CurrentColorado Rocky Mountain Health PlansPolicy N/A

Zolgensma (North Carolina) Prior Authorization Form - Community Planopen_in_new

Prior authorization form for Zolgensma (gene therapy) for treatment of spinal muscular atrophy (SMA) for community plan members (North Carolina). Specifies required clinical information, diagnostic/genetic confirmation, baseline labs, dosing limits, concurrent therapy, and provider attestation for a single-dose administration.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyZolgensma (North Carolina) Prior Authorization Form - Community Planopen_in_new

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProvider must submit the completed PA form with genetic test results, baseline functional scores, baseline labs (including anti-AAV9 titer ≤1:50), prescriber signature/NPI, and beneficiary demographics to obtain authorization for Zolgensma.

SourceLink

POLICY UPDATE CHANGES

No material changes

1 doseAuthorized dosing events

<2 yrsAge eligibility

≤1.1e14 vg/kgDose threshold

Anti-AAV9 ≤1:50Antibody threshold

Coverage Summary

Coverage stance: covered_with_criteria for single-dose onasemnogene abeparvovec (Zolgensma) prior authorization. This is a prior authorization form to document eligibility for a one-time (single) dose of Zolgensma for patients under 2 years of age with genetically confirmed spinal muscular atrophy (SMA). Authorization requires meeting all criteria in the "Authorization Criteria / Required Clinical Information" section of the form, including genetic confirmation, prescriber specialty/consultation, baseline functional and laboratory documentation, absence of advanced disease and active viral infection, dosing limits, and prescriber attestation/signature.

Key thresholds and dosing

Maximum total dose≤ 1.1 x 10^14 vector genomes (vg) per kg

Anti-AAV9 antibody titer≤ 1:50 (ELISA binding immunoassay)

Authorized dosing events1 dose (single-dose therapy)

Length of therapySingle dose

Provider Actions and Documentation Requirements

Prior Authorization

Submit completed prior authorization form with documentation

Provider must submit this completed PA form including genetic test results, baseline functional scores (CHOP-INTEND or HINE Section 2 or newborn screen), baseline labs (anti-AAV9 titer, LFTs, platelets, INR, troponin-I), prescriber signature, NPI, and beneficiary demographics to obtain authorization for Zolgensma.

Genetic test results (documentation of bi-allelic SMN1 mutations or specified examples)
Baseline functional scores (CHOP-INTEND, HINE Section 2, or newborn screening results)
Baseline labs: anti-AAV9 titer, liver function tests, platelet count, INR, troponin‑I
Prescriber signature
Prescriber NPI
Beneficiary demographics (name, DOB, ID, gender, contact info)

Documentation Required

Document absence of advanced disease and active viral infection

Provider must document that the beneficiary does not have advanced SMA (examples include complete paralysis of limbs, permanent ventilator dependence, tracheostomy, or non‑invasive ventilation beyond use for sleep) and must confirm there is no active viral infection at the time of infusion.

Advanced disease examples: complete paralysis of limbs, permanent ventilator dependence, tracheostomy, or non‑invasive ventilation beyond use for sleep (absence of these must be documented)
No active viral infection requirement (must attest beneficiary has no active viral infection at infusion)

Billing Rule

Single-dose therapy

Zolgensma is authorized as a one‑time single‑dose therapy per the form; total administered dose must not exceed the specified vector genome per kilogram maximum.

Maximum total dose: ≤ 1.1 x 10^14 vector genomes (vg) per kg
Length of therapy: single dose

Denial Risk

Risk of denial for unmet criteria

Claims may be denied or prior authorization requests declined if required elements are missing or criteria are not met, as specified on the form.

Missing genetic confirmation of bi‑allelic SMN1 mutations
Missing baseline laboratory documentation (including anti‑AAV9 antibody titer > not meeting ≤1:50 threshold or absent labs)
Missing prescriber specialty/neurology consultation, prescriber signature, or NPI
Total dose exceeds the ≤ 1.1 x 10^14 vg/kg threshold
Concurrent therapy documentation (e.g., whether prescribed with Spinraza) or other required documentation absent

Background

Background: This prior authorization form is used to document clinical eligibility for single-dose onasemnogene abeparvovec (Zolgensma) in infants and children with genetically confirmed spinal muscular atrophy (SMA) and to capture baseline functional scores and laboratory tests required to proceed with gene therapy. The form collects genetic confirmation of bi-allelic SMN1 mutations, baseline motor/ screening measures, baseline labs, dosing information, and prescriber attestation.

Scope/location: This form is for community plan members in North Carolina and specifies required clinical information, diagnostic/genetic confirmation, baseline labs, dosing limits, concurrent therapy, and provider attestation for a single-dose administration.

Clinical Evidence & Measurement

No formal clinical trials are listed on the form. The clinical data required by the PA to assess eligibility include baseline functional measures such as the CHOP-INTEND score, HINE Section 2 motor milestone score, or newborn screening results indicating SMA, and baseline laboratory measures including anti-AAV9 antibody titer (≤ 1:50 by ELISA), liver function tests, platelet counts, INR, and troponin-I.

Quick reference — eligibility & thresholds

Age eligibilityAge <2 years

Anti-AAV9 antibody threshold≤ 1:50 (ELISA binding immunoassay)

Dose thresholdTotal dose must not exceed 1.1 x 10^14 vg/kg

Authorized dosing events1 dose