ModifiedColorado Rocky Mountain Health PlansPolicy N/A

Kevzara (sarilumab) prior authorization and medical necessity

Defines prior authorization, initial and reauthorization clinical criteria, and prescribing requirements for Kevzara (sarilumab) for rheumatoid arthritis, polymyalgia rheumatica, and polyarticular juvenile idiopathic arthritis for UnitedHealthcare Pharmacy programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyKevzara (sarilumab) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeMaterial revisions (added pJIA criteriastep therapy updates)

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, prior therapy trials or claims history, and rheumatologist prescribing/consultation information.

SourceLink

POLICY UPDATE CHANGES

Added clinical coverage criteria for pJIA (polyarticular juvenile idiopathic arthritis).

Updated RA step requirement noting specific adalimumab products and removed preferred adalimumab footnote; later removed examples and referenced drug coverage tools for preferred products.

Added 'Actemra or Tyenne' to step criteria where applicable.

Noted that UnitedHealthcare may approve initial and reauthorization based solely on claim/medication history, diagnosis codes and/or claim logic; automated processes vary by program.

3covered indications listed

12 motypical authorization duration

1new pJIA criteria

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Coverage Criteria for Kevzara (sarilumab)

Initial Authorization — Rheumatoid Arthritis

Covered when ALL of the following are met

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

Prior therapy requirement

(a) Step-required pathway
- i) Prior DMARD or targeted immunomodulator: i. One of the following: - a. History of failure to a 3-month trial of one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses, unless contraindicated or intolerant (document drug, date, duration) - OR - - b. Patient has been previously treated with a targeted immunomodulator FDA-approved for RA as documented by claims history or medical records (document drug, date, duration) [e.g., adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib]
- ii) Preferred product failures: ii. History of failure, contraindication, or intolerance to two of the following preferred products (document drug, date, duration): one of the preferred adalimumab products; Cimzia (certolizumab); Enbrel (etanercept); Rinvoq (upadacitinib); Simponi (golimumab); Xeljanz/XR (tofacitinib)
- iii) Actemra/Orencia failure: iii. History of failure, contraindication, or intolerance to both: Actemra (tocilizumab) or Tyenne (tocilizumab-aazg) AND Orencia (abatacept) (document drug, date, duration)
(b) Current-user pathway: (b) Both of the following: - i. Patient is currently on Kevzara therapy as documented by claims history or submission of medical records (document date and duration) - AND - - ii. Patient has not received a manufacturer-supplied sample or assistance via KevzaraConnect as a means to establish current use (patients established by samples/assistance must meet initial criteria as new to therapy)

Concomitant therapy restriction: 3) Patient is not receiving Kevzara in combination with another targeted immunomodulator (e.g., adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib)

Prescriber requirement: 4) Prescribed by or in consultation with a rheumatologist

Reauthorization — Rheumatoid Arthritis

Covered when ALL of the following are met

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

Concomitant therapy restriction: 2) Patient is not receiving Kevzara in combination with another targeted immunomodulator (e.g., adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib)

Authorization will be issued for 12 months.

Initial Authorization — PMR

Covered when ALL of the following are met

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

Steroid failure/tolerance: 2) Inadequate response to corticosteroids or inability to tolerate corticosteroid taper

Prescriber requirement: 4) Prescribed by or in consultation with a rheumatologist

Reauthorization — PMR

Covered when ALL of the following are met

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

Initial Authorization — pJIA

Covered when ALL of the following are met

pJIA Initial: 1) Diagnosis of active polyarticular juvenile idiopathic arthritis

Prescriber requirement: 3) Prescribed by or in consultation with a rheumatologist

Authorization will be issued for 12 months.

Reauthorization — pJIA

Covered when ALL of the following are met

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

Authorization will be issued for 12 months.

Authorization behavior and step therapy history

Policy-level authorization behaviors and step therapy history

Automated approval/reauthorization: UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; use of automated approval and re-approval processes varies by program and/or therapeutic class.

Supply limits may be in place.

Step therapy history and updates: Step therapy historically required failure of a 3-month trial of a non-biologic DMARD unless contraindicated OR prior treatment with an FDA-approved targeted immunomodulator; preferred product examples and specific adalimumab product lists have been updated over time and providers should reference drug coverage tools for current preferred product lists.

See change control history for timeline of updates.

Use of Kevzara in combination with another targeted immunomodulator is not permitted. The policy explicitly excludes concurrent therapy with another targeted immunomodulator across indications; examples listed in the criteria include adalimumab, certolizumab (Cimzia), etanercept (Enbrel), baricitinib (Olumiant), abatacept (Orencia), upadacitinib (Rinvoq), golimumab (Simponi), and tofacitinib (Xeljanz/XR). Providers should ensure the patient is not receiving any of these or other targeted immunomodulators when requesting coverage for Kevzara.

Historical edits to this policy removed or altered prescriber-related requirements and illustrative examples over multiple updates. Change control notes document removal of a prescriber requirement from reauthorization criteria and iterative updates to step therapy examples; providers should rely on the current criteria text and referenced drug coverage tools for the most up-to-date lists rather than prior examples.

Authorizations and reauthorizations for Kevzara may be processed using automated logic derived from prior claim/medication history, ICD-10 diagnosis codes, and other claim-based rules. When this claim logic is used, approvals can be granted without submission of additional clinical records; conversely, requests that are not supported by claims history or diagnosis codes may be denied. Providers should be aware that program-specific automated processes and supply limits may apply and that lack of supporting claims or documentation can affect the outcome of an authorization request.

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for Kevzara (sarilumab). Requests must include supporting documentation as described below; initial and continuation approvals are contingent on meeting the clinical criteria and documentation requirements.

Prior authorization required before administration or dispensing.
Include drug name, dates and duration of prior therapy trials, and relevant clinical rationale.

Note

Prior Authorization and Reauthorization Rules

Initial authorization and reauthorization decisions may be made using previous claim/medication history, submitted medical records, diagnosis codes (ICD-10), and/or automated claim logic. Supply limits may apply.

Approvals may be granted based solely on claims or medication history where available.
Automated approval/reauthorization processes vary by program and therapeutic class.
If claim history is not available, submission of medical records may be required to confirm current therapy.

Drug and Indication Background

Kevzara (sarilumab) is an interleukin-6 (IL-6) receptor antagonist. It is indicated for treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs), and for polymyalgia rheumatica in patients with inadequate response to corticosteroids or who cannot tolerate tapering. Kevzara is also indicated for patients with active polyarticular juvenile idiopathic arthritis when appropriate by weight and clinical criteria. These indications reflect the drug's mechanism targeting the IL-6 pathway to reduce inflammatory activity.

Definitions and Abbreviations

DMARD — definition and examples

DefinitionDisease-modifying antirheumatic drug — medications intended to slow or modify the underlying disease process in rheumatoid arthritis rather than only treating symptoms.

ExamplesMethotrexate; Leflunomide; Sulfasalazine.

ContextDMARDs are referenced as prior therapy in RA criteria: Kevzara is indicated for patients with inadequate response or intolerance to one or more DMARDs.

polyarticular juvenile idiopathic arthritis (pJIA)

AbbreviationpJIA = polyarticular juvenile idiopathic arthritis.

Indication contextKevzara is indicated for treatment of patients who weigh >=63 kg with active pJIA.

Policy Revision History

2025-06-xxrevisedLatest

Added 'Actemra or Tyenne' to step criteria where applicable.

2025-04-xxrevised

Removed examples for adalimumab step therapy and added footnote directing providers to drug coverage tools for preferred product lists.

2024-08-xxadded