ModifiedColorado Rocky Mountain Health PlansPolicy CS2026D0142A

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

Medical benefit drug policy governing one-time intrathecal Itvisma for treatment of spinal muscular atrophy (SMA) in patients aged 2 years and older with confirmed SMN1 mutation; applies to UnitedHealthcare Community Plan clinical coverage (state-specific exceptions noted).

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy CS2026D0142A

Change TypeNew policy added (effective 06/01/2026)

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with medical records confirming SMN1 mutation/deletion, documentation of SMN2 copy number (2 or 3), baseline HFMSE assessment, and anti-AAV9 antibody titer ≤ 1:50.

SourceLink

POLICY UPDATE CHANGES

New Medical Benefit Drug Policy

onetreatment per lifetime authorized

≥2yminimum age

2–3 copiesSMN2 required

≤1:50anti-AAV9 titer max

HFMSE

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Coverage Criteria for Itvisma (onasemnogene abeparvovec‑brve)

Covered when ALL of the following are met

Itvisma is proven and medically necessary for one treatment per lifetime for SMA when ALL of the following are met:

Eligibility criteria: 1) Submission of medical records confirming mutation or deletion of genes in chromosome 5q consistent with SMA, defined as either: (a) homozygous deletion or mutation of SMN1 (e.g., homozygous deletion of exon 7 at locus 5q13), OR (b) compound heterozygous SMN1 mutation (e.g., deletion of SMN1 exon 7 on one allele and mutation of SMN1 on the other allele).

Documentation must be provided in medical records (e.g., chart notes, laboratory values).

Genetic and molecular requirements: 2) Submission of medical records confirming patient has 2 or 3 copies of the SMN2 gene.SMN2 = 2 or 3 copies

Medical records (e.g., chart notes, laboratory values) must document SMN2 copy number.

Age requirement: 3) Patient is ≥ 2 years of age.≥ 2 years

Respiratory support restrictions: 4) Patient is not dependent on invasive ventilation or tracheostomy, AND not using non-invasive ventilation except for naps and nighttime sleep.

Prescriber qualification: 5) Prescribed by a neurologist with expertise in the treatment of spinal muscular atrophy (SMA).

Concomitant therapy restriction: 6) Patient will not receive routine concomitant SMN-modifying therapy (e.g., risdiplam, nusinersen); any current authorizations for such therapies will be terminated upon Itvisma approval.

Immunologic threshold: 7) Anti-AAV9 antibody titer is not elevated above 1:50.anti-AAV9 ≤ 1:50

Prior gene therapy: 8) Patient has never received gene therapy for SMA in their lifetime (e.g., prior onasemnogene abeparvovec products).

Admission intent: 9) Provider does not request planned inpatient admission solely for the purpose of administering Itvisma.

Authorization limits: 10) Authorization will be issued for no more than one treatment per lifetime and for no longer than 45 days from approval.

Coverage for Itvisma (onasemnogene abeparvovec‑brve) is limited to a single lifetime intrathecal administration for the treatment of spinal muscular atrophy (SMA) when all required criteria are met. Key scope limits include: the patient must be ≥ 2 years of age; documentation must confirm biallelic SMN1 mutation/deletion and an SMN2 copy number of 2 or 3 copies; the patient must not be dependent on invasive ventilation or a tracheostomy and must not use non‑invasive ventilation beyond naps/nighttime; the treating prescriber should be a neurologist experienced in SMA; the patient must not be receiving routine concomitant SMN‑modifying therapy; and the anti‑AAV9 antibody titer must be ≤ 1:50.

This policy is intended to assist in interpreting UnitedHealthcare standard benefit plans; when deciding coverage, the applicable federal, state, or contractual benefit plan requirements must be referenced because those requirements may differ from the standard plan and will govern in the event of a conflict.

Itvisma is not covered for: patients younger than 2 years of age; SMA cases without chromosome 5q mutations/deletions; or routine combination therapy with other SMN‑modifying agents. Additionally, local, state, or contractual benefit terms may impose further exclusions or variations and should be checked prior to submission.

Coding and Test Requirements

Applicable HCPCS (reference)HCPCS

C9399	Unclassified drugs or biologicals.
J3490	Unclassified drugs.
J3590	Unclassified biologics.

Applicable ICD-10 Diagnosis Codes (reference)ICD-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.

Anti‑AAV9 antibody titer requirement (threshold)

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

Testing requirementProvider must confirm patient does not have an elevated anti-AAV9 antibody titer above 1:50 prior to administration

Consequence of elevationElevated anti-AAV9 titer (>1:50) is a common denial trigger for coverage

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization May Be Required

Prior authorization requirements depend on the member's specific plan and governing benefit terms. Before requesting authorization, verify the member's plan benefits and any federal, state, or contractual rules that may alter prior authorization requirements or coverage determinations.

Authorization may be required depending on the member's benefit plan.
Check for plan-specific prior authorization forms, timelines, and submission channels.

Note

Governing Benefit Requirements Take Precedence

Conflicts between this policy and federal, state, or contractual benefit requirements take precedence. If a governing requirement (e.g., state mandate, Medicaid/Medicare rule, or specific contract language) conflicts with this policy, the governing requirement will control and may result in coverage or denial that differs from this policy.

Confirm applicable federal, state, and contract terms before applying this policy.
When a conflict exists, follow the governing requirement; document rationale if coverage is granted contrary to 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 muscle weakness. SMN2 copy number is the primary predictor of clinical phenotype, with fewer copies associated with more severe disease. Itvisma is an intrathecal adeno‑associated viral vector gene therapy delivering onasemnogene abeparvovec intended to restore SMN protein production in eligible patients aged ≥ 2 years.

Definitions and Product Information

Itvisma (onasemnogene abeparvovec-brve) — intrathecal AAV gene therapy

Generic descriptionItvisma (onasemnogene abeparvovec-brve) is an intrathecal AAV vector–based gene therapy formulation that delivers onasemnogene abeparvovec directly into the cerebrospinal fluid for treatment of spinal muscular atrophy (SMA)

Indication summaryIndicated for treatment of SMA in adult and pediatric patients 2 years of age and older with confirmed SMN1 mutation; one treatment per lifetime

Formulation and administrationConcentrated formulation administered as a single intrathecal injection independent of patient weight to target motor neurons with lower vector dose

Clinical intentAims to restore SMN protein production and halt disease progression by addressing the genetic root cause of SMA

Intrathecal onasemnogene abeparvovec — definitions / alternate phrasing