CurrentmhnPolicy CP.PHAR.346

Sarilumab (Kevzara)

Clinical policy defining medical necessity criteria, initial and continued approval requirements, exclusions, dosing, and coding implications for sarilumab (Kevzara) for Medicaid line of business including RA, PMR, and polyarticular JIA.

Policy Summary

Payermhn

PolicySarilumab (Kevzara)

Policy CodePolicy CP.PHAR.346

Change TypeMultiple substantive revisions (indication addition, criteria alignment, duration extension)

Effective DateJul 18, 2017

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, CDAI/RAPID3 scores, ESR/CRP, weight) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added newly approved polyarticular juvenile idiopathic arthritis indication.

Reiterated requirement against combination use with a bDMARD or JAKi from Section III to Sections I and II.

For pJIA: removed minimum cJADAS-10 > 8.5 requirement and baseline cJADAS-10 documentation; removed requirement to show decrease in cJADAS-10 in continued therapy.

Extended initial approval durations to 12 months for chronic conditions and allowed bypass of conventional therapies if member has failed a biologic agent.

2Q 2026 annual review: no significant changes; references reviewed and updated.

3Covered Indications

200 mg q2wMaximum Dose

12 monthsApproval Duration

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≥63 kgpJIA Weight Threshold

Coverage Summary

Coverage stance: sarilumab (Kevzara) is covered with criteria when all indication-specific requirements are met for rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), or polyarticular juvenile idiopathic arthritis (pJIA). Approval requires diagnosis-specific documentation, rheumatology prescribing or consultation, and meeting prior-therapy/assessment requirements as specified in the policy.

Step therapy / failure requirements: For RA and pJIA, required trials include ≥ 3 consecutive months of methotrexate (MTX) (or intolerance/contraindication plus another conventional DMARD trial) and ≥ 3 consecutive months of a TNF antagonist and ≥ 3 consecutive months of tocilizumab (Actemra) unless contraindicated; PMR requires failure of a systemic corticosteroid for ≥ 2 weeks or documented corticosteroid flare while tapering. Specific alternative/exception pathways (e.g., bypass if previously failed a biologic) are outlined in the policy.

Prescriber specialty and thresholds: Requests must be prescribed by or in consultation with a rheumatologist. Age/weight thresholds: RA — age ≥ 18 years; PMR — age ≥ 50 years; pJIA — age ≥ 2 years and weight ≥ 63 kg for pJIA dosing eligibility.

Combination therapy and dosing limits: Combination use with other biological DMARDs or Janus kinase inhibitors is prohibited due to additive immunosuppression risk. The dose must not exceed 200 mg every two weeks. Approval duration for initial and continued therapy is 12 months.

Initial Therapy Criteria

Initial Approval Criteria - Other diagnoses/indications

Covered only if one of the following applies:

ANY of the following

Drug has recently (within last 6 months) undergone a label change not yet reflected in this policy and use falls under formulary/no coverage or non-formulary pathways (see CP.PMN.255 or CP.PMN.16).
Requested use is not listed in Section III and does not meet the label-change scenario; refer to off-label use policy CP.PMN.53.

Continuation Therapy Criteria

Continued Therapy - All Indications

Continued coverage when ALL of the following are met:

ALL of the following

ONE of
- Member is currently receiving medication via Centene benefit or previously met initial approval criteria.
- Member currently receiving medication and is enrolled in a state/product with continuity of care regulations.
ONE of (evidence of response)
- For RA, ONE of
  - Decrease in CDAI or RAPID3 score from baseline.

Unproven / Exclusions

No combination use with biological DMARDs or Janus kinase inhibitors

ALL of the following

No combination use with biological DMARDs or Janus kinase inhibitors (JAKi).
Requests for combination use with biological DMARDs or JAK inhibitors will be denied/not authorized due to increased additive immunosuppression risk, increased risk of neutropenia, and increased risk of serious infections.
Provider action: Provider must submit documentation supporting that member meets all approval criteria; requests for combination therapy will be denied per policy.

Provider Actions

Documentation Required

Submission of supporting documentation

Provider must submit documentation supporting that the member meets all approval criteria. Required supporting documents include office/clinic notes, laboratory results (e.g., ESR, CRP), baseline and/or follow-up disease activity assessments (CDAI or RAPID3), and weight. Submission should reference the applicable approval criteria in the policy when available.

Office/clinic notes
Laboratory results (ESR, CRP)
CDAI or RAPID3 scores
Weight

Documentation Required

Baseline disease activity documentation

For baseline disease activity documentation: RA requires documentation of either a Clinical Disease Activity Index (CDAI) score or a RAPID3 score as specified in the initial RA criteria. For PMR, baseline inflammatory markers must be documented (baseline ESR ≥ 30 mm/hr or baseline CRP ≥ 10 mg/L) per the PMR initial criteria.

RA: CDAI or RAPID3 (see Appendices F and G)

Applicable Codes

HCPCS Codes (informational)HCPCS

J3590	Unclassified drugs or biologicals
C9399	Unclassified drugs or biologicals

Clinical Evidence & References

Key evidence and guidance sources referenced in the policy include the manufacturer prescribing information: Kevzara Prescribing Information; May 2025.

Clinical guideline and disease activity guidance cited include the 2021 American College of Rheumatology (ACR) RA guideline and the 2019 ACR guideline for juvenile idiopathic arthritis.

Polymyalgia rheumatica classification and management references include the 2015 EULAR/ACR PMR recommendations and the 2012 EULAR/ACR provisional classification criteria for PMR used for diagnostic scoring.

Background

Background: Sarilumab (Kevzara) is an interleukin-6 (IL-6) receptor antagonist that is FDA-approved for adult rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), and active polyarticular juvenile idiopathic arthritis (pJIA) in patients who weigh ≥ 63 kg.

Rationale for combination restriction: The policy prohibits combination use with other biological DMARDs or Janus kinase inhibitors because of additive immunosuppression and associated increased risks (including neutropenia and serious infections).

Prescriber and dosing notes: Therapy is required to be prescribed by or in consultation with a rheumatologist, and the policy limits dosing to a maximum of 200 mg subcutaneously every two weeks.

Definitions & Appendices

Glossary / Definitions:

MTX — Methotrexate (definition and role as the required conventional DMARD trial in the policy).

DMARD — Disease-modifying antirheumatic drug (conventional synthetic agents such as sulfasalazine, leflunomide, hydroxychloroquine referenced in criteria).

bDMARD — Biological disease-modifying antirheumatic drug (biologic agents referenced in exclusions and step therapy).

CDAI — Clinical Disease Activity Index (composite RA disease activity score; see Appendix F for scoring details).

RAPID3 — Routine Assessment of Patient Index Data 3 (patient-reported pooled index for RA; see Appendix G for scoring details).

Appendix linkage: The policy references scoring and classification appendices (Appendix E/F/G/H) for RA classification, CDAI, RAPID3, and PMR criteria; these appendices should be linked or appended for scoring details when documenting baseline and continued therapy assessments.

Revision History

04.03.23RT4 addition

RT4: added newly approved polyarticular juvenile idiopathic arthritis (pJIA) indication (material change).

02.20.22Annual review

2Q 2022 annual review: reiterated requirement against combination use with a biological DMARD (bDMARD) or Janus kinase inhibitor (JAKi) from Section III into Sections I and II (material change).

01.23.25Annual review / criteria edit

Policy Summary

Payermhn

PolicySarilumab (Kevzara)

Policy CodePolicy CP.PHAR.346

Change TypeMultiple substantive revisions (indication addition, criteria alignment, duration extension)

Effective DateJul 18, 2017

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, CDAI/RAPID3 scores, ESR/CRP, weight) supporting that member meets all approval criteria.

SourceLink

On This Page

Medical justification stating inability to conduct CDAI re-assessment, and submission of RAPID3 score associated with disease severity similar to initial CDAI assessment or improved.

For PMR, BOTH of

Documentation of decreased signs and symptoms of PMR.
ONE of
- Reduction of CRP from baseline.
- Reduction of ESR from baseline.

For pJIA: Member is responding positively to therapy.

No combination use with biological DMARDs or Janus kinase inhibitors (see Section III).

If request is for dose increase, new dose does not exceed 200 mg every two weeks.

Continued Therapy - Other diagnoses/indications

Same referral to label-change or off-label policies as initial criteria

ANY of the following

Refer to CP.PMN.255 or CP.PMN.16 if label change within 6 months applies.
If use not listed in Section III and label-change scenario does not apply, refer to off-label use policy CP.PMN.53.

PMR: Baseline ESR ≥ 30 mm/hr or CRP ≥ 10 mg/L

Prior Authorization

Prior authorization required

Prior authorization may be required for sarilumab and for referenced comparator agents. Specifically, PA may be required for TNF antagonists, tocilizumab (Actemra), adalimumab products, and Xeljanz; providers must follow the applicable prior authorization processes for those agents when referenced in the criteria.

TNF antagonists
Tocilizumab (Actemra)
Adalimumab products
Xeljanz (tofacitinib)

Denial Risk

Combination therapy exclusion

Requests for combination use of sarilumab with biological DMARDs or Janus kinase inhibitors will not be authorized. Combination use with bDMARDs or JAK inhibitors is excluded due to additive immunosuppression and increased risk of neutropenia and serious infections; such requests are subject to denial.

Combination use with any bDMARD or JAKi is not authorized and will be denied

Billing Rule

Adhere to HCPCS coding guidance

HCPCS codes J3590 and C9399 are listed for informational purposes only. Providers should reference current professional coding guidance prior to claim submission and verify applicable billing instructions before filing claims.

J3590
C9399

2Q 2025 annual review (P&T 05.25): for pJIA removed minimum cJADAS-10 > 8.5 requirement and baseline cJADAS-10 documentation from initial criteria and removed requirement for decrease in cJADAS-10 in continued therapy to align with competitor analysis and 2019 ACR guidance (material change).

09.08.25 / 11.25 (P&T)Policy update

September/November 2025 updates: extended initial approval durations to 12 months for chronic conditions and added allowance to bypass conventional therapies if member has failed a biologic agent (material change).

01.20.26 / P&T 05.262Q 2026 annual reviewLatest

2Q 2026 annual review (01.20.26; P&T Approval Date 05.26): no significant changes; references reviewed and updated.