ModifiedColorado Rocky Mountain Health PlansPolicy CS2026D0142A

Itvisma (onasemnogene abeparvovec-brve) — Medical Benefit Drug Policy (Intrathecal administration for SMA)

Covers one lifetime intrathecal administration of Itvisma for treatment of spinal muscular atrophy (SMA) in patients 2 years and older with qualifying SMN1/SMN2 genetic findings; applies to Colorado Rocky Mountain Health Plans (UnitedHealthcare Community Plan documentation).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyItvisma (onasemnogene abeparvovec-brve) — Medical Benefit Drug Policy

Policy CodePolicy CS2026D0142A

Change TypeNew policy added

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit medical records confirming SMN1 mutation/deletion and SMN2 copy number; authorization limited to one lifetime treatment and ≤45 days from approval.

SourceLink

POLICY UPDATE CHANGES

New Medical Benefit Drug Policy for Itvisma (onasemnogene abeparvovec-brve).

New Medical Benefit Drug Policy

onetreatment per lifetime authorized

≥2minimum patient age for coverage

2–3required SMN2 copy number

≤1:50max anti-AAV9 titer

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≤45dauthorization duration

Coverage Criteria for Itvisma (onasemnogene abeparvovec-brve)

Medical necessity criteria (Initial)

Covered when ALL of the following are met:

Itvisma coverage criteria: 1) Medical records confirm SMN1 mutation: homozygous deletion or mutation of SMN1 (e.g., homozygous deletion of exon 7 at locus 5q13) OR compound heterozygous mutation of SMN1 (e.g., deletion of SMN1 exon 7 on one allele and mutation on the other).

Submit genetic testing results / chart notes confirming SMN1 findings.

2) Medical records confirm patient has 2 or 3 SMN2 gene copies.

Submit documented SMN2 copy number (laboratory report).

3) Patient is ≥ 2 years of age.>= 2 years

Age documented in chart.

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

Document respiratory support status in medical record.

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

Provider specialty or documentation of expertise required.

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.

Provider attestation required; medical record will be reviewed.

7) Anti‑AAV9 antibody titer is not elevated above 1:50.<= 1:50

Laboratory titer report required.

8) Patient has never received prior gene therapy for SMA (lifetime).

Document prior treatment history (e.g., prior onasemnogene products).

9) Provider does not request a planned inpatient admission solely to administer Itvisma.

Admission intent must be documented if applicable.

10) Prophylactic glucocorticoid (e.g., prednisolone or equivalent) will be given per FDA‑approved Itvisma labeling, and Itvisma will be administered as a single‑dose intrathecal injection per FDA labeling.

Provider attestation of prophylactic steroid use and intrathecal single‑dose administration required.

Itvisma is not covered in the following situations: treatment of SMA in patients younger than 2 years of age; SMA that does not involve chromosome 5q mutations or deletions; and routine combination treatment with concomitant SMN‑modifying therapies (for example, risdiplam or nusinersen). These exclusions follow the policy statement that such uses are not proven or medically necessary.

This Medical Benefit Drug Policy is intended to assist interpretation of UnitedHealthcare standard benefit plans. Providers must reference applicable federal, state, or contractual requirements for coverage decisions, since those requirements may differ from the standard benefit plan and will govern in the event of a conflict.

Use of Itvisma is explicitly identified as not medically necessary for: patients younger than 2 years of age; patients with SMA that does not have chromosome 5q mutations or deletions; and routine combination therapy with concomitant SMN‑modifying agents.

This document segment does not list additional specific conditions labeled as not medically necessary; reviewers should consult plan‑specific contractual, state, or federal rules for any further exclusions or requirements.

Coding and Test Requirements

Referenced HCPCS/NDC groupHCPCS

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

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.

Anti‑AAV9 antibody titer requirement (maximum allowable)

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

Measurement basisReported as a dilution titer (e.g., 1:50) as documented in patient's laboratory records

Denial risk if exceededCoverage may be denied if anti-AAV9 titer is documented above 1:50

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization will be issued for no more than one lifetime treatment and for no longer than 45 days from approval. Provider must confirm the patient has never received prior gene therapy for SMA (e.g., Zolgensma, Itvisma).

One lifetime treatment limit
Authorization duration: ≤ 45 days from approval
Patient must be gene-therapy naïve

Denial Risk

Documentation Required — Denial Risk if Missing

Submit medical records confirming a homozygous SMN1 deletion or compound heterozygous SMN1 mutation, SMN2 copy number (2 or 3 copies), and the patient’s age (≥ 2 years). Missing documentation of SMN1 homozygous deletion/compound heterozygous mutation or SMN2 copy number may result in claim or authorization denial.

Background on Spinal Muscular Atrophy

Spinal muscular atrophy (SMA) is a rare autosomal recessive neurodegenerative disorder caused primarily by biallelic pathogenic variants in SMN1 that result in loss of survival motor neurons, leading to progressive muscle weakness and hypotonia. SMN2 copy number correlates with clinical phenotype and is used in treatment decision making; this policy addresses the intrathecal AAV‑based gene therapy Itvisma (onasemnogene abeparvovec‑brve) as a single intrathecal administration for patients aged ≥ 2 years with qualifying SMN1/SMN2 genetic findings.

Definitions and Key Terms

Itvisma — drug identification and administration details

Drug name (brand and generic)Itvisma (onasemnogene abeparvovec-brve)

Route and dosing formSingle intrathecal injection (concentrated formulation administered directly to the central nervous system), independent of patient weight

Indication for administrationTreatment of spinal muscular atrophy (SMA) in patients ≥ 2 years with confirmed SMN1 mutation/deletion

Authorization limitsOne lifetime treatment; authorization duration not to exceed 45 days from approval

SMN2 copy number — definition and relevance

DefinitionSMN2 copy number = the number of copies of the SMN2 gene present in a patient; it is used to predict SMA clinical phenotype

Policy Revision History

2026-06-01policy_createdLatest

New medical benefit drug policy for Itvisma (onasemnogene abeparvovec-brve) established effective June 1, 2026.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyItvisma (onasemnogene abeparvovec-brve) — Medical Benefit Drug Policy

Policy CodePolicy CS2026D0142A

Change TypeNew policy added

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit medical records confirming SMN1 mutation/deletion and SMN2 copy number; authorization limited to one lifetime treatment and ≤45 days from approval.

SourceLink

On This Page

Documentation: SMN1 mutation/deletion (homozygous deletion or compound heterozygous mutation)
Documentation: SMN2 copy number = 2 or 3
Documentation: patient age ≥ 2 years

Documentation Required

Provider and Administration Requirements

Providers must attest that the prescribing clinician is a neurologist with expertise in SMA and that the patient will receive prophylactic glucocorticoid per FDA labeling and Itvisma as a single-dose intrathecal injection. Provider must not request inpatient admission solely to administer Itvisma.

Prescriber: neurologist experienced in SMA
Per-label prophylactic prednisolone (or equivalent)
Administration: single-dose intrathecal injection
No planned inpatient admission solely for administration

Prior Authorization

Concomitant Therapy Restriction

Patient must not receive routine concomitant SMN-modifying therapy (e.g., Evrysdi, Spinraza). Any current authorizations for SMN-modifying therapy will be terminated upon Itvisma approval.

Discontinue routine concomitant SMN-modifying therapy
Examples: Evrysdi (risdiplam), Spinraza (nusinersen)
Existing SMN-modifying therapy authorizations may be terminated

Note

Plan-Specific and Contractual Requirements

Before applying this policy, check federal, state, or contractual benefit plan requirements; those requirements govern in the event of a conflict.

Federal, state, or contractual requirements take precedence over this policy
Policy is informational and may be modified

Policy requirement for coverageDocumentation of 2 or 3 SMN2 gene copies is required for coverage

Clinical relevanceHigher SMN2 copy number generally correlates with a less severe SMA phenotype and influences treatment decisions

Scope: Interpretation of UnitedHealthcare standard benefit plans

Purpose of this policyProvides assistance in interpreting UnitedHealthcare standard benefit plans regarding medical benefit drugs

Contractual precedenceFederal, state, or contractual benefit plan requirements govern in the event of a conflict

Use guidanceBefore using this policy, check applicable federal, state, or contractual requirements; UnitedHealthcare may modify policies as necessary