demonstration of disease response with improvement in symptoms from baseline and normalization or improvement of serum markers

Reauthorization period: 1 year

Provider Actions and Prior Authorization Process

Prior Authorization

Prior Authorization Required

Prior Authorization is required for this drug. Complete and submit the AvMed pharmacy prior authorization/step-edit request form. Fax completed form to 1-305-671-0200. Incomplete, incorrect, or illegible forms (including missing phone/fax numbers) may delay processing or result in denial.

Fax: 1-305-671-0200
Use AvMed pharmacy prior authorization/step-edit request form (prescriber must sign; preprinted stamps not valid)

Documentation Required

Prescriber / Contact Information

Prescriber information must be provided on the authorization form. The prescribing physician must sign and clearly print their name (preprinted stamps are not valid). Include office contact name, phone and fax numbers, and DEA or NPI number. Authorization may be delayed if prescriber/contact information is incomplete.

Prescriber signature and printed name required (no preprinted stamps)
Office contact name, phone number, fax number
DEA or NPI number

Step Therapy

Step Therapy / Prior Treatment Requirements

Step therapy and prior treatment trials must be documented on the form and supported by chart notes or paid pharmacy claims where indicated. Specific required prior treatments vary by diagnosis and must be met prior to approval.

General: Document trials and failures of NSAIDs and corticosteroids when required (e.g., SJIA: >3 months consecutively within last 4 months). Paid claims will be reviewed for verification.
AOSD: Trial and failure of at least 1 week of glucocorticoids (≤10 mg/day prednisolone equivalent) AND ≥4 weeks of NSAIDs within last 3 months; trial and failure of Kineret® required.
CAPS/DIRA and others: Trial and failure of Kineret® required where specified
Pericarditis: Failed therapy within last 6 months with one of: aspirin (750–1000 mg q8h x30d), ibuprofen (600–800 mg q8h x30d), indomethacin (25–50 mg q8h x30d), prednisone (0.2–0.5 mg/kg daily x90d), and failed colchicine (0.5–1.2 mg x90d)

Documentation Required

Required Supporting Documentation

Required supporting documentation must be submitted with the request. Provide recent laboratory results, genetic testing (when applicable), and clinic/office notes demonstrating diagnosis, disease activity, and prior therapy trials and failures. Reauthorization requires current progress notes documenting CRP/SAA and symptoms.

Laboratory results: CRP, Serum Amyloid A (SAA), and/or ESR — submit labs collected within the last 30 days for CAPS/DIRA indications; other diagnoses specify last 2 months or as noted
Specific lab thresholds where required (examples): CRP >15 mg/L, ESR >45 mm/hr for some indications; pericarditis: CRP >10 mg/L or ESR >20 mm/hr
Genetic testing results: documentation of NLRP3 (CIAS1) mutations for CAPS or IL1RN mutations for DIRA when required
Clinic notes/chart documentation: date of diagnosis, symptom duration (fever, active joints), weight, dosing, documentation of trials and failures (include paid claims where applicable)
Reauthorization: current progress notes documenting CRP/SAA levels and ongoing monitoring for infections/TB

Laboratory Thresholds and Coding Guidance

Laboratory thresholds — CRP, SAA, ESR (inv-08)

CRP normal< 8 mg/L

SAA normal< 10 mg/L

Active disease — general threshold (example)CRP > 15 mg/L or ESR > 45 mm/hr

Recurrent pericarditis thresholdsCRP > 10 mg/L or ESR > 20 mm/hr

Prior therapy / requirement	Verification method
Trial and failure of NSAIDs and corticosteroids (for SJIA): >3 months consecutively within the last 4 months	Pharmacy paid claims or chart notes confirming medication fills and duration; chart documentation of trial/failure
Trial and failure of at least 1 week of glucocorticoids (≤10 mg/day prednisone equivalent) AND ≥4 weeks of NSAIDs (for AOSD) within last 3 months	Pharmacy paid claims or chart notes verifying medication trials and dates; provider notes documenting inadequate response or intolerance
Trial and failure of Kineret (anakinra) (required for CAPS and DIRA)	Pharmacy paid claims confirming prior anakinra therapy or chart notes documenting trial and outcome
Failure of aspirin, ibuprofen, indomethacin, or prednisone and colchicine (for recurrent pericarditis) as specified (e.g., aspirin 750–1000 mg q8h ×30 days; ibuprofen 600–800 mg q8h ×30 days; indomethacin 25–50 mg q8h ×30 days; prednisone 0.2–0.5 mg/kg daily ×90 days; colchicine 0.5–1.2 mg ×90 days)	Pharmacy paid claims to verify medication fills and durations or chart notes documenting treatment courses and failure within the last 6 months
General requirement: prior trials of specified therapies (NSAIDs, corticosteroids, anakinra, colchicine, etc.) as detailed per diagnosis	Pharmacy paid claims or chart notes must be submitted to verify prior trials and failures

Site of Care and Specialty Pharmacy

Billing Rule

Specialty pharmacy — medication provided by PropriumRx

Arcalyst is supplied through a specialty pharmacy; the form indicates PropriumRx will provide the medication and the site of administration is not explicitly restricted on the form.

Medication being provided by a Specialty Pharmacy — PropriumRx
Site of administration is not specified/restricted on the prior authorization form

Background — Drug and Indications

Arcalyst (rilonacept) is an interleukin‑1 (IL‑1) inhibitor used for several autoinflammatory conditions. The policy covers indications including Systemic Juvenile Idiopathic Arthritis (SJIA), Adult‑onset Still’s Disease (AOSD), Cryopyrin‑Associated Periodic Syndromes (CAPS: FCAS, MWS, NOMID), Deficiency of IL‑1 receptor antagonist (DIRA), and recurrent pericarditis.

Dosing varies by indication and age: pediatric/adolescent CAPS and DIRA dosing is weight‑based with a loading dose of 4.4 mg/kg (maximum 320 mg) and maintenance 2.2 mg/kg weekly (maximum 160 mg); adult/adolescent ≥18 dosing typically uses a 320 mg loading dose (two 160 mg injections) followed by 160 mg once weekly. For recurrent pericarditis the form lists initial 320 mg, maintenance 160 mg weekly.

The authorization form requires objective evidence of active disease (for example, recent elevated inflammatory markers such as CRP or SAA submitted within the last 30 days for CAPS and DIRA, or CRP/ESR thresholds specified for SJIA, AOSD, and pericarditis) and documentation of prior therapy trials and failures where applicable (NSAIDs, corticosteroids, anakinra/Kineret, colchicine, etc.).

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