CurrentMass General Brigham Health PlanPolicy N/A

Spinraza (nusinersen) coverage

Defines Mass General Brigham Health Plan coverage, prior authorization, dosing, monitoring, and continuation criteria for Spinraza (nusinersen) for members with spinal muscular atrophy (SMA). Applies to Medical and Specialty medication benefits where Spinraza is covered.

Policy Summary

PayerMass General Brigham Health Plan

PolicySpinraza (nusinersen) coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2025

Next Review DateMay 14, 2025

Key ActionObtain prior authorization and submit molecular genetic confirmation of SMA plus baseline motor function documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 mgdose per administration

every 4 monthsmaintenance dosing interval

4 loading dosesloading dose schedule

12 monthstypical approval duration

Coverage Criteria for Spinraza (nusinersen)

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Initial Therapy

Covered when ALL of the following are met:

Initial authorization criteria: Member has documented diagnosis of SMA type 1, 2, or 3 confirmed by molecular genetic testing

Baseline motor function: Clinical documentation of baseline (pre-treatment) motor function skills has been submitted

Care established: Member has established care with an SMA multidisciplinary care center

No disqualifying conditions: Member has none of: hospitalization for surgery or pulmonary event within past 2 months, active infection, brain or spinal cord disease, meningitis, implanted CSF shunt, treatment with another investigational drug within 1 month of evaluation

Prescriber qualifications: Prescribed by a neurologist with expertise in the management of SMA

Continuation / Reauthorization

Requests for reauthorization will be approved when the following criteria are met:

Clinical assessment: Physician documentation of assessment of improvement in clinical outcomes via motor function using HINE, CHOP-INTEND, HFMSE or other age-appropriate motor function scale

Assessments required at baseline and prior to each dose

Laboratory monitoring: At baseline and prior to each dose obtain platelet count, coagulation tests (PT, aPTT) and quantitative spot urine protein test

Duration consideration: Therapy may be continued until disease progression or unacceptable toxicity; discontinuation determined based on age-appropriate performance and patient-reported outcomes; improvement may require several months to a year

Provider Action Items and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Spinraza (nusinersen). Coverage is authorized only when all applicable clinical criteria in the policy are met and prior authorization is obtained.

Benefit: Pharmacy Benefit (Prior Authorization applies)
Program Type: Commercial/Exchange
Effective Date: 2025-06-01

Step Therapy

No step therapy requirements are specified for Spinraza (nusinersen) in this policy.

Documentation Required

Required Clinical Documentation

Required clinical documentation includes molecular genetic confirmation of SMA and baseline motor function assessment. Submit documentation of: confirmed SMA type (1, 2, or 3) by molecular genetic testing, baseline (pre-treatment) motor function using HINE, CHOP-INTEND, HFMSE or other age-appropriate motor scale, and evidence that the member has established care with an SMA multidisciplinary care center.

Molecular genetic test confirming SMA type (1, 2, or 3)
Baseline (pre-treatment) motor function documentation: HINE, CHOP-INTEND, HFMSE or other age-appropriate motor scale
Documentation of established care with an SMA multidisciplinary care center
Prescribing clinician: neurologist with expertise in SMA

Denial Risk

Denial Triggers and Common Reasons for Denial

Requests may be denied if documentation is incomplete or criteria are not met. Common denial triggers include absence of molecular genetic confirmation of SMA, missing baseline motor function assessment, lack of documentation showing established care with an SMA multidisciplinary center, prescription not from a neurologist experienced in SMA, or presence of exclusionary conditions (recent hospitalization for surgery or pulmonary event within 2 months, active infection, brain/spinal cord disease, meningitis, implanted CSF shunt, recent investigational drug treatment).

No molecular genetic confirmation of SMA type 1, 2, or 3
Missing baseline motor function scores (HINE, CHOP-INTEND, HFMSE, or equivalent)
No documentation of established care with an SMA multidisciplinary care center
Prescriber is not a neurologist with SMA expertise
Presence of exclusionary conditions: hospitalization for surgery or pulmonary event within past 2 months, active infection, brain or spinal cord disease, meningitis, implanted CSF shunt, recent investigational drug within 1 month

Background

Spinraza (nusinersen) is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. It is administered intrathecally and requires documented baseline motor function assessment and periodic monitoring (including laboratory tests) to support initial authorization and reauthorization. Dosing includes a series of four loading doses followed by maintenance dosing every 4 months; the first three loading doses are given at 14-day intervals with a fourth loading dose 30 days after the third. Providers should ensure molecular genetic confirmation of SMA type 1, 2, or 3 and that the prescriber is a neurologist with expertise in SMA when seeking coverage.

OpenPayer

Spinraza (nusinersen) coverage

Coverage Criteria for Spinraza (nusinersen)

Dosing Schedule and Coding Details

Provider Action Items and Authorization

Background

Definitions