CurrentUnitedHealthcarePolicy 2026D0142A

Itvisma (Onasemnogene Abeparvovec-Brve)

UnitedHealthcare Medical Benefit Drug Policy for Itvisma governing coverage for commercial and individual exchange plans, detailing medical necessity criteria for one lifetime intrathecal administration in patients aged ≥ 2 years with SMA due to SMN1 mutation and related requirements, applicable HCPCS and ICD-10 codes, and administrative considerations.

Policy Summary

PayerUnitedHealthcare

PolicyItvisma (Onasemnogene Abeparvovec-Brve)

Policy CodePolicy 2026D0142A

Change TypeNew policy

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit prior authorization with medical records confirming SMN1 mutation/deletion and SMN2 copy number (2 or 3 copies); authorization is limited to one lifetime treatment and not longer than 45 days from approval.

POLICY UPDATE CHANGES

New Medical Benefit Drug Policy created for Itvisma.

1Lifetime treatments allowed

≥2Minimum patient age for coverage

2-3Required SMN2 copy number

≤1:50Max anti-AAV9 antibody titer

Coverage Summary

Itvisma (onasemnogene abeparvovec-brve) is covered with medical necessity criteria as a single lifetime intrathecal administration for the treatment of spinal muscular atrophy (SMA) in patients ≥ 2 years of age with confirmed biallelic SMN1 mutation/deletion and 2 or 3 SMN2 gene copies. The policy requires that treatment be prescribed by a neurologist with SMA expertise, that the patient not be ventilator-dependent, not have an anti-AAV9 antibody titer above 1:50, and receive prophylactic glucocorticoid per FDA labeling; patients must not have previously received gene therapy for SMA. The applicable HCPCS code is C9309 (Injection, onasemnogene abeparvovec-brve, per treatment). Authorization is limited to one treatment per lifetime and will be issued for no longer than 45 days from approval.

Coverage thresholds

Age≥ 2 years

SMN2 gene copies2 or 3 copies

Anti-AAV9 antibody titer≤ 1:50 (patient must not have elevated titer above 1:50)

Lifetime treatments allowed1

Medically Necessary (Initial Therapy) Criteria

Medically Necessary (coverage) criteria

Itvisma is proven and medically necessary for one treatment per lifetime for the treatment of spinal muscular atrophy (SMA) in patients who meet ALL of the following criteria:

ALL of the following

ALL of the following
- ONE of
  - Homozygous gene deletion or mutation of survival motor neuron 1 (SMN1) gene (e.g., homozygous deletion of exon 7 at locus 5q13)
  - Compound heterozygous mutation of SMN1 gene (e.g., deletion of SMN1 exon 7 (allele 1) and mutation of SMN1 (allele 2))
Submission of medical records confirming that patient has 2 or 3 SMN2 gene copiesSMN2 copies = 2 or 3
Patient is ≥ 2 years of ageAge ≥ 2 years
ALL of the following
- NOT dependent on
  - Invasive ventilation or tracheostomy
  - Use of non-invasive ventilation beyond use for naps and nighttime sleep
Prescribed by a neurologist with expertise in the treatment of SMA
Patient is not to receive routine concomitant SMN modifying therapy (e.g., Evrysdi (risdiplam), Spinraza (nusinersen)); patient's medical record will be reviewed and any current authorizations for SMN modifying therapy will be terminated upon Itvisma approval
Patient does not have an elevated anti-AAV9 antibody titer above 1:50Anti-AAV9 titer ≤ 1:50
Patient will receive prophylactic prednisolone (or glucocorticoid equivalent) prior to and following receipt of Itvisma in accordance with the FDA approved Itvisma labeling
Patient will receive Itvisma as a single-dose intrathecal injection in accordance with the FDA approved labelingSingle-dose intrathecal administration
Patient has never received gene therapy treatment (i.e., Zolgensma (onasemnogene abeparvovec-xioi), Itvisma) for SMA in the patient's lifetime
Provider does not request a planned inpatient admission for the sole purpose of administering Itvisma
Authorization will be issued for no more than one treatment per lifetime and for no longer than 45 days from approvalLimit: 1 treatment per lifetime; authorization ≤ 45 days

Not Medically Necessary / Exclusions

Not medically necessary / Exclusions

Itvisma is not proven or medically necessary for:

ANY of the following

The treatment of SMA for patients younger than 2 years of ageAge < 2 years excluded
SMA without chromosome 5q mutations or deletions
The routine combination treatment of SMA with concomitant SMN modifying therapy

Provider Actions & Administrative Requirements

Prior Authorization

Prior authorization required; one lifetime treatment limit

Authorization will be issued for no more than one treatment per lifetime and for no longer than 45 days from approval; submission of medical records confirming genetic testing (SMN1 mutation/deletion and SMN2 copy number) required.

C9309
Authorization valid for up to 45 days from approval

Documentation Required

Genetic and clinical documentation

Provider must submit medical records (chart notes, laboratory values) confirming SMN1 mutation/deletion and SMN2 copy number (2 or 3 copies) and attest to baseline HFMSE assessment within 2 weeks prior to administration (for quality purposes).

Documentation Required

Specialist prescribing requirement

Prescription must be by a neurologist with expertise in the treatment of SMA.

Billing Rule

Administration setting restriction

Provider must not request a planned inpatient admission for the sole purpose of administering Itvisma.

Documentation Required

Concomitant therapy prohibition

Patient must not receive routine concomitant SMN modifying therapy (e.g., Evrysdi, Spinraza); the patient's medical record will be reviewed and any current authorizations for SMN modifying therapy will be terminated upon Itvisma approval.

Documentation Required

Steroid prophylaxis required per FDA labeling

Patient will receive prophylactic prednisolone (or glucocorticoid equivalent) prior to and following receipt of Itvisma in accordance with the FDA‑approved Itvisma labeling.

Clinical Evidence

Itvisma vs sham: mean difference 1.88 (95% CI 0.51–3.25), p=0.0074STEER trial — HFMSE change at 52 weeks

Mean change 0.17 (SD 2.88) at 52 weeksSTRENGTH trial — HFMSE change (treatment-experienced)

Key evidence includes the Phase 3 randomized, double-blind, sham-controlled STEER trial (treatment‑naive patients) reporting mean change from baseline in HFMSE at 52 weeks of Itvisma 2.39 vs sham 0.51 (difference 1.88; 95% CI: 0.51, 3.25; p = 0.0074), and the Phase 3b single-arm STRENGTH trial (treatment‑experienced patients) reporting mean change from baseline in HFMSE at 52 weeks of 0.17 (SD 2.88). The Hammersmith Functional Motor Scale – Expanded (HFMSE) is defined in the policy as a 33‑item scale (maximum score 66) assessing motor function in SMA.

Background & Definitions

Background: Itvisma is an intrathecal formulation of onasemnogene abeparvovec for patients aged ≥ 2 years with SMA due to confirmed SMN1 mutation. The active ingredient is identical to Zolgensma but formulated at a higher concentration for a smaller delivery volume and administered as a single intrathecal injection independent of patient weight. Itvisma is an AAV vector-based single‑dose gene therapy delivered directly to the central nervous system to restore SMN protein production and address the genetic root cause of SMA.

Term	Definition
Itvisma
Onasemnogene abeparvovec-brve, an AAV vector-based gene therapy indicated for treatment of SMA in patients ≥2 years with confirmed SMN1 mutation.
HFMSE
Hammersmith Functional Motor Scale - Expanded; a 33-item scale (maximum score 66) assessing motor function in SMA.

Policy Summary

PayerUnitedHealthcare

PolicyItvisma (Onasemnogene Abeparvovec-Brve)

Policy CodePolicy 2026D0142A

Change TypeNew policy

Effective DateMay 1, 2026

Next Review Date

On This Page

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

OpenPayer

Itvisma (Onasemnogene Abeparvovec-Brve)

Coverage Summary

Medically Necessary (Initial Therapy) Criteria

Not Medically Necessary / Exclusions

Applicable Codes

Provider Actions & Administrative Requirements

Clinical Evidence

Background & Definitions

Revision History