Onasemnogene abeparvovec (Itvisma) — Intrathecal Injection Coverage Criteria
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Policy governs medical necessity and coverage requirements for onasemnogene abeparvovec-brve (Itvisma) intrathecal injection for treatment of spinal muscular atrophy (SMA) in patients aged 2 years and older, for Blue Cross Blue Shield North Carolina members and providers practicing within NC.
Added applicable revenue codes 0891 and 0892 associated with the policy HCPCS code(s).
Coverage Criteria for Onasemnogene abeparvovec (Itvisma) Intrathecal Injection
Initial / single-dose approval criteria
Covered when ALL of the following are met
- 1) Age: Patient is 2 years of age or older.
- 2) Diagnosis: Diagnosis of 5q spinal muscular atrophy (SMA) documented in the medical record.
3) Genetic confirmation
- a: Homozygous deletion of SMN1 exon 7.
- b: Compound heterozygosity for SMN1 exon 7 deletion and a small mutation.
- 4) SMN2 copy number: SMN2 copy number is four or fewer copies (≤ 4).
- 5) Concomitant therapy: Requested agent will be used in combination with systemic corticosteroids.
- 6) Advanced SMA exclusion: Patient does NOT have advanced SMA (e.g., complete paralysis of limbs or permanent ventilator dependence as defined).
- 7) Anti-AAV9 antibody titer: Laboratory testing confirms anti-AAV9 antibody titer ≤ 1:50.
- 8) Liver function monitoring: Baseline liver function assessed prior to therapy and monitored for at least 3 months after therapy.
- 9) Prescriber qualifications: Prescriber is a board-certified neurologist or pediatric neurologist experienced in SMA management and practices in a research academic setting.
- 10) Network requirement (NC members receiving care in NC): For North Carolina members seeking care in North Carolina, the provider is in the Blue Premier health system network.
- 11) Prior gene therapy: No prior treatment with onasemnogene abeparvovec (Itvisma) or other gene replacement therapy for SMA.
- 12) Concurrent SMA therapies: Patient will not be treated concurrently with risdiplam (Evrysdi) and/or nusinersen (Spinraza); any existing authorizations for those agents will be closed upon approval of Itvisma.
- 13) Dosing: Requested dose is within FDA labeled dosing for the requested indication.
- Operational note: Duration of approval: 30 days (one-time, single-dose treatment per lifetime).
Patients meeting the primary coverage criteria are excluded if they have advanced SMA. Examples of advanced disease include complete paralysis of the limbs or permanent ventilator dependence, which the policy defines as either invasive ventilation via tracheostomy or ≥ 16 hours of respiratory assistance per day continuously for at least 14 days in the absence of an acute, reversible illness or a perioperative state. Documentation of the absence of advanced SMA is required in the medical record for approval.
Concurrent treatment with other SMA disease-modifying therapies is prohibited. Specifically, the patient must not be treated concurrently with risdiplam (Evrysdi™) and/or nusinersen (Spinraza®). If onasemnogene abeparvovec-brve (Itvisma®) is approved, any existing authorizations for those agents will be closed. Operationally, providers should not submit overlapping authorizations for these agents; prior authorizations for risdiplam or nusinersen will be terminated if Itvisma is approved for the member.
Applicable Coding and Clinical Test Parameters
| 0891 | Special Processed Drugs - FDA Approved Cell Therapy (revenue code) |
| 0892 | Special Processed Drugs - FDA Approved Gene Therapy (revenue code) |
Provider Requirements and Authorization Actions
Prior authorization required (30-day approval)
Prior authorization is required. The request must include documentation that the patient meets all listed medical necessity criteria. Approval duration is 30 days for a one-time, single-dose lifetime treatment.
Concurrent therapy not permitted — existing authorizations closed
Concurrent treatment with risdiplam (Evrysdi) and/or nusinersen (Spinraza) is prohibited; if Itvisma is approved, any existing authorizations for those agents will be closed.
Required medical record documentation
Medical record documentation must be provided to support all approval criteria.
- Patient age (≥ 2 years)
- Diagnosis of 5q spinal muscular atrophy (SMA)
- Genetic confirmation: either homozygous SMN1 exon 7 deletion OR compound heterozygosity for SMN1 exon 7 deletion and a small mutation
- SMN2 copy number (≤ 4 copies)
- Anti-AAV9 (AAV9) antibody titer (≤ 1:50)
- Baseline and follow-up liver function testing (baseline prior to therapy and monitored for at least 3 months)
- Use in combination with systemic corticosteroids
- Prescriber qualifications (board-certified neurologist or pediatric neurologist experienced in SMA practicing in a research academic setting)
- Confirmation of no prior onasemnogene abeparvovec or other gene replacement therapy
- Requested dose within FDA-labeled dosing
- For NC members receiving care in NC, provider enrollment in Blue Premier network
Triggers for denial
Requests may be denied if the patient does not meet the policy criteria or falls under exclusions.
- Patient is younger than 2 years of age
- No documented diagnosis of 5q SMA or lack of required genetic confirmation (SMN1 exon 7 deletion or compound heterozygosity)
- SMN2 copy number greater than 4
- Anti-AAV9 antibody titer > 1:50
- Presence of advanced SMA (e.g., complete limb paralysis or permanent ventilator dependence as defined)
- Prior treatment with onasemnogene abeparvovec or other gene replacement therapy
- Concurrent treatment with risdiplam or nusinersen
Definitions and Clinical Terms
Background
Onasemnogene abeparvovec-brve (Itvisma®) is an FDA-labeled, one-time, single-dose gene replacement therapy administered via intrathecal injection for the treatment of 5q spinal muscular atrophy in patients aged ≥ 2 years with SMN1 gene mutations. The labeled dose is a single intrathecal injection of 1.2 x 10^14 vector genomes (vg). Treatment requires genetic confirmation of SMA, pre-treatment assessment including SMN2 copy number and anti-AAV9 antibody titer, baseline liver function testing with monitoring for at least 3 months after therapy, and use in combination with systemic corticosteroids. Approval is for a single lifetime dose with a duration of authorization of 30 days.
Revision History and Policy Updates
Added applicable revenue codes 0891 (Special Processed Drugs - FDA Approved Cell Therapy) and 0892 (Special Processed Drugs - FDA Approved Gene Therapy).
Policy notification issued for coding change effective 2026-04-01 adding revenue codes 0891 and 0892.
Original medical policy criteria issued.
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