Cigna revised its SMA coverage policy to rename Risdiplam to Spinal Muscular Atrophy - Evrysdi and add Evrysdi oral tablets with updated documentation and authorization timelines. Initial approvals now require documented genetic confirmation (bi‑allelic pathogenic SMN1 variants), specified SMN2 copy-number criteria, a baseline motor assessment with validated scales, verification of no prior Zolgensma or Itvisma, and are granted for 4 months. Ongoing therapy approvals require the same genetic/SMN2 criteria, specialist involvement, and documented clinical improvement or stabilization and are authorized for 1 year. Evrysdi is not considered medically necessary for patients with complete limb paralysis or permanent ventilator dependence, nor for concurrent use with Spinraza. The policy references FIREFISH, SUNFISH, and RAINBOWFISH trials and aligns SMN2-based treatment pathways with guideline evidence.
March 2026 Revision: Title, therapies excluded, and authorization durations
Summary of Revisions Effective 2026-03-15
This Cigna coverage policy (IP0063) for Spinal Muscular Atrophy - Evrysdi reflects several targeted updates consolidated across annual and selected revisions. Key changes include renaming the title from "Risdiplam" to Spinal Muscular Atrophy - Evrysdi, addition of Evrysdi oral tablets to the policy, and updates to documentation and authorization durations. For initial therapy, the initial authorization duration was shortened from 6 months to 4 months; for patients currently receiving Evrysdi, the prior durations were revised with the current standard of a 1-year renewal for continuing therapy.
The revision history also added Itvisma (intrathecal onasemnogene abeparvovec-brve) to the list of gene therapies that must not have been previously received for initial approvals, alongside Zolgensma (intravenous onasemnogene abeparvovec-xioi). The policy updated genetic language from "bi-allelic mutation" to bi-allelic pathogenic variants and removed several prior restrictions and requirements (e.g., contraception, hepatic impairment exclusion, and the 6-Minute Walk Test from motor assessment lists). Selected revision notes dated 08/15/2025 and 03/15/2026 document these cumulative changes.
Criteria for Continued Coverage and Demonstrated Clinical Response
Renewal Criteria for Patients Currently Receiving Evrysdi (Ongoing Therapy)
For patients already on Evrysdi, the policy authorizes treatment for 1 year if criteria are satisfied. Required elements include documented genetic confirmation of bi-allelic pathogenic variants in SMN1, meeting the same SMN2 copy number rules as initial therapy (two or three copies, or four copies with objective signs of SMA Types 1–3), and prescription by an appropriate specialist or after specialist consultation. Additionally, the patient must demonstrate a positive clinical response or stabilization from pretreatment baseline within the past 4 months, documented by one of the same motor function instruments allowed at baseline, or by the prescribing physician’s documented monitoring/assessment.
This renewal structure emphasizes measurable clinical benefit (improvement or stabilization) or physician-documented response as the basis for continued coverage. The policy lists the same set of validated motor scales that can be used for documenting response.
Explicit Non‑Covered Populations and Concomitant Therapy Exclusion
Restrictions and Conditions Considered Not Medically Necessary
The policy explicitly identifies several conditions in which Evrysdi is considered not medically necessary. These include patients with complete paralysis of all limbs and those with permanent ventilator dependence; the policy states data are needed to determine benefit in these advanced SMA populations. The policy also designates concurrent use of Evrysdi with Spinraza (nusinersen intrathecal injection) as not medically necessary pending further study on combined efficacy and safety.
This section formalizes exclusions for advanced disease states and combination therapy, reflecting that the available evidence has not established benefit for those scenarios. The list is noted as not exhaustive and may be updated as new published data become available.
Evidence Basis (FIREFISH, SUNFISH, RAINBOWFISH) and Guideline Alignment
Clinical Evidence and Guideline Context Referenced in the Policy
The policy summarizes pivotal clinical studies supporting Evrysdi efficacy: FIREFISH (infantile-onset/Type 1), SUNFISH (later-onset Types 2 and 3), and RAINBOWFISH (presymptomatic infants). Results cited include improvements in sitting ability and survival without permanent ventilation in Type 1 (FIREFISH), motor function gains in later-onset disease (SUNFISH, Part 2 at Month 12), and high rates of sitting without support at 12 months in presymptomatic infants (RAINBOWFISH primary endpoint reached in treated populations). The policy also references newborn screening working group guidance that historically recommended immediate treatment for infants with two or three SMN2 copies, and later updates extending immediate treatment recommendations to infants with four copies.
These evidence and guideline citations are used to define the SMN2 copy number–based pathways for coverage and to justify the emphasis on early treatment and presymptomatic intervention when supported by SMN2 status and objective findings.
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