Currentmedical mutual - ohioPolicy N/A

Evrysdi (risdiplam) — Coverage Criteria (Spinal Muscular Atrophy)

This policy governs prior authorization, initial and renewal coverage criteria, and length of authorization for Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA) for Medical Mutual - Ohio members.

Policy Summary

Payermedical mutual - ohio

PolicyEvrysdi (risdiplam) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2020

Next Review DateAug 21, 2025

Key ActionObtain prior authorization and submit baseline motor function, respiratory tests, and weight to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial approval period

12 morenewal approval period

≥2 moFDA-approved minimum age

oral dailyadministration

PA requiredauthorization requirement

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Initial Therapy

Covered when ALL of the following are met:

Initial Approval - SMA: Patient must not have previously received treatment with SMA gene therapy (e.g., onasemnogene abeparvovec); AND patient will not use Evrysdi in combination with other agents for SMA (e.g., onasemnogene abeparvovec, nusinersen); AND patient does not have impaired hepatic function as defined by elevated laboratory values; AND patient retains meaningful voluntary motor function (e.g., manipulate objects using upper extremities, ambulate); AND patient has a diagnosis of 5q spinal muscular atrophy confirmed by either homozygous deletion of the SMN1 gene or dysfunctional SMN1 mutation; AND patient has one of the following phenotypes: SMA I or II confirmed by genetic testing OR SMA III confirmed by genetic testing with symptomatic disease (i.e., impaired motor function and/or delayed motor milestones); AND baseline documentation of one or more of the following: motor function/milestones using validated scales (HINE, HFMSE, CHOP INTEND, 6MWT, ULM, MFM32, RULM, etc.), respiratory function tests (e.g., FVC), exacerbations necessitating hospitalization and/or antibiotic therapy for respiratory infection in the preceding year/timeframe, or patient weight (for patients without a gastrostomy tube).none

FDA-labeled indication applies

Continuation / Renewal

Renewal is provided when ALL of the following are met:

Renewal Criteria: Patient must not have previously received treatment with SMA gene therapy (e.g., onasemnogene abeparvovec); AND absence of unacceptable toxicity that would preclude safe administration of the drug (examples include significant hepatic impairment); AND patient has responded to therapy compared to pretreatment baseline as demonstrated by one or more of: stability or improvement in motor function/milestones (validated scales: HINE, HFMSE, CHOP INTEND, 6MWT, ULM, MFM32, RULM, etc.), stability or improvement in respiratory function tests (e.g., FVC), reduction in exacerbations necessitating hospitalization and/or antibiotic therapy for respiratory infection in the preceding year/timeframe, stable or increased patient weight (for patients without a gastrostomy tube), or slowed rate of decline in the aforementioned measures.response vs baseline

Response may be assessed using listed validated measures

Patients with permanent ventilator dependence are not recommended for approval. The policy states that data are insufficient to determine whether this advanced SMA population would derive benefit from Evrysdi.

Use of Evrysdi in combination with other SMA agents is not permitted. Examples include concomitant treatment with onasemnogene abeparvovec or nusinersen.

Evrysdi is not recommended for circumstances outside the policy's Recommended Authorization Criteria. Specifically, the Company does not recommend approval for patients with permanent ventilator dependence due to lack of data on benefit. Additionally, use in combination with other SMA therapies (for example, onasemnogene abeparvovec or nusinersen) is prohibited. The policy indicates that criteria will be updated as new published data become available.

Provider Responsibilities and Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for pharmacy coverage of Evrysdi; approvals are granted only when the initial or renewal criteria and length of authorization in this policy are met.

Step Therapy

Therapy sequencing and combination restriction

Patient must not have previously received SMA gene therapy and Evrysdi must not be used in combination with other SMA agents (e.g., onasemnogene abeparvovec, nusinersen).

Documentation Required

Required baseline and supporting documentation

Baseline clinical documentation must be provided at initiation and may be requested for reauthorization; include validated motor scales, respiratory tests, exacerbation history, and weight when applicable.

Motor function/milestones using validated scales (HINE, HFMSE, CHOP INTEND, 6MWT, ULM, MFM32, RULM, etc.)
Respiratory function tests (e.g., forced vital capacity [FVC])
Exacerbations requiring hospitalization and/or antibiotic therapy in the prior year/timeframe
Patient weight (for patients without a gastrostomy tube)
The Company may request additional records, test results, and provider credentials to support medical necessity

Denial Risk

Denial risk and required documentation

The Company may deny reimbursement if the drug or services are determined to be not medically necessary, investigational/experimental, not within member benefits, or if billing/practice is inappropriate or excessive.

Additional documentation supporting medical necessity must be provided upon request
Denial may follow determination of investigational use, lack of medical necessity, out-of-scope benefits, or inappropriate/excessive billing

Key Definitions

5q spinal muscular atrophy (SMA) — definition and included phenotypes

DefinitionSMA due to SMN protein deficiency resulting from SMN1 gene deletion or dysfunctional SMN1 mutations (5q SMA).

Included phenotypesSMA I or II confirmed by genetic testing; SMA III confirmed by genetic testing with symptomatic disease (impaired motor function and/or delayed motor milestones).

Age / FDA indicationFDA-approved for patients two months of age and older (Evrysdi oral solution once daily; dosing varies by age/weight).

Genetic confirmation requiredDiagnosis must be confirmed by either homozygous deletion of SMN1 or a dysfunctional SMN1 mutation.

Baseline documentation recommendedObtain baseline motor function/milestones using validated scales (HINE, HFMSE, CHOP INTEND, 6MWT, ULM, MFM32, RULM), respiratory tests (e.g., FVC), exacerbation history, or patient weight (if no gastrostomy).

OpenPayer

Evrysdi (risdiplam) — Coverage Criteria (Spinal Muscular Atrophy)

Coverage Criteria for Evrysdi (risdiplam)

Provider Responsibilities and Authorization Requirements

Key Definitions

Background