CurrentAvMedPolicy N/A

Kineret (anakinra) prior authorization and step-edit coverage criteria

Prior authorization and step therapy requirements for coverage of Kineret (anakinra) for multiple inflammatory and autoinflammatory indications for AvMed members; applies to prescribers and pharmacy/specialty staff submitting requests.

Policy Summary

PayerAvMed

PolicyKineret (anakinra) prior authorization and step-edit coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a signed prior authorization/step-edit request form with complete patient, prescriber, drug, dosing, diagnosis, and supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial/reauthorization period

100 mg dailystandard adult dosing

90 daysestablished-on-therapy window

CRP >10–15 mg/Llab activity thresholds

Coverage Criteria for Kineret (anakinra)

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ALL of the following

Member must be at least 18 years of age
At least 2 of the following
- Fever >39°C, lasting 1 week or longer
- Arthralgia or arthritis, lasting 2 weeks or longer
- Typical rash
- Leukocytosis >10,000/mm3 with >80% polymorphonuclear cells
- Disease activity based on DAS28 of ≥ 3.2 at screening
ANY of the following
- C-Reactive Protein (CRP) >15 mg/L within the last 2 months of this request
- Erythrocyte Sedimentation Rate (ESR) >45 mm/hr within the last 2 months of this request
- ≥ 2 joints that are painful/swollen for at least 2 weeks within the last 3 months of this request
Member must have had trial and failure with at least 1 week of glucocorticoids (dose: ≤10 mg/day prednisolone equivalent) AND at least 4 weeks of NSAIDs within the last 3 months of this request

Initial Therapy and Dosing

Initial therapy and dosing

Diagnosis-specific initial authorization criteria and dosing:

General dosing: Adult dosing commonly cited as SubQ 100 mg daily for multiple indications (RA, SJIA, AOSD, TRAPS, HIDS/MKD, FMF); pediatric and weight-based dosing specified for CAPS and DIRA with maximum daily doses noted; indication-specific maximums apply (see individual diagnosis criteria)

Initial Authorization usually 12 months except RA where authorization length is indefinite

Established / Continuation Therapy

Established therapy

Covered when ONE of the following is met:

Established on Kineret: Member has been established on Kineret for at least 90 days AND prescription claims history indicates at least a 90-day supply of Kineret was dispensed within the past 130 days (verified by chart notes or pharmacy paid claims)

May be used in lieu of failing two preferred biologics for RA; applicable to continuation/established therapy determinations

Step Therapy Requirements

Step	Requirement
1	Member tried and failed, has a contraindication, or intolerance to TWO preferred biologics (preferred adalimumab product; Enbrel; Rinvoq/Rinvoq LQ; preferred tocilizumab product [Actemra SC or Tyenne SC]; Xeljanz/XR) — verified by chart notes or pharmacy paid claims
1 (alternative)	Member has been established on Kineret for at least 90 days AND prescription claims history indicates at least a 90-day supply of Kineret was dispensed within the past 130 days (verified by chart notes or pharmacy paid claims)

Laboratory and Diagnostic Thresholds

CRP / ESR / SAA thresholds

CRP threshold for active diseaseCRP >15 mg/L noted for AOSD; CRP >10 mg/L referenced for TRAPS, HIDS/MKD, FMF and general active disease

ESR threshold for active diseaseESR >45 mm/hr (documented within the last 2 months for AOSD; ESR or CRP acceptable for DIRA reauthorization)

SAA response targetSerum Amyloid A (SAA) levels <10 mg/L cited as part of reauthorization disease-response assessment

Lab timing requirementRelevant labs (CRP, ESR, SAA) must be collected within the last 30 days for many autoinflammatory indications; AOSD allows CRP/ESR within last 2 months

Use in documentationProviders must submit lab results documenting CRP, ESR, and/or SAA to demonstrate active disease or response as specified per diagnosis (submit labs collected within the required time window)

Provider Submission and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Providers must submit a signed prior authorization/step-edit request form with complete patient, prescriber, drug, dosing, diagnosis, and contact information. Incomplete, incorrect, or illegible information (including missing phone/fax or NPI) may delay review or result in denial. Use of samples to initiate therapy does not meet step-edit/preauthorization criteria.

Fax requests to 1-305-671-0200
Prescriber signature must be hand-signed (preprinted stamps not valid)
Include office contact name, phone number, fax number, and prescriber NPI

Step Therapy

Step Edits — Rheumatoid Arthritis

Step edits for Rheumatoid Arthritis — For approval of Kineret (anakinra) for moderate-to-severe active rheumatoid arthritis, all criteria must be met: diagnosis verified, prescribed by or in consultation with a Rheumatologist, and member must have tried and failed at least one DMARD for ≥3 months (hydroxychloroquine, leflunomide, methotrexate, or sulfasalazine). Documentation of prior trials must be verified by chart notes or pharmacy paid claims.

DMARD trial duration: at least 3 months per agent
Acceptable verification: chart notes or pharmacy paid claims
Reauthorization criteria for rheumatoid arthritis: length of authorization is indefinite for this indication only

Documentation Required

Required Supporting Documentation

Required supporting documentation — To support each checked clinical criterion, provide all relevant documentation including diagnosis, chart notes verifying prior therapy trials and failures, pharmacy paid claims, laboratory results, diagnostic testing, and genetic testing when requested. Failure to provide required documentation (lab results, diagnostics, chart notes, pharmacy paid claims, genetic test results) may result in denial.

Lab results: CRP, ESR, Serum Amyloid A (SAA) when indicated; labs should be recent (typically within 30 days, CRP within 2 months for some indications)
Genetic confirmation: MVK gene testing for HIDS/MKD; MEFV gene exon 10 mutation for FMF; NLRP3 (CIAS1) mutations for CAPS when required
Proof of prior therapies: pharmacy paid claims or chart notes (e.g., 90-day supply dispensed evidence where applicable)
Documentation of disease activity and specialist consultation when required (Rheumatologist or Immunologist)

Denial Risk

Concomitant Biologic Therapy Not Permitted

Concomitant biologic therapy — The Health Plan considers use of concomitant therapy with more than one biologic immunomodulator (e.g., Dupixent, Entyvio, Humira, Rinvoq, Stelara, other IL‑1 antagonists) prescribed for the same or different indications to be experimental and investigational. Safety and efficacy of these combinations have not been established and will not be permitted. If initiating Kineret, indicate whether a previously prescribed biologic will be discontinued and provide medication names and effective dates.

Member must NOT be receiving another IL‑1 antagonist (e.g., Ilaris, Arcalyst) for indications where exclusion applies
Checkbox on form: Will the member be discontinuing a previously prescribed biologic if approved for requested medication? — document medication to be discontinued and medication to be initiated with effective dates

Denial Risk

Submission Completeness and Denial Risk

Submission completeness — Ensure every field on the PA/step-edit form is complete and legible. Missing phone/fax, NPI, prescriber signature, or insufficient clinical documentation may delay processing or lead to denial. Specialty pharmacy provisioning and non‑formulary considerations should be noted; documentation of medical necessity required when drug is non‑formulary.

Medication provided by Specialty Pharmacy — Proprium Rx (as applicable)
Use of samples to initiate therapy does not meet criteria
Previous therapies will be verified through pharmacy paid claims or submitted chart notes

Key Definitions and Genetic Criteria

CAPS (Cryopyrin-associated periodic syndromes) — key requirements

Definition of CAPSCryopyrin-associated periodic syndromes (CAPS) include Familial Cold Autoinflammatory Syndrome (FCAS), Muckle‑Wells Syndrome (MWS), and Neonatal‑Onset Multisystem Inflammatory Disease (NOMID)

Genetic confirmation requirementMember must have documented laboratory evidence of a genetic mutation in CIAS1/NLRP3 (submit genetic testing results)

Clinical symptom requirementMember must have at least two CAPS‑typical symptoms (e.g., urticaria‑like rash, cold‑triggered episodes, sensorineural hearing loss, musculoskeletal symptoms, chronic aseptic meningitis, skeletal abnormalities)

Inflammatory marker requirementMember must have elevated serum markers indicative of active disease (CRP and SAA) with labs collected within the last 30 days

Specialist involvementTreatment must be prescribed by or in consultation with a Rheumatologist or Immunologist with expertise in CAPS diagnosis

HIDS/MKD and FMF — genetic and clinical requirements

HIDS/MKD genetic confirmationProvider must submit genetic confirmation of HIDS/MKD (DNA analysis showing mutations in the MVK gene or enzymatic studies showing markedly reduced mevalonate kinase activity)

HIDS/MKD clinical activity requirementHistory of >3 febrile acute flares within a 6‑month period when not receiving prophylactic treatment; labs documenting CRP >10 mg/L within the last 30 days

FMF genetic confirmationProvider must submit genetic confirmation of active Type 1 FMF disease (MEFV gene exon 10 mutation)

FMF clinical activity requirementType 1 FMF with recurrent attacks averaging ≥1 documented attack per month over prior 6 months, each lasting ~12–72 hours; labs documenting CRP >10 mg/L within the last 30 days; trial and failure of maximally dosed colchicine (children 2 mg/day; adults 3 mg/day)

Specialist involvement for bothPrescribed by or in consultation with a Rheumatologist or Immunologist with expertise in the diagnosis

Background on Anakinra (Kineret)

Anakinra (Kineret) is an interleukin‑1 receptor antagonist used for multiple inflammatory and autoinflammatory conditions. Coverage for Kineret requires diagnosis-specific clinical and laboratory criteria and specialist involvement as appropriate (rheumatology or immunology). The prior authorization request form must include dosing, diagnosis, weight when applicable, and supporting clinical documentation; incomplete requests may be delayed or denied. Standard adult SubQ dosing listed on the form is 100 mg daily for indications such as rheumatoid arthritis.

Site of Care and Dispensing

Note

Specialty pharmacy distribution (Proprium Rx); coverage may vary

Medication is provided through the specialty pharmacy (Proprium Rx); specialty distribution, plan coverage, and formulary restrictions may apply and non‑formulary drugs may require additional medical necessity documentation.

Use of samples to initiate therapy does not meet step‑edit/preauthorization criteria.
Previous therapies will be verified through pharmacy paid claims or submitted chart notes.