CurrentViva HealthPolicy IC-0826

Itvisma (intrathecal) for Spinal Muscular Atrophy — Coverage Criteria

This policy governs prior authorization, coverage criteria, dosing, and administration requirements for intrathecal Itvisma for members with 5q spinal muscular atrophy (SMA) age ≥2 years. It affects providers requesting coverage from Viva Health for a single-course intrathecal gene therapy dose.

Policy Summary

PayerViva Health

PolicyItvisma (intrathecal) for Spinal Muscular Atrophy — Coverage Criteria

Policy CodePolicy IC-0826

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit required clinical documentation (medical records, chart notes, lab results, confirmatory diagnostics) with the prior authorization request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 doseinitial authorization course

1.2×10^14dose (vg per vial)

≥2 yrsminimum age

≤1:50anti-AAV9 titer

weekly ×1 moplatelet monitoring

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Initial Approval

Covered when ALL of the following are met:

Age: Member must be at least 2 years of age

Genetic confirmation: Diagnosis of 5q spinal muscular atrophy confirmed by either bi-allelic deletion or dysfunctional point mutation of the SMN1 gene

No advanced disease: Patient must not have advanced disease (e.g., complete limb paralysis, permanent ventilation support)

Treatment history and motor function (either of the following): Option A: Member is treatment-naïve to any SMN-targeting agents AND is able to sit independently but has never had the ability to walk independently; OR Option B: Member has received prior SMN-targeting agents AND has one or more of: able to sit independently but never walked independently; OR has \u2264 3 copies of SMN2; OR achieved and subsequently lost the ability to walk independently

Administration and provider: Will only be administered intrathecally via lumbar puncture by healthcare professionals experienced in performing lumbar punctures (e.g., interventional radiologist or neurologist)

Clinical stability and infection: Member is clinically stable in overall baseline health (e.g., hydration, nutrition, respiratory status) and does not have an active infection including clinically important localized infections prior to administration

Anti-AAV9 antibody: Baseline anti-AAV9 antibody titer ≤ 1:50 measured by ELISA≤ 1:50

Laboratory monitoring: Baseline liver function assessed prior to initiating therapy and monitored for at least 3 months; baseline platelet counts assessed prior to initiating therapy and monitored at least weekly for the first month and as clinically indicated until return to baseline

Vaccination and concomitant medications: Member is up to date with all vaccinations (including seasonal RSV prophylaxis) prior to initiating therapy; Itvisma is used concomitantly with systemic corticosteroids per dosing guidance

Prior gene therapy exclusion and combination therapy: Member must not have previously received SMA gene therapy (e.g., onasemnogene abeparvovec-xioi [Zolgensma]) and Itvisma will not be used in combination with other SMN-targeting agents

Required documentation: Submission of supporting clinical documentation (medical records, chart notes, lab results, and confirmatory diagnostics) related to diagnosis, step therapy, and clinical markers (e.g., genetic/mutational testing) is REQUIRED on all authorization requests

Failure to submit required records may result in denial

Renewal Criteria

Renewal limitations

Authorization duration: Initial prior authorization is provided for one treatment course (1 dose) and prior authorization validity may NOT be renewed; duration of authorization must not be exceeded

Member must not have previously received treatment with SMA gene therapy (for example, onasemnogene abeparvovec-xioi [Zolgensma]) and Itvisma must not be used in combination with other SMN‑targeting agents (e.g., nusinersen, risdiplam, onasemnogene abeparvovec-xioi).

Coding and Dosage

HCPCS codesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals (hospital outpatient use)

NDCNDC

71894-0200-xx

Itvisma carton containing one 1.2×10^14 vg/3 mL single-dose vial (NDC)

Covered ICD-10 diagnosis codesICD-10Covered

G12.0	Infantile spinal muscular atrophy, type I [Werdnig-Hoffmann]
G12.1	Other inherited spinal muscular atrophy
G12.25	Progressive spinal muscle atrophy
G12.8	Other spinal muscular atrophies and related syndromes
G12.9	Spinal muscular atrophy, unspecified

inv-07: anti-AAV9 antibody titer

Baseline anti-AAV9 antibody titerMust be ≤1:50 prior to administration

Assay methodMeasured by ELISA

TimingBaseline titer must be obtained prior to initiating Itvisma

inv-08: Itvisma dose

Dose amount1.2 × 10^14 vector genomes (vg) per 3 mL vial

Administration routeIntrathecal bolus injection over ~1–2 minutes

Units per treatment1 treatment of 1.2 × 10^14 vg/3 mL

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required and limited to a single treatment course (one dose). Initial authorization validity is for one treatment course and renewals are not allowed.

Prior authorization limited to one dose; no renewals.

Step Therapy

Step Therapy / Prior SMN‑Targeting Agent Conditions

Step therapy and prior-agent conditions apply. Member may be treatment‑naïve to SMN‑targeting agents (e.g., nusinersen, risdiplam) and meet specified functional criteria (able to sit independently but never walked independently). Alternatively, members with prior exposure to SMN‑targeting agents may qualify if they meet one or more clinical conditions (able to sit independently but never walked independently; ≤3 copies of SMN2; or achieved and subsequently lost independent walking).

Treatment‑naïve pathway: member is treatment‑naïve to SMN‑targeting agents and able to sit independently but never walked independently.
Prior‑agent exception: prior receipt of SMN‑targeting agents plus ≥1 of: able to sit independently but never walked independently; ≤3 SMN2 copies; achieved then lost independent walking.

Documentation Required

Required Clinical Documentation

Submission of supporting clinical documentation (medical records, chart notes, lab results, confirmatory diagnostics) is REQUIRED for all prior authorization requests. Include documentation related to diagnosis, step therapy, and relevant clinical markers (genetic and mutational testing) when applicable.

Provide documentation via direct upload through the PA web portal or by fax.
Include genetic confirmation of 5q SMA (bi‑allelic SMN1 deletion or dysfunctional point mutation) when applicable.

Denial Risk

Documentation Submission Required

Failure to submit required medical records may result in denial due to inability to establish medical necessity.

Records will be reviewed at time of submission as part of the evaluation.
Ensure documentation of baseline labs (anti‑AAV9 titer, liver function, platelet counts) and vaccination status when applicable.

Background

Itvisma is an intrathecal gene therapy indicated for certain patients with 5q spinal muscular atrophy (SMA). Eligibility requires confirmed diagnosis (biallelic SMN1 mutation), clinical stability for lumbar puncture, and procedural administration as an intrathecal lumbar puncture by experienced clinicians.

Key clinical requirements include that the member be clinically stable with no active infection, be up to date on vaccinations (including seasonal RSV prophylaxis), have baseline liver function and platelet counts assessed (with platelets monitored at least weekly for the first month), and have a baseline anti‑AAV9 antibody titer ≤ 1:50 measured by ELISA. Itvisma is administered intrathecally and is not to be combined with other SMN‑targeting therapies.

OpenPayer

Itvisma (intrathecal) for Spinal Muscular Atrophy — Coverage Criteria

Coverage Criteria

Coding and Dosage

Provider Actions and Prior Authorization

Background

Definitions