CurrentBlue Cross Blue Shield - IowaPolicy 05.02.26

Kevzara (sarilumab) — medical necessity and prior authorization criteria

Policy governing medical necessity and prior authorization criteria for Kevzara (sarilumab) for rheumatologic indications (rheumatoid arthritis, polymyalgia rheumatica, polyarticular juvenile idiopathic arthritis) and certain compendial uses for Wellmark Blue Cross and Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyKevzara (sarilumab) — medical necessity and prior authorization criteria

Policy CodePolicy 05.02.26

Change TypeNo material changes

Effective DateFeb 28, 2025

Next Review Date

Key ActionObtain prior authorization and submit documentation of prior treatment failures or contraindications and required laboratory/test results.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

>=63 kgpJIA weight threshold

2 preferredrequired prior preferred failures

2quantity limit (syringes)

2quantity limit (pens)

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Coverage and Medical Necessity Criteria

Polymyalgia Rheumatica (PMR)

Polymyalgia rheumatica (PMR) — Covered when ALL of the following are met:

ALL of the following

Member has a diagnosis of polymyalgia rheumatica according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria.
- Rheumatoid factor (RF)
- Anti-cyclic citrullinated peptide (anti-CCP)
- C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR)
Member has had an inadequate response to systemic corticosteroids or cannot tolerate a corticosteroid taper.
Other possible causes of signs and symptoms have been ruled out (for example, rheumatoid arthritis, polymyositis, fibromyalgia, osteoarthritis).

Polymyalgia Rheumatica (PMR) — Authorization/Continuation

Authorization / Duration — Covered continuation when ALL of the following are met:

ALL of the following

Authorization of 12 months may be granted for adult members for treatment of polymyalgia rheumatica when the member meets the initial coverage criteria above and achieves or maintains a positive clinical response.
Positive clinical response is evidenced by improvement from baseline in any of the following: morning stiffness, hip or shoulder pain, hip or shoulder range of motion, or C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR).

Billing, Weight Thresholds, and Related Codes

Provider billing codes (general instruction)mixed

No codes listed

Weight for pJIA — >= 63 kg

Weight threshold>= 63 kg

Applies toMembers with polyarticular juvenile idiopathic arthritis (pJIA)

Authorization durationAuthorization of 12 months may be granted when criteria met

Methotrexate trial — >= 3 months at adequate dosing (>=15 mg/week)

Required methotrexate trial>= 3 months at adequate dosing (titrated to at least 15 mg/week)

Alternatives notedIntolerance or contraindication to methotrexate qualifies instead of trial

Other csDMARDs

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required — Prior authorization required

Prior authorization is required for Kevzara. Initial approvals may be granted for up to 12 months when the specified clinical criteria are met (see Criteria for Initial Approval and Authorization sections).

Initial approvals may be granted for up to 12 months when indication-specific clinical criteria and treatment history are met.
Do not administer to members with active tuberculosis; documented negative TB test within 6 months is required for biologic/targeted synthetic DMARD–naive patients (see Other).

Step Therapy

Step therapy before non-preferred — Policy requires failure/intolerance to preferred products

The plan requires failure or intolerance to at least two of the health plan's preferred products before a non-preferred product (e.g., Kevzara) will be approved, unless clinical circumstances exclude the use of all preferred products, the member is already receiving the non-preferred product with a positive therapeutic outcome, or only one preferred product exists for the indication.

Preferred products include (but may not be limited to): adalimumab-aacf; Enbrel; Cosentyx; Otezla; Rinvoq; Skyrizi; Stelara; Tremfya; Xeljanz/Xeljanz XR.

Definitions and Background

Compendial uses — Non-FDA labeled indications supported by compendia

Compendial uses listedImmune checkpoint inhibitor-related inflammatory arthritis

Compendial uses listedGiant cell arteritis (GCA)

RequirementMust meet Preferred Drug Plan Design and applicable initial/continuation criteria

Contraindications to methotrexate (examples)

BreastfeedingContraindication example to methotrexate

Chronic liver disease / alcohol use disorderClinical diagnosis of alcohol use disorder; alcoholic liver disease or other chronic liver disease

Documentation Required

PROVIDER ACTIONS — For initial requests submit chart notes/medical records/claims history documenting prior medications tried and response, biomarker test results, and rationale

Providers must submit documentation to support prior authorization requests. For initial requests include chart notes, medical record documentation, or claims history showing prior medications tried and responses, and laboratory/biomarker results when applicable. For continuation requests provide chart notes documenting positive clinical response.

For initial requests: chart notes/medical records/claims history that document prior medications tried (including dose, duration, and clinical response) and documentation of clinical reasons to avoid preferred therapies when applicable.
Include laboratory results or biomarker testing when applicable (e.g., RF, anti-CCP, CRP, ESR).
For continuation requests: chart notes or medical record documentation supporting positive clinical response.
If therapy is not advisable, submit documentation of contraindication or clinical reason to avoid the preferred product(s).

Denial Risk

PROVIDER ACTIONS — Requests may be denied if member has not met required prior treatments or provided required documentation

Requests may be denied if the member has not met required step-therapy or prior-treatment criteria, or if required documentation is incomplete. Specifically, denials may occur when the member has not had inadequate response or intolerable adverse events to the required preferred products, when chart notes do not document prior therapy dose/duration/response, or when requisite diagnostic testing/lab results are missing.

Kevzara is considered not medically necessary for members who do not meet the criteria set forth in this policy.
Denial triggers include lack of documentation of prior treatment failures, contraindications, or intolerance; absence of required biomarker or TB testing when applicable; and concomitant use with another biologic or targeted synthetic DMARD for the same indication.
Members receiving samples or manufacturer's patient assistance program supply must still meet initial approval criteria to continue coverage.

Step Therapy

Step therapy / prior treatment — Conventional DMARDs and prior therapy requirements

For several indications (including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and immune checkpoint inhibitor–related toxicity) members must have had inadequate response to, or contraindication/intolerance to, conventional synthetic DMARDs (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) or an adequate trial of NSAIDs/intra-articular glucocorticoids when indicated prior to approval of Kevzara.

Rheumatoid arthritis: inadequate response/intolerance to at least two preferred biologic/targeted products OR clinical reason to avoid specified preferred products plus inadequate response to remaining preferred options; often requires prior trial of methotrexate (≥3 months at adequate dose) unless contraindicated.
Polyarticular JIA: inadequate response to methotrexate or another conventional synthetic DMARD at adequate dose/duration, or inadequate response to scheduled NSAIDs/intra-articular glucocorticoids plus risk factors for poor outcome.
Immune checkpoint inhibitor–related toxicity: inadequate response to corticosteroids or to a conventional synthetic DMARD, or intolerance/contraindication to these therapies.