CurrentBaylor Scott & White Health PlanPolicy 230

Nusinersen (Spinraza) Coverage

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This policy governs medical-necessity and prior-authorization requirements for nusinersen (Spinraza) used to treat spinal muscular atrophy. It applies across lines of business unless otherwise specified, subject to the member’s benefit plan, applicable Medicare or Medicaid requirements, and federal or state rules.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyNusinersen (Spinraza) Coverage

Policy CodePolicy 230

Change TypeRevised

Effective DateOct 1, 2026

Last ReviewSep 24, 2026

Next Review DateSep 24, 2027

Key ActionPrior authorization is required for nusinersen (Spinraza).

SourceLink

POLICY UPDATE CHANGES

Initial motor testing criteria were updated to remove the requirement for a baseline assessment.

Renewal requests now require use of the same motor assessment tool used for the prior authorization unless the provider explains why a change is clinically appropriate.

RequiredPrior authorization

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CurrentBaylor Scott & White Health PlanPolicy 230

Nusinersen (Spinraza) Coverage

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Sign up for baylor_scott_and_white_health_plan Policy 230 alerts

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Policy Summary

PayerBaylor Scott & White Health Plan

PolicyNusinersen (Spinraza) Coverage

Policy CodePolicy 230

Change TypeRevised

Effective DateOct 1, 2026

Last ReviewSep 24, 2026

Next Review DateSep 24, 2027

Key ActionPrior authorization is required for nusinersen (Spinraza).

SourceLink

POLICY UPDATE CHANGES

Initial motor testing criteria were updated to remove the requirement for a baseline assessment.

Renewal requests now require use of the same motor assessment tool used for the prior authorization unless the provider explains why a change is clinically appropriate.

RequiredPrior authorization

Covered disease types when criteria are met

4Accepted motor assessment tools

6 monthsRenewal documentation window

SMA 0, 4Experimental and investigational indications

Coverage Criteria

Initial therapy criteria

Covered when ALL of the following are met.

Initial therapy

Covered SMA diagnosis: Member has SMA type 1, 2, or 3.
Qualified prescriber: Nusinersen is prescribed by or provided in consultation with a neurologist with expertise in diagnosing SMA.
Qualified administrator
- Board-certified neurologist: Nusinersen is administered by a board-certified neurologist.
- Qualified physical medicine and rehabilitation specialist: Nusinersen is administered by a board-certified physical medicine and rehabilitation specialist with subspecialty certification in neuromuscular medicine.
Genetic confirmation
- Homozygous 5q SMA alteration: Genetic confirmation shows a 5q SMA homozygous gene deletion or homozygous mutation.
- Compound heterozygous mutations: Genetic confirmation shows compound heterozygous mutations.
Ventilatory status: Member is not dependent on invasive ventilation or tracheostomy and does not use non-invasive ventilation beyond naps and nighttime sleep.
Motor ability testing
- CHOP-INTEND: The request includes motor ability testing using the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorder (CHOP-INTEND).
- HFMSE: The request includes motor ability testing using the Hammersmith Functional Motor Scale Expanded (HFMSE).
- HINE-2: The request includes motor ability testing using the Hammersmith Infant Neurological Exam Section 2 (HINE-2).
- RULM: The request includes motor ability testing using the Revised Upper Limb Module (RULM).
FDA-approved administration: Nusinersen will be dosed and administered according to FDA-approved labeling.
No prior failure: The member has not previously failed nusinersen.

Renewal therapy criteria

Covered for renewal when ALL of the following are met.

Renewal therapy

Initial criteria remain met: Member meets all initial-therapy criteria.
One qualifying motor outcome
- CHOP-INTEND: Improvement or maintenance of at least a 4-point increase from the pre-nusinersen treatment baseline, or improvement in more categories of motor milestones than worsening.At least a 4-point increase or maintenance
- HFMSE: Improvement or maintenance of at least a 3-point increase from the pre-nusinersen treatment baseline, or improvement in more categories of motor milestones than worsening.At least a 3-point increase or maintenance

Treatment after gene therapy

For members who previously received gene therapy, covered when ALL of the following are met.

Clinical decline: The member has experienced a decline in clinical status that represents a potential failure or abatement of gene-therapy efficacy.
Therapy phase
- Starting nusinersen: The member meets all criteria under Initial requests when starting therapy with nusinersen.
- Continuing nusinersen: The member meets all criteria under Renewal requests when continuing therapy with nusinersen.

Treatment of SMA type 0 and type 4 with nusinersen is considered experimental and investigational because the effectiveness of this treatment strategy has not been established.

Routine concomitant treatment with nusinersen is not proven or medically necessary for members who have previously received gene replacement therapy.

Routine concomitant treatment of SMA with nusinersen after prior gene replacement therapy is not medically necessary.

Coding and Outcome Measures

Covered CPT CodesCPTCovered

96450

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

ICD-10 CodesICD-10

G12.0	Infantile spinal muscular atrophy, type I [Werdnig-Hoffmann]
G12.1	Other inherited spinal muscular atrophy
G12.8	Other spinal muscular atrophies and related syndromes
G12.9	Spinal muscular atrophy, unspecified

HCPCS CodesHCPCS

C9489	Nusinersen 0.1 mg
J2326	Nusinersen (Spinraza)

Renewal documentation timing

Timing windowWithin 6 months of the next expected nusinersen administration

Measurement toolUse the same measurement tool used for the previous nusinersen authorization

Change in toolIf reuse is not appropriate, explain the reason for the change and provide a detailed clinical assessment of current status

CHOP-INTEND outcome

Baseline outcomeImprovement or maintenance of at least a 4-point increase from the pre-nusinersen treatment baseline

Motor-milestone alternativeImprovement in more categories of motor milestones than worsening

Provider Submission and Review Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for all nusinersen (Spinraza) requests.

Documentation Required

Initial Request Documentation

Submit documentation for the initial request demonstrating that all coverage criteria are met, including diagnosis, specialist involvement, administration qualifications, genetic confirmation, respiratory status, motor testing, FDA-labeled dosing, and treatment history.

Diagnosis of spinal muscular atrophy (SMA) type 1, 2, or 3.
Prescription by or consultation with a neurologist experienced in diagnosing SMA.
Administration by a board-certified neurologist or a board-certified physical medicine and rehabilitation specialist with subspecialty certification in neuromuscular medicine.
Genetic confirmation showing a 5q SMA homozygous gene deletion or homozygous mutation, or compound heterozygous mutations.

Clinical Background

Spinal muscular atrophy (SMA) is generally an inherited autosomal-recessive disorder caused by chromosome 5q mutations that result in deficient survival motor neuron proteins. It causes progressive muscle weakness that may affect ambulation, head and neck control, swallowing, and breathing. Nusinersen is an SMN2-directed antisense oligonucleotide that increases exon 7 inclusion in SMN2 messenger RNA and production of full-length SMN protein. It is indicated for pediatric and adult patients with SMA caused by 5q SMN1 mutations and has been associated with achieving, maintaining, or improving motor milestones.

SMA Disease-Type Definitions

SMA type 0

OnsetCongenital

Clinical phenotypeRespiratory insufficiency at birth

Typical outcomeDeath occurs within weeks after birth

SMA type 1

OnsetInfantile onset; symptomatic by 6 months of age

SeverityMost severe phenotype; infants are profoundly hypotonic

Disease courseInfants often succumb to complications by the second year of life

Initial Therapy Criteria

Initial requests

Initial therapy may be covered when ALL of the following are met.

Covered SMA diagnosis: Member has a diagnosis of spinal muscular atrophy (SMA) type 1, 2, or 3.
Qualified prescriber: Nusinersen is prescribed by or in consultation with a neurologist with expertise in the diagnosis of SMA.
Qualified administrator
- Board-certified neurologist: Nusinersen will be administered by a board-certified neurologist.

Renewal and Continuation Criteria

Renewal requests

Renewal requires continued satisfaction of ALL initial criteria plus ONE qualifying motor outcome measure.

Initial criteria remain met: The member meets all initial-therapy criteria.
One qualifying motor outcome measure
- CHOP-INTEND: Improvement or maintenance of at least a 4-point increase from the pre-nusinersen treatment baseline, or improvement in more categories of motor milestones than worsening.At least a 4-point increase or maintenance
- HFMSE: Improvement or maintenance of at least a 3-point increase from the pre-nusinersen treatment baseline, or improvement in more categories of motor milestones than worsening.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyNusinersen (Spinraza) Coverage

Policy CodePolicy 230

Change TypeRevised

Effective DateOct 1, 2026

Last ReviewSep 24, 2026

Next Review DateSep 24, 2027

Key ActionPrior authorization is required for nusinersen (Spinraza).

SourceLink

On This Page

HINE-2: Improvement or maintenance of at least a 2-point or maximum-score increase in the ability to kick from the pre-nusinersen treatment baseline; or improvement or maintenance of at least a 1-point increase in motor milestones of head control, rolling, sitting, crawling, standing, or walking from the pre-nusinersen treatment baseline; or improvement in more categories of motor milestones than worsening.At least a 2-point or maximum-score kicking increase, or at least a 1-point milestone increase

RULM: Improvement or maintenance of at least a 2-point increase from the pre-nusinersen treatment baseline, or improvement in more categories of motor milestones than worsening.At least a 2-point increase or maintenance

Qualifying measureCHOP-INTEND

HFMSE outcome

Baseline outcomeImprovement or maintenance of at least a 3-point increase from the pre-nusinersen treatment baseline

Motor-milestone alternativeImprovement in more categories of motor milestones than worsening

Qualifying measureHFMSE

HINE-2 outcome

Kicking outcomeImprovement or maintenance of at least a 2-point or maximum-score increase in the ability to kick from the pre-nusinersen treatment baseline

Motor-milestone outcomeImprovement or maintenance of at least a 1-point increase in head control, rolling, sitting, crawling, standing, or walking from the pre-nusinersen treatment baseline

Motor-milestone alternativeImprovement in more categories of motor milestones than worsening

RULM outcome

Baseline outcomeImprovement or maintenance of at least a 2-point increase from the pre-nusinersen treatment baseline

Motor-milestone alternativeImprovement in more categories of motor milestones than worsening

Qualifying measureRULM

Documentation that the member is not dependent on invasive ventilation or tracheostomy and does not use non-invasive ventilation beyond naps and nighttime sleep.

Motor ability testing using CHOP-INTEND, HFMSE, HINE-2, or RULM.

Confirmation that nusinersen will be dosed and administered according to FDA-approved labeling.

Confirmation that the member has not previously failed nusinersen.

Documentation Required

Renewal Documentation

For renewal requests, submit documentation showing that all initial criteria continue to be met and that a qualifying motor outcome measure was obtained within 6 months before the next expected nusinersen administration. Use the same measurement tool as the previous authorization unless the provider explains why a change is inappropriate and supplies a detailed current clinical assessment.

CHOP-INTEND: improvement or maintenance of at least a 4-point increase from baseline, or improvement in more motor-milestone categories than worsening.
HFMSE: improvement or maintenance of at least a 3-point increase from baseline, or improvement in more motor-milestone categories than worsening.
HINE-2: improvement or maintenance of at least a 2-point (or maximum-score) increase in kicking; or at least a 1-point increase in specified motor milestones; or improvement in more motor-milestone categories than worsening.
RULM: improvement or maintenance of at least a 2-point increase from baseline, or improvement in more motor-milestone categories than worsening.

Note

Clinical Review

All nusinersen requests are reviewed by both a clinical pharmacist and a medical director.

Clinical review applies to initial and renewal requests.
Submit sufficient clinical documentation for review by both disciplines.

Denial Risk

Type 0 or Type 4 SMA

Nusinersen for SMA type 0 or type 4 is considered experimental and investigational because the effectiveness of this treatment strategy has not been established.

Type 0 SMA: experimental and investigational.
Type 4 SMA: experimental and investigational.

Denial Risk

Prior Gene Replacement Therapy

Routine concomitant nusinersen treatment is not proven or medically necessary for patients who have previously received gene replacement therapy. Nusinersen may be considered after gene therapy only when there has been a decline in clinical status representing potential failure or abatement of gene therapy efficacy and the applicable initial or renewal criteria are met.

For a new nusinersen course after gene therapy, the member must meet all initial-request criteria.
For continued nusinersen after gene therapy, the member must meet all renewal-request criteria.

Denial Risk

Ventilatory Support Dependence

Initial requests are not covered when the member has respiratory support dependence that exceeds the policy limits.

Invasive ventilation or tracheostomy dependence is not permitted.
Non-invasive ventilation beyond naps and nighttime sleep is not permitted.

Denial Risk

Prior Nusinersen Failure

Initial requests are not covered when the member has previously failed nusinersen treatment.

The initial request must include confirmation that the member has not previously failed nusinersen.

SMA type 2

OnsetIntermediate SMA with symptoms prior to 18 months of age

Motor abilityUsually develops the ability to sit

Functional limitationUsually cannot stand or walk unassisted

SMA type 3

OnsetJuvenile onset, generally by 18 months

Initial functionAble to stand and walk

Disease courseLoss of function as disease progresses; individuals may live into their thirties and beyond

SMA type 4

OnsetLate- or adult-onset, beginning in the second or third decade of life

SeverityLeast severe SMA phenotype

Functional courseCan walk during adult years but may experience mild muscle weakness

Qualified physical medicine and rehabilitation specialist:

Nusinersen will be administered by a board-certified physical medicine and rehabilitation specialist with subspecialty certification in neuromuscular medicine.

Genetic confirmation

Homozygous 5q SMA alteration: The member has genetic confirmation with a 5q SMA homozygous gene deletion or homozygous mutation.
Compound heterozygous mutations: The member has genetic confirmation with compound heterozygous mutations.

Ventilatory status: The member is not dependent on invasive ventilation or tracheostomy and does not use non-invasive ventilation beyond naps and nighttime sleep.

Motor ability testing

CHOP-INTEND: The request is accompanied by motor ability testing using the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorder (CHOP-INTEND).
HFMSE: The request is accompanied by motor ability testing using the Hammersmith Functional Motor Scale Expanded (HFMSE).
HINE-2: The request is accompanied by motor ability testing using the Hammersmith Infant Neurological Exam Section 2 (HINE-2).
RULM: The request is accompanied by motor ability testing using the Revised Upper Limb Module (RULM).

FDA-approved administration: Nusinersen will be dosed and administered according to FDA-approved labeling.

No prior failure: The member has not previously failed nusinersen.

At least a 3-point increase or maintenance