CurrentUnitedHealthcarePolicy 2025 P 1328-7

Evrysdi®(risdiplam) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

UnitedHealthcare prior authorization/notification policy for Evrysdi (risdiplam) governing initial and reauthorization criteria for commercial plan members for the treatment of spinal muscular atrophy (SMA), including requirements when patient received prior gene replacement therapy.

Policy Summary

PayerUnitedHealthcare

PolicyEvrysdi®(risdiplam) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1328-7

Change TypeCriteria additions and revisions

Effective DateJun 1, 2025

Next Review Date

Key ActionSubmit prior authorization; for patients with prior gene replacement therapy include medical records documenting clinically meaningful functional decline since gene therapy.

SourceLink

POLICY UPDATE CHANGES

Added criteria for patients that have documented decline from pretreatment baseline status following administration of gene replacement therapy.

Revised criteria for patients that have documented decline from pretreatment baseline status following administration of gene replacement therapy.

Updated criteria to align with labeled indication in patients of all ages.

12 monthsAuthorization duration

DocumentationReauthorization requirement

Prior gene therapySpecial-case coverage

Coverage Summary

UnitedHealthcare prior authorization/notification policy (Program Number 2025 P 1328-7) for Evrysdi (risdiplam) governs initial and reauthorization criteria for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. The policy covers Evrysdi for this indication with a covered_with_criteria stance. Prior authorization and reauthorization approvals are issued for 12 months per the policy.

Initial Authorization Criteria

Continuation / Reauthorization Criteria

Special-case Coverage / Exclusions

Patients who previously received gene replacement therapy (e.g., Zolgensma [onasemnogene abeparvovec-xioi]) may be considered for Evrysdi only when medical records document a clinically meaningful functional decline since receiving gene replacement therapy. The policy requires submission of documentation (for example, chart notes or laboratory values) that demonstrates decline from pretreatment baseline status — the policy gives loss of a motor milestone as an example of clinically meaningful functional decline.

Applicable Codes

Diagnosis codes referencedICD-10

No codes listed

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Evrysdi. Approvals (initial and reauthorization) are issued for 12 months when policy criteria are met.

Documentation Required

Documentation for prior gene therapy recipients

For patients who previously received gene replacement therapy, submit medical records (e.g., chart notes, laboratory values) documenting a clinically meaningful functional decline since receiving gene replacement therapy (example: loss of motor milestone).

Clinical Evidence & References

Reference: Evrysdi [package insert], Genentech, Inc; September 2024. No trial metrics or additional metric cards are provided in the policy references.

Definitions

SMN modifying therapy: Therapies that modify survival motor neuron levels (example: nusinersen [Spinraza]).

Gene replacement therapy: Therapies such as onasemnogene abeparvovec-xioi (Zolgensma).

Clinically meaningful functional decline: A decline requiring documentation in the medical record; the policy specifically cites loss of a motor milestone as an example and requires submission of supporting records.

Revision History

7/2022revision

Updated criteria to align with labeled indication in patients of all ages; expanded criteria to all ages.

12/2024addition

Added criteria requiring submission of medical records documenting a clinically meaningful functional decline (e.g., loss of motor milestone) since receiving gene replacement therapy.

4/2025revisionLatest

Revised wording/criteria related to documented decline from pretreatment baseline status following administration of gene replacement therapy.