CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sarilumab (Kevzara) — Coverage Criteria for RA, PMR, and pJIA

Defines prior authorization, documentation, prescriber specialty, and clinical criteria for coverage of sarilumab (Kevzara) for rheumatoid arthritis, polymyalgia rheumatica, and polyarticular juvenile idiopathic arthritis for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySarilumab (Kevzara) — Coverage Criteria for RA, PMR, and pJIA

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes documenting prior therapies, relevant labs, and TB screening to support initiation or continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Indications covered (RA, PMR, pJIA)

12 monthsTypical authorization duration

63 kgWeight threshold for pJIA

6 monthsRecent negative TB test required

Coverage Criteria for Sarilumab (Kevzara)

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Initial and continuation criteria — Rheumatoid arthritis

Covered when ALL of the following are met for RA

RA initial coverage: Member is an adult with moderately to severely active rheumatoid arthritis and has had inadequate response or intolerance to one or more DMARDs

FDA‑approved indication; see Appendix A for contraindications/intolerance

Biomarker criteria: Member has either: (a) positive rheumatoid factor (RF) or anti‑cyclic citrullinated peptide (anti‑CCP); OR (b) has been tested for RF, anti‑CCP, and C‑reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR)

One of these biomarker pathways must be satisfied

Methotrexate requirement: Member has experienced an inadequate response to at least a 3‑month trial of methotrexate at adequate dosing (titrated to ≥15 mg/week) OR has an intolerance or contraindication to methotrexate≥15 mg/week for ≥3 months

See Appendix A for listed contraindications/intolerance

Authorization duration/continuation: Authorization may be granted for 12 months when criteria are met and may be renewed when the member achieves or maintains a positive clinical response≥20% improvement

Positive clinical response defined as ≥20% improvement from baseline in tender joint count, swollen joint count, pain, or disability

Initial and continuation criteria — Polymyalgia rheumatica

Covered when ANY of the following are met for PMR

PMR criteria: Member has experienced any of: (1) inadequate response to systemic corticosteroids; (2) disease flare during taper of systemic corticosteroids; (3) inadequate response to methotrexate; OR (4) intolerance or contraindication to both systemic corticosteroids and methotrexate

See Appendix A for contraindications/intolerance; authorization of 12 months may be granted when any is met

PMR continuation: Authorization may be renewed for 12 months when the member achieves or maintains a positive clinical response

Positive clinical response evidenced by low disease activity or improvement in morning stiffness, hip/shoulder pain or range of motion, or CRP/ESR

Initial and continuation criteria — Polyarticular juvenile idiopathic arthritis

Covered when ALL of the following are met for polyarticular JIA in patients >=63 kg

pJIA baseline: Member has active polyarticular juvenile idiopathic arthritis and weighs ≥63 kg>=63 kg

FDA‑approved indication

Prior biologic requirement: Member has previously received a biologic or targeted synthetic drug indicated for active polyarticular JIA

Alternative pathway for authorization; e.g., prior use of Xeljanz

Conventional therapy failure: Member has had inadequate response to methotrexate or another conventional synthetic DMARD given at adequate dose and duration OR inadequate response to scheduled NSAIDs and/or intra‑articular glucocorticoids PLUS at least one risk factor for poor outcome (e.g., involvement of ankle, wrist, hip, sacroiliac joint, or TMJ; presence of erosive disease or enthesitis; delay in diagnosis)

Risk factors referenced in policy; adequate dose/duration per standard practice

Coverage is limited to the FDA‑approved indications listed in this policy (adult rheumatoid arthritis, polymyalgia rheumatica, and polyarticular juvenile idiopathic arthritis for patients weighing >= 63 kg). All other indications are considered experimental/investigational and not medically necessary and may be denied.

The requested medication may not be used concomitantly with any other biologic drug or targeted synthetic drug for the same indication. Concurrent use with another agent in these classes for the same condition is not permitted and would preclude coverage.

Use of this medication for diagnoses or indications other than those specifically listed in this policy (RA, PMR, and pJIA as described) is not medically necessary because such uses are considered experimental or investigational.

Key Dosing, Weight and Screening Thresholds

inv-07: Weight threshold for pJIA (>= 63 kg)

Weight threshold>= 63 kg

Applies toPolyarticular juvenile idiopathic arthritis (pJIA)

Authorization implicationAuthorization of 12 months may be granted for members weighing >= 63 kg who meet clinical criteria

inv-08: Methotrexate adequate dosing (>= 15 mg/week for at least 3 months)

Adequate methotrexate dose>= 15 mg/week

Minimum durationAt least 3 months

AlternativeIntolerance or contraindication to methotrexate satisfies requirement (see Appendix A)

inv-09: TB screening recency requirement (within 6 months)

Required TB screening windowDocumented negative TB test within 6 months prior to initiating therapy

Accepted testsTuberculosis skin test (PPD), interferon-release assay (IGRA), or chest x-ray

If positiveFurther testing to exclude active TB; treat latent TB before initiation; do not administer if active TB

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. When criteria are met, authorization may be granted for up to 12 months.

Typical authorization length: 12 months when criteria are met
Member may not receive the requested medication concomitantly with any other biologic or targeted synthetic drug for the same indication

Documentation Required

Required Documentation

Initial and continuation requests must include sufficient documentation to support the diagnosis, prior therapies and response, and relevant laboratory testing.

Initial requests: chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable) and response to therapy; if a therapy is not advisable, provide clinical rationale
Initial requests (RA only): laboratory results or chart documentation of biomarker testing (RF, anti-CCP, and CRP and/or ESR) if applicable
Continuation requests: chart notes or medical record documentation supporting positive clinical response

Step Therapy

Step Therapy / Prior Trials Required

Therapy trials are required prior to approval unless there is documented intolerance or contraindication. Requirements vary by indication.

Rheumatoid arthritis: inadequate response to at least a 3-month trial of methotrexate at adequate dosing (≥15 mg/week) OR documented intolerance/contraindication to methotrexate; alternatively, prior receipt of a biologic or targeted synthetic DMARD may qualify
Polymyalgia rheumatica: inadequate response to systemic corticosteroids, or disease flare during corticosteroid taper, or inadequate response to methotrexate, or intolerance/contraindication to both systemic corticosteroids and methotrexate
Polyarticular juvenile idiopathic arthritis (≥63 kg): inadequate response to methotrexate or another conventional synthetic DMARD (e.g., leflunomide, sulfasalazine, hydroxychloroquine) at adequate dose/duration; OR inadequate response to scheduled NSAIDs and/or intra-articular glucocorticoids plus risk factors for poor outcome (e.g., ankle/wrist/hip/SIJ/TMJ involvement, erosive disease or enthesitis, delay in diagnosis)

Documentation Required

TB Screening Requirement

For biologic- or targeted-synthetic–naïve patients, a documented negative TB screening test (PPD, IGRA, or chest x-ray) within 6 months is required prior to initiation. If TB screening is positive, further testing is required to exclude active disease; do not administer medication for active TB. If latent TB is identified, TB treatment must be started before initiation.

Negative TB test within 6 months required for biologic/targeted-synthetic–naïve patients
If TB screening positive: confirm no active disease; do not start medication if active TB; start latent TB treatment prior to initiation

Denial Risk

Denial Trigger — Unlisted Indications

Requests for indications not listed in the FDA-approved or policy-defined indications are considered experimental/investigational and will be denied.

All indications not specifically FDA-approved or included in the policy criteria are considered not medically necessary

Background

Sarilumab (Kevzara) is a monoclonal antibody approved for: (1) adult patients with moderately to severely active rheumatoid arthritis after inadequate response or intolerance to one or more DMARDs; (2) adult patients with polymyalgia rheumatica who have had an inadequate response to corticosteroids or cannot tolerate corticosteroid taper; and (3) patients with active polyarticular juvenile idiopathic arthritis who weigh >= 63 kg. Before initiation, patients who are biologic‑ or targeted synthetic–naïve require documented TB screening within 6 months, and the drug must not be administered to patients with active tuberculosis. Concomitant use with other biologic or targeted synthetic agents for the same indication is prohibited.

Definitions

inv-16: Definition of biologic- or targeted synthetic–naïve

DefinitionHas not previously received biologic or targeted synthetic drugs associated with increased TB risk

Screening requirementRequires documented negative TB test within 6 months prior to initiating therapy

Implication if positiveIf TB screening is positive, further testing to exclude active disease and treatment of latent TB prior to initiation is required

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySarilumab (Kevzara) — Coverage Criteria for RA, PMR, and pJIA

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes documenting prior therapies, relevant labs, and TB screening to support initiation or continuation.

SourceLink

On This Page

High‑risk features: Member has risk factors for disease severity and potentially a more refractory course and meets at least one: (a) involvement of high‑risk joints (e.g., cervical spine, wrist, or hip); (b) high disease activity; or (c) judged to be at high risk for disabling joint disease

See Appendix B for details

pJIA continuation: Authorization may be renewed for 12 months when the member achieves or maintains a positive clinical response

Positive clinical response evidenced by decreased number of active joints, improved range of motion, or improved functional ability