CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Kevzara (sarilumab) — Medical Necessity and Authorization Criteria

Defines medical necessity and authorization requirements for Kevzara (sarilumab) for rheumatoid arthritis, polymyalgia rheumatica, and polyarticular juvenile idiopathic arthritis for Medicaid members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKevzara (sarilumab) — Medical Necessity and Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2018

Next Review DateN/A

Key ActionObtain prior authorization with documentation of indication-specific criteria and required chart documentation including TB screening.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization length

2 syringes / 28dquantity limit

200 mg q2wadult/pJIA dosing

within 6 monthsTB screening

Coverage Criteria for Kevzara (sarilumab)

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ALL of the following

Prescribed by, or in consultation with, a specialist in rheumatology.
ANY of the following
- Member has been tested for either of the following biomarkers and the test was positive: (i) Rheumatoid factor (RF); or (ii) Anti-cyclic citrullinated peptide (anti-CCP).
- Member has been tested for ALL of the following biomarkers: (i) RF; (ii) Anti-CCP; (iii) C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR).
ANY of the following
- Member has experienced an inadequate response to at least a 3-month trial of methotrexate despite adequate dosing (i.e., titrated to 20 mg/week).
- Member has an intolerance or contraindication to methotrexate (see Appendix).
Documentation that member has had an inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab (Humira) at maximum tolerated doses.
For all indications, submission of the member's chart or medical record is required, documenting medical necessity based on the criteria corresponding to the applicable indication; Kevzara will not be used concomitantly with an injectable biologic response modifier or other specified biologic/targeted agents; member must have a documented negative TB test within 6 months prior to initiating therapy if biologic/targeted DMARD–naïve (see policy for testing details).
See general policy requirements for concomitant therapy exclusions and TB screening.

Coding and Dosing Information

Covered codes / dosing infomixed

NDC / HCPCS not specified

No specific billing codes listed in document; quantity limit: 2 syringes every 4 weeks (28 days); Dosing for indicated adults and pJIA patients >63 kg: 200 mg subcutaneously once every 2 weeks.

inv-08: Weight threshold for pJIA

Weight thresholdMember must weigh 63 kg or greater to qualify for pJIA indication

Disease requirementDocumented moderate to severe active polyarticular disease

Prior therapy trial (NSAID/DMARD)At least a 1‑month trial and failure of an oral NSAID OR oral DMARD unless contraindicated or intolerant

Prior biologic trial (adalimumab)Inadequate response, intolerance, or contraindication to at least a 3‑month trial of adalimumab at maximum tolerated doses

Combination useMay be used alone or in combination with methotrexate

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Kevzara; submit documentation demonstrating the member meets the indication‑specific criteria. Approvals are typically for 12 months and quantity is limited to 2 syringes every 28 days.

Submit member chart/medical record showing applicable criteria per indication.
Typical authorization length: 12 months.
Quantity limit: 2 syringes every 4 weeks (28 days).

Step Therapy

Step therapy requirements

For RA and pJIA, the member must have prior trials with documented inadequate response, intolerance, or contraindication to specified therapies before Kevzara is approved; methotrexate and adalimumab trials are explicitly required unless contraindicated.

Methotrexate: ≥3‑month trial at adequate dosing (titrated to 20 mg/week) or documented intolerance/contraindication (RA).
Adalimumab: ≥3‑month trial at maximum tolerated doses with inadequate response, intolerance, or contraindication (RA and pJIA).
pJIA: at least a 1‑month trial and failure of NSAID or oral DMARD unless contraindicated.

Documentation Required

Required chart documentation

Submit the member's chart or medical record documenting medical necessity per the applicable indication; documentation must include specialist involvement, relevant biomarkers or inflammatory markers (for RA), prior therapy trials and responses, weight for pJIA, and TB screening results.

Prescribed by or in consultation with a rheumatology specialist (required for all indications).
RA biomarker documentation: positive RF or anti‑CCP OR testing for RF, anti‑CCP, and CRP and/or ESR.
Record prior therapy trials (methotrexate, adalimumab, NSAID/DMARD) with duration and response.
Document member weight (≥63 kg) for pJIA eligibility.
Document negative TB test within 6 months if biologic‑naïve (PPD, IGRA, or chest x‑ray) and any follow‑up if positive.

Denial Risk

Non‑approved indications (not medically necessary)

Requests for indications that are not FDA‑approved or compendial uses are considered experimental/investigational and are not medically necessary; such requests may be denied.

All other indications not FDA‑approved or compendial are considered experimental/investigational and not medically necessary.

Billing Rule

Concomitant biologic/targeted therapy prohibited

Kevzara must not be used concomitantly with other injectable biologic response modifiers or specified oral targeted agents; concurrent use is prohibited and may lead to denial.

Prohibited concomitant injectable biologics include TNF‑inhibitors (e.g., adalimumab, etanercept, infliximab) and IL‑inhibitors (examples listed in policy).
Prohibited oral targeted agents include apremilast, tofacitinib, baricitinib, and upadacitinib.

Background

Sarilumab (Kevzara) is an interleukin‑6 receptor antagonist indicated for: (1) adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more DMARDs; (2) adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper; and (3) treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients who weigh 63 kg or greater. Prior to initiation in biologic‑naïve patients, a documented negative TB test (PPD, IGRA, or chest x‑ray) within 6 months is required; positive or suspicious results require further evaluation and management per the policy.

OpenPayer

Kevzara (sarilumab) — Medical Necessity and Authorization Criteria

Coverage Criteria for Kevzara (sarilumab)

Coding and Dosing Information

Provider Actions and Authorization Requirements

Background

Definitions and Pre-initiation Requirements