CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Kevzara (sarilumab) — Coverage Criteria

Covers prior-authorization criteria, documentation, prescriber requirements, dosing considerations, and continuation criteria for Kevzara (sarilumab) for rheumatoid arthritis, polymyalgia rheumatica, and polyarticular juvenile idiopathic arthritis for plan members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKevzara (sarilumab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes showing prior therapy trials and documentation of positive clinical response or TB screening as required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Indications covered (RA, PMR, pJIA ≥63 kg)

12 monthsAuth duration

6 monthsTB screening

RheumatologistPrescriber

Kevzara (sarilumab) Coverage Criteria

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ALL of the following

Member is an adult with moderately to severely active rheumatoid arthritis (RA).
Member has had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
Biomarker requirement
- Member has been tested and is positive for either Rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP).
- Member has been tested for ALL of the following: RF; anti-CCP; and C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR).
Methotrexate requirement
- Member has experienced an inadequate response to at least a 3-month trial of methotrexate despite adequate dosing (i.e., titrated to at least 15 mg/week).
- Member has an intolerance or contraindication to methotrexate (see Appendix A).
Authorization may be granted for up to 12 months for adult members who achieve or maintain a positive clinical response (e.g., ≥20% improvement from baseline in tender/swollen joint count, pain, or disability).

Polymyalgia rheumatica (PMR)

Covered for polymyalgia rheumatica when ANY of the following are met:

ANY of the following

Member has experienced an inadequate response to systemic corticosteroids.
Member has experienced a disease flare during a taper with systemic corticosteroids.
Member has experienced an inadequate response to methotrexate.
Member has an intolerance or contraindication to both systemic corticosteroids and methotrexate (see Appendix A).
Authorization may be granted for up to 12 months for members who achieve or maintain a positive clinical response, evidenced by low disease activity or improvement in morning stiffness, hip or shoulder pain, range of motion, or CRP/ESR from baseline.

Polyarticular juvenile idiopathic arthritis (pJIA)

Covered for polyarticular juvenile idiopathic arthritis for members weighing ≥63 kg when ALL of the following are met:

ALL of the following

Member has active polyarticular juvenile idiopathic arthritis and weighs 63 kg or greater.
Prior biologic/ts-drug
- Member has previously received a biologic or targeted synthetic drug indicated for active polyarticular juvenile idiopathic arthritis (e.g., Xeljanz).
Failure of conventional therapy or risk factors
- Member has had an inadequate response to methotrexate or another conventional synthetic disease-modifying drug (e.g., leflunomide, sulfasalazine, hydroxychloroquine) given at adequate dose and duration.
- Member has had an inadequate response to scheduled NSAIDs and/or intra-articular glucocorticoids and has one or more risk factors for poor outcome: involvement of ankle, wrist, hip, sacroiliac joint, and/or TMJ; presence of erosive disease or enthesitis; delay in diagnosis; elevated inflammatory markers; or symmetric disease.
- Member has risk factors for disease severity and potentially a more refractory course (see Appendix B) and also meets one of: high-risk joint involvement (e.g., cervical spine, wrist, or hip); high disease activity; or judged to be at high risk for disabling joint disease.
Authorization of up to 12 months may be granted for members who achieve or maintain a positive clinical response, evidenced by improvement from baseline in number of active joints, number of joints with limited movement, or functional ability.

Universal safety requirements

Universal safety requirements — for all indications:

ALL of the following

Member has had a documented negative tuberculosis (TB) test (tuberculin skin test [PPD], interferon-gamma release assay [IGRA], or chest x-ray) within 6 months of initiating therapy if naïve to biologic or targeted synthetic drugs. If TB screening is positive, further testing must confirm no active disease; do not administer medication to members with active TB. If latent TB is present, TB treatment must be started before initiation of therapy.
Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

Prior Authorization, Documentation, and Provider Requirements

Denial Risk

Indication Not Covered

All indications not listed as FDA-approved are considered experimental/investigational and are not covered. Prior authorization requests for uses outside the approved or compendial indications may be denied as not medically necessary.

Non‑FDA or non‑compendial uses are considered experimental/investigational and are not covered.

Documentation Required

Required Documentation for Initial and Continuation Requests

Submit complete clinical documentation with initial and continuation prior authorization requests. Incomplete documentation may delay review or result in denial.

Initial requests: chart notes, medical records, or claims history documenting prior medications tried and response to therapy, or documentation of clinical reasons to avoid specific therapies.
Initial requests (RA): laboratory results or chart documentation of biomarker testing (RF, anti‑CCP, and CRP and/or ESR) when applicable.
Continuation requests: chart notes or medical record documentation supporting a positive clinical response (see condition‑specific response criteria).

Documentation Required

TB Screening Documentation

A negative TB screening result must be documented within 6 months prior to initiating therapy for members who are biologic/targeted‑synthetic‑naïve. If TB screening is positive, additional evaluation is required to exclude active disease; do not administer therapy for active TB. If latent TB is identified, initiate TB treatment prior to starting the requested medication.

Acceptable TB screening: PPD (skin test), IGRA, or chest x‑ray.
If TB test is positive: obtain further testing to rule out active TB before approving therapy; require documentation of latent TB treatment initiation if applicable.
Do not administer the requested medication to members with active TB infection.

Step Therapy

Step Therapy and Prior Treatment Requirements

Step therapy and prior treatment requirements must be documented in the medical record as part of the prior authorization review.

Rheumatoid arthritis (RA): document inadequate response to at least a 3‑month trial of methotrexate at adequate dosing (≥15 mg/week) unless there is documented intolerance or contraindication. Biomarker testing (RF, anti‑CCP, and CRP/ESR) documentation per criteria is required when applicable.
Polymyalgia rheumatica (PMR): document inadequate response to systemic corticosteroids or disease flare during steroid taper, or inadequate response to methotrexate, or intolerance/contraindication to both corticosteroids and methotrexate.
Polyarticular juvenile idiopathic arthritis (≥63 kg): document inadequate response to methotrexate or another conventional synthetic DMARD at adequate dose/duration, and trials of scheduled NSAIDs and/or intra‑articular glucocorticoids when specified; include risk factors for poor outcome when applicable.

Clinical Background

Sarilumab (Kevzara) is an interleukin-6 (IL-6) receptor antagonist indicated for inflammatory rheumatologic conditions. This policy covers its use for: adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more DMARDs; adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper; and patients with active polyarticular juvenile idiopathic arthritis (pJIA) who weigh 63 kg or greater.

Prior authorization may be granted when indication-specific clinical criteria and documentation requirements are met, and universal safety requirements apply: for biologic/ts-naïve patients a documented negative TB test within 6 months is required before initiation; active TB is an exclusion and latent TB must be treated prior to starting therapy. Concomitant use with another biologic or targeted synthetic for the same indication is not permitted.

Definitions and Risk Factors

inv-15: Contraindication to methotrexate

Alcohol-related liver diseaseClinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease

Drug interactions or toxicity riskConcomitant drug interactions or risk of treatment‑related toxicity that preclude methotrexate use

Reproductive considerationsPregnancy, planning pregnancy, or breastfeeding—methotrexate contraindicated

Significant comorbidity or hypersensitivitySignificant comorbidity (e.g., severe liver or kidney disease, blood dyscrasias, uncontrolled hypertension) or hypersensitivity/history of intolerance to methotrexate

inv-16: Risk factors for severe/refractory pJIA

Seropositive autoantibodiesPositive rheumatoid factor (RF) or positive anti‑cyclic citrullinated peptide (anti‑CCP)

Pre-existing joint damage or high‑risk jointsPre-existing erosive joint damage or involvement of high‑risk joints (e.g., cervical spine, wrist, hip, ankle, sacroiliac joint, temporomandibular joint)

High disease activity or inflammatory markersHigh disease activity, elevated inflammatory markers (e.g., CRP/ESR), symmetric disease, or erosive disease suggesting more severe/refractory course

Delay in diagnosis or enthesitisDelay in diagnosis or presence of enthesitis which increase risk for poor outcomes

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKevzara (sarilumab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes showing prior therapy trials and documentation of positive clinical response or TB screening as required.

SourceLink

On This Page

OpenPayer

Kevzara (sarilumab) — Coverage Criteria

Kevzara (sarilumab) Coverage Criteria

Dosing & Coding Details

Prior Authorization, Documentation, and Provider Requirements

Clinical Background

Definitions and Risk Factors