CurrentMass General Brigham Health PlanPolicy N/A

Kevzara (sarilumab) prior authorization and coverage

Policy governs prior authorization, step therapy, quantity limits, and medical necessity criteria for Kevzara (sarilumab) for Mass General Brigham Health Plan members across specified benefits (pharmacy/medical), including RA, pJIA, and PMR.

Policy Summary

PayerMass General Brigham Health Plan

PolicyKevzara (sarilumab) prior authorization and coverage

Policy CodePolicy N/A

Change TypeMaterial clinical updates

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document trials and failures (or contraindications/intolerances) to required conventional and biologic/JAK therapies; for reauthorization, submit documentation showing clinical improvement or low disease activity.

SourceLink

POLICY UPDATE CHANGES

Added Tyenne as a preferred tocilizumab product in RA and pJIA criteria.

Added criteria for polyarticular juvenile idiopathic arthritis (pJIA).

Updated reauthorization criteria to require documentation of clinical response to therapy.

3 indicationsapproved indications listed

24 monthsstandard approval duration

1 pack/4 wksquantity limit per strength

90 daysnew-to-plan continuity window

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Coverage and Medical Necessity Criteria

Initial Therapy for Rheumatoid Arthritis

Covered when ALL of the following are met for rheumatoid arthritis:

RA main: 1) Diagnosis of moderately to severely active rheumatoid arthritis (RA).

RA biologic_jak_trials: 2) Trial and failure, contraindication, or intolerance to TWO of the following agents: Cimzia, Enbrel, Humira (AbbVie) or specified adalimumab products (Adalimumab-adaz, Adalimumab-fkjp, Hadlima, Amjevita/Nuvaila), Rinvoq, Simponi, Xeljanz or Xeljanz XR, Actemra/Tyenne.

List of specific agents provided in policy.

RA Orencia: 3) Trial and failure, contraindication, or intolerance to Orencia (abatacept).

Policy lists Orencia separately as required.

RA conventional_therapy: 4) Minimum 3-month trial and failure, contraindication, or intolerance to ONE conventional DMARD at maximally tolerated dose: methotrexate, leflunomide, or sulfasalazine.3 months

Maximally tolerated doses required.

Initial Therapy for pJIA

Covered when ALL of the following are met for active polyarticular juvenile idiopathic arthritis (pJIA):

pJIA diagnosis: 1) Diagnosis of active polyarticular juvenile idiopathic arthritis (pJIA).

pJIA conventional: 2) Trial and failure of conventional therapies at maximally tolerated doses: leflunomide and methotrexate.

Specific agents listed.

pJIA biologic_jak_trials: 3) Trial and failure, contraindication, or intolerance to TWO of the following: Cimzia, Enbrel, Humira (AbbVie) or specified adalimumab products, Xeljanz, Rinvoq or Rinvoq LQ, Actemra/Tyenne.

List of specific agents provided in policy.

pJIA Orencia: 4) Trial and failure, contraindication, or intolerance to Orencia (abatacept).

Initial Therapy for Polymyalgia Rheumatica

Covered when ALL of the following are met for polymyalgia rheumatica (PMR):

PMR diagnosis: 1) Diagnosis of polymyalgia rheumatica (PMR).

PMR steroid_response: 2) Member has either inadequate response to corticosteroids (e.g., prednisone) OR cannot tolerate tapering of corticosteroids.

One of these conditions required.

Continuation of Therapy

Reauthorization/Continuation of therapy:

Continuation: Documentation is submitted supporting improvement in the member's condition as evidenced by low disease activity or improvement in signs and symptoms of the condition.

Requests for reauthorization for all diagnoses will be granted when this criterion is met.

An authorization exception for members new to the plan may be granted when the member transferred coverage within the prior 90 days and is currently receiving the requested medication. This continuity provision excludes

Requests that do not meet the new-to-plan continuity requirements must instead meet the standard diagnosis-specific coverage criteria for the requested indication in order to be approved.

Provider Responsibilities, Prior Authorization, and Step Therapy

Prior Authorization
Prior Authorization Required
Prior authorization is required for Kevzara (sarilumab). Members who are new to the plan within the past 90 days and are currently receiving the requested medication may be eligible for a 90-day continuity authorization (does not apply when product was obtained only as samples or via manufacturer patient assistance programs). All other prior authorization requests must meet the diagnosis-specific coverage criteria.
Prior authorization required for Kevzara (sarilumab).
90-day continuity window for members new to plan (within past 90 days) currently receiving treatment; excludes samples or manufacturer patient assistance programs.
Specialty medication — must be filled at contracted specialty pharmacy per plan guidance.

Step Therapy
Step Therapy Requirements
Step therapy is required for labeled indications. For rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), patients must have trials of and failure, contraindication, or intolerance to specified prior therapies before approval of Kevzara.

Key Terms and Drug Definition

Kevzara (sarilumab) — definition and indications summary

Drug classInterleukin-6 (IL-6) receptor antagonist

Brand (generic)Kevzara (sarilumab)

FDA‑listed indicationsAdult polymyalgia rheumatica (PMR); adult moderately to severely active rheumatoid arthritis (RA); active polyarticular juvenile idiopathic arthritis (pJIA) in patients weighing ≥63 kg.

pJIA weight-based noteIndicated for pJIA only in patients who weigh 63 kilograms or more.

Policy scopeCoverage criteria apply for RA, pJIA (weight ≥63 kg), and PMR per prior authorization requirements.

Background and Pharmacology

Sarilumab (Kevzara) is an interleukin-6 receptor antagonist referenced in this policy as a treatment option for moderately to severely active rheumatoid arthritis, for polymyalgia rheumatica (PMR), and for polyarticular juvenile idiopathic arthritis (pJIA) in eligible pediatric patients. The policy aligns use of sarilumab with guideline- and product-label–based indications and requires that use meet the specified diagnostic and prior-therapy criteria.

When used for these indications, prior authorization is required and approvals are granted only when the applicable step-therapy and documentation requirements are met, or when the member qualifies for the 90-day new-to-plan continuity exception described above.

Policy Changes and Revision History

2025-06-01criteria_updateLatest

RA and pJIA criteria updated to include Tyenne as a preferred tocilizumab product.

2025-01-01criteria_added

Added criteria for polyarticular juvenile idiopathic arthritis (pJIA).

2025-01-01reauthorization_revision

Policy Summary

PayerMass General Brigham Health Plan

PolicyKevzara (sarilumab) prior authorization and coverage

Policy CodePolicy N/A

Change TypeMaterial clinical updates

Effective DateJun 1, 2025

Next Review DateN/A

SourceLink

On This Page

Policy lists Orencia separately.

RA: Trial and failure, contraindication, or intolerance to TWO tumor necrosis factor (TNF) inhibitors (examples listed: Cimzia, Enbrel, Humira and biosimilars, Simponi) OR failure of targeted DMARDs (e.g., Rinvoq, Xeljanz/XR) where specified.
RA: Trial and failure, contraindication, or intolerance to BOTH Orencia and one conventional DMARD trial (methotrexate, leflunomide, or sulfasalazine) with a minimum 3-month trial at maximally tolerated doses for the conventional agent.
pJIA: Trial and failure, contraindication, or intolerance to conventional therapies (methotrexate and/or leflunomide) and to TWO of the biologic/targeted agents listed (e.g., Cimzia, Enbrel, Humira and biosimilars, Xeljanz, Rinvoq, Actemra), and trial/failure of Orencia where specified.
Polymyalgia rheumatica (PMR): Inadequate response to corticosteroids or inability to taper corticosteroids may be required per diagnosis-specific guidance.

Documentation Required
Reauthorization Documentation Required
For continuation/reauthorization, documentation must demonstrate clinical response and improvement (for example, low disease activity or reduced signs and symptoms). Reauthorization requests for all diagnoses will be granted only when submitted documentation supports ongoing benefit.
Reauthorization requires documentation of treatment response and clinical improvement (e.g., low disease activity).
Include objective and/or clinician-assessed measures of improvement relevant to the diagnosis in the request.

Denial Risk
Denial Triggers / Risk
Common denial triggers include failure to meet the diagnosis-specific step therapy requirements, lack of documentation of prior trials or reasons for exceptions (contraindication/intolerance), and requests outside the 90-day continuity window for new-to-plan members.
Missing documentation of required prior therapy trials or lack of rationale for contraindication/intolerance.
Request does not meet diagnosis-specific criteria (e.g., insufficient prior biologic or conventional DMARD trials).
Requesting continuity beyond the 90-day new-to-plan window without meeting standard prior authorization criteria.

Reauthorization criteria updated to require documentation of clinical response to therapy (documentation of improvement/low disease activity).

2024-10-09review

Reviewed and updated for October P&T; updated RA criteria to include Amjevita (Nuvaila) as a preferred adalimumab product and made other preferred drug list changes.

2023-11-15review_and_update

Reviewed and updated for November P&T; removed TB requirement, updated preferred drugs list, added polymyalgia rheumatica indication, and removed appendix effective 01/01/2024.