CurrentColorado Rocky Mountain Health PlansPolicy 2026D0142A

Itvisma (Onasemnogene Abeparvovec-Brve)

Defines UnitedHealthcare Commercial and Individual Exchange medical benefit drug policy coverage criteria, exclusions, and billing codes for Itvisma (onasemnogene abeparvovec-brve) for treatment of SMA in patients ≥ 2 years of age. Specifies clinical documentation, prescribing provider qualifications, administration route, treatment frequency limits, and applicable HCPCS/ICD-10 codes.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyItvisma (Onasemnogene Abeparvovec-Brve)

Policy CodePolicy 2026D0142A

Change TypeNew policy; related policy link added 06/01/2026

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit genetic testing and SMN2 copy number documentation and request prior authorization limited to one lifetime treatment for up to 45 days from approval.

POLICY UPDATE CHANGES

New Medical Benefit Drug Policy created effective 05/01/2026.

06/01/2026 update added reference link to Community Plan Medical Benefit Drug Policy for Itvisma.

1Lifetime treatments allowed

≥2Minimum age for coverage

2-3Eligible SMN2 copy number

≤1:50Antibody titer threshold

Coverage stance: covered_with_criteria for Itvisma (onasemnogene abeparvovec-brve). Scope: UnitedHealthcare Commercial and Individual Exchange medical benefit drug policy for treatment of SMA in patients ≥ 2 years with biallelic SMN1 mutations. Policy-level key thresholds: one treatment per lifetime; patient must have SMN2 = 2–3 copies; patient must not have an anti-AAV9 antibody titer > 1:50. Additional requirements include neurologist prescriber with SMA expertise, single-dose intrathecal administration, prophylactic prednisolone per FDA labeling, no routine concomitant SMN-modifying therapy, and no prior gene therapy for SMA.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required and duration limit

Prior authorization is required for Itvisma. Authorization is limited to one lifetime treatment and will be issued for no longer than 45 days from approval. Providers must obtain prior approval before claim submission.

Affected code(s): C9309

Documentation Required

Submit genetic testing and SMN2 copy number documentation

Submit documentation of genetic testing confirming SMN1 mutation or deletion and documentation of SMN2 copy number (2 or 3 copies). Acceptable records include chart notes, genetic testing reports, and laboratory values showing either homozygous deletion or mutation of SMN1 (e.g., deletion of exon 7) or compound heterozygous SMN1 mutation and SMN2 copy number testing results.

Genetic testing report confirming SMN1 biallelic mutation or deletion
SMN2 copy number documentation (must be 2 or 3 copies)
Relevant chart notes or laboratory values supporting results

Documentation Required

Prescribing provider specialty

The prescribing provider must be a neurologist with expertise in the treatment of spinal muscular atrophy (SMA).

Documentation Required

Vaccination / prophylaxis and administration route adherence

Patient must receive prophylactic prednisolone (or glucocorticoid equivalent) prior to and following Itvisma in accordance with FDA‑approved labeling. Itvisma must be administered as a single‑dose intrathecal injection per the FDA labeling.

Prophylactic prednisolone (or equivalent) given before and after administration per FDA label
Administration route: single‑dose intrathecal injection (per FDA labeling)

Documentation Required

Concomitant therapy termination

Any current authorizations for routine concomitant SMN modifying therapies (e.g., Evrysdi, Spinraza) will be terminated upon approval of Itvisma. Providers should not expect concurrent authorization for other SMN modifying therapies once Itvisma is approved.

Denial Risk

Gene therapy prior exposure exclusion

Prior receipt of any gene therapy for SMA (for example, Zolgensma or prior Itvisma) is an exclusion and will result in claim denial.

Documentation Required

Inpatient admission restriction

Do not request a planned inpatient admission for the sole purpose of administering Itvisma. Authorization should not be sought for inpatient admission when the only reason is administration of the gene therapy.

Applicable Codes

HCPCS (administration / drug code)HCPCSCovered

C9309

Injection, onasemnogene abeparvovec-brve, per treatment

ICD-10 (diagnosis codes referenced)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

Clinical Evidence

0.17STRENGTH (Phase 3b OL) — mean change in HFMSE at Week 52: 0.17 (SD 2.88), indicates stabilization

STEER (Phase 3 randomized, double-blind, sham-controlled): Mean change in HFMSE at 52 weeks was Itvisma +2.39 vs sham +0.51 (difference 1.88; 95% CI 0.51–3.25; p=0.0074).

STRENGTH (Phase 3b open-label): Mean change in HFMSE at Week 52 was 0.17 (SD 2.88), indicating stabilization over 52 weeks.

Definitions relevant to evidence: Itvisma refers to intrathecal onasemnogene abeparvovec-brve gene therapy; HFMSE is the Hammersmith Functional Motor Scale – Expanded, a 33-item motor function measure with maximum score 66, higher scores indicate better motor function.

Background

Background: Itvisma is an intrathecal AAV vector-based formulation of onasemnogene abeparvovec intended for patients aged 2 years and older with SMA due to biallelic SMN1 mutation. The active ingredient is identical to Zolgensma but Itvisma is a concentrated formulation delivered via a single intrathecal injection into the CSF, uses a lower dose independent of patient weight, and targets motor neurons directly; by contrast, Zolgensma is administered intravenously and dosed by patient weight for pediatric patients <2 years.

Definitions

Itvisma (onasemnogene abeparvovec-brve): An adeno-associated virus (AAV) vector-based gene therapy indicated for treatment of SMA in adult and pediatric patients ≥ 2 years with confirmed SMN1 mutation.

HFMSE: The Hammersmith Functional Motor Scale – Expanded is a 33-item motor function measure for SMA with a maximum total score of 66; higher scores indicate better motor function.

Revision History

2026-05-01policy_created

New Medical Benefit Drug Policy created effective 05/01/2026.

2026-06-01policy_updatedLatest

06/01/2026 update added reference link to Community Plan Medical Benefit Drug Policy for Itvisma.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyItvisma (Onasemnogene Abeparvovec-Brve)

Policy CodePolicy 2026D0142A

Change TypeNew policy; related policy link added 06/01/2026

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit genetic testing and SMN2 copy number documentation and request prior authorization limited to one lifetime treatment for up to 45 days from approval.

On This Page

OpenPayer

Itvisma (Onasemnogene Abeparvovec-Brve)

Coverage Summary

Provider Actions & Prior Authorization

Applicable Codes

Clinical Evidence

Background

Definitions

Revision History