CurrentMass General Brigham Health PlanPolicy N/A

Spinraza (nusinersen)

Prior authorization policy for medical-benefit use of Spinraza (nusinersen) for treatment of spinal muscular atrophy (SMA) under MassHealth UPPL; defines initial and continuation authorization criteria, exclusions, documentation requirements, and approval durations.

Policy Summary

PayerMass General Brigham Health Plan

PolicySpinraza (nusinersen)

Policy CodePolicy N/A

Change TypeCriteria updates; exclusions; recertification and duration standardization

Effective DateMay 11, 2026

Next Review Date

Key ActionSubmit prior authorization with genetic test confirming SMA and SMN2 copy number, neurologist documentation, and current motor function test results per recency rules.

SourceLink

POLICY UPDATE CHANGES

Removed criteria that allowed use after gene therapy and added restriction if previously utilized gene therapy.

Clarified recertification requirement that functional tests are required for all requests regardless of response.

Updated SMN2 copy number criteria to allow use in members with 2 or 3 copies or selected patients with 4 copies (symptomatic or pre-symptomatic infants).

Updated approval durations: initial 7 months; reauthorizations 12 months.

7Initial Authorization Criteria (count)

4Reauthorization Criteria (count)

7 months

Coverage Summary

Scope: Prior authorization policy for medical-benefit use of Spinraza (nusinersen) for treatment of spinal muscular atrophy (SMA) under MassHealth UPPL. Coverage stance: covered with criteria when authorization criteria are met.

Drug & indication: Spinraza (nusinersen), an SMN2-directed antisense oligonucleotide indicated for treatment of SMA in pediatric and adult patients.

Benefit type & program: Medical-benefit prior authorization under the MassHealth UPPL program (prior authorization required).

Approval durations: Initial approval 7 months; Reauthorization 12 months.

Supportive thresholds (used in criteria): Current motor function testing must be within the last year for initial requests and for reauthorization be within the past 3 months or up to 12 months if the member is being followed regularly. Permanent ventilator dependence is defined as ANY of: endotracheal tube; tracheotomy tube; or ≥14 days continuous respiratory assistance for ≥16 hours/day.

Initial Authorization (ALL required)

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

ALL of the following

Diagnosis of Spinal Muscular Atrophy
Genetic confirmation: Copy of genetic test confirming diagnosis of SMA (e.g. SMN1 homozygous gene deletion or mutation or compound heterozygous mutation)
ONE of the following (SMN2 copy criteria)
- 2 or 3 copies: Copy of genetic test confirming member has 2 or 3 copies of SMN2
- 4 copies with symptomatic or pre-symptomatic infant: Copy of genetic test confirming member has 4 copies of SMN2 AND one of: Member is symptomatic OR Member is a pre-symptomatic infant diagnosed via newborn screening
Prescriber is a neurologist or consult notes from a neurologist are provided
Motor function test recency: Current (within the last year) motor function test (e.g. HFMSE, HINE, CHOP INTEND, WHO Motor Milestones, etc.)within the last year
Prior gene therapy exclusion: Member has not previously received treatment with a gene therapy for spinal muscular atrophy
No permanent ventilator dependence (NONE of the following)
- Endotracheal tube: Member has an endotracheal tube
- Tracheotomy tube: Member has a tracheotomy tube
- Prolonged respiratory assistance: Member had at least 14 days of continuous respiratory assistance for at least 16 hours per day≥14 days, ≥16 hours/day
Combination therapy exclusion: Requested agent will NOT be used in combination with Evrysdi
Dosing is appropriate within the FDA labelingper FDA labeling

Continuation of Therapy / Reauthorization (ALL required)

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

ALL of the following

Meets initial criteria: Member meets ALL initial authorization criteria
Motor function test recency for reauth: Current motor function tests (defined as within the past 3 months or up to 12 months if the member is being followed regularly based on past test dates)within past 3 months or up to 12 months if regularly followed
Response or medical necessity

Unproven / Exclusions

Explicit exclusions: Members who have previously received SMA gene therapy are disallowed from receiving Spinraza under this policy.

Permanent ventilator dependence exclusion: 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 at least 16 hours per day. Members meeting any of these are excluded.

Combination therapy exclusion: Requested agent will NOT be used in combination with Evrysdi.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Spinraza under the medical benefit. Requests for members new to the plan who are currently receiving treatment may be reviewed.

Documentation Required

Submit genetic and neurologist documentation

Submit a copy of genetic testing confirming the diagnosis of SMA and documenting SMN2 copy number as applicable. Provide neurologist prescriber information or neurologist consult notes with the request.

Applicable Codes

Medical Benefit - drug (no specific HCPCS/CPT codes provided in document)mixed

No codes listed

Clinical Evidence & References

Evidence entries cited in the brief: Spinraza [package insert], Biogen, Inc.; 2024 Apr and UpToDate: Spinal muscular atrophy (Bodamer OA, 2020).

Note: The brief does not include trial metric cards or specific trial statistics to reproduce; no additional trial metrics are provided in the brief.

Background

Background: Spinraza (nusinersen) is an SMN2-directed antisense oligonucleotide indicated for treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. This policy governs medical-benefit prior authorization for Spinraza under the MassHealth UPPL program.

Key definitions:

Permanent ventilator dependence: Defined by ANY of: endotracheal tube; tracheotomy tube; ≥14 days of continuous respiratory assistance for ≥16 hours per day.

Current motor function test: Motor function testing performed within the last year for initial requests; for reauthorization defined as within the past 3 months or up to 12 months if the member is being followed regularly based on past test dates.

Revision History

2026-05-11policy_updateLatest

Removed allowance for use after prior SMA gene therapy; added explicit exclusion for members who previously received gene therapy. Clarified recertification requirement that functional (motor) tests are required for all reauthorization requests regardless of response; tests may be up to 12 months old if the member is followed regularly.

2024-07-01policy_update

Expanded SMN2 copy number criteria to allow use in members with 2 or 3 copies of SMN2 and in selected patients with 4 copies (symptomatic individuals or pre-symptomatic infants diagnosed via newborn screening).

2023-04-01policy_update