Currentsierra health and lifePolicy 2026D0142A

Itvisma (Onasemnogene Abeparvovec-Brve) — Medical Benefit Drug Policy (Intrathecal gene therapy for SMA)

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Defines medical benefit coverage criteria for a single-dose intrathecal Itvisma for treatment of spinal muscular atrophy (SMA) in patients aged ≥2 years with qualifying SMN1/SMN2 genetics and other clinical requirements, for UnitedHealthcare Commercial and Individual Exchange plans.

Policy Summary

Payersierra health and life

PolicyItvisma (Onasemnogene Abeparvovec-Brve) — Medical Benefit Drug Policy

Policy CodePolicy 2026D0142A

Change TypeMinor — no material clinical or coverage changes

Effective Date05/01/2026

Next Review DateN/A

Key ActionObtain prior authorization — limited to one lifetime intrathecal treatment and authorized for no more than 45 days from approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1authorized treatments per patient

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Currentsierra health and lifePolicy 2026D0142A

Itvisma (Onasemnogene Abeparvovec-Brve) — Medical Benefit Drug Policy (Intrathecal gene therapy for SMA)

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Policy Summary

Payersierra health and life

PolicyItvisma (Onasemnogene Abeparvovec-Brve) — Medical Benefit Drug Policy

Policy CodePolicy 2026D0142A

Change TypeMinor — no material clinical or coverage changes

Effective Date05/01/2026

Next Review DateN/A

Key ActionObtain prior authorization — limited to one lifetime intrathecal treatment and authorized for no more than 45 days from approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1authorized treatments per patient

≥2minimum patient age for coverage

≤1:50max anti-AAV9 titer

05/01/2026policy effective

Coverage Criteria for Itvisma (onasemnogene abeparvovec-brve)

Medical necessity criteria for Itvisma

Covered when ALL of the following are met

Genetic confirmation: Submission of medical records confirming homozygous deletion or mutation of SMN1 OR compound heterozygous SMN1 mutation (e.g., homozygous deletion of exon 7 at locus 5q13 or deletion of SMN1 exon 7 on one allele and mutation on the other)

SMN2 copy number: Submission of medical records confirming patient has 2 or 3 SMN2 gene copies2 or 3 copies

Age: Patient is at least 2 years of age>= 2 years

Ventilation status: Patient is not dependent on invasive ventilation or tracheostomy and not dependent on non-invasive ventilation beyond naps and nighttime sleep

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

Concomitant SMN therapy: Patient is not to receive routine concomitant SMN modifying therapy (e.g., risdiplam, nusinersen); any current authorizations for SMN modifying therapy will be terminated upon Itvisma approval

Examples: Evrysdi (risdiplam), Spinraza (nusinersen)

Antibody titer: Patient does not have an elevated anti-AAV9 antibody titer above 1:50<= 1:50

Glucocorticoid prophylaxis: Patient will receive prophylactic prednisolone or glucocorticoid equivalent prior to and following receipt of Itvisma per FDA labeling

Route and dosing: Itvisma will be given as a single-dose intrathecal injection in accordance with FDA approved labelingsingle intrathecal dose

No prior gene therapy: Patient has never received gene therapy treatment for SMA in their lifetime (e.g., Zolgensma or Itvisma)

No planned inpatient solely for administration: Provider does not request a planned inpatient admission for the sole purpose of administering Itvisma

Authorization duration: Authorization will be issued for no more than one treatment per lifetime and for no longer than 45 days from approval<= 45 days

Itvisma is considered not proven or medically necessary for certain clinical situations. Specifically, Itvisma is not indicated for the treatment of SMA in patients younger than 2 years of age, for SMA cases that do not involve chromosome 5q SMN1 mutations or deletions, or for the routine combination use with other SMN‑modifying therapies.

The excerpt does not list additional explicit policy exclusions beyond those above; however, coverage determinations must be made in the context of the member’s specific benefit plan. In the event of any conflict, the member-specific benefit plan governs, and applicable federal or state mandates should be checked before applying this policy.

Use of Itvisma in patients younger than 2 years, in individuals with SMA lacking chromosome 5q (SMN1) mutations or deletions, or as a routine combination therapy with other SMN‑modifying agents is explicitly identified as not medically necessary. Providers should also confirm member benefit terms because the member‑specific plan may impose additional limits or requirements that affect coverage.

Coding and Test Requirements

Applicable HCPCSHCPCSCovered

C9309

Injection, onasemnogene abeparvovec-brve, per treatment

Referenced ICD-10 CodesICD-10

G12.0	Infantile spinal muscular atrophy, type I [Werdnig-Hoffmann]
G12.1	Other inherited spinal muscular atrophy
G12.8	Other SMAs and related syndromes
G12.9	Spinal muscular atrophy, unspecified
G12.25	Progressive spinal muscle atrophy

inv-07: Anti-AAV9 antibody titer — maximum allowable titer value

Maximum allowable anti-AAV9 antibody titerAnti-AAV9 antibody titer ≤ 1:50

Action if titer exceeds thresholdRequests with anti-AAV9 antibody titer above 1:50 are denial triggers

Documentation requirementMedical records must document measured anti-AAV9 antibody titer prior to administration

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior authorization required; limited to one lifetime treatment and ≤45 days

Prior authorization is required. Authorization will be issued for no more than one treatment per lifetime and for no longer than 45 days from approval.

Applicable HCPCS: C9309 (Injection, onasemnogene abeparvovec-brve, per treatment)

Prior Authorization

Follow the member-specific benefit plan for prior authorization requirements

This policy is intended to assist interpretation of standard benefit plans, but the member-specific benefit plan document governs coverage decisions and prior authorization processes when differences exist.

In the event of a conflict, the member-specific benefit plan document governs.
Check member-specific plan and applicable federal/state mandates before using this policy.

Background on Spinal Muscular Atrophy and Therapy

Spinal muscular atrophy (SMA) is an autosomal recessive neurodegenerative disorder caused primarily by biallelic SMN1 variants leading to motor neuron loss and progressive weakness. SMN2 copy number is used as a predictor of disease severity; Itvisma delivers an SMN transgene via an AAV vector as an intrathecal, single‑dose gene therapy for eligible patients aged ≥2 years.

Key Definitions

inv-17: Itvisma — intrathecal formulation description and indication summary

Formulation descriptionIntrathecal formulation of onasemnogene abeparvovec-brve; concentrated formulation in a smaller delivery volume administered directly to the central nervous system via a single intrathecal injection independent of patient weight

Indication summarySingle-dose intrathecal gene therapy indicated for treatment of spinal muscular atrophy (SMA) in patients ≥ 2 years of age meeting coverage criteria

Dosing route and frequencyAdministered as a single intrathecal injection per FDA labeling

inv-18: SMN2 copy number — definition and clinical relevance

DefinitionSMN2 copy number = the number of SMN2 gene copies a patient has; correlates with SMA clinical phenotype and prognosis

Clinical relevance

Policy Revision History

2026-05-01policy_effective_date

Policy effective date for medical benefit coverage criteria for Itvisma (onasemnogene abeparvovec-brve).

2025-11package_insert_publication

Itvisma package insert published by Novartis Gene Therapies, Inc. (November 2025).

2025-02package_insert_publication

Zolgensma package insert published by Novartis Gene Therapies, Inc. (February 2025).

Policy Summary

Payersierra health and life

PolicyItvisma (Onasemnogene Abeparvovec-Brve) — Medical Benefit Drug Policy

Policy CodePolicy 2026D0142A

Change TypeMinor — no material clinical or coverage changes

Effective Date05/01/2026

Next Review DateN/A

Key ActionObtain prior authorization — limited to one lifetime intrathecal treatment and authorized for no more than 45 days from approval.

SourceLink

On This Page

Step Therapy

Do not administer routine concomitant SMN-modifying therapy

Routine concomitant SMN-modifying therapy is not allowed; any current authorizations for SMN modifying therapies will be terminated upon Itvisma approval.

Examples of SMN modifying therapies: Evrysdi (risdiplam), Spinraza (nusinersen).

Note

No step therapy specified in this excerpt

No step therapy specifics are provided in this policy excerpt.

Documentation Required

Required documentation to support authorization

Submit medical records confirming SMN1 mutation or deletion and documentation of SMN2 copy number, patient age, ventilation status, anti-AAV9 antibody titer, prescriber specialty, and attestation regarding concomitant SMN therapies.

Confirm homozygous SMN1 deletion or compound heterozygous SMN1 mutation (e.g., deletion of exon 7).
Document 2 or 3 SMN2 gene copies.
Document patient is ≥ 2 years old and not dependent on invasive ventilation or on non-invasive ventilation beyond naps/nighttime.
Provide anti-AAV9 antibody titer (must be ≤ 1:50) and prescriber is a neurologist with expertise in SMA.
Attest that patient will not receive routine concomitant SMN modifying therapy.

Documentation Required

Cite Itvisma and Zolgensma package inserts and member plan documentation

Reference the Itvisma and Zolgensma package inserts and the member-specific benefit plan when prescribing and documenting coverage rationale.

Itvisma [package insert]. Novartis Gene Therapies, Inc. November 2025.
Zolgensma [package insert]. Novartis Gene Therapies, Inc. February 2025.

Denial Risk

Conditions that will lead to denial

Requests will be denied if they exceed one lifetime treatment, are for patients younger than 2 years, if anti-AAV9 antibody titer is above 1:50, if the patient is dependent on invasive ventilation or on chronic non-invasive ventilation beyond naps/nighttime, if the patient has previously received SMA gene therapy, if a planned inpatient admission is requested solely to administer Itvisma, or if concurrent routine SMN modifying therapy is planned.

Prior receipt of any SMA gene therapy (e.g., Zolgensma or Itvisma) is a denial trigger.
Anti-AAV9 antibody titer must not be elevated above 1:50.

Denial Risk

Member-specific benefit plan governs coverage and denials

Coverage decisions and denials are governed by the member-specific benefit plan document when it differs from this policy; failure to follow the member-specific plan or applicable mandates may lead to denial.

This policy is informational and does not override the member-specific benefit plan.
Verify member-specific plan terms before submitting authorization requests.

Higher SMN2 copy number generally predicts less severe SMA phenotype; used to help predict disease severity

Required documentationSubmission of medical records confirming patient has 2 or 3 SMN2 gene copies is required for coverage

inv-19: Itvisma / Zolgensma — relation between intrathecal and intravenous formulations and package insert references

Relationship between formulationsItvisma and Zolgensma share the identical active ingredient (onasemnogene abeparvovec) but differ in formulation and route: Itvisma is concentrated for intrathecal administration independent of weight; Zolgensma is formulated for intravenous, weight-based administration

Regulatory referencesPrescribing and coverage should reference the Itvisma and Zolgensma package inserts

Package insert citationsItvisma [package insert], Novartis Gene Therapies, Inc. November 2025; Zolgensma [package insert] (referenced)