ModifiedCignaPolicy N/A

Inflammatory Conditions - Kevzara Prior Authorization Policy

Defines Cigna prior authorization requirements, medical necessity criteria, covered indications, and not-covered uses for Kevzara (sarilumab subcutaneous injection) across prescription benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Kevzara Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMODIFIED

Effective Date

Next Review Date03/19/2025

Key ActionPrior authorization is required; ensure initial therapy is prescribed by or in consultation with a specialist and document required prior therapy trials and objective response for continuation.

POLICY UPDATE CHANGES

Polymyalgia rheumatica was added as a newly approved condition.

Polyarticular Juvenile Idiopathic Arthritis was added as a newly approved indication.

For rheumatoid arthritis and polymyalgia rheumatica initial approvals, requirement that patient is ≥ 18 years of age was added.

COVID-19 and cytokine release syndrome associated with COVID-19 references were removed from the policy statement.

Condition Not Covered: Concurrent use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug wording changed.

Review date updated to 03/19/2025; selected revision on 04/23/2025.

3Covered Indications (FDA-approved)

2Not Covered / Excluded Uses Listed

1 yrContinuation Duration

Coverage Summary

Coverage stance: covered_with_criteria for Kevzara (sarilumab) when used for its FDA‑approved indications: Rheumatoid Arthritis (adults), Polyarticular Juvenile Idiopathic Arthritis (patients weighing ≥63 kg), and Polymyalgia Rheumatica (adults). This policy defines Cigna prior authorization requirements, medical necessity criteria, covered indications, and not‑covered uses for Kevzara across prescription benefit plans. Effective/last review date: 03/19/2025 (selected revision 04/23/2025).

Key thresholds

Age requirement> 18 years

Weight for PJIA>= 63 kg

Trial duration for conventional synthetic DMARD>= 3 months

Established therapy duration>= 6 months

Initial approval duration6 months

Continuation approval duration1 year

FDA-Approved Indications — Rheumatoid Arthritis

FDA-Approved Indications — Polyarticular Juvenile Idiopathic Arthritis (PJIA)

FDA-Approved Indications — Polymyalgia Rheumatica

Requirements Applicable to Approvals

Conditions Not Covered (Not Medically Necessary)

Denial Risk

Not covered uses will be denied

Claims for Kevzara for indications not listed in the policy (for example, ankylosing spondylitis) and claims for concurrent use with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition are considered not medically necessary and will be denied.

Not medically necessary for non-listed indications (e.g., ankylosing spondylitis).
Claims for concurrent use with another biologic or a targeted synthetic oral small molecule drug will be denied.

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of Kevzara. Initial approvals are typically issued for 6 months; continuation (established patient) approvals are typically issued for 1 year. In cases where approval duration is given in months, 1 month = 30 days.

Prior authorization is required for prescription benefit coverage.
Initial approval duration: 6 months.
Continuation (established patients) approval duration: 1 year.
1 month = 30 days when approvals are authorized in months.

Documentation Required

Specialist involvement and documentation of trials/response

Applicable Codes

Drugs / Biologic identifiers mentioned (appendix examples)mixed

No codes listed

Clinical Evidence & References

Prescribing Information: Regeneron/SanofiAventis; June 2024 (Kevzara subcutaneous injection prescribing information).

ACR Guideline (Rheumatoid Arthritis): 2021 ACR guideline recommends adding a biologic or a targeted synthetic DMARD when methotrexate at the maximum tolerated dose is insufficient.

Ankylosing Spondylitis Trial: Phase II ALIGN study did not demonstrate efficacy for sarilumab in ankylosing spondylitis.

Background & Definitions

Background: Kevzara (sarilumab) is an interleukin‑6 (IL‑6) receptor inhibitor approved for rheumatoid arthritis (adults with moderate to severe active disease with inadequate response/intolerance to ≥1 DMARD), polyarticular juvenile idiopathic arthritis (patients weighing ≥63 kg), and polymyalgia rheumatica (adults with inadequate response to or intolerance of corticosteroids). Cigna requires prior authorization for Kevzara; initial approval typically requires prescription by or consultation with a specialist (typically a rheumatologist) and documents trials of prior therapies and evidence of therapeutic response for continuation.

Revision History

03/08/2023added

Polymyalgia rheumatica was added as a newly approved condition (Early Annual Revision).

06/19/2024added

Polyarticular Juvenile Idiopathic Arthritis (PJIA) was added as a newly approved indication (Selected Revision).

09/11/2024revised

For initial approvals for rheumatoid arthritis and polymyalgia rheumatica, a requirement that the patient is ≥ 18 years of age was added.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Kevzara Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMODIFIED

Effective Date

Next Review Date03/19/2025

On This Page

Initial therapy must be prescribed by or in consultation with a specialist (typically a rheumatologist). Documentation must show prior trials of the required conventional synthetic DMARD or other systemic therapy as applicable, and for continuation approvals the patient must have been established on therapy ≥6 months with documentation of beneficial clinical response by at least one objective measure or improvement in at least one symptom.

Initial prescription by or in consultation with a specialist (rheumatologist).
Document trial of required conventional synthetic DMARD or other systemic therapy per indication.
For continuation approvals: patient established on therapy ≥6 months.
Continuation requires documentation of beneficial response on at least one objective measure or improvement in at least one symptom.

Documentation Required

Exception to DMARD trial

An exception to the requirement for a trial of one conventional synthetic DMARD can be made if the patient has already had a 3-month trial of at least one biologic other than the requested drug. A biosimilar of the requested biologic does not count toward this exception.

3-month trial of at least one biologic (other than the requested drug) can waive the conventional synthetic DMARD trial.
Biosimilars of the requested biologic do not count.

04/23/2025removedLatest

References to COVID-19 and forwarding reviews for COVID-19/cytokine release syndrome to the Medical Director were removed from the policy statement.

09/11/2024revised

Wording updated for 'Conditions Not Covered': Concurrent use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug (clarified terminology).

03/19/2025revised

Administrative update: Review date updated in header (Review Date 03/19/2025; selected revision 04/23/2025).