CurrentBaylor Scott & White Health PlanPolicy 253

Onasemnogene Abeparvovec (Zolgensma®) Coverage

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This policy governs medical necessity and prior authorization for onasemnogene abeparvovec (Zolgensma) for members with spinal muscular atrophy. It applies across lines of business unless the applicable benefit plan, federal requirements, Medicare criteria, or Texas Medicaid guidance governs instead.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyOnasemnogene Abeparvovec (Zolgensma®) Coverage

Policy CodePolicy N/A

Change TypeMinor formatting update

Effective Date09/01/2026

Next Review Date08/27/2027

Key ActionPrior authorization is required for onasemnogene abeparvovec (Zolgensma); submit documentation demonstrating that all policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

The 2025 update added a requirement that supporting documentation be submitted and standardized indication, prescriber, dosing, and member terminology.

The 2026 review documented minor formatting changes.

RequiredAuthorization status

<2 yearsMaximum member age

≤1:50Anti-AAV9 titer threshold

1 lifetime

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CurrentBaylor Scott & White Health PlanPolicy 253

Onasemnogene Abeparvovec (Zolgensma®) Coverage

Customize your policy alerts

Sign up for baylor_scott_and_white_health_plan Policy 253 alerts

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Policy Summary

PayerBaylor Scott & White Health Plan

PolicyOnasemnogene Abeparvovec (Zolgensma®) Coverage

Policy CodePolicy N/A

Change TypeMinor formatting update

Effective Date09/01/2026

Next Review Date08/27/2027

Key ActionPrior authorization is required for onasemnogene abeparvovec (Zolgensma); submit documentation demonstrating that all policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

The 2025 update added a requirement that supporting documentation be submitted and standardized indication, prescriber, dosing, and member terminology.

The 2026 review documented minor formatting changes.

RequiredAuthorization status

<2 yearsMaximum member age

≤1:50Anti-AAV9 titer threshold

1 lifetime

Coverage Criteria

Initial Therapy

Onasemnogene abeparvovec (Zolgensma®) may be considered medically necessary when ALL of the following criteria are met:

Member has Type 1 spinal muscular atrophy (SMA).

Member has a genetically confirmed mutation or deletion of genes in chromosome 5q resulting in either homozygous gene deletion or mutation (e.g., homozygous deletion of SMN1 exon 7 at locus 5q13), or compound heterozygous mutation (e.g., deletion of SMN1 exon 7 [allele 1] and mutation of SMN1 [allele 2]).

Member is less than 2 years of age.< 2 years

Onasemnogene is prescribed by or in consultation with a neurologist with expertise in the diagnosis of SMA.

Member has a baseline anti-AAV9 antibody titer of ≤1:50 as measured by ELISA.≤ 1:50

Onasemnogene will be dosed and administered according to FDA-approved labeling.

Member has none of the exclusionary conditions described below.

Member has received prophylaxis against influenza and respiratory syncytial virus (RSV) if recommended by the American Academy of Pediatrics (AAP).

Therapy with nusinersen (Spinraza®) or risdiplam (Evrysdi®), if applicable, will be discontinued.

Experimental and Investigational Uses

Onasemnogene for the following indications is considered experimental and investigational because the effectiveness of this strategy has not been established:

ANY of the following indications

Treatment of pre-symptomatic patients diagnosed by newborn screening who are unlikely to develop SMA.
Treatment of symptomatic later-onset SMA beyond 2 years of age.> 2 years
Treatment of SMA without chromosome 5q mutations or deletions.
Routine combination treatment of SMA with concomitant survival motor neuron (SMN)-modifying therapy, such as nusinersen (Spinraza®) or risdiplam (Evrysdi®).

Coverage is excluded for members with invasive-ventilator dependency, use of invasive ventilatory support, or dependence on non-invasive ventilation beyond use for naps and nighttime sleep.

Coverage is excluded for active infection, including acute infections such as a cold, flu, gastroenteritis, otitis media, or bronchiolitis, or chronic uncontrolled infection such as chronic active hepatitis B.

Coverage is excluded for preexisting liver impairment defined as ALT, AST, or total bilirubin levels greater than 2 times the upper limit of normal, except when elevated due to neonatal jaundice.

Coverage is excluded for concomitant ongoing immunosuppressive therapy or immunosuppressive therapy received within 3 months before starting treatment, including corticosteroids, cyclosporine, tacrolimus, methotrexate, cyclophosphamide, intravenous immunoglobulin, or rituximab.

Coverage is excluded for asymptomatic SMA; SMA Types 2, 3, or 4; or advanced SMA, including complete paralysis of limbs or permanent ventilator dependence.

Repeat administration of onasemnogene is experimental and investigational because the effectiveness of repeat treatment has not been established. Only ONE treatment per lifetime is considered medically necessary.

Coding and Clinical Thresholds

HCPCS CodesHCPCS

J3399

Injection, onasemnogene abeparvovec-xioi, per treatment, up to 5x10^15 vector genomes.

ICD-10 CodesICD-10

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

Member age

Coverage age requirementMember must be less than 2 years of age.

Applicable therapyThe age requirement applies to onasemnogene abeparvovec (Zolgensma) treatment.

Age-based exclusionTreatment for symptomatic later-onset SMA beyond 2 years of age is experimental and investigational.

Liver function

ALT and ASTALT or AST levels must not be greater than 2 times ULN.

Total bilirubinTotal bilirubin must not be greater than 2 times ULN.

Provider Actions and Review Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit documentation demonstrating that all medical-necessity criteria for onasemnogene abeparvovec (Zolgensma®) are met. Coverage remains subject to the member’s applicable benefit plan, Evidence of Coverage, or Summary Plan Description.

Step Therapy

Discontinue Other SMN-Modifying Therapy

If applicable, discontinue therapy with nusinersen (Spinraza®) or risdiplam (Evrysdi®) before initiating onasemnogene. Routine combination treatment with another SMN-modifying therapy is experimental and investigational.

Document that nusinersen or risdiplam will be discontinued, if applicable.
Do not request routine concomitant treatment with nusinersen or risdiplam.

Clinical Background

Spinal muscular atrophy is caused by a defective or missing SMN1 gene. The resulting deficiency affects motor neurons, causing progressive motor neuron loss and muscle weakness. Disease progression may lead to respiratory impairment and paralysis; in untreated infants with Type 1 SMA, the disease can be fatal.

Definitions

Bi-allelic chromosome 5q/SMN1 mutation or deletion

Required genetic findingA genetically confirmed mutation or deletion of genes in chromosome 5q is required.

Homozygous abnormalityAn acceptable finding is a homozygous gene deletion or mutation, such as homozygous deletion of exon 7 at locus 5q13.

Compound heterozygous abnormalityAn acceptable finding is a compound heterozygous mutation, such as deletion of SMN1 exon 7 on one allele and an SMN1 mutation on the other allele.

Acceptable anti-AAV9 antibody titer

Testing methodThe baseline anti-AAV9 antibody titer must be measured by ELISA.

Maximum acceptable titerThe titer must be no more than 1:50.

Initial Onasemnogene Therapy

Covered when all policy criteria are met.

Initial onasemnogene therapy

Diagnosis and genetic confirmation: Member has Type 1 spinal muscular atrophy and a genetically confirmed chromosome 5q/SMN1 mutation or deletion, consisting of either a homozygous gene deletion or mutation or a compound heterozygous mutation.
Age: Member is less than 2 years of age.<2 years
Specialist prescribing: Onasemnogene is prescribed by or provided in consultation with a neurologist with expertise in the diagnosis of SMA.

Step Therapy Requirements

Step	Requirement	Coverage determination
1	If applicable, discontinue nusinersen (Spinraza) or risdiplam (Evrysdi) before onasemnogene treatment. Routine combination therapy with these agents is experimental and investigational.	Discontinuation required before treatment

Quantity Limits

Quantity limit

Lifetime limitOnly one treatment with onasemnogene abeparvovec (Zolgensma) is medically necessary per lifetime.

Repeat administrationRepeat administration of onasemnogene is not medically necessary.

Coverage status of repeat treatmentRepeat administration is considered experimental and investigational because the effectiveness of this strategy has not been established.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyOnasemnogene Abeparvovec (Zolgensma®) Coverage

Policy CodePolicy N/A

Change TypeMinor formatting update

Effective Date09/01/2026

Next Review Date08/27/2027

Key ActionPrior authorization is required for onasemnogene abeparvovec (Zolgensma); submit documentation demonstrating that all policy criteria are met.

SourceLink

On This Page

Neonatal jaundice exception

Bilirubin elevation due to neonatal jaundice is excepted from the liver impairment exclusion.

Documentation Required

Required Clinical Documentation

Submit complete clinical documentation supporting every applicable coverage criterion for onasemnogene abeparvovec. Documentation must establish the diagnosis, genetic confirmation, age, prescriber qualifications, laboratory findings, treatment plan, and required preventive care.

Type 1 spinal muscular atrophy (SMA) diagnosis.
Genetically confirmed chromosome 5q mutation or deletion involving SMN1, including qualifying homozygous or compound heterozygous findings.
Member is less than 2 years of age.
Prescription by, or consultation with, a neurologist with expertise in diagnosing SMA.
Baseline anti-AAV9 antibody titer of ≤1:50 by ELISA.
Dosing and administration according to FDA-approved labeling.
Documentation that all listed exclusion conditions are absent.
Influenza and respiratory syncytial virus (RSV) prophylaxis, when recommended by the American Academy of Pediatrics (AAP).
Plan to discontinue nusinersen or risdiplam, if applicable.

Note

Clinical Review

All requests are reviewed by a clinical pharmacist and medical director after the required documentation is submitted.

Allow clinical review to confirm that the diagnosis, laboratory results, treatment plan, and eligibility criteria are supported.

Denial Risk

Clinical Eligibility Exclusions

Onasemnogene is not medically necessary when any specified exclusion applies. Requests should be denied when the member has an excluded ventilation status, infection, liver impairment, immunosuppressive therapy, excluded SMA status, or advanced disease.

Invasive-ventilator dependency, use of invasive ventilatory support, or non-invasive ventilation beyond naps and nighttime sleep.
Active acute infection or chronic uncontrolled infection, such as chronic active hepatitis B.
Preexisting liver impairment with ALT, AST, or total bilirubin greater than 2 times the upper limit of normal, except bilirubin elevation due to neonatal jaundice.
Ongoing immunosuppressive therapy or immunosuppressive therapy within 3 months before treatment, including corticosteroids, cyclosporine, tacrolimus, methotrexate, cyclophosphamide, intravenous immunoglobulin, or rituximab.
Asymptomatic SMA or SMA Types 2, 3, or 4.
Advanced SMA, such as complete paralysis of the limbs or permanent ventilator dependence.

Denial Risk

Repeat Treatment Not Covered

Only one treatment per lifetime is medically necessary. Repeat administration of onasemnogene is experimental and investigational because the effectiveness of more than one lifetime treatment has not been established.

Do not submit repeat onasemnogene administration as medically necessary.

Denial Risk

Uncovered Indications

Onasemnogene for indications outside the covered Type 1 SMA criteria is experimental and investigational because effectiveness has not been established. This includes presymptomatic or later-onset disease and SMA without qualifying chromosome 5q mutations or deletions.

Presymptomatic patients identified by newborn screening who are unlikely to develop SMA.
Symptomatic later-onset SMA beyond 2 years of age.
SMA without chromosome 5q mutations or deletions.
Routine combination treatment with another SMN-modifying therapy, including nusinersen or risdiplam.

TimingThe antibody titer must be established at baseline before treatment.

Antibody testing: Member has a baseline anti-AAV9 antibody titer of no more than 1:50 as measured by ELISA.≤1:50 by ELISA

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

No contraindicating conditions

Member is not dependent on invasive ventilation and is not dependent on non-invasive ventilation beyond naps and nighttime sleep.
Member does not have an active acute infection or chronic uncontrolled infection.
Member does not have preexisting liver impairment with ALT, AST, or total bilirubin greater than 2 times the upper limit of normal, except when the bilirubin elevation is due to neonatal jaundice.>2 times ULN is exclusionary
Member is not receiving ongoing immunosuppressive therapy and has not received immunosuppressive therapy within 3 months before treatment.
Member does not have asymptomatic SMA, SMA Type 2, Type 3, or Type 4, or advanced SMA such as complete paralysis of the limbs or permanent ventilator dependence.

Preventive prophylaxis: Member has received prophylaxis against influenza and RSV if recommended by the American Academy of Pediatrics.

Other SMN-modifying therapy: Therapy with nusinersen (Spinraza) or risdiplam (Evrysdi), if applicable, will be discontinued.