CurrentBlue Cross Blue Shield - IowaPolicy 05.02.10

Kineret (anakinra) drug coverage

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.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyKineret (anakinra) drug coverage

Policy CodePolicy 05.02.10

Change TypeNo material changes

Effective DateMay 29, 2026

Next Review DateApr 1, 2026

Key ActionSubmit prior authorization with chart notes, prior medication history, and documented negative TB test within 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period

>=2preferred products trial

10+compendial uses listed

28 syr/28dRA quantity limit

prohibitedconcomitant biologics

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.

Coverage Criteria for Kineret (anakinra)

inv-01: FDA-Approved Indications

Covered when criteria for the specific FDA‑approved indication are met

FDA indications list: Moderately to severely active rheumatoid arthritis in adults after failure of >=1 DMARD; Cryopyrin‑Associated Periodic Syndromes (CAPS), including Neonatal‑Onset Multisystem Inflammatory Disease (NOMID); Deficiency of Interleukin‑1 Receptor Antagonist (DIRA)

from policy FDA‑Approved Indications

inv-02: Compendial Uses

Covered compendial uses when approval criteria are met

Compendial uses list: Systemic juvenile idiopathic arthritis (sJIA); Adult‑onset Still's disease (AOSD); Multicentric Castleman's disease; Recurrent pericarditis; Hyperimmunoglobulin D syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD); Schnitzler's syndrome; Gout and pseudogout (calcium pyrophosphate deposition); CAR T‑cell related toxicities (CRS); Erdheim‑Chester disease; Immune checkpoint inhibitor‑related HLH‑like syndrome

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:

A. Preferred product failure: Member has had an inadequate response to treatment or intolerable adverse event with at least TWO of the preferred products (Enbrel, adalimumab‑aacf, Rinvoq, Simponi, Xeljanz/Xeljanz XR)

chunk 14

B. Clinical reason to avoid TNF‑inhibitors plus other failures: Member has a clinical reason to avoid TNF‑inhibitors (Enbrel, adalimumab‑aacf, Simponi) AND has had an inadequate response to treatment or intolerable adverse event with the preferred products Rinvoq AND Xeljanz or Xeljanz XR

chunk 14

C. Current effective treatment: Member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's assistance programs) and is experiencing a positive therapeutic outcome

chunk 14

inv-04: Moderately to Severely Active Rheumatoid Arthritis — Authorization criteria

Authorization of 12 months may be granted when ALL of the following are met:

RA auth all: A) Member meets either: (1) positive biomarker testing for RF or anti‑CCP; OR (2) has been tested for RF and anti‑CCP and CRP and/or ESR; B) Member has had an inadequate response to at least a 3‑month trial of methotrexate at adequate dosing (titrated to >=15 mg/week) or has intolerance/contraindication to methotrexate; C) Member has had an inadequate response to at least a 3‑month trial of a biologic or targeted synthetic drug (e.g., Rinvoq, Xeljanz) or has intolerance to such agents

chunk 16

inv-05: Adult-onset Still's Disease (AOSD) — Authorization criteria

Authorization of 12 months may be granted when both criteria are met:

AOSD auth all: A) Member has active systemic features (e.g., fever, arthralgia/arthritis, evanescent rash, lymphadenopathy, hepatomegaly, splenomegaly, sore throat); B) Member has had an inadequate response to at least one of: NSAIDs, corticosteroids, or a conventional synthetic drug (e.g., methotrexate)

chunk 17

inv-06: Systemic Juvenile Idiopathic Arthritis (sJIA) — Authorization criteria

Authorization of 12 months may be granted when both criteria are met:

sJIA auth all: A) Member has active systemic features (e.g., fever, evanescent rash, lymphadenopathy, hepatomegaly, splenomegaly, or serositis); B) Member has had an inadequate response to NSAIDs or systemic glucocorticoids

chunk 18

inv-07: NOMID/CAPS — Authorization

Authorization may be granted:

NOMID/CAPS auth: Authorization of 12 months may be granted for treatment of cryopyrin‑associated periodic syndromes (CAPS), including NOMID

chunk 19

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)
chunk 18
prior therapy failure: Member has had an inadequate response to NSAIDs or systemic glucocorticoids
chunk 18

sJIA continuation: Authorization of 12 months may be granted for members (including new) using medication for sJIA who achieve or maintain positive clinical response as evidenced by low disease activity or improvement in systemic features or joint counts or function20% improvement in joint/tender/swollen counts or improvement in systemic features

inv-09: NOMID/CAPS

Neonatal‑Onset Multisystem Inflammatory Disease (NOMID/CAPS)

NOMID initial: Authorization of 12 months may be granted for treatment of CAPS/NOMID

chunk 19

NOMID continuation: Authorization of 12 months may be granted for members (including new) who achieve or maintain positive clinical response as evidenced by improvement in fever, skin rash, joint symptoms, CNS symptoms, or inflammatory markers (SAA, CRP, ESR)

chunk 31

inv-10: DIRA

Deficiency of interleukin-1 receptor antagonist (DIRA)

DIRA: Authorization of 12 months may be granted for the treatment of genetically confirmed DIRA due to IL1RN mutationsgenetic confirmation

chunk 20

inv-11: Recurrent Pericarditis Initial and Continuation

Recurrent Pericarditis

Pericarditis initial

episodes: Member has had at least two episodes of pericarditis>=2 episodes
chunk 21
prior therapy failure: Member has failed at least 2 agents of standard therapy (e.g., colchicine, NSAIDs, corticosteroids)
chunk 21

Pericarditis continuation: Authorization of 12 months may be granted for members (including new) who achieve or maintain positive clinical response as evidenced by improvement in pericarditic chest pain, pericardial rubs, ECG, pericardial effusion, or CRP

chunk 32

inv-12: Multicentric Castleman's Disease

Multicentric Castleman's Disease

Initial MCD: Authorization of 12 months may be granted when ALL of the following are met: requested medication used as a single‑agent AND disease has progressed following treatment of relapsed/refractory or progressive disease

chunk 22

Continuation MCD: Authorization of 12 months may be granted for reauthorization when member has not experienced disease progression or unacceptable toxicityno progression

chunk 33

inv-13: HIDS/MKD

Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)

HIDS/MKD: Authorization of 12 months may be granted when ALL of the following are met: A) Member has had active flares within the last 6 months; AND B) Physician's Global Assessment >= 2 OR C‑reactive protein (CRP) > 10 mg/LPGA >=2 or CRP >10 mg/L

Logical structure: both A and (B OR C).

inv-14: Schnitzler's syndrome

Schnitzler's syndrome

Schnitzler initial: Authorization of 12 months may be granted when ALL of the following are met: A) Urticarial rash, monoclonal IgM (or IgG) gammopathy and at least two systemic signs/symptoms (fever, joint pain/inflammation, bone pain, palpable lymph nodes, hepatosplenomegaly, leukocytosis, elevated ESR or abnormal bone morphology); AND B) Other possible causes have been ruled out (e.g., HIDS, AOSD, urticarial hypocomplementemic vasculitis, acquired C1 inhibitor deficiency, cryoglobulinemia)

chunk 24

inv-15: Gout and Pseudogout Flares

Gout and pseudogout flares

Gout/pseudogout initial: Authorization of 12 months may be granted for adults when ALL of the following are met: A) Member has experienced at least three gout flares in the last 12 months; AND B) Member has had an inadequate response, intolerance, or contraindication to NSAIDs, colchicine, and corticosteroids>=3 flares in 12 months

chunk 25

inv-16: CAR T and Immune Checkpoint Inhibitor–Related Toxicities

CAR T‑cell and Immune Checkpoint Inhibitor–Related Toxicities

CAR T CRS management: Authorization of 1 month may be granted for management of CAR T‑cell induced cytokine release syndrome when CRS is refractory to high‑dose corticosteroids and anti‑IL‑6 therapy and Kineret will be used as replacement for a second dose of tocilizumab when supplies are limited/unavailable

chunk 26

CAR T prophylaxis: Authorization of 3 months may be granted for prophylaxis of CAR T‑cell‑induced toxicity in members at high risk of developing high‑grade ICANS; continuation requires meeting all coverage requirementshigh risk of ICANS

chunk 26

ICI‑related HLH‑like: Authorization of 6 months may be granted for immune checkpoint inhibitor‑related toxicity (immunotherapy‑related HLH‑like syndrome) when member has HLH‑like syndrome AND either inadequate response to systemic corticosteroids OR intolerance/contraindication to corticosteroids

inv-17: Erdheim-Chester Disease

Erdheim‑Chester Disease

Erdheim‑Chester: Authorization of 12 months may be granted for the treatment of Erdheim‑Chester disease

chunk 27

inv-18: Rheumatoid Arthritis Continuation

Moderately to severely active rheumatoid arthritis (RA)

RA continuation: Authorization of 12 months may be granted for members using the requested medication for moderately to severely active RA who achieve or maintain positive clinical response evidenced by at least 20% improvement from baseline in tender joint count, swollen joint count, pain, or disability>=20% improvement

chunk 29

inv-19: AOSD and Other Indications

Adult‑onset Still's disease (AOSD) and Other indications

AOSD/sJIA continuation: Authorization of 12 months may be granted for members using medication for AOSD or sJIA who achieve or maintain positive clinical response as evidenced by low disease activity or improvement in any of: number of active joints, limitation of movement, functional ability, or systemic features

chunk 30

Other indications continuation: Authorization of 12 months may be granted for other indications outlined in initial approval when members achieve or maintain positive clinical response evidenced by low disease activity or symptom improvement

chunk 35

inv-20: Coverage criteria

Covered when ALL of the following are met

TB screening: Member has documented negative TB test (TST or IGRA) within 12 months prior to initiating therapy for persons who are naïve to biologic or targeted synthetic drugs; if screening is positive, further testing to exclude active disease (e.g., chest x‑ray) is required and latent TB must be treated before initiationwithin 12 months

chunk 36

No concomitant biologic/targeted therapy: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug; do not administer if active TB is presentN/A

chunk 36

Dosing and quantity limits: Approvals may be subject to dosing limits per FDA labeling/accepted compendia; specific quantity limits: RA: 28 syringes/28 days; NOMID and DIRA dosing guidance (initial 1 mg/kg, maintenance 3–4 mg/kg, max 8 mg/kg daily); all other indications: 112 syringes/28 days

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

CRP — lab threshold

CRP thresholdC-reactive protein (CRP) > 10 mg/L

ContextUsed as part of HIDS/MKD authorization criteria requiring active flares within the last 6 months plus PGA ≥2 or CRP >10 mg/L

Supporting actionSubmit recent CRP laboratory result with prior authorization request

Physician's Global Assessment

Physician's Global Assessment (PGA) threshold>= 2 (greater than or equal to 2)

ContextPGA ≥2 is required (alternatively CRP >10 mg/L) along with active flares within the last 6 months for HIDS/MKD

Supporting actionDocument PGA score in chart notes for prior authorization

TB screening window; quantity limits; NOMID/DIRA dosing

TB screening windowDocumented negative TST or IGRA within 12 months prior to initiating therapy for biologic/targeted synthetic–naïve members

Quantity limit — Rheumatoid arthritis28 syringes per 28 days

Quantity limit — Other indications112 syringes per 28 days

NOMID and DIRA dosing notesNOMID and DIRA: initial dosing 1 mg/kg; maintenance 3–4 mg/kg; maximum up to 8 mg/kg daily (per policy quantity/dosing guidance)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

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

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

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

Denial Risk

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

Documentation Required

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

FDA-Approved Indications

Rheumatoid arthritis (RA)Moderately to severely active RA in adults who have failed ≥1 DMARD

Cryopyrin-Associated Periodic Syndromes (CAPS)Includes Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

Deficiency of Interleukin-1 Receptor Antagonist (DIRA)Genetically confirmed DIRA due to IL1RN mutations

Compendial Uses

sJIASystemic juvenile idiopathic arthritis

AOSDAdult-onset Still's disease

Other compendial usesMulticentric Castleman's disease; recurrent pericarditis; HIDS/MKD; Schnitzler's syndrome; gout/pseudogout; CAR T-cell CRS; Erdheim-Chester disease; ICI-related HLH-like syndrome

Active flares (HIDS/MKD) — definition

Timeframe for flaresActive flares within the last 6 months

Clinical thresholdsPlus Physician's Global Assessment ≥ 2 OR CRP > 10 mg/L

Documentation requiredChart notes documenting number/timing of flares and PGA or CRP values for prior authorization

Active systemic features (sJIA)

Systemic features listFever; evanescent rash; lymphadenopathy; hepatomegaly; splenomegaly; serositis

Use in sJIA criteriaPresence of one or more of these active systemic features is required (plus inadequate response to NSAIDs or systemic glucocorticoids)

Documentation requiredRecord of specific systemic features in chart notes for prior authorization

Quantity limits

Quantity limit — RAMaximum 28 syringes per 28 days

Quantity limit — NOMID and DIRA dosingNOMID and DIRA: initial dosing 1 mg/kg; maintenance 3–4 mg/kg; maximum up to 8 mg/kg daily (guidance in policy)

Quantity limit — Other indicationsMaximum 112 syringes per 28 days for all other indications

TB screening

TB screening requirementDocumented negative TST or IGRA within 12 months before initiating therapy for biologic/targeted synthetic–naïve members

Positive screen follow-upIf TB screening is positive, further testing (e.g., chest x-ray) to exclude active disease is required and latent TB must be treated before initiation

Concomitant therapy exclusionDo not administer if active TB infection is present; member cannot use concomitant biologic or targeted synthetic drugs

Policy Revision History

May 29, 2026Policy effective dateLatest

Policy current effective date set to May 29, 2026 (Reviewed/Revised April 2026).

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyKineret (anakinra) drug coverage

Policy CodePolicy 05.02.10

Change TypeNo material changes

Effective DateMay 29, 2026

Next Review DateApr 1, 2026

Key ActionSubmit prior authorization with chart notes, prior medication history, and documented negative TB test within 12 months.

SourceLink

On This Page

See chunk 30 for joint/functional metrics