CurrentCignaPolicy IP0182

Spinal Muscular Atrophy - Spinraza

Policy governing medical necessity, documentation, and authorization criteria for use of Spinraza (nusinersen) for treatment of spinal muscular atrophy for Cigna members.

Policy Summary

PayerCigna

PolicySpinal Muscular Atrophy - Spinraza

Policy CodePolicy IP0182

Change TypeMultiple substantive revisions (authorization durations, documentation, gene therapy exclusions, coding)

Effective DateThe policy effective date is in force until updated or retired.

Next Review Date

Key ActionPrescribing physician must confirm patient has not received Zolgensma or Itvisma and attest if claims history is unavailable.

SourceLink

POLICY UPDATE CHANGES

Policy title changed from 'Nusinersen' to 'Spinal Muscular Atrophy - Spinraza'; documentation requirements updated throughout the policy.

Initial authorization duration revised from 6 months to 3 months; initial therapy genetic testing language changed to require bi-allelic pathogenic variants; added requirement that patient has not received Zolgensma or Itvisma; removed 6-Minute Walk Test as baseline motor assessment and removed follow-on Spinraza criteria.

For patients currently receiving Spinraza, reauthorization duration changed from 12 months to 4 months and additional criteria for currently receiving patients were added; maintenance dosing guidance for missed doses clarified.

Conditions Not Covered and concurrent use of Evrysdi statements were updated.

Itvisma added to list of gene therapies the patient should not have received; note added for physician attestation if claims history unavailable.

CPT code 96450 removed from coding information.

Clarified missed maintenance dose guidance: missed maintenance doses for at least 8 months but less than 16 months followed by one additional dose 14 days later (corrected from previously stating two doses).

Annualpolicy undergoes annual review

3+revision history entries

IP0182policy identifier

≥11reference list

Coverage and Medical Necessity Criteria

Initial Therapy — Spinraza (nusinersen)

Covered when ALL of the following are met:

Initial Therapy - revised requirements: Initial authorization duration: 3 months; genetic testing demonstrates bi-allelic pathogenic variants in SMN1; patient has not received Zolgensma or Itvisma (if claims history unavailable, prescribing physician must confirm no prior Itvisma); removed requirement limiting onset of symptoms to age ≤15 years; 6-Minute Walk Test removed as a baseline motor assessment option.

Full detailed criteria language is in the policy document.

Continuation / Reauthorization — Patients Currently Receiving Spinraza

Covered when ALL of the following are met for patients currently receiving Spinraza:

Patients Currently Receiving Spinraza: Reauthorization duration updated to 4 months (previously 12 months); added specific criteria for patients currently receiving therapy; corrected missed maintenance dose guidance: missed maintenance doses for at least 8 months but less than 16 months followed by one additional dose 14 days later.

Policy Summary

PayerCigna

PolicySpinal Muscular Atrophy - Spinraza

Policy CodePolicy IP0182

Change TypeMultiple substantive revisions (authorization durations, documentation, gene therapy exclusions, coding)

Effective DateThe policy effective date is in force until updated or retired.

Next Review Date

Key ActionPrescribing physician must confirm patient has not received Zolgensma or Itvisma and attest if claims history is unavailable.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Full detailed criteria language is in the policy document.

Conditions Not Covered: The policy excludes coverage in the situations specified in the Conditions Not Covered statement as updated in the revision history. Refer to the policy text for the enumerated excluded conditions as revised on the listed revision dates.

Concurrent use of Evrysdi: The policy language regarding concurrent use of Evrysdi was updated in the revision history. The updated statement governs circumstances under which Evrysdi may not be used concurrently with Spinraza and clarifies the policy position; see the policy for the exact concurrent-use restrictions as revised.

Billing and Coding

Removed CPT CodesCPTNot Covered

96450

CPT code previously listed but removed

Provider Requirements and Authorization details

Prior Authorization

Authorization durations

Initial authorization duration: Approvals for new starts are limited to 3 months. Prescribers must request reauthorization with required documentation before expiration to continue therapy.

Initial authorization = 3 months
Reauthorization for patients currently receiving therapy = 4 months (see reauthorization callout)

Denial Risk

Prior gene therapy requirement

Prior gene therapy requirement: Patient must NOT have previously received onasemnogene abeparvovec (Zolgensma) or rovanasemogene carboxyl (Itvisma). If claims history is unavailable or does not show prior gene therapy, the prescribing physician must attest that the patient has not received Zolgensma or Itvisma.

Exclude prior receipt of Zolgensma (onasemnogene abeparvovec)
Exclude prior receipt of Itvisma (rovanasemogene carboxyl)
If no claims/history available, prescriber attestation is required

Documentation Required

Required documentation

Required documentation: Provide baseline assessments, genetic testing demonstrating bi-allelic pathogenic variants in SMN1 (per policy genetic testing language), prior treatment history, baseline motor function assessment, and all other records requested at authorization and reauthorization.

Genetic testing: documentation of bi-allelic pathogenic variants
Baseline clinical assessment and motor function testing (as described in policy)
Prior treatment and claims history (including documentation re: gene therapies and disease-modifying therapies)
For reauthorization: documentation of clinical benefit and adherence to the dosing schedule

Denial Risk

Denial triggers

Denial triggers: Requests may be denied if required documentation is missing, genetic testing does not confirm bi-allelic pathogenic variants, the patient has received excluded prior gene therapies (Zolgensma or Itvisma), or reauthorization requirements and timelines are not met.

Missing or incomplete genetic testing showing bi-allelic pathogenic variants
Lack of prescriber attestation or evidence that patient has not received Zolgensma or Itvisma when claims are absent
Failure to provide baseline or follow-up clinical documentation at initial or reauthorization
Nonadherence to required dosing/maintenance schedule as specified in policy

Clinical Background and Evidence

Background: This policy on Spinraza (nusinersen) is grounded in contemporary clinical evidence and practice guidance. The referenced literature includes pivotal nusinersen trials and related SMA research that inform treatment algorithms and recommendations for infants identified through newborn screening.

Key citations and clinical sources referenced in the policy include major nusinersen studies (ENDEAR, CHERISH, NURTURE, EMBRACE) and recent review and guideline publications on SMA therapeutics and newborn screening–based treatment recommendations. These sources support the policy updates and the clinical rationale for authorization, documentation, and reauthorization requirements.

Clinical Definitions and Guidance

SMN2-related recommendations — newborn screening guidance

SMN2 copy-number guidancePolicy references revised newborn screening treatment recommendations for infants with 4 copies of SMN2 (per Glascock et al. 2020).

Treatment recommendation for newbornsNewborns identified by screening with SMN2 copy-number guidance should follow the revised treatment algorithm described in the referenced guidance (Glascock et al. 2020).

Source of recommendationsRecommendations are drawn from the revised newborn screening treatment guidance: Glascock J et al., J Neuromuscul Dis. 2020;7(2):97-100.

Policy incorporationPolicy text was updated to reference these revised SMN2-related recommendations in defining treatment expectations for infants identified through newborn screening.

Clinical contextReferenced recommendations inform clinical decision-making about initiating therapy based on SMN2 copy number in presymptomatic infants.