CurrentBaylor Scott & White Health PlanPolicy 230

Nusinersen (Spinraza) — Medical Coverage Policy

Defines medical necessity criteria, prior authorization, coding, and renewal requirements for nusinersen (Spinraza) for treatment of spinal muscular atrophy (SMA) for Baylor Scott & White Health Plan members.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyNusinersen (Spinraza) — Medical Coverage Policy

Policy CodePolicy 230

Change TypeMaterial criteria and documentation updates

Effective DateOct 1, 2025

Next Review DateSep 8, 2026

Key ActionSubmit prior authorization with baseline motor ability testing (CHOP-INTEND, HFMSE, HINE-2, or RULM) and required documentation for initial and renewal requests.

SourceLink

POLICY UPDATE CHANGES

Added requirement that submitted documentation accompany requests (updated initial and renewal request heading and standardized language for indication, prescriber, dosing).

Rearranged and standardized initiation criteria order and dosing language; experimental/investigational language updated.

Extended timeline to 6 months for documentation of motor function and added explicit definition for improvement or maintenance on motor function tests.

Types 1-3covered SMA diagnoses

6 monthsdocumentation window

Initial + Renewal + Post-genecriteria sets

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Coverage Criteria for Nusinersen (Spinraza)

Initial Therapy

Covered when ALL of the following are met for initial requests:

Diagnosis: Member has a diagnosis of spinal muscular atrophy (SMA) type 1, 2, or 3.

Genetic confirmation of 5q SMA via homozygous gene deletion or homozygous mutation, or compound heterozygous mutations.

Prescriber expertise: Nusinersen is prescribed by or in consultation with a neurologist with expertise in the diagnosis of SMA or a board certified physical medicine and rehabilitation specialist with subspecialty certification in neuromuscular medicine.

Administration and dosing: Nusinersen will be administered by an appropriate clinician and dosed according to FDA-approved labeling.

Baseline assessment: Request is accompanied by baseline motor ability testing using one of the following: CHOP-INTEND, HFMSE, HINE-2, or RULM.

Respiratory status: Member is not dependent on invasive ventilation or tracheostomy and is not dependent on non-invasive ventilation beyond naps and nighttime sleep.

No prior nusinersen failure: Member has not previously failed nusinersen.

Continuation Therapy / Renewal

Covered when ALL of the following are met for renewal requests:

Continuation of initial criteria: Member continues to meet all initial criteria.

Outcome measurement timeframe: Documentation provided of one accepted motor outcome measure within 6 months of the next expected nusinersen administration. The same measurement tool used at baseline must be used for continuation unless the provider documents why a different tool is appropriate.6 months

Outcome improvement definitions: One of the following must be met: CHOP-INTEND — improvement or maintenance of at least a 4-point increase from pre-nusinersen baseline or improvement in more motor milestone categories than worsening; HFMSE — improvement or maintenance of at least a 3-point increase from pre-nusinersen baseline or improvement in more categories than worsening; HINE-2 — improvement or maintenance of at least a 1-point increase in listed motor milestones (head control, rolling, sitting, crawling, standing, or walking) or at least a 2-point increase in ability to kick (or to maximum score) from baseline, or improvement in more categories than worsening; RULM — improvement or maintenance of at least a 2-point increase from baseline or improvement in more categories than worsening.

Use after Gene-replacement Therapy

Covered when ALL of the following are met for members who have received prior gene therapy:

Decline after gene therapy: Member has experienced clinical decline that represents potential failure or abatement of gene therapy efficacy.

If initiating nusinersen after gene therapy: Member must meet all initial request criteria if starting nusinersen following gene-replacement therapy.

If continuing nusinersen after gene therapy: Member must meet renewal criteria if continuing nusinersen following gene-replacement therapy.

Use of nusinersen for SMA Type 0, SMA Type 4, and all other indications not specifically listed in this policy is considered experimental and investigational because effectiveness for these populations has not been established.

Routine concomitant treatment with nusinersen for members who have previously received gene replacement therapy is not proven or medically necessary. Requests for such use will be reviewed by clinical staff; clinicians should exercise caution and provide justification when proposing nusinersen after gene-replacement therapy, as routine combined therapy is not supported by evidence.

Billing and Coding

Covered CPT CodesCPTCovered

96450

Chemotherapy administration, into central nervous system (CNS) (eg, intrathecal) requiring spinal puncture

Applicable ICD-10 CodesICD-10

G12.0	Infantile spinal muscular atrophy, type [Werdnig-Hoffmann]
G12.1	Other inherited spinal muscular atrophy
G12.8	Other spinal muscular atrophies and related syndromes

HCPCS / J-codesHCPCS

C9489	Nusinersen (description/HCPCS - listed)
J2326	Nusinersen (Spinraza)

Motor score change thresholds for continuation

CHOP-INTENDImprovement or maintenance of at least a 4-point increase from pre-nusinersen treatment baseline, or improvement in more categories of motor milestones than worsening

HFMSEImprovement or maintenance of at least a 3-point increase from pre-nusinersen treatment baseline, or improvement in more categories of motor milestones than worsening

HINE-2Improvement or maintenance of at least a 1-point increase in listed motor milestones (head control, rolling, sitting, crawling, standing, walking) OR at least a 2-point increase in ability to kick (or maximum score), or improvement in more categories of motor milestones than worsening

RULMImprovement or maintenance of at least a 2-point increase from pre-nusinersen treatment baseline, or improvement in more categories of motor milestones than worsening

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for all initial and renewal nusinersen (Spinraza) requests. Failure to obtain prior authorization may result in denial of the request.

Applies to initial and continuation therapy
All requests reviewed by a clinical pharmacist and medical director

Documentation Required

Required Clinical Documentation

Required clinical documentation must accompany all prior authorization requests. Initial requests must include baseline motor ability testing using an accepted tool. Renewal requests must include documentation of outcomes using the same measurement tool used at baseline (unless the provider documents why a different tool is appropriate) within 6 months of the next expected nusinersen administration.

Accepted baseline/renewal motor testing tools: CHOP-INTEND, HFMSE, HINE-2, RULM

Definitions and Accepted Tests

Genetic confirmation for SMA diagnosis

Genetic confirmation (definitive)Presence of 5q SMA homozygous gene deletion or homozygous mutation

Genetic confirmation (alternative)Compound heterozygous mutations confirming SMA diagnosis

Diagnostic contextGenetic confirmation as above is required to establish diagnosis of spinal muscular atrophy (SMA) for coverage

Accepted motor function tests

CHOP-INTENDAccepted for baseline and follow-up motor ability testing

HFMSE (Hammersmith Functional Motor Scale Expanded)Accepted for baseline and follow-up motor ability testing

Background

Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disorder caused by mutations in the SMN1 gene on chromosome 5q leading to insufficient survival motor neuron (SMN) protein and progressive loss of motor neurons with resultant weakness affecting head control, ambulation, swallowing, and respiration. Clinical phenotype ranges from congenital or severe infantile forms (including Type 0) through later-onset forms (up to Type 4), with severity often modified by SMN2 copy number.

Nusinersen is an antisense oligonucleotide that targets SMN2 pre-mRNA splicing to increase production of full-length SMN protein. It is administered intrathecally and has demonstrated benefit in improving or maintaining motor milestones in clinical studies for the indicated SMA populations; use should follow the policy’s criteria for diagnosis confirmation, prescriber expertise, dosing, and baseline and follow-up motor assessments.

Revision History

2025-10-01Effective DateLatest

Policy effective date established for Nusinersen (Spinraza) coverage criteria.

2025-09-08Material Revision

Added requirement that submitted documentation accompany requests; standardized initiation and renewal headings and dosing language; rearranged criteria order; updated experimental/investigational language and simplified background.

2024-09-09