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    v1.0.28
    OpenPayerPolicy UpdatesImmunology/Rheumatologymeridian Sarilumab (Kevzara) Coverage Update | Ope…
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    CurrentmeridianPolicy MDN.CP.PHAR.346

    Clinical Policy: Sarilumab (Kevzara)

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    Defines Meridian Health Plan medical necessity, dosing, clinical criteria appendices, contraindications, boxed warnings, and product availability for sarilumab (Kevzara). Applies to providers requesting coverage for sarilumab for Meridian members.

    Policy Summary
    Payermeridian
    PolicyClinical Policy: Sarilumab (Kevzara)
    Policy CodePolicy MDN.CP.PHAR.346
    Change TypeAdded PMR and pJIA indicationsreferences updated
    Effective DateSep 1, 2023
    Last ReviewApr 14, 2025
    Next Review DateApr 10, 2025
    Key ActionSubmit prior authorization with documented dosing (e.g., RA: 200 mg SC every 2 weeks) and required clinical documentation supporting diagnosis and disease activity.
    SourceLink
    POLICY UPDATE CHANGES

    added criteria for newly approved polymyalgia rheumatica (PMR) indication to policy

    added newly approved polyarticular juvenile idiopathic arthritis indication

    references reviewed and updated

    200 mgapproved RA dosing every 2 weeks (max dose)
    150 / 200 mgavailable strengths
    serious infectionsboxed warning

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    hypersensitivity
    contraindication
    Appendix HPMR criteria

    Coverage and Medical Necessity Criteria

    Initial and continuation therapy criteria (summary)

    Covered when ALL of the following are met (context provided in appendices and dosing section).

    Primary coverage requirements: Indication appropriate per policy (e.g., rheumatoid arthritis, polymyalgia rheumatica per PMR provisional criteria, or polyarticular juvenile idiopathic arthritis as noted in policy updates); documentation of disease classification and activity using the applicable scoring system (ACR 2010 criteria for RA with total score ≥ 6; CDAI, RAPID3, or PMR provisional scoring per Appendix H as applicable); prior therapy and methotrexate/DMARD failure considerations documented when required (definition and examples in Appendix D, e.g., persistent joint pain/swelling, abnormal ESR/CRP, or impaired activities of daily living); dosing consistent with approved regimen (RA dosing: 200 mg subcutaneously every 2 weeks) and product strength recorded; no contraindication to sarilumab (no known hypersensitivity to sarilumab or any inactive ingredient); and clinician documentation and prior authorization submitted.

    Derived from dosing, appendices, contraindication, and required documentation sections.

    Contraindication: Patients with a known hypersensitivity to sarilumab or to any of its inactive ingredients are excluded from coverage and should not receive the medication.

    Use of sarilumab in a patient with a documented hypersensitivity to sarilumab or any inactive ingredient is contraindicated and such use would be considered not medically necessary and denied.

    Scoring Thresholds and Classification Guidance

    Scoring thresholds for disease activity/classification
    ACR 2010 RA classificationTotal score ≥ 6 of 10 required to classify a patient as having definite rheumatoid arthritis.
    CDAI (Clinical Disease Activity Index)Score interpretation: ≤2.8 = remission; 2.8–10 = low disease activity; 10–22 = moderate disease activity; >22 = high disease activity.
    RAPID3 (Routine Assessment of Patient Index Data 3)Score interpretation: ≤3 = remission; 3.1–6 = low disease activity; 6.1–12 = moderate disease activity; >12 = high disease activity.
    PMR provisional classification (2012 EULAR/ACR)PMR scoring thresholds: score ≥4 without ultrasound or ≥5 with ultrasound (see PMR algorithm for component items).

    Prior Authorization, Documentation, and Step Therapy

    Prior Authorization

    Prior authorization required — document dose & product strength

    Prior authorization is required for sarilumab. For rheumatoid arthritis, document dosing as 200 mg subcutaneously once every 2 weeks; available product strengths include 150 mg and 200 mg single‑dose prefilled syringes/pens.

    • Prior authorization must include the prescribed product strength and dosing schedule (RA: 200 mg SC every 2 weeks).
    • Product availability: single‑dose prefilled syringe/pen 150 mg and 200 mg (1.14 mL).
    Step Therapy

    Step therapy context — MTX/DMARD failure definition

    Document prior methotrexate (MTX) or other DMARD failure per the policy definition: failure may be based on lack of clinical response such as persistent joint pain/swelling/tenderness, lack of improvement in ESR/CRP, or impaired activities of daily living.

    • Examples of positive response (used to judge failure if absent): reduction in joint pain/swelling/tenderness; improvement in ESR/CRP; improvements in activities of daily living.

    Key Definitions and Classification Criteria

    MTX or DMARD failure — definition and considerations
    Definition of MTX/DMARD failureLack of clinical response such as persistent joint pain/swelling/tenderness, failure to improve ESR/CRP, or no improvement in activities of daily living after an adequate trial.
    Pregnancy/child‑bearing considerationsChild‑bearing age is not an absolute contraindication to methotrexate; use may be acceptable in patients who do not intend immediate pregnancy after informed counseling.
    Alcohol use considerationsSocial alcohol use is not a contraindication; MTX may be contraindicated only if patient consumes >14 units of alcohol per week; excessive alcohol may worsen outcomes and should be avoided for those seeking response.
    Examples of positive response to MTX/DMARDReduction in joint pain/swelling/tenderness; improvement in ESR/CRP values; improved activities of daily living.
    PMR classification criteria (2012 EULAR/ACR provisional)

    Policy Background and Drug Overview

    Sarilumab is an interleukin-6 (IL-6) receptor antagonist approved for rheumatoid arthritis and has expanded indications noted in this policy. Providers should be aware of its contraindication for patients with known hypersensitivity and the associated boxed warning for risk of serious infections when considering therapy.

    Policy Summary
    Payermeridian
    PolicyClinical Policy: Sarilumab (Kevzara)
    Policy CodePolicy MDN.CP.PHAR.346
    Change TypeAdded PMR and pJIA indicationsreferences updated
    Effective DateSep 1, 2023
    Last ReviewApr 14, 2025
    Next Review DateApr 10, 2025
    Key ActionSubmit prior authorization with documented dosing (e.g., RA: 200 mg SC every 2 weeks) and required clinical documentation supporting diagnosis and disease activity.
    SourceLink
    On This Page
    Coverage and Medical Necessity CriteriaScoring Thresholds and Classification GuidancePrior Authorization, Documentation, and Step TherapyKey Definitions and Classification CriteriaPolicy Background and Drug Overview
    Documentation Required

    Required clinical documentation — classification & activity measures

    Include disease classification and objective disease activity measures in the prior authorization documentation — e.g., ACR 2010 classification scoring for RA, CDAI, RAPID3, or PMR classification scoring per Appendix H — to support medical necessity.

    • ACR 2010: total score ≥ 6 of 10 for classification of definite RA.
    • CDAI interpretation ranges (remission ≤2.8; low 2.8–10; moderate 10–22; high >22).
    • RAPID3 interpretation ranges (remission ≤3; low 3.1–6; moderate 6.1–12; high >12).
    • PMR provisional criteria: required age ≥50, bilateral shoulder aching, abnormal CRP/ESR; score ≥4 without ultrasound or ≥5 with ultrasound.
    Denial Risk

    Contraindication-triggered denial — known hypersensitivity

    Do not prescribe sarilumab to patients with known hypersensitivity to sarilumab or any inactive ingredient; use in such patients is a contraindication and may lead to denial of coverage.

    • Contraindication listed: known hypersensitivity to sarilumab or any inactive ingredient.
    • Presence of this contraindication would be considered not medically necessary/denied.
    Required core criteria for PMRAge ≥ 50 years; bilateral shoulder aching; and abnormal CRP and/or ESR — all are required per the 2012 EULAR/ACR provisional criteria.
    Scoring thresholds (without ultrasound)A score of ≥4 using the algorithm (components include morning stiffness >45 minutes, hip pain/limited ROM, absence of RF/ACPA, absence of other joint involvement, etc.) classifies PMR without ultrasound.
    Scoring thresholds (with ultrasound)A score of ≥5 using the algorithm (includes ultrasound findings such as subdeltoid bursitis, biceps tenosynovitis, or glenohumeral synovitis) classifies PMR with ultrasound.
    PMR algorithm componentsComponents scored include morning stiffness duration, hip pain/limited ROM, absence of RF/ACPA, absence of other joint involvement, and specific shoulder/hip ultrasound findings when applicable.