Kineret (anakinra) drug coverage
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Defines prior authorization, documentation, prescriber specialty, and medical necessity criteria for Kineret (anakinra) for FDA-approved indications and specified compendial uses for Wellmark Blue Cross and Blue Shield members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Kineret (anakinra)
inv-01: FDA-Approved Indications
Covered when criteria for the specific FDA‑approved indication are met
from policy FDA‑Approved Indications
inv-02: Compendial Uses
Covered compendial uses when approval criteria are met
from policy Compendial Uses
inv-03: Initial approval — Rheumatoid Arthritis
Criteria for initial approval for rheumatoid arthritis will only apply when at least ONE of the following criteria are met:
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inv-04: Moderately to Severely Active Rheumatoid Arthritis — Authorization criteria
Authorization of 12 months may be granted when ALL of the following are met:
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inv-05: Adult-onset Still's Disease (AOSD) — Authorization criteria
Authorization of 12 months may be granted when both criteria are met:
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inv-06: Systemic Juvenile Idiopathic Arthritis (sJIA) — Authorization criteria
Authorization of 12 months may be granted when both criteria are met:
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inv-07: NOMID/CAPS — Authorization
Authorization may be granted:
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inv-08: sJIA Initial and Continuation
Systemic juvenile idiopathic arthritis (sJIA) — Initial authorization
sJIA initial
- systemic features: Member has active systemic features (e.g., fever, evanescent rash, lymphadenopathy, hepatomegaly, splenomegaly, or serositis)
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- prior therapy failure: Member has had an inadequate response to NSAIDs or systemic glucocorticoids
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See chunk 30 for joint/functional metrics
inv-09: NOMID/CAPS
Neonatal‑Onset Multisystem Inflammatory Disease (NOMID/CAPS)
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inv-10: DIRA
Deficiency of interleukin-1 receptor antagonist (DIRA)
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inv-11: Recurrent Pericarditis Initial and Continuation
Recurrent Pericarditis
Pericarditis initial
- episodes: Member has had at least two episodes of pericarditis>=2 episodes
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- prior therapy failure: Member has failed at least 2 agents of standard therapy (e.g., colchicine, NSAIDs, corticosteroids)
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inv-12: Multicentric Castleman's Disease
Multicentric Castleman's Disease
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inv-13: HIDS/MKD
Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)
Logical structure: both A and (B OR C).
inv-14: Schnitzler's syndrome
Schnitzler's syndrome
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inv-15: Gout and Pseudogout Flares
Gout and pseudogout flares
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inv-16: CAR T and Immune Checkpoint Inhibitor–Related Toxicities
CAR T‑cell and Immune Checkpoint Inhibitor–Related Toxicities
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inv-17: Erdheim-Chester Disease
Erdheim‑Chester Disease
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inv-18: Rheumatoid Arthritis Continuation
Moderately to severely active rheumatoid arthritis (RA)
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inv-19: AOSD and Other Indications
Adult‑onset Still's disease (AOSD) and Other indications
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inv-20: Coverage criteria
Covered when ALL of the following are met
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This policy may not apply to members covered under the Federal Employee Program (FEP). Benefit determinations for FEP members are made by the Federal Employee Program and are subject to the applicable FEP contract language rather than this policy.
Do not administer Kineret to members with active tuberculosis (TB) infection. Prior to initiating therapy in members who are naïve to biologic or targeted synthetic therapies, there must be documentation of a negative TB test (TST or IGRA) within 12 months. If TB screening is positive, further evaluation (for example, chest x‑ray) is required to exclude active disease; if latent TB is identified, latent TB treatment must be started before initiating Kineret.
Members may not receive Kineret concomitantly with any other biologic drug or targeted synthetic drug. Prior authorization requires documentation that the member is not using another biologic or targeted synthetic agent at the time of Kineret initiation or during therapy.
Do not administer Kineret to members with active tuberculosis infection. If TB screening is positive, active TB must be excluded prior to initiation and latent TB must be treated before starting Kineret.
Procedures, Billing Codes, and Measurement Thresholds
Prior Authorization, Documentation, and Provider Requirements
Prior Authorization Required
Prior authorization is required for Kineret. Approvals are typically granted for up to 12 months when the member meets the applicable clinical criteria; select indications may have shorter durations (e.g., 1 month for CAR T-cell CRS, 3 months for CAR T prophylaxis, 6 months for immune checkpoint inhibitor–related toxicity).
- Prior authorization required for all indications
- Typical approval duration: 12 months when criteria met; select situations: 1, 3, or 6 months per criteria
Step-Therapy / Preferred Drug Requirements
The plan generally requires trials of the plan's preferred products (two preferred agents) before approving a non-preferred product such as Kineret for many indications. Exceptions include: documented clinical contraindication or intolerance to preferred products, current treatment with the requested non-preferred drug with demonstrated positive therapeutic outcome, or when only one preferred product exists for the indication.
- Step-therapy: trial of TWO preferred products (e.g., Enbrel, adalimumab-aacf, Rinvoq, Simponi, Xeljanz/XR) required for many indications
- Exceptions: contraindication/intolerance to preferred products, current successful therapy with non-preferred product, or only one preferred product available
Documentation Required for Prior Authorization
Prior authorization requests must include required documentation. Failure to submit chart notes, medical records, laboratory results, or claims history supporting diagnosis, prior therapies tried, biomarker testing (when applicable), and evidence of positive clinical response for continuation requests may result in denial.
- Initial requests: chart notes/medical records/claims history showing prior medications tried and responses, biomarker testing results when applicable
- Continuation requests: chart notes or medical records documenting positive clinical response
- Failure to provide required documentation may result in denial
Not Medically Necessary If Criteria Unmet
Kineret is considered not medically necessary and requests will be denied if the member does not meet the listed coverage criteria (including step-therapy, required prior therapies, dosing limits, and documentation requirements).
- Not medically necessary if coverage criteria are unmet
- Denial possible for lack of required prior therapies, missing documentation, or failure to meet indication-specific criteria
TB Screening, Follow-up, and Concomitant Therapy Exclusion
TB screening is required and concomitant biologic/targeted synthetic therapy is not permitted. For members naïve to biologic or targeted synthetic drugs associated with increased TB risk, a documented negative TB test (TST or IGRA) within 12 months prior to initiation is required. If screening is positive, further evaluation to exclude active disease (e.g., chest x-ray) is required; do not administer Kineret if active TB is present. If latent TB is identified, TB treatment must be started prior to initiating Kineret.
- Documented negative TB test (TST or IGRA) within 12 months required for biologic-/targeted-synthetic–naïve members
- Positive TB screening requires confirmatory testing to exclude active disease (e.g., chest x-ray); active TB = contraindication to initiation
- Latent TB: must begin TB treatment before starting Kineret
- Requests may be denied if no documented negative TB test within 12 months or if member is receiving another biologic/targeted synthetic therapy
Background and Drug Overview
Kineret (anakinra) is an interleukin‑1 receptor antagonist indicated for multiple inflammatory conditions, including moderately to severely active rheumatoid arthritis (in adults after failure of one or more DMARDs) and certain cryopyrin‑associated periodic syndromes such as NOMID. The policy also addresses selected compendial uses (for example, systemic juvenile idiopathic arthritis, adult‑onset Still’s disease, recurrent pericarditis, HIDS/MKD, Schnitzler’s syndrome, gout/pseudogout flares, CAR T‑cell–related toxicities, and others) and aligns coverage with FDA labeling, accepted compendia, and required prior‑authorization documentation and monitoring (including TB screening and quantity limits by indication).
Definitions and Measurement Thresholds
Policy Revision History
Policy current effective date set to May 29, 2026 (Reviewed/Revised April 2026).
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