CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Kevzara (sarilumab) — coverage criteria for RA, PMR, and pJIA

Covers medical necessity criteria, prior authorization requirements, documentation, and continuation criteria for Kevzara (sarilumab) for rheumatoid arthritis, polymyalgia rheumatica, and polyarticular juvenile idiopathic arthritis for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKevzara (sarilumab) — coverage criteria for RA, PMR, and pJIA

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of prior therapies, biomarker testing, and TB screening; authorization may be granted for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3indications with coverage criteria (RA, PMR, pJIA ≥63 kg)

12 monthstypical authorization duration

TB testing requiredtuberculosis screening prior to initiation

Rheumatologistrequired prescribing specialty

Coverage and Medical Necessity Criteria

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Initial Therapy — Rheumatoid Arthritis

Covered when ALL of the following are met for adult RA:

RA diagnosis: Member is an adult with moderately to severely active rheumatoid arthritis (RA)

Prior DMARD/biologic history: Member has had an inadequate response or intolerance to one or more DMARDs OR has previously received a biologic or targeted synthetic drug indicated for RA

Methotrexate trial or contraindication: Member has experienced an inadequate response to at least a 3-month trial of methotrexate at adequate dosing OR has intolerance/contraindication to methotrexate

Biomarker testing (if applicable): Member has laboratory testing: rheumatoid factor (RF), anti-CCP, and CRP and/or ESR as documented

Initial Therapy — Polymyalgia Rheumatica

Covered when ANY of the following are met for adult PMR:

Inadequate response to corticosteroids: Member has experienced an inadequate response to systemic corticosteroids

Disease flare on taper: Member has experienced a disease flare during a corticosteroid taper

Inadequate response to methotrexate: Member has experienced an inadequate response to methotrexate

Intolerance/contraindication to corticosteroids and methotrexate: Member has intolerance or contraindication to both systemic corticosteroids and methotrexate

Initial Therapy — Polyarticular Juvenile Idiopathic Arthritis

Covered when ALL of the following are met for pJIA in members weighing 63 kg:

Weight and diagnosis: Member weighs >= 63 kg AND has active polyarticular juvenile idiopathic arthritis (pJIA)weight >= 63 kg

Prior therapy or risk factors: Member has previously received a biologic or targeted synthetic drug for pJIA OR had inadequate response to scheduled NSAIDs and/or intra-articular glucocorticoids and has one or more risk factors for poor outcome OR had inadequate response to methotrexate or another conventional synthetic DMARD administered at adequate dose and duration

Risk factors include ankle/wrist/hip/SIJ/TMJ involvement, erosive disease or enthesitis, delayed diagnosis, elevated inflammatory markers, symmetric disease, involvement of high-risk joints, high disease activity, or other listed risk factors (Appendix B).

Continuation Therapy

Covered for continuation when members demonstrate positive clinical response as specified for each condition:

RA continuation: For RA: member achieves or maintains a positive clinical response evidenced by disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability.>=20% improvement in specified measures

PMR continuation: For PMR: member demonstrates low disease activity or improvement in signs/symptoms such as morning stiffness, hip or shoulder pain, hip or shoulder range of motion, or CRP/ESR.

pJIA continuation: For pJIA (>=63 kg): member demonstrates improvement or low disease activity evidenced by fewer active joints, improved range of motion, or improved functional ability.

Universal Pre-initiation Requirements

All indications require the following before initiation:

TB testing and treatment: Member must have a documented negative tuberculosis (TB) test (within 6 months if biologic-naive). If TB screening is positive, confirm no active disease and treat latent TB prior to initiation. Do not administer the medication to members with active TB.

No concomitant biologic/targeted synthetic therapy: Member must not be receiving the requested medication concomitantly with any other biologic or targeted synthetic drug for the same indication.

All indications for sarilumab (Kevzara) other than the listed EDA-approved indications are considered experimental/investigational and not medically necessary.

Use of Kevzara (sarilumab) for any condition not included in the approved indications — adult rheumatoid arthritis, adult polymyalgia rheumatica, or polyarticular juvenile idiopathic arthritis in patients weighing ≥ 63 kg — is considered not medically necessary.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — typical 12-month approvals. Prior authorization is required for these indications; authorization of up to 12 months may be granted when indication-specific criteria are met. Requests must document prior therapy trials or contraindications as specified by the indication.

Authorization duration: up to 12 months for qualifying indications (e.g., rheumatoid arthritis, polymyalgia rheumatica, polyarticular juvenile idiopathic arthritis).
Indication-specific criteria (biomarkers, prior therapies, or contraindications) must be met for approval.

Step Therapy

Step Therapy / Prior Trials

Step therapy / prior trials required. For initial requests, members must have trialed and had an inadequate response to, or have documented intolerance/contraindication to, specified conventional agents before approval of biologic or targeted synthetic agents.

Rheumatoid arthritis: inadequate response to at least a 3-month trial of methotrexate at adequate dosing, unless intolerance/contraindication documented.
Polymyalgia rheumatica: inadequate response to systemic corticosteroids, or disease flare during steroid taper, or intolerance/contraindication to corticosteroids and methotrexate.
Polyarticular juvenile idiopathic arthritis (≥63 kg): inadequate response to scheduled NSAIDs and/or intra-articular glucocorticoids and inadequate response to methotrexate or another conventional synthetic DMARD (e.g., leflunomide, sulfasalazine, hydroxychloroquine) at adequate dose/duration.

Documentation Required

Required Documentation

Required documentation for initial and continuation requests. Submit chart notes, medical records, claims history, lab results, and biomarker testing as applicable to support medical necessity, prior therapy trials, intolerance/contraindication, and clinical response for continuation.

Initial requests: laboratory results and biomarker testing (e.g., RF, anti-CCP, CRP, ESR) when applicable; chart notes or claims history documenting prior medications tried and response to therapy; documentation of clinical reasons to avoid required therapies if applicable.
Continuation requests: chart notes or medical record documentation supporting positive clinical response.
Include documentation of dosing and duration for prior trials and any intolerance or contraindication details (see Appendix A where applicable).

Denial Risk

TB Infection Contraindication

TB screening and contraindication. Members must have documented negative TB screening prior to initiation. Do not administer medication to members with active TB; if latent TB is identified, TB treatment must be started before initiating therapy.

Acceptable testing: documented negative tuberculosis test within 6 months of initiating therapy for biologic- or targeted synthetic–naive persons, or per clinical guidance.
If TB screening is positive, further evaluation to exclude active disease is required before therapy initiation.
If latent TB is present, treatment for latent TB must be started prior to initiation of the requested medication.

Codes, Weight Thresholds, and References

References / sourcemixed

Kevzara [package insert]	Reference to FDA package insert for dosing and administration (Feb 2024)
Genovese MC et al. Arthritis Rheumatol. 2015;67(6):1424-37	Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: phase III study
Strand V et al. RMD Open. 2017;e000416	Sarilumab improves patient-reported outcomes in RA patients with inadequate response/intolerance to TNF inhibitors
Testing for TB Infection. CDC	CDC guidance on testing for TB infection
Smolen JS et al. Ann Rheum Dis. 2020;79:685-699	EULAR recommendations for management of rheumatoid arthritis
Aletaha D et al. Arthritis Rheum. 2010;62(9):2569-81	2010 RA classification criteria (ACR/EULAR)
Fraenkel L et al. Arthritis Care Res. 2021	2021 ACR guideline for the treatment of rheumatoid arthritis

Primary package insert referencemixed

Kevzara [package insert]

Bridgewater, NJ: Sanofi-aventis, U.S. LLC / Regeneron Pharmaceuticals, Inc; February 2024.

inv-09: Weight threshold for pJIA

Weight threshold>= 63 kg

Applies toPolyarticular juvenile idiopathic arthritis (pJIA)

Authorization duration when criteria metUp to 12 months

Requirement contextThreshold used to gate initial and continuation coverage for pJIA (members weighing 63 kg or greater)

OpenPayer

Kevzara (sarilumab) — coverage criteria for RA, PMR, and pJIA

Coverage and Medical Necessity Criteria

Prior Authorization, Documentation, and Provider Requirements

Codes, Weight Thresholds, and References

Clinical Definitions and Response Criteria

Background and Drug Information