CurrentUnitedHealthcarePolicy N/A

Kevzara (sarilumab) prior authorization criteria

Defines prior authorization and reauthorization clinical criteria for coverage of Kevzara (sarilumab) injections for rheumatoid arthritis, polymyalgia rheumatica, and polyarticular juvenile idiopathic arthritis for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyKevzara (sarilumab) prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2024

Next Review DateN/A

Key ActionFor rheumatoid arthritis, prior authorization requires diagnosis of moderately to severely active RA and inadequate response or intolerance to one or more DMARDs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3covered indications listed

12 moauthorization duration

DMARD trialRA prerequisite

no comboconcomitant therapy exclusion

Coverage Criteria for Kevzara (sarilumab)

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

RA DMARD: (2) Inadequate response or intolerance to one or more DMARDs (e.g., methotrexate, leflunomide, sulfasalazine)

RA no combo: (3) Patient is not receiving Kevzara in combination with another targeted immunomodulator (examples listed)

Authorization will be issued for 12 months

Reauthorization - Rheumatoid Arthritis

Reauthorization for rheumatoid arthritis — Covered when ALL of the following are met

RA reauth response: (1) Documentation of positive clinical response to Kevzara therapy

RA reauth no combo: (2) Patient is not receiving Kevzara in combination with another targeted immunomodulator

Authorization will be issued for 12 months

Initial Therapy - Polymyalgia Rheumatica

Initial authorization for polymyalgia rheumatica — Covered when ALL of the following are met

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

PMR steroid fail: (2) Inadequate response to corticosteroids or inability to tolerate corticosteroid taper

PMR no combo: (3) Patient is not receiving Kevzara in combination with another targeted immunomodulator

Authorization will be issued for 12 months

Reauthorization - Polymyalgia Rheumatica

Reauthorization for polymyalgia rheumatica — Covered when ALL of the following are met

PMR reauth response: (1) Documentation of positive clinical response to Kevzara therapy

PMR reauth no combo: (2) Patient is not receiving Kevzara in combination with another targeted immunomodulator

Authorization will be issued for 12 months

Initial Therapy - pJIA

Initial authorization for polyarticular juvenile idiopathic arthritis — Covered when ALL of the following are met

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

pJIA no combo: (2) Patient is not receiving Kevzara in combination with another targeted immunomodulator

Authorization will be issued for 12 months

Reauthorization - pJIA

Reauthorization for pJIA — Covered when ALL of the following are met

pJIA reauth response: (1) Documentation of positive clinical response to Kevzara therapy

pJIA reauth no combo: (2) Patient is not receiving Kevzara in combination with another targeted immunomodulator

Authorization will be issued for 12 months

Requests where the patient is receiving Kevzara in combination with another targeted immunomodulator will not meet approval criteria. Examples of targeted immunomodulators that cannot be used concomitantly with Kevzara include: adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Olumiant (baricitinib), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), and Xeljanz/Xeljanz XR (tofacitinib).

Coding & Weight Thresholds

pJIA dosing threshold — minimum weight requirement

pJIA minimum weight>= 63 kg

Authorization duration for pJIAAuthorization will be issued for 12 months

Indication for pJIAActive polyarticular juvenile idiopathic arthritis

Concomitant targeted immunomodulator exclusionPatient must not be receiving Kevzara in combination with another targeted immunomodulator

Step	Requirement
1	Trial of one or more disease-modifying antirheumatic drugs (DMARDs) with inadequate response or intolerance (examples: methotrexate, leflunomide, sulfasalazine)

Provider Action Requirements and Documentation

Prior Authorization

RA initial authorization — DMARD trial requirement

Provider must document diagnosis of moderately to severely active rheumatoid arthritis and prior inadequate response or intolerance to one or more DMARDs (examples: methotrexate, leflunomide, sulfasalazine). Authorization will be issued for 12 months.

Examples of DMARDs: methotrexate, leflunomide, sulfasalazine
Auth duration: 12 months

Prior Authorization

PMR initial authorization

Provider must document diagnosis of polymyalgia rheumatica (PMR) and inadequate response to corticosteroids or inability to tolerate corticosteroid taper. Requests will not be approved if Kevzara is prescribed with another targeted immunomodulator. Authorization will be issued for 12 months.

Must document corticosteroid response/tapering history
Do not combine with other targeted immunomodulators (denial risk)
Auth duration: 12 months

Prior Authorization

pJIA initial authorization

Provider must document diagnosis of active polyarticular juvenile idiopathic arthritis (pJIA). Kevzara must not be given in combination with another targeted immunomodulator. Authorization will be issued for 12 months.

pJIA diagnosis required
No concomitant targeted immunomodulator (denial risk)
Auth duration: 12 months

Documentation Required

Reauthorization clinical response

Documentation of positive clinical response to Kevzara therapy is required for reauthorization. Patient must not be receiving Kevzara in combination with another targeted immunomodulator. Authorization will be issued for 12 months.

Document objective or clinician-assessed improvement on therapy
No concomitant targeted immunomodulator (denial risk)
Reauthorization interval: 12 months

Denial Risk

Concomitant targeted immunomodulator — denial risk

Requests where Kevzara is prescribed concomitantly with another targeted immunomodulator (examples: adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib) will not meet approval criteria and are at risk for denial.

Examples of targeted immunomodulators: adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Olumiant (baricitinib), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), Xeljanz/Xeljanz XR (tofacitinib)

Initial Therapy Criteria by Indication

Initial - Rheumatoid Arthritis

Initial authorization rules by indication

RA init 1: Diagnosis of moderately to severely active rheumatoid arthritis

RA init 2: Inadequate response or intolerance to one or more DMARDs

RA init 3: Not receiving Kevzara in combination with another targeted immunomodulator

Authorization will be issued for 12 months

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization requirements

continuation response: Documentation of positive clinical response to Kevzara therapy is required for reauthorization

Authorization will be issued for 12 months

continuation no combo: Patient must not be receiving Kevzara in combination with another targeted immunomodulator

Background on Kevzara (sarilumab)

Kevzara (sarilumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis after inadequate response or intolerance to one or more DMARDs, for polymyalgia rheumatica after inadequate response to corticosteroids or inability to tolerate corticosteroid taper, and for active polyarticular juvenile idiopathic arthritis in patients meeting the policy weight threshold. Authorization for approved indications is issued for 12 months and concomitant use with other targeted immunomodulators is not permitted per the coverage criteria.

Definitions and Examples

DMARDs — definition and examples referenced in policy

DefinitionDisease-modifying antirheumatic drugs (DMARDs): agents used to slow progression of rheumatic disease

Examples listed in policyMethotrexate; leflunomide; sulfasalazine

Role in prior authorization for RAInadequate response or intolerance to one or more DMARDs is required before Kevzara approval for rheumatoid arthritis

Policy Summary

PayerUnitedHealthcare

PolicyKevzara (sarilumab) prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2024

Next Review DateN/A

Key ActionFor rheumatoid arthritis, prior authorization requires diagnosis of moderately to severely active RA and inadequate response or intolerance to one or more DMARDs.

SourceLink

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