CurrentCignaPolicy N/A

Inflammatory Conditions - Kineret Prior Authorization

Cigna prior authorization policy governing medical necessity criteria, prescriber requirements, approval durations, and nonrecommended uses for Kineret (anakinra subcutaneous injection) across FDA-approved indications and other supported uses.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Kineret Prior Authorization

Policy CodePolicy N/A

Change TypeAnnual revision; targeted additions and criterion updates

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; initial approvals require specialist prescribing or consultation and continuation requires documentation of established therapy and objective or symptomatic improvement.

POLICY UPDATE CHANGES

Annual Revision, Summary of Changes = No criteria changes.

Castleman Disease, Erdheim-Chester Disease, and CAR T-cell therapy–related toxicities were added to Other Uses with Supportive Evidence in 2025.

Pericarditis indication added and criteria updated; CRP > 1 mg/dL required and prior episode counts specified.

Rheumatoid arthritis initial approval age requirement set to ≥18 years and other age thresholds added for SJIA and AOSD in 2024.

9Named Covered Indications (FDA-approved + supported)

3Named Not Recommended Conditions (examples)

6Specialist types listed for consultation/prescribing

Coverage Summary

Coverage stance: covered_with_criteria for Kineret (anakinra) per the policy. Scope: Cigna prior authorization policy governing medical necessity criteria, prescriber consultation requirements, approval durations, and nonrecommended uses for Kineret across FDA-approved indications and other supported uses. The policy names 9 covered indications (FDA-approved and other uses with supportive evidence). Approvals vary by indication: initial approvals are typically 6 months for many indications, with continuation approvals typically 1 year; pericarditis initial approval is 3 months with continuation 1 year; CAR T-cell–related toxicities approvals are 1 month. Initial approvals require specialist prescribing or consultation and prior authorization is recommended.

Key thresholds & review dates

Pericarditis CRP threshold> 1 mg/dL

CAPS continuation established duration>= 6 months established on therapy

DIRA continuation established duration>= 6 months established on therapy

Rheumatoid arthritis continuation established duration>= 6 months established on therapy

Pericarditis continuation established duration>= 3 months established on therapy

Last review date2026-02-18

StatusCURRENT

Initial Therapy Criteria (by indication)

FDA-Approved Indications - Cryopyrin-Associated Periodic Syndromes (CAPS)

Approve for the duration noted if the patient meets ONE of the following (A or B):

A) Initial Therapy

The medication is being used for treatment of familial cold autoinflammatory syndrome (FCAS), Muckle-Wells Syndrome (MWS), and/or neonatal onset multisystem inflammatory disease (NOMID) formerly known as CINCA
The medication is prescribed by or in consultation with a rheumatologist, geneticist, allergist/immunologist, or a dermatologist

B) Patient is Currently Receiving Kineret

Patient has been established on this medication for at least 6 months
One of

Continuation Therapy Criteria

For continuation review the policy requires documentation that the patient is "established on therapy" for the specified minimum duration (commonly >= 6 months; 3 months for pericarditis; 1 month for CAR T‑cell related indications) and that the patient has either shown improvement on at least one standardized or laboratory-based "objective measure" from baseline OR experienced improvement in at least one symptom. The policy defines Established on therapy as having received the medication for the specified minimum duration prior to continuation review, and Objective measure as standardized or laboratory/clinical markers (e.g., CRP, ESR, CDAI, DAS28, RAPID-3) demonstrating improvement from baseline.

Continuation criteria for patients currently receiving Kineret

For patients currently receiving Kineret, continuation requires documentation of the established duration and either objective improvement from baseline or improvement in at least one symptom.

CAPS - Continuation (B): Patient has been established on this medication for at least 6 months>= 6 months

A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy

CAPS - One of

Unproven / Exclusions

Not medically necessary: the policy states Kineret is considered not medically necessary for any other uses not listed. Examples specifically called out include ankylosing spondylitis, lupus arthritis, and osteoarthritis. The policy also excludes concurrent use of Kineret with another biologic or a targeted synthetic oral small molecule drug (combination therapy), while explicitly permitting combination with conventional synthetic DMARDs.

Not medically necessary for other uses

Not medically necessary for other uses: Kineret is considered not medically necessary for uses not listed in the policy (examples include ankylosing spondylitis, lupus arthritis, osteoarthritis)

Combination therapy exclusion: Concurrent administration with another biologic or targeted synthetic oral small molecule drug is not recommended (does NOT exclude conventional synthetic DMARDs)

Applicable Codes

DrugNDCCovered

No codes listed

Relevant Biologic/Targeted DMARDs (appendix examples for prior therapy requirement)mixed

adalimumab (Humira)	TNF inhibitor — example biologic listed in appendix
etanercept (Enbrel)	TNF inhibitor — example biologic listed in appendix
tocilizumab (Actemra)	IL-6 inhibitor — example biologic listed in appendix
abatacept (Orencia)	T-cell costimulation modulator — example biologic listed in appendix
rituximab (Rituxan)	CD20-directed cytolytic antibody — example biologic listed in appendix
sarilumab (Kevzara)	IL-6 inhibitor — example biologic listed in appendix

No codes listed

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Kineret. All approvals are provided for the durations specified per indication. Because of the specialized skills required for evaluation and diagnosis and monitoring, initial approval requires Kineret to be prescribed by or in consultation with a physician who specializes in the condition being treated; approvals are provided for the duration noted in the policy (months).

Documentation Required

Document objective response or symptom improvement for continuation

For continuation (patients currently receiving Kineret) documentation must show the patient has been established on therapy for the required duration (commonly 6 months; for pericarditis at least 3 months) and either: (1) when assessed by at least one objective measure the patient experienced a beneficial clinical response from baseline; or (2) compared with baseline the patient experienced improvement in at least one symptom.

Clinical Evidence & Guidelines

Background evidence note: Kineret is an interleukin‑1 (IL‑1) receptor antagonist with FDA indications for CAPS, DIRA, and rheumatoid arthritis, and it is used off‑label or with supportive evidence for conditions such as Still's disease (SJIA/AOSD), recurrent pericarditis, and CAR T‑cell therapy–related toxicities. Clinical guidelines (EULAR/ACR, EULAR/PReS, ACC, NCCN) support IL‑1 blockade for many IL‑1–mediated diseases and list Kineret as a recommended option in select guideline contexts.

Evidence / Guidelines

Guideline referencesEULAR/ACR 2021, ACR 2021 RA guideline, EULAR/PReS 2024 Still's disease, ACC 2025 pericarditis, multiple NCCN 2025–2026 recommendations

Background

Kineret is an interleukin‑1 (IL‑1) receptor antagonist. FDA‑labeled indications include treatment of cryopyrin‑associated periodic syndromes (CAPS, including NOMID), deficiency of interleukin‑1 receptor antagonist (DIRA), and rheumatoid arthritis in adults. Off‑label or other supported uses described in the policy include Still's disease (systemic juvenile idiopathic arthritis and adult‑onset Still's disease), recurrent or refractory pericarditis, immunotherapy‑related toxicities associated with CAR T‑cell therapy, Castleman disease, Erdheim‑Chester disease, and other autoinflammatory conditions. Guideline sources cited in the policy (EULAR/ACR 2021, EULAR/PReS 2024, ACC 2025, and NCCN 2025–2026 recommendations) endorse IL‑1 blockade broadly for IL‑1 mediated disorders and list Kineret as a treatment option in selected circumstances.

Revision History

02/28/2024clarified

Annual Revision (02/28/2024): Annual Revision, Summary of Changes = No criteria changes noted in history but multiple prior selected revisions recorded; clarifications to wording of criteria and notes were made previously.

04/24/2024revised

Selected Revision (04/24/2024): Rheumatoid arthritis initial approval age requirement added (≥18 years); SJIA initial approval age requirement added (≥2 years); AOSD initial approval age requirement added (≥18 years); conditions and terminology edits recorded.

02/26/2025clarified

Annual Revision (02/26/2025): Wording edits for rheumatoid arthritis and Still's disease criteria and notes; policy language refined (examples moved to notes, mutation rephrased to 'biallelic pathogenic variants').

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Kineret Prior Authorization

Policy CodePolicy N/A

Change TypeAnnual revision; targeted additions and criterion updates

Effective Date

Next Review Date

On This Page

When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)

Examples: resolution of fever, improvement in rash or skin manifestations, clinically significant improvement or normalization of serum markers (e.g., C-reactive protein, amyloid A), reduction in proteinuria, and/or stabilization of serum creatinine

Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom

Examples: fewer cold-induced attacks; less joint pain/tenderness, stiffness, or swelling; decreased fatigue; improved function or activities of daily living.

FDA-Approved Indications - Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

Approve for the duration noted if the patient meets ONE of the following (A or B):

A) Initial Therapy

Genetic testing has confirmed bi-allelic pathogenic variants in the IL1RN gene
The medication is prescribed by or in consultation with a rheumatologist, geneticist, dermatologist, or a physician specializing in the treatment of autoinflammatory disorders

B) Patient is Currently Receiving Kineret

Patient has been established on this medication for at least 6 months
One of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)
  Examples: improvement in rash or skin manifestations, clinically significant improvement or normalization of serum markers (e.g., CRP, ESR), reduction in proteinuria, and/or stabilization of serum creatinine
- Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom
  Examples: improvement of skin or bone symptoms; less joint pain/tenderness, stiffness, or swelling.

FDA-Approved Indications - Rheumatoid Arthritis

Approve for the duration noted if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient is > 18 years of age
Patient has had a 3-month trial of a biologic OR targeted synthetic DMARD for this condition, unless intolerant
This is a 3-month trial of at least one biologic other than the requested drug. A biosimilar of the requested biologic does not count. Conventional synthetic DMARDs do not count.
The medication is prescribed by or in consultation with a rheumatologist

B) Patient is Currently Receiving Kineret

Patient has been established on therapy for at least 6 months
One of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)
  Examples: CDAI, DAS28-ESR or CRP, PAS-II, RAPID-3, SDAI
- Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom
  Examples: decreased joint pain, morning stiffness, fatigue; improved function; decreased soft tissue swelling

Other Uses with Supportive Evidence - Castleman Disease

Approve for the duration noted if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient is ≥ 18 years of age
The medication is being used for multicentric disease that is relapsed/refractory or progressive
The medication is prescribed by or in consultation with an oncologist or hematologist

B) Patient is Currently Receiving Kineret

Patient has been established on this medication for at least 6 months
One of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)
  Examples: clinically significant improvement or normalization of serum markers (e.g., CRP, ESR, fibrinogen, albumin, hemoglobin), increased BMI, reduction in lymphadenopathy
- Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom
  Examples: constitutional symptoms such as fatigue, physical function

Other Uses with Supportive Evidence - Erdheim-Chester Disease

Approve for 1 year if the patient meets BOTH of the following (A and B):

Patient is >18 years of age

The medication is prescribed by or in consultation with an oncologist or hematologist

Other Uses with Supportive Evidence - Immunotherapy-Related Toxicities Associated with CAR T-Cell Therapy

Approve for 1 month if the patient has been or will be treated with a CAR T-cell therapy.

Patient has been or will be treated with a CAR T-cell therapy

Examples of immunotherapy-related toxicities include Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and other toxicities

Other Uses with Supportive Evidence - Pericarditis

Approve for the duration noted if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient is ≥ 18 years of age
Patient has recurrent pericarditis
Prior to starting treatment with Kineret, the patient had a history of at least three episodes of pericarditis
Patient has C-reactive protein (CRP) level > 1 mg/dL> 1 mg/dL
One of
- For the current episode, the patient is receiving standard treatment
- Standard treatment is contraindicated
The medication is prescribed by or in consultation with a cardiologist or rheumatologist

B) Patient is Currently Receiving Kineret

Patient has been established on this medication for at least 3 months
One of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)
  Examples: normalization of inflammatory biomarkers such as ESR and/or CRP, continued resolution of fever
- Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom
  Examples: resolution of chest pain or pericarditis pain

Other Uses with Supportive Evidence - Still's Disease, Adult Onset (AOSD)

Approve for the duration noted if the patient meets ONE of the following (A or B). Note: AOSD and SJIA are considered the same disease but differ in age of onset.

A) Initial Therapy

Patient is > 18 years of age
The medication is prescribed by or in consultation with a rheumatologist

B) Patient is Currently Receiving Kineret

Patient has been established on this medication for at least 6 months
One of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)
  Examples: resolution of fever, improvement in rash or skin manifestations, normalization of serum markers (e.g., CRP, ESR), and/or reduced dosage of corticosteroids
- Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom
  Examples: less joint pain/tenderness, stiffness, swelling; decreased fatigue; improved function or ADLs

Other Uses with Supportive Evidence - Systemic Juvenile Idiopathic Arthritis (SJIA)

Approve for the duration noted if the patient meets ONE of the following (A or B). Note: For a patient ≥ 18 years of age, refer to AOSD.

A) Initial Therapy

Patient is > 2 years of age
The medication is prescribed by or in consultation with a rheumatologist

B) Patient is Currently Receiving Kineret

Patient has been established on this medication for at least 6 months
One of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)
  Examples: resolution of fever, improvement in rash or skin manifestations, clinically significant improvement or normalization of serum markers (e.g., CRP, ESR), and/or reduced dosage of corticosteroids
- Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom
  Examples: less joint pain/tenderness, stiffness, or swelling; decreased fatigue; improved function or ADLs

When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)

Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom

Examples: fewer cold-induced attacks; less joint pain/tenderness, stiffness, or swelling; decreased fatigue; improved function or activities of daily living.

DIRA - Continuation (B): Patient has been established on this medication for at least 6 months>= 6 months

A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy

DIRA - One of

When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)
Examples: improvement in rash or skin manifestations, clinically significant improvement or normalization of serum markers (e.g., CRP, ESR), reduction in proteinuria, and/or stabilization of serum creatinine
Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom
Examples: improvement of skin or bone symptoms; less joint pain/tenderness, stiffness, or swelling.

RA - Continuation (B): Patient has been established on therapy for at least 6 months>= 6 months

A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy

RA - One of

When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)
Examples: CDAI, DAS28-ESR or CRP, PAS-II, RAPID-3, SDAI
Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom
Examples: decreased joint pain, morning stiffness, fatigue; improved function; decreased soft tissue swelling

Castleman - Continuation (B): Patient has been established on this medication for at least 6 months>= 6 months

A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy

Castleman - One of

When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)
Examples: clinically significant improvement or normalization of serum markers (e.g., CRP, ESR, fibrinogen, albumin, hemoglobin), increased BMI, reduction in lymphadenopathy
Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom
Examples: constitutional symptoms such as fatigue, physical function

Pericarditis - Continuation (B): Patient has been established on this medication for at least 3 months>= 3 months

A patient who has received < 3 months of therapy or who is restarting therapy is reviewed under Initial Therapy

Pericarditis - One of

When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)
Examples: normalization of inflammatory biomarkers such as ESR and/or CRP, continued resolution of fever
Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom
Examples: resolution of chest pain or pericarditis pain

AOSD - Continuation (B): Patient has been established on this medication for at least 6 months>= 6 months

A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy

AOSD - One of

When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)
Examples: resolution of fever, improvement in rash or skin manifestations, normalization of serum markers (e.g., CRP, ESR), and/or reduced dosage of corticosteroids
Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom
Examples: less joint pain/tenderness, stiffness, swelling; decreased fatigue; improved function or ADLs

SJIA - Continuation (B): Patient has been established on this medication for at least 6 months>= 6 months

A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy

SJIA - One of

When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested drug)
Examples: resolution of fever, improvement in rash or skin manifestations, clinically significant improvement or normalization of serum markers (e.g., CRP, ESR), and/or reduced dosage of corticosteroids
Compared with baseline (prior to initiating the requested drug), patient experienced an improvement in at least one symptom
Examples: less joint pain/tenderness, stiffness, or swelling; decreased fatigue; improved function or ADLs

Documentation Required

Specialist consultation requirement for initial approvals

Initial approvals require Kineret to be prescribed by or in consultation with a physician who specializes in the condition being treated. Example specialist types listed in the policy include rheumatologist, geneticist, allergist/immunologist, dermatologist, oncologist/hematologist, and cardiologist (specialist required varies by indication).

Rheumatologist
Geneticist
Allergist/Immunologist
Dermatologist
Oncologist/Hematologist
Cardiologist

Billing Rule

Approval durations

Typical approval durations in the policy: initial approvals are commonly 6 months for many indications with continuation approvals for patients already receiving therapy typically approved for 1 year. Indication-specific durations: pericarditis initial approval is 3 months (continuation 1 year), CAR T-cell–related toxicities are approved for 1 month, and Erdheim–Chester disease is approved for 1 year.

Denial Risk

Not medically necessary for other uses

Kineret is considered not medically necessary for uses not listed in the policy. Examples explicitly noted as not recommended include ankylosing spondylitis, lupus arthritis, and osteoarthritis. Concurrent use with another biologic or a targeted synthetic oral small molecule drug is also considered not medically necessary (combination therapy excluded, though conventional synthetic DMARDs are not excluded).

04/23/2025clarified

Selected Revision (04/23/2025): Removed COVID-19/Cytokine release syndrome COVID-specific review language; COVID-19 removed from Other Uses with Supportive Evidence.

06/11/2025added

Selected Revision (06/11/2025): Castleman Disease, Erdheim-Chester Disease, and Immunotherapy-Related Toxicities (CAR T-cell) were added to Other Uses with Supportive Evidence.

08/13/2025added

Selected Revision (08/13/2025): Immunotherapy-related toxicities associated with CAR T-cell therapy added with note about examples of toxicities.

11/05/2025revised

Selected Revision (11/05/2025): Pericarditis was added to Other Uses with Supportive Evidence; criteria specified including CRP > 1 mg/dL and requirement for prior history of at least three episodes for initial therapy, and initial approval/continuation durations (3 months initial, 1 year continuation).

11/24/2025added

NCCN (11/24/2025) references list Kineret for Castleman Disease as an alternative for relapsed/refractory progressive multicentric disease; supports policy additions for 2025.

11/21/2025added

NCCN (11/21/2025) references list Kineret as first-line or subsequent treatment for Erdheim-Chester disease, supporting policy additions in 2025.

11/11/2025added

NCCN (11/11/2025) guidelines list Kineret for management of CAR T-cell–related toxicities (CRS, ICANS), supporting policy additions in 2025.

02/18/2026clarifiedLatest

Annual Revision (02/18/2026): Annual Revision, Summary of Changes = No criteria changes. Marked as latest review date in policy history.