CurrentMass General Brigham Health PlanPolicy N/A

Spinraza (nusinersen) — Coverage Criteria (Spinal Muscular Atrophy)

Defines prior authorization, coverage criteria, and reauthorization requirements for Spinraza (nusinersen) under the plan's pharmacy and medical benefits for commercial/exchange members.

Policy Summary

PayerMass General Brigham Health Plan

PolicySpinraza (nusinersen) — Coverage Criteria (Spinal Muscular Atrophy)

Policy CodePolicy N/A

Change TypeMaterial clinical updates and duration revisions

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with genetic test confirming SMA (including SMN2 copy number), current motor function testing, prescriber documentation, and Zolgensma attestation when applicable.

SourceLink

POLICY UPDATE CHANGES

Allowed use of Spinraza in members with 2 or 3 copies of SMN2 and in certain patients with 4 copies of SMN2 (symptomatic or pre-symptomatic infants).

Initial approval duration updated to 7 months and reauthorization to 12 months.

Recertification criteria adjusted to allow current functional tests to be >3 months (up to 12 months) old if member is being followed regularly.

Specific criteria and testing requirements when member previously received onasemnogene abeparvovec (Zolgensma) were added.

7Initial approval duration

12Reauthorization duration

2-4SMN2 groups

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Coverage and Medical Necessity Criteria

inv-01: Initial Authorization

Authorization may be granted when ALL the following criteria are met:

Initial Authorization

Diagnosis of Spinal Muscular Atrophy (SMA)
Genetic confirmation: One of the following genetic confirmations: (1) copy of genetic test confirming diagnosis of SMA (e.g., SMN1 homozygous gene deletion or mutation or compound heterozygous mutation); OR (2) copy of genetic test confirming member has 2 or 3 copies of SMN2 and member is symptomatic; OR (3) copy of genetic test confirming member has 4 copies of SMN2 AND one of the following: member is a pre-symptomatic infant diagnosed via newborn screening.1 of
Specifies allowed SMN2 copy-number groups
Prescriber and testing: Prescriber is a neurologist or consult notes from a neurologist are provided; current motor function test within the last year (e.g., HFMSE, HINE, CHOP-INTEND, WHO Motor Milestones).
Prior Zolgensma: If the member has previously received Zolgensma (onasemnogene abeparvovec), ALL of the following are required: attestation that the member had an inadequate response to Zolgensma; pre-treatment baseline motor function test (prior to treatment with any SMA agent); post‑Zolgensma motor function tests; and pre‑Zolgensma baseline motor function test if different than the pre‑treatment baseline. Pre‑ and post‑Zolgensma testing should be within 1 year pre‑ and post‑administration.
Ventilator dependence: Member does not have evidence of permanent ventilator dependence defined as any of the following: endotracheal tube; tracheotomy tube; OR at least 14 days of continuous respiratory assistance for ≥16 hours per day.
Concomitant therapy: Requested agent will NOT be used in combination with Evrysdi.
Dosing is appropriate within the FDA labeling.

inv-02: Continuation / Reauthorization

Reauthorization may be granted when member meets ALL initial criteria and the following:

Reauthorization

Functional response: Current motor function test documenting positive response to therapy based on the same test previously provided. Test must be within the past 3 months, or >3 months up to 12 months if the member is being followed regularly.1 of
Accepts disease stabilization or reduction in expected motor decline as medical necessity for continuing therapy.
Ventilator dependence: Member does not have evidence of permanent ventilator dependence defined as any of the following: endotracheal tube; tracheotomy tube; OR at least 14 days of continuous respiratory assistance for ≥16 hours per day.

Requested agent will not be used in combination with Evrysdi. This combination is explicitly excluded and requests that propose concurrent use with Evrysdi may be denied.

Members with permanent ventilator dependence are excluded from coverage. Permanent ventilator dependence is defined as any of the following: presence of an endotracheal tube, presence of a tracheotomy tube, or at least 14 days of continuous respiratory assistance for ≥16 hours per day.

Coding, Tests, and Assessment Timing

Covered CPT Codesmixed

No codes listed

Motor function test recency

Initial authorization motor function testCurrent motor function test within the last year (examples: HFMSE, HINE, CHOP-INTEND, WHO Motor Milestones)

Reauthorization motor function test - standardCurrent motor function test within the past 3 months documenting positive response to therapy (same test previously provided)

Reauthorization motor function test - alternateIf member is being followed regularly, motor function test may be >3 months old up to 12 months

Provider Responsibilities and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for Spinraza (nusinersen) under the plan. Requests will be reviewed for members new to the plan who are currently receiving therapy and for all new starts; authorization must be obtained prior to therapy initiation or continuation as applicable. Contact numbers: All Plans (Medical/Specialty): Phone: 877-519-1908; Fax: 855-540-3693. Non-specialty medications: Phone: 800-711-4555; Fax: 844-403-1029.

Benefit: Medical and Specialty Medications
Program Type: Quantity Limit
Step Therapy: None specified
Specialty Limitations: N/A
Exceptions: N/A

Denial Risk

Triggers for denial

Requests will be denied when any of the following denial triggers are present: dosing inconsistent with FDA labeling; member has evidence of permanent ventilator dependence (including presence of an endotracheal tube, tracheotomy tube, or requirement of at least 14 consecutive days of respiratory assistance for ≥16 hours/day); requested agent is to be used in combination with Evrysdi; or required documentation (e.g., confirmatory genetic testing, motor function testing, neurologist prescriber or consult) is not provided.

Key Definitions and Genetic Confirmation

Genetic confirmation requirements

Required genetic documentationCopy of genetic test confirming diagnosis of SMA (examples: SMN1 homozygous gene deletion, SMN1 mutation, or compound heterozygous mutation)

SMN2 copy-number documentation (2 or 3 copies)Copy of genetic test confirming member has 2 or 3 copies of SMN2; member must be symptomatic

SMN2 copy-number documentation (4 copies)Copy of genetic test confirming member has 4 copies of SMN2 and either the member is symptomatic or is a pre-symptomatic infant diagnosed via newborn screening

Clinical Background

Spinal muscular atrophy (SMA) is a neuromuscular disorder caused by insufficient survival motor neuron (SMN) protein, commonly due to deletion or mutation of the SMN1 gene; the number of SMN2 copies modifies disease severity. Spinraza (nusinersen) is an SMN2-directed antisense oligonucleotide approved for treatment in pediatric and adult patients. Coverage under this policy requires documented diagnosis, genetic confirmation as specified (including SMN2 copy-number criteria), neurologist prescriber or consult notes, and baseline motor function testing as described in the criteria. The policy also specifies exclusions (for example, permanent ventilator dependence) and that the requested agent must not be used in combination with Evrysdi.