ModifiedCignaPolicy N/A

Inflammatory Conditions - Kineret Prior Authorization

Defines Cigna's prior authorization requirements, medical necessity criteria, approvals durations, and covered/not-covered indications for Kineret (anakinra subcutaneous injection) for prescription benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Kineret Prior Authorization

Policy CodePolicy N/A

Change TypeMaterial revisions and additions to indications and age criteria

Effective DateN/A

Next Review DateFeb 26, 2025

Key ActionSubmit prior authorization with diagnosis-specific documentation and specialist prescriber/consultation as indicated.

SourceLink

POLICY UPDATE CHANGES

Systemic Juvenile Idiopathic Arthritis: For initial approval, a requirement that the patient is ≥ 2 years of age was added.

Rheumatoid Arthritis: For initial approval, a requirement that the patient is ≥ 18 years of age was added.

Still's Disease, Adult Onset: For initial approval, a requirement that the patient is ≥ 18 years of age was added, and several prior therapy requirements were removed for initial therapy.

Castleman Disease, Erdheim-Chester Disease, and CAR T-cell immunotherapy–related toxicities were added to Other Uses with Supportive Evidence.

Conditions Not Covered: Concurrent use with another biologic or with a targeted synthetic oral small molecule drug is specified as not covered.

≥8indications

6 moinitial approval

1 yr

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continuation approval

listedexplicit exclusions

Coverage Criteria and Indications

Immunotherapy-Related Toxicities (CAR T-cell)

Covered for Immunotherapy-Related Toxicities associated with CAR T-cell Therapy

CAR T-cell toxicity: Approve for 1 month if prescribed for a patient who has been or will be treated with a CAR T-cell therapy

Examples of CAR T-cell therapies include idecabtagene vicleucel, lisocabtagene maraleucel, ciltacabtagene autoleucel, tisagenlecleucel, axicabtagene ciloleucel, and others

Initial Therapy

Approve for 6 months if ALL of the following are met

Initial Therapy (SJIA/Still's disease): Patient is > 2 years of age; AND the medication is prescribed by or in consultation with a rheumatologistage > 2 years for SJIA; specialist prescriber or consultation required

For adult-onset Still's disease use AOSD criteria for patients >=18 years

Continuation Therapy

Approve for 1 year if ALL of the following are met

Continuation Therapy: Patient has been established on this medication for at least 6 months; AND patient meets at least ONE of: (a) beneficial clinical response by at least one objective measure from baseline OR (b) improvement in at least one symptom compared with baselineestablished therapy >= 6 months

Examples of objective measures include resolution of fever, improvement in rash, normalization of CRP/ESR, reduced corticosteroid dose; symptom examples include less joint pain/tenderness, stiffness, swelling, decreased fatigue, improved function

Kineret (anakinra) is considered not medically necessary for any uses not specifically listed as covered in this policy. The policy's CONDITIONS NOT COVERED section explicitly states that Kineret is not medically necessary for ANY other use(s) beyond the indications and supportive uses enumerated in the coverage criteria.

Examples of conditions that are not medically necessary for Kineret include ankylosing spondylitis, where trial data are inconsistent and guidelines do not list Kineret as an option, lupus arthritis, where only small preliminary pilot data exist, and osteoarthritis, where controlled trials did not demonstrate benefit. These specific conditions are listed in the policy's CONDITIONS NOT COVERED section and may be denied as not medically necessary.

The policy states that concurrent use of Kineret with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition is not covered. Combination therapy with these agents is not recommended because of higher adverse event risk and a lack of controlled data demonstrating additive benefit. This prohibition does not exclude concomitant use with conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine).

The policy specifically lists ankylosing spondylitis among conditions considered not medically necessary and indicates that any other uses not specified in the coverage sections are likewise not medically necessary. Requests for Kineret for ankylosing spondylitis or other unspecified indications will be reviewed under the CONDITIONS NOT COVERED language and may be denied.

Uses that appear under the policy's 'CONDITIONS NOT COVERED' heading (for example, ankylosing spondylitis, lupus arthritis, and osteoarthritis) are explicitly considered not medically necessary for Kineret and are subject to denial. The list is not exhaustive and may be updated as new evidence becomes available.

Provider Requirements, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for prescription benefit coverage of Kineret. Approvals are provided for the indication-specific durations in the policy (typically initial approvals for 6 months and continuation approvals for 1 year where specified). Initial approval requires that Kineret be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., rheumatologist, geneticist, allergist/immunologist, dermatologist, oncologist/hematologist as applicable).

Approvals vary by indication (see FDA-Approved Indications and Other Uses sections) — initial therapy commonly 6 months; continuation commonly 1 year.
1 month = 30 days for authorization duration calculations.

Documentation Required

Documentation and Step-Therapy Changes for Still's Disease/SJIA

For initial therapy of Still's disease (Adult-Onset Still's Disease and Systemic Juvenile Idiopathic Arthritis), documentation must confirm the patient meets the age requirement (≥18 years for AOSD; >2 years for SJIA) and that the medication is prescribed by or in consultation with a rheumatologist. Recent step-therapy prior requirements for Still's disease were removed — prior trials of corticosteroids or conventional synthetic DMARDs are no longer required for initial approval.

Coding, Authorization Codes, and Appendix

Covered/authorization administrative codesmixed

NDC/HCPCS/CPT not listed

Document does not list specific billing codes for Kineret in this section.

Policy Statement - product listedmixed

Kineret (anakinra SC injection)

Listed as the covered product; prior authorization required per policy statement.

Appendix: Examples of biologics and oral targeted therapiesmixed

Kineret	anakinra SC injection (listed among biologics; inhibition of IL-1)
Adalimumab SC Products	Humira and biosimilars - Inhibition of TNF
Tocilizumab Products	Actemra - Inhibition of IL-6
Rituximab IV Products	Rituxan - CD20-directed cytolytic antibody
Oral Therapies/Targeted Synthetic Oral Small Molecule Drugs	Examples listed (e.g., apremilast, JAK inhibitors, TYK2 inhibitor, upadacitinib, tofacitinib)

Initial approval duration — typical durations

Initial approval (typical)6 months for initial therapy unless otherwise noted (e.g., indication-specific criteria must be met)

Continuation approval (typical)1 year for patients established on therapy ≥6 months and demonstrating benefit or symptom improvement

CAR T-cell–related use1 month when prescribed for immunotherapy-related toxicities associated with CAR T-cell therapy

Definitions and Disease Overview

CAPS — definition and IL-1 blocker context

DefinitionCryopyrin-Associated Periodic Syndromes (CAPS) are a spectrum of three rare genetic syndromes: familial cold autoinflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS), and neonatal-onset multisystem inflammatory disease (NOMID/CINCA)

Disease spectrumCAPS represents a single condition along a continuum of severity (FCAS → MWS → NOMID) with variable systemic and tissue/organ inflammation

IL-1 blocker contextIL-1 blockers (including Kineret) are recommended as standard of care across the CAPS spectrum to control symptoms and normalize inflammatory markers; dose/frequency may be adjusted to control disease activity and growth in children

DIRA — definition and treatment context

DefinitionDeficiency of Interleukin-1 Receptor Antagonist (DIRA) is caused by recessive loss-of-function pathogenic variants in the IL1RN gene (bi-allelic mutations)

Background

Kineret (anakinra) is an interleukin-1 (IL-1) receptor antagonist that blocks IL-1–mediated inflammation and is used to treat IL-1–driven autoinflammatory disorders. The policy notes Kineret's clinical role for IL-1–mediated conditions such as Cryopyrin-Associated Periodic Syndromes (CAPS) and DIRA, and for certain inflammatory diseases (e.g., rheumatoid arthritis and Still's disease/SJIA) and other indications supported by guidelines or evidence. The CONDITIONS NOT COVERED section further clarifies situations where Kineret use is unsupported or not recommended.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Kineret Prior Authorization

Policy CodePolicy N/A

Change TypeMaterial revisions and additions to indications and age criteria

Effective DateN/A

Next Review DateFeb 26, 2025

Key ActionSubmit prior authorization with diagnosis-specific documentation and specialist prescriber/consultation as indicated.

SourceLink

On This Page

Still's disease initial therapy: documentation of age and specialist prescriber/consultation required.
Policy history: prior step-therapy requirements for initial Still's disease therapy were removed (see revision notes).

Billing Rule

Coding-Based Denials

Claims that are not submitted with covered diagnosis or procedure codes under the applicable coverage policy will be denied. When billing, providers must use the most appropriate codes as of the effective date of service; services billed for conditions or diagnoses not covered under this policy will be denied as not covered.

Coding-based denials: Missing or non-covered ICD-10/CPT/HCPCS codes will result in denial.
Use the applicable covered diagnosis/procedure codes listed in the policy when submitting claims.

Denial Risk

Combination Biologic/Targeted Oral Therapy Not Allowed

Kineret is considered not medically necessary when used concurrently with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition. Combination therapy with other biologics or targeted synthetic oral small molecules is generally not covered due to higher potential adverse events and lack of evidence for additive benefit. This restriction does not apply to combination with conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine).

Concurrent use with another biologic or targeted synthetic oral small molecule drug for an inflammatory condition is not covered.
Concomitant use with conventional synthetic DMARDs is allowed.

Documentation Required

Documentation Requirements for Initial and Continued Therapy

Required documentation for initial therapy (Still's disease/SJIA) must include confirmation of patient age per indication, diagnosis-specific evidence as applicable, and that the prescriber is a specialist or that there has been specialist consultation. For continuation requests, documentation should show the patient has been on Kineret for at least 6 months and has experienced clinical benefit (objective measures or symptom improvement compared with baseline).

Initial therapy (Still's disease/SJIA): confirm age (≥18 years for AOSD; >2 years for SJIA) and specialist prescriber/consultation.
Continuation: ≥6 months on therapy and evidence of benefit by objective measures (e.g., CRP/ESR normalization, symptom reduction) or documented symptom improvement.
Rheumatoid arthritis and other indications have their own documentation and prior-therapy requirements (see respective indication criteria).

Clinical features/support

DIRA presents with skin and bone manifestations; genetic confirmation is required for initial approval

Treatment contextTreatment with agents that block both IL-1α and IL-1β, including Kineret, is recommended; Kineret produced remission in a natural-history study of genetically confirmed patients

Still's disease / SJIA / AOSD — definition and guideline context

DefinitionStill's disease encompasses systemic juvenile idiopathic arthritis (SJIA) and adult-onset Still's disease (AOSD), considered the same disease differing by age of onset

Guideline recommendationEULAR/PReS joint guidelines recommend initiating IL-1 or IL-6 inhibitors as early as possible after diagnosis; no single preferred agent is specified

Complication and treatmentMacrophage activation syndrome (MAS), a life-threatening complication, should be treated with high-dose steroids and, if needed, therapies that include Kineret

SJIA and AOSD relationship — same disease, different age of onset

RelationshipSystemic juvenile idiopathic arthritis (SJIA) and adult-onset Still's disease (AOSD) are considered the same disease (Still's disease) but differ in age of onset

Clinical routingFor patients <18 years refer to SJIA criteria; for patients ≥18 years refer to AOSD criteria

Policy history notePolicy revisions explicitly added notes clarifying SJIA and AOSD are the same disease with differing age of onset