ModifiedmhnPolicy CP.PHAR.244

Anakinra (Kineret) coverage

Defines medical necessity, prior authorization, and coverage criteria for anakinra (Kineret) across indications including rheumatoid arthritis, CAPS (NOMID/CINCA), DIRA, and EUA use for COVID-19 in hospitalized adults; applies to Medicaid line of business.

Policy Summary

Payermhn

PolicyAnakinra (Kineret) coverage

Policy CodePolicy CP.PHAR.244

Change TypeMaterial revisions (approval duration extendedRA sequencing clarified)

Effective DateAug 16, 2024

Next Review DateMay 26, 2026

Key ActionSubmit prior authorization with supporting documentation including diagnosis, rheumatologist involvement, prior DMARD/biologic history, and baseline disease activity score.

SourceLink

POLICY UPDATE CHANGES

Extended initial approval durations to 12 months for chronic conditions.

For RA, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy.

12 monthsInitial approval duration for chronic conditions

100 mg/dayRA maximum dose

8 mg/kg/dayNOMID/DIRA max dose

MedicaidLine of business

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.

10 daysEUA COVID-19 duration

Coverage Criteria for Anakinra (Kineret)

Initial Therapy - Rheumatoid Arthritis

Initial approval for Rheumatoid Arthritis (must meet ALL):

RA initial approval: 1. Diagnosis of rheumatoid arthritis (RA) documented per American College of Rheumatology (ACR) criteria; 2. Prescribed by or in consultation with a rheumatologist; 3. Age ≥ 18 years; 4. Either: (a) failure of a ≥ 3 consecutive month trial of methotrexate (MTX) at up to maximally indicated doses OR (b) intolerance/contraindication to MTX and failure of a ≥ 3 consecutive month trial of at least one conventional DMARD (e.g., sulfasalazine, leflunomide, hydroxychloroquine) at up to maximally indicated doses unless contraindicated; 5. Failure of ALL of the following agents, each used for ≥ 3 consecutive months unless contraindicated or clinically significant adverse effects: (a) one adalimumab product (unless member has history of failure of two TNF blockers), (b) Actemra (tocilizumab), and (c) if member has not responded or is intolerant to one or more TNF blockers, Xeljanz/Xeljanz XR (unless cardiovascular risk outweighs benefit); 6. Documentation of baseline disease activity score by either CDAI or RAPID3; 7. No combination use with biological DMARDs or Janus kinase (JAK) inhibitors; 8. Dose must not exceed BOTH: (a) 100 mg per day AND (b) 1 syringe per day.

Approval duration: 12 months

Initial Therapy - NOMID/CINCA and DIRA

Initial approval for Cryopyrin‑Associated Periodic Syndromes (NOMID/CINCA) and DIRA (must meet ALL):

NOMID/CINCA initial approval: 1. Diagnosis of NOMID (neonatal‑onset multisystem inflammatory disease/CINCA) documented; 2. Prescribed by or in consultation with a rheumatologist; 3. No combination use with biological DMARDs or JAK inhibitors; 4. Dose does not exceed 8 mg/kg per day (see Appendix E for dose rounding guidelines).8 mg/kg/day

Approval duration: 12 months

DIRA initial approval: 1. Diagnosis of DIRA (deficiency of interleukin-1 receptor antagonist) confirmed (e.g., loss-of-function IL1RN mutation); 2. Prescribed by or in consultation with a rheumatologist; 3. No combination use with biological DMARDs or JAK inhibitors; 4. Dose does not exceed 8 mg/kg per day (see Appendix E for dose rounding guidelines).8 mg/kg/day

Approval duration: 12 months

EUA - Coronavirus-19 Infection

COVID‑19 EUA use (hospitalized adults):

EUA initiation: 1. Kineret under EUA is authorized only for use in hospitalized adults; initiation of outpatient treatment is not authorized; 2. Hospitalized adults must have positive SARS-CoV-2 test with pneumonia requiring supplemental oxygen and be at risk for severe respiratory failure per EUA criteria (see Appendix I and SAVE-MORE trial evidence); 3. Authorized regimen for hospitalized subcutaneous administration is 100 mg once daily.

Approval duration: Not applicable

EUA duration limit: 1. EUA-authorized administration is a subcutaneous injection given daily for 10 days in the hospitalized setting; outpatient continuation or outpatient initiation is not authorized.duration=10 days

Approval duration: Not applicable

Continuation Therapy

Continued therapy (all indications except COVID‑19 EUA):

Continued therapy general: 1. Member is currently receiving medication via the Centene benefit, or previously met initial approval criteria, or is in continuity of care per state regulations; 2. For RA: evidence of clinical response defined as a decrease in CDAI or RAPID3 from baseline OR medical justification if CDAI reassessment cannot be performed with submission of RAPID3 showing comparable or improved severity; for all other indications: member is responding positively to therapy; 3. No combination use with biological DMARDs or JAK inhibitors; 4. If request is for a dose increase, new dose must not exceed: RA — 100 mg per day; DIRA/NOMID — 8 mg/kg per day.

Approval duration: 12 months

Indication-specific dosing coverage

Covered when dosing, indication, and contraindication conditions are met

Adult RA (standard): Anakinra 100 mg subcutaneous once daily for RA; maximum 100 mg/day.dose=100 mg/day

Ensure no contraindication to product (see Appendix C).

NOMID/DIRA (pediatric/weight-based): Initial dosing typically 1–2 mg/kg subcutaneously once daily (may be divided BID); adjust in 0.5–1 mg/kg increments; maximum 8 mg/kg/day; use weight-based syringe/vial recommendations for quantity calculations.max=8 mg/kg/day

See Appendix E for dose rounding and vial/syringe guidance.

EUA-authorized COVID-19 use: Authorized regimen: 100 mg subcutaneous once daily for 10 days for hospitalized adults meeting EUA criteria.duration=10 days

Initial Approval Duration

Covered when criteria for medical necessity are met; policy now allows extended initial approvals for chronic indications.

Initial approval duration: Initial approvals for chronic conditions may be granted for up to 12 months.12 months

Per policy update (2Q 2026).

RA Step Therapy/Bypass

Coverage sequencing for rheumatoid arthritis therapies.

RA therapy sequencing: If a member has failed a biologic agent for RA, bypassing conventional therapy requirements is allowed; members are not required to retry conventional DMARD therapy after biologic failure. For initial RA approvals, unless bypass applies, member must meet conventional therapy and biologic/JAK sequencing requirements outlined in the RA initial criteria (including trials of methotrexate/conventional DMARDs and specified biologic/JAK agents).N/A

Documentation of prior biologic failure should be provided when seeking bypass.

Combination therapy with other potent immunomodulators is not authorized because of additive immunosuppression and increased infection risk. Specifically, concurrent use of biological DMARDs (bDMARDs) or other potent immunosuppressants — including but not limited to tumor necrosis factor antagonists, interleukin-directed agents, anti‑CD20 monoclonal antibodies, selective co‑stimulation modulators, integrin receptor antagonists, TYK2 inhibitors, sphingosine 1‑phosphate receptor modulators, and Janus kinase inhibitors (JAKi) — is excluded from coverage when used in combination with anakinra.

Anakinra is contraindicated in individuals with a known hypersensitivity to E. coli–derived proteins, Kineret, or any component of the product. Presence of such hypersensitivity will trigger denial of coverage.

Coverage determinations under this clinical policy are subject to the terms, conditions, exclusions, and limitations contained in the member’s governing coverage documents (for example, evidence of coverage, certificate of coverage, or insurance contract). For Medicaid members, applicable state Medicaid provisions take precedence where they conflict with this policy.

Use of anakinra for indications not FDA‑approved and not specifically addressed in this policy is not authorized unless there is sufficient documentation of efficacy and safety consistent with the off‑label use policy CP.PMN.53 or the member’s evidence of coverage. Providers requesting coverage for off‑label indications must submit supporting clinical evidence per plan requirements.

Within the portions of the policy extracted here, there are no additional explicit not medically necessary conditions beyond the stated exclusions for non‑FDA indications and prohibited combination therapy; routine coverage decisions remain guided by the clinical criteria and the member’s coverage documents.

Billing and Coding

Codes referenced in document portionmixed

N/A	No explicit CPT/HCPCS/ICD-10/NDC codes listed in this portion of the policy.

HCPCS CodesHCPCS

J3590

Unclassified biologics

Appendix B examples / preferred adalimumab productsmixed

adalimumab-fkjp	preferred adalimumab product example
adalimumab-adaz	preferred adalimumab product example
adalimumab-adbm	added to listed examples of preferred adalimumab products
adalimumab-aaty	unbranded adalimumab example added to preferred products

inv-16: Maximum dosing — quick reference for maximum doses by indication (RA and NOMID/DIRA)

Rheumatoid arthritis (adult)Maximum dose = 100 mg per day (100 mg SC once daily); limit 1 syringe/day.

NOMID/CINCAMaximum dose = 8 mg/kg per day (weight‑based; see Appendix E for rounding).

DIRAMaximum dose = 8 mg/kg per day (weight‑based; see Appendix E for rounding).

inv-17: Weight-based vial/syringe recommendation — syringe counts by total mg ranges for multi-syringe dosing guidance

≤ 104.99 mg1 syringe (100 mg/0.67 mL)

105 to 209.99 mg

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for Kineret (anakinra). Providers must submit a prior authorization request and include supporting clinical documentation demonstrating the member meets all approval criteria. Failure to provide required documentation may result in denial.

PA required for adalimumab products, Actemra, and Xeljanz/Xeljanz XR may also be applicable per policy notes

Documentation Required

Indication and Dosing Documentation

Document the indication and dosing regimen in the PA request. For rheumatoid arthritis (RA) include the RA-specific dosing: 100 mg subcutaneously once daily (maximum 100 mg/day). For weight-based indications (e.g., NOMID, DIRA) provide weight and calculations supporting initial and maintenance doses per the dosing guidance.

Include the exact dosing regimen and any dose calculations (weight-based when applicable).
State the specific diagnosis/indication being treated.

Definitions

inv-31: Anakinra (Kineret) — brief definition of the drug (IL-1 receptor antagonist)

Drug classAnakinra (Kineret) is an interleukin-1 (IL-1) receptor antagonist.

Primary formulations referencedSingle-use prefilled syringe: 100 mg/0.67 mL.

FDA-approved uses (selected)Indicated for RA (adults), CAPS (NOMID), and DIRA.

inv-32: CAPS / NOMID / DIRA — definitions for CAPS, NOMID, and DIRA terms used in the policy

CAPS (overview)Cryopyrin-associated periodic syndromes (CAPS) — group of IL-1 associated autoinflammatory disorders including NOMID/CINCA.

NOMID / CINCANeonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurologic cutaneous and articular (CINCA) syndrome.

Background

Anakinra (Kineret) is an interleukin‑1 receptor antagonist indicated for inflammatory disorders mediated by IL‑1. It is used in adults with rheumatoid arthritis to reduce signs and symptoms and in autoinflammatory disorders such as cryopyrin‑associated periodic syndromes (including NOMID/CINCA) and deficiency of the interleukin‑1 receptor antagonist (DIRA). For rheumatoid arthritis the usual subcutaneous regimen is 100 mg once daily; the product is supplied as a 100 mg/0.67 mL single‑use prefilled syringe. The policy also references an FDA Emergency Use Authorization for hospitalized adults with COVID‑19 meeting EUA criteria (authorized regimen: 100 mg SC daily for 10 days when applicable).

Revision History & Policy Changes

2026-05-26policy_reviewLatest

2Q 2026 annual review: references reviewed and updated; extended initial approval durations for chronic conditions set to 12 months (approval duration clarified).

2025-09-08clarification

For rheumatoid arthritis, added clarification allowing bypass of conventional therapies if a member has failed a biologic agent (avoids stepping back to conventional therapy).

2025-11-25approval_note

Policy Summary

Payermhn

PolicyAnakinra (Kineret) coverage

Policy CodePolicy CP.PHAR.244

Change TypeMaterial revisions (approval duration extendedRA sequencing clarified)

Effective DateAug 16, 2024

Next Review DateMay 26, 2026

Key ActionSubmit prior authorization with supporting documentation including diagnosis, rheumatologist involvement, prior DMARD/biologic history, and baseline disease activity score.

SourceLink

On This Page

EUA-specific authorization; see SAVE-MORE trial evidence.

2 syringes (100 mg/0.67 mL each)

210 to 314.99 mg3 syringes (100 mg/0.67 mL each)

315 to 419.99 mg4 syringes (100 mg/0.67 mL each)

420 to 524.99 mg5 syringes (100 mg/0.67 mL each)

525 to 629.99 mg6 syringes (100 mg/0.67 mL each)

630 to 734.99 mg7 syringes (100 mg/0.67 mL each)

735 to 839.99 mg8 syringes (100 mg/0.67 mL each)

Documentation Required

Documentation & Medical Necessity

Submit all relevant clinical documentation to demonstrate medical necessity. Providers should include office chart notes, specialty consultation notes, baseline assessment scores (CDAI or RAPID3 for RA), laboratory results, prior therapy trials and durations, and documentation of intolerances or contraindications when claimed. Adhere to the clinical policy criteria and accepted standards of medical practice when submitting evidence to support the request.

Office notes and specialist documentation
Laboratory results and baseline disease activity scores (CDAI or RAPID3) for RA
Documentation of prior medication trials (drug name, dose, duration) and reasons for discontinuation (failure, intolerance, contraindication)
Evidence supporting off‑label use when applicable per CP.PMN.53

Step Therapy

Step Therapy for Rheumatoid Arthritis

For RA, step therapy requires trials and failures of conventional therapies before approval of Kineret unless bypass criteria apply. Specifically, members must have failed a ≥3 month trial of methotrexate at maximally indicated doses, or have intolerance/contraindication to methotrexate plus failure of ≥3 months of at least one conventional DMARD (e.g., sulfasalazine, leflunomide, hydroxychloroquine).

Document duration and dosing of methotrexate and other conventional DMARDs (≥3 months each).
If methotrexate is not tolerated or contraindicated, document the reason and trials of alternate conventional DMARD(s).

Step Therapy

Step Therapy and TNFi/Adalimumab Bypass

Step therapy interactions and bypass: the policy requires failure of specified biologic/TNFi agents (including one adalimumab product) and other agents (Actemra, Xeljanz) per the RA criteria. Prior authorization may be required for these comparator products; when submitting a PA for Kineret, include documentation of trials/failures of TNFi/adalimumab products as applicable. Coding submissions may reference J3590 for unclassified biologics per coding guidance.

Document trial and failure of one adalimumab product (or history of two TNF blocker failures when applicable).
Include PA documentation for comparator biologics when applicable.

Step Therapy

Bypass of Conventional Therapy After Biologic Failure

RA bypass of conventional therapy after biologic failure: if a member has previously failed a biologic agent, they may bypass retreatment with conventional therapies and proceed with biologic or alternative advanced therapy per the policy clarification. Document the prior biologic failure(s) clearly (agent, duration, reason for discontinuation).

Provide clear evidence of biologic failure (agent name, treatment dates, clinical response or adverse events).
Indicate that bypass of conventional therapies is being requested due to prior biologic failure.

DIRA (relation)DIRA is referenced alongside CAPS/NOMID as an IL-1–related autoinflammatory condition treated by anakinra.

inv-33: CAPS — Cryopyrin-associated periodic syndromes definition and examples (FCAS, MWS, NOMID)

DefinitionCryopyrin-associated periodic syndromes (CAPS) are IL-1 associated autoinflammatory disorders that include Familial Cold Autoinflammatory Syndrome (FCAS), Muckle‑Wells syndrome (MWS), and Neonatal‑onset Multisystem Inflammatory Disease (NOMID/CINCA).

ExamplesFCAS (familial cold autoinflammatory syndrome); MWS (Muckle‑Wells syndrome); NOMID (neonatal‑onset multisystem inflammatory disorder, aka CINCA).

Clinical relevanceCAPS are indications for anakinra therapy per FDA labeling (NOMID/CINCA specifically cited).

inv-34: DIRA — definition of Deficiency of Interleukin-1 Receptor Antagonist

DefinitionDeficiency of Interleukin-1 Receptor Antagonist (DIRA) is an autosomal recessive disorder caused by loss-of-function mutations in IL1RN leading to absent or nonfunctional IL-1Ra.

Genetic basisPatients are homozygous or compound heterozygous for loss-of-function IL1RN mutations (nonsense, frameshift, deletions described).

Treatment relevanceDIRA is an FDA‑labeled indication for anakinra treatment.

inv-35: Health Plan — definition of 'Health Plan' as used in the document

Meaning in this policy'Health Plan' refers to a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC or an affiliate.

ScopeCoverage decisions are subject to the member's coverage documents, state and federal requirements, and applicable Health Plan administrative policies.

Not a guaranteeThe policy is a guide to medical necessity and does not constitute a contract or guarantee of payment.

Policy updated with biosimilar verbiage and reference updates; documentation notes P&T approval activity related to RA sequencing/bypass.