Continuation of Therapy — Spinraza (nusinersen) for Spinal Muscular Atrophy
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Defines prior authorization, continuation (reauthorization) criteria, and approval durations for Spinraza (nusinersen) under the Mass General Brigham Health Plan medical benefit, primarily for MassHealth UPPL members.
Removed criteria that allowed use after gene therapy and added restriction for prior utilization of gene therapy.
Recertification criteria clarified that functional tests are required for all requests regardless of response and further defined current motor function tests.
Updated restrictions to allow Spinraza use in members with 2 or 3 copies of SMN2 or in certain patients with 4 copies of SMN2 (symptomatic or pre-symptomatic infants).
Updated approval durations to 7 months initial and 12 months reauthorization.
Coverage Criteria for Spinraza (nusinersen)
Initial authorization criteria
Authorization may be granted for members new to the plan who are currently receiving treatment, and for new authorizations when ALL criteria are met.
ALL of the following
- Diagnosis of Spinal Muscular Atrophy (genetic confirmation required)
Genetic confirmation: SMN1 homozygous deletion/mutation or compound heterozygous mutation
SMN2 copy requirements
- SMN2 copy = 2 or 3 (documented by genetic test)
- 4 copies conditional: SMN2 copy = 4 documented by genetic test AND member is symptomatic OR is a pre-symptomatic infant identified by newborn screening
- Prescriber is a neurologist or neurologist consult notes are provided
- Baseline (current within the last year) motor function test is provided (examples: HFMSE, HINE, CHOP INTEND, WHO Motor Milestones)
- Member has not previously received gene therapy for spinal muscular atrophy
- Requested agent will NOT be used in combination with Evrysdi
- Dosing consistent with FDA labeling
Reauthorization criteria
Reauthorization may be granted when member meets ALL initial criteria and additional follow-up criteria.
ALL of the following
- Meets all initial authorization criteria
- Current motor function tests within past 3 months (or up to 12 months if the member is being followed regularly based on past test dates)
Clinical benefit or necessity
- Positive response to therapy demonstrated by improvement in motor function tests from baseline
- Medical necessity for continuing therapy (e.g., disease stabilization or reduced rate of motor decline)
- Member does not have evidence of permanent ventilator dependence (endotracheal tube OR tracheotomy tube OR ≥14 days continuous respiratory assistance ≥16 hours/day)
- Member has NOT previously received treatment with a gene therapy for spinal muscular atrophy
Initial Therapy
Initial therapy
Initial authorization for Spinraza (nusinersen) may be granted when ALL of the following are satisfied; initial approvals will be granted for 7 months.
ALL of the following
- Diagnosis of SMA with genetic confirmation (SMN1 homozygous deletion/mutation or compound heterozygous mutation)
SMN2 copy requirements
- Documented 2 or 3 copies of SMN2
- 4 copies conditional: Documented 4 copies of SMN2 AND member is symptomatic OR is a pre-symptomatic infant identified via newborn screening
- Prescriber is a neurologist or neurologist consult notes provided
- Baseline motor function test available (current within the last year; examples: HFMSE, HINE, CHOP INTEND, WHO Motor Milestones)
- No prior gene therapy for SMA
- Requested agent will not be used in combination with Evrysdi
- Dosing appropriate within FDA labeling
- Outcome: Initial approval duration: 7 months
Continuation / Reauthorization Criteria
Continuation/Reauthorization
Reauthorization (continuation) requests require evidence of ongoing benefit or medical necessity and will be granted for 12 months when criteria are met.
ALL of the following
- Meets all initial authorization criteria
- Current motor function tests within past 3 months or up to 12 months if the member is being followed regularly based on past test dates
Evidence of benefit
- Improvement in motor function tests from baseline
- Medical necessity for continuing therapy (disease stabilization or reduced rate of motor decline)
- No evidence of permanent ventilator dependence (endotracheal tube OR tracheotomy tube OR ≥14 days continuous respiratory assistance ≥16 hours/day)
- No prior gene therapy for spinal muscular atrophy
- Outcome: Reauthorization approval duration: 12 months
Coding and Test Recency
Provider Actions, Documentation, and Billing
Prior authorization required; authorizations considered when criteria met
Prior authorization is required for Spinraza (nusinersen) under the medical benefit. Authorizations will be considered for members new to the plan who are currently receiving treatment and for new starts when all initial criteria are met; reauthorization requests must meet all initial criteria plus the reauthorization requirements (including current motor function evidence).
- Program type: Prior Authorization (medical benefit).
- Authorizations considered for members new to the plan who are currently receiving treatment and for new starts when all criteria are met.
- Reauthorization requires meeting initial criteria and additional continuation criteria (see reauthorization rules).
Denial risks: prior gene therapy or combination with Evrysdi
Requests will be denied if the member has previously received gene therapy for spinal muscular atrophy or if the requested agent will be used in combination with Evrysdi, as both conditions preclude coverage.
- Member has previously received treatment with a gene therapy for SMA — coverage precluded.
- Requested agent will not be used in combination with Evrysdi — combination use is not allowed.
Required documentation for authorization
Providers must submit documentation demonstrating the diagnosis and clinical and genetic confirmation of SMA, prescriber specialty, current motor function testing, and confirmation of no prior gene therapy.
- Diagnosis of Spinal Muscular Atrophy.
- Copy of genetic test confirming SMA (e.g., SMN1 homozygous deletion/mutation or compound heterozygous mutation) and documentation of SMN2 copy number (2 or 3 copies; 4 copies allowed only if symptomatic or pre-symptomatic infant).
- Prescriber is a neurologist or provide consult notes from a neurologist.
- Current motor function test results (examples: HFMSE, HINE, CHOP INTEND, WHO Motor Milestones); for reauthorization, tests must be within the past 3 months or up to 12 months if the member is followed regularly.
- Documentation that the member has not previously received gene therapy for SMA.
- Evidence that the requested dosing is appropriate within FDA labeling.
Approval duration and billing period
Initial authorizations will be granted for 7 months; reauthorizations will be granted for 12 months.
- Initial approval duration: 7 months.
- Reauthorization approval duration: 12 months.
Definitions and Test Examples
Site of Care / Benefit Setting
Medical benefit — hospital outpatient site of care
Spinraza is covered under the medical benefit and the site of care is identified as hospital outpatient (medical benefit setting; site not further specified).
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