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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty Drugsallcareadvantage Zolgensma Prior Auth Coverage | O…
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    CurrentallcareadvantagePolicy 093.1

    Onasemnogene abeparvovec-xioi (Zolgensma) coverage

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    Defines prior authorization, coverage criteria, and limits for onasemnogene abeparvovec-xioi (Zolgensma) for AllCare members with spinal muscular atrophy (SMA), focusing on pediatric patients under 2 years of age.

    Policy Summary
    Payerallcareadvantage
    PolicyOnasemnogene abeparvovec-xioi (Zolgensma) coverage
    Policy CodePolicy 093.1
    Change TypeNo material changes
    Effective DateAug 15, 2019
    Last ReviewAug 15, 2019
    Next Review DateAug 14, 2021
    Key ActionObtain prior authorization with genetic confirmation of bi-allelic SMN1 mutations, specialist diagnosis, anti-AAV9 titer ≤1:50, monitoring plan, and dose within FDA label.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    single treatmentapproval length / quantity limit
    <2 yearsFDA-approved age
    ≤1:50anti-AAV9 titer
    1.1 x 10^14 vg/kgFDA dose limit

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Coverage Criteria

    Initial therapy (medical necessity)

    Covered when ALL of the following are met

    ALL of the following

    • Genetic confirmation: Documentation of a diagnosis of SMA type I with genetic testing confirmation of bi-allelic SMN1 deletions or pathogenic variants.
    • Provider specialty: Diagnosis made by a neurologist, neuromuscular specialist, or pediatrician with expertise in treating SMA.
    • Prior gene therapy: Patient has NOT previously received gene replacement therapy for SMA.

      If patient previously received gene replacement therapy = deny.

    • Age and disease stage: Either patient is ≤6 months of age and does not have advanced SMA at baseline (e.g., complete paralysis of limbs), OR patient is >6 months but <2 years and has previously received nusinersen (Spinraza) before 6 months with a positive clinical response.age ≤6 months OR (6 months < age < 2 years with prior nusinersen and positive response)

      If >6 months and <2 years without prior nusinersen and positive response = deny.

    • Antibody and monitoring: Anti-AAV9 (serotype 9) antibody titer ≤1:50 and agreement to monitor AST, ALT, total bilirubin, prothrombin time, platelets, and troponin‑I.anti-AAV9 ≤1:50
    • Dose: Prescribed dose is within the FDA labeled dose of 1.1 x 10^14 vector genomes per kg (vg/kg).≤ 1.1 x 10^14 vg/kg

    Use of onasemnogene abeparvovec-xioi (Zolgensma) in patients with advanced SMA (for example, complete paralysis of the limbs or permanent ventilator-dependence) has not been evaluated and is not supported by this policy. The original clinical studies were open-label, single-arm trials enrolling patients with symptom onset before 6 months of age and baseline anti-AAV9 titers ≤ 1:50, so extrapolation to more advanced disease states is limited. Providers should consider these limitations when submitting requests and include clinical information documenting baseline functional status; requests for patients with advanced disease are unlikely to meet the policy criteria.

    Requests that do not meet the approval criteria will be denied. Common non‑approved scenarios include: lack of genetic confirmation of bi‑allelic SMN1 deletions or pathogenic variants; diagnosis not made by a neurologist, neuromuscular specialist, or pediatrician experienced in SMA; prior receipt of gene replacement therapy for SMA; patients older than the policy’s age-based indications without required prior treatment (e.g., >6 months and <2 years without prior nusinersen with a documented positive clinical response); anti‑AAV9 antibody titer > 1:50; absence of an agreed monitoring plan; or a prescribed dose outside the FDA labeled dose. Ensure documentation of these elements is provided with the authorization request to avoid denial.

    Initial Therapy

    Initial therapy

    Initial authorization for a single administration when criteria are met.

    ALL of the following

    • Diagnosis: SMA type I with genetic confirmation of bi-allelic SMN1 deletions or pathogenic variants.
    • Specialist: Diagnosis by a neurologist, neuromuscular specialist, or pediatrician with expertise in treating SMA.
    • Antibody: Anti-AAV9 (serotype 9) antibody titer ≤1:50.
    • Monitoring: Agreement to monitor AST, ALT, total bilirubin, prothrombin time, platelets, and troponin‑I.
    • Dose limit: Prescribed dose within the FDA labeled dose of 1.1 x 10^14 vector genomes per kg (vg/kg).

    Provider Actions & Documentation Requirements

    Prior Authorization

    Prior authorization required for Zolgensma (single treatment)

    Prior authorization is required for onasemnogene abeparvovec-xioi (Zolgensma); approval is for a single treatment and only when all listed approval criteria are met (including genetic confirmation, appropriate specialist diagnosis, anti-AAV9 titer ≤1:50, monitoring plan, and dose within the FDA labeled dose).

    • Approval is for a single treatment (one fill) when all criteria are satisfied.
    Step Therapy

    Prior nusinersen requirement for older infants

    For patients older than 6 months but younger than 2 years, the policy requires prior treatment with nusinersen (Spinraza) given before 6 months of age with a documented positive clinical response; if applicable, nusinersen must be discontinued prior to onasemnogene.

    • If >6 months and <2 years without prior nusinersen with positive response = deny.
    • Therapy with Spinraza, if applicable, will be discontinued prior to gene therapy.
    Documentation Required

    Required documentation for prior authorization

    Submit documentation of genetic testing confirming bi‑allelic SMN1 deletions or pathogenic variants, a diagnosis made by a neurologist, neuromuscular specialist, or pediatrician experienced in SMA, prior treatment history (including prior gene therapy and Spinraza), anti‑AAV9 antibody titer results, a monitoring plan for specified labs, and the prescribed dose.

    • Genetic test confirming bi‑allelic SMN1 deletions or pathogenic variants.
    • Diagnosis by a neurologist, neuromuscular specialist, or pediatrician with SMA expertise.
    • History of prior gene replacement therapy and Spinraza (nusinersen) treatment.
    • Anti‑AAV9 (serotype 9) antibody titer ≤ 1:50.
    • Monitoring plan for AST, ALT, total bilirubin, prothrombin time, platelets, and troponin‑I.
    • Prescribed dose within FDA labeled dose of 1.1 x 10^14 vg/kg.
    Denial Risk

    Denial conditions for missing genetic confirmation or specialist diagnosis

    The request will be denied if genetic confirmation of bi‑allelic SMN1 deletions/pathogenic variants is not provided, if the diagnosis was not made by an appropriate specialist, if the patient previously received gene replacement therapy, or if age/prior‑treatment conditions (e.g., >6 months and <2 years without prior nusinersen and positive response) are not met.

    • Denial triggers include: lack of bi‑allelic SMN1 genetic confirmation; inappropriate diagnosing provider; prior gene replacement therapy; age/prior‑treatment criteria not met.

    Coding & Test Thresholds

    inv-04: anti-AAV9 antibody titer — required threshold for approval
    Required anti-AAV9 antibody titer≤ 1:50 (measured by ELISA)
    Measurement methodELISA as used in clinical trials
    Policy consequenceAnti-AAV9 titer >1:50 = denial of request
    inv-05: FDA labeled dose — 1.1 x 10^14 vg/kg
    FDA labeled dose1.1 x 10^14 vector genomes per kg (vg/kg)
    Dose checkPrescribed dose must be within the FDA labeled dose to approve
    Policy field referenceCriteria require confirmation dose is within 1.1 x 10^14 vg/kg

    Step Therapy / Sequencing

    Patient populationStep therapy requirementClinical response requiredPolicy action
    Patients older than 6 months but younger than 2 years requiring onasemnogene (Zolgensma)
    Prior treatment with nusinersen (Spinraza) given before 6 months of age is required
    Documentation of a positive clinical response to nusinersen (Spinraza) when given before 6 months of age
    If prior nusinersen given with positive response and all other criteria met, proceed to approve single onasemnogene treatment; if not, deny

    Quantity Limits

    inv-15: onasemnogene abeparvovec-xioi (Zolgensma) — single treatment
    Treatment frequencySingle treatment (one administration)
    Quantity limitSingle treatment per course
    Approval lengthUp to single treatment

    Site of Care

    Note

    Hospital outpatient administration by a healthcare professional

    Onasemnogene (Zolgensma) must be administered by a healthcare professional in an outpatient hospital setting (site of care not otherwise specified in the policy).

    • Policy states administration is by a healthcare professional; setting listed as hospital outpatient.

    Definitions

    inv-11: Advanced SMA — examples and note that use in such patients not evaluated
    Examples of advanced SMAComplete paralysis of limbs; permanent ventilator-dependence
    Evaluation statusUse of onasemnogene in advanced SMA has not been evaluated
    Policy implicationPatients with advanced SMA are not supported by the policy for treatment
    inv-12: Bi-allelic SMN1 mutation — genetic confirmation required
    Genetic confirmation requiredBi-allelic SMN1 deletions or pathogenic variants (two mutated or deleted copies)
    FDA approved indicationSMA in pediatric patients <2 years with bi-allelic SMN1 mutations
    Denial riskLack of genetic confirmation = denial of request

    Background

    Onasemnogene abeparvovec-xioi (Zolgensma) is an AAV9‑based single‑administration gene replacement therapy approved for the treatment of pediatric patients younger than 2 years of age with spinal muscular atrophy due to bi‑allelic SMN1 mutations. The pivotal evaluations were open‑label, single‑arm trials in infants with symptom onset before 6 months; enrolled patients had baseline anti‑AAV9 antibody titers ≤ 1:50. The safety and effectiveness of repeat dosing have not been evaluated.

    Policy Summary
    Payerallcareadvantage
    PolicyOnasemnogene abeparvovec-xioi (Zolgensma) coverage
    Policy CodePolicy 093.1
    Change TypeNo material changes
    Effective DateAug 15, 2019
    Last ReviewAug 15, 2019
    Next Review DateAug 14, 2021
    Key ActionObtain prior authorization with genetic confirmation of bi-allelic SMN1 mutations, specialist diagnosis, anti-AAV9 titer ≤1:50, monitoring plan, and dose within FDA label.
    SourceLink
    On This Page
    Coverage CriteriaInitial TherapyProvider Actions & Documentation RequirementsCoding & Test ThresholdsStep Therapy / SequencingQuantity LimitsSite of CareDefinitionsBackground