CurrentUnitedHealthcarePolicy CSLA2O25D00123C

Qalsody (tofersen) (for Louisiana Only)

Policy governs medical benefit coverage criteria for Qalsody (tofersen) for treatment of amyotrophic lateral sclerosis (ALS) with SOD1 mutation for UnitedHealthcare members in Louisiana.

Policy Summary

PayerUnitedHealthcare

PolicyQalsody (tofersen) (for Louisiana Only)

Policy CodePolicy CSLA2O25D00123C

Change TypeRevised coverage criteriaauthorization duration updated

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with medical records confirming ALS diagnosis, pathogenic SOD1 mutation, baseline functional status, and required attestations.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria; removed criterion requiring the member is not dependent on tracheostomy.

Authorization duration changed from no more than 6 months to no more than 12 months.

12 monthsmaximum initial or renewal authorization length

J1304HCPCS code listed for tofersen

G12.21Diagnosis code listed for ALS

Louisianapolicy application state

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Initial Therapy

Covered when ALL of the following are met

Initial therapy: Diagnosis of amyotrophic lateral sclerosis (ALS)

Initial therapy: Submission of medical records (chart notes, previous medical history, diagnostic testing including imaging, nerve conduction studies, laboratory values) to support the diagnosis of ALS

Initial therapy: Submission of medical records confirming a pathogenic mutation in the SOD1 (superoxide dismutase 1) gene

Initial therapy: Provider attestation that the patient’s baseline functional ability has been documented prior to initiating treatment

Initial therapy: Patient is not dependent on invasive ventilation

Initial therapy: Qalsody (tofersen) dosing is in accordance with United States FDA–approved labeling

Initial therapy: Qalsody is prescribed by, or in consultation with, a neurologist with expertise in the diagnosis of ALS

Initial therapy: Initial authorization will be for no more than 12 months

Continuation Therapy

Covered when ALL of the following are met

Continuation therapy: Patient is currently receiving Qalsody (tofersen) therapy

Continuation therapy: Patient is not dependent on invasive ventilation

Continuation therapy: Provider attestation that the patient has slowed disease progression from baseline

Continuation therapy: Qalsody is prescribed by, or in consultation with, a neurologist with expertise in the diagnosis of ALS

Continuation therapy:

The policy has an operational change removing the prior explicit exclusion for members dependent on tracheostomy. The previous version required that the member "is not dependent on tracheostomy"; that restriction has been deleted from the revised coverage criteria effective 08/01/2025. Clinical reviewers and authorization staff should therefore not apply tracheostomy dependence as an automatic exclusion when evaluating requests for Qalsody (tofersen) under this policy.

The FDA approval status for Qalsody (tofersen) is provided for informational purposes only. Qalsody is an antisense oligonucleotide indicated under accelerated approval for treatment of adults with ALS who have a pathogenic SOD1 gene mutation; this approval is based on reduction in plasma neurofilament light chain and continued approval may depend on verification of clinical benefit in confirmatory trials. FDA approval alone does not constitute a coverage determination under this policy.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation Qalsody (tofersen) therapy. Initial authorization will be for up to 12 months; continuation authorizations are also limited to no more than 12 months. Providers must submit required documentation (see items) with the prior authorization request and attestations; incomplete documentation may result in denial or delay of the request.

Initial authorization: up to 12 months
Continuation authorization: up to 12 months
Prior authorization required before initiation of therapy
Qalsody must be prescribed by or in consultation with a neurologist experienced in ALS
Dosing must follow FDA-approved labeling

Note

Provider Submission Requirements and Actions

Providers must submit supporting medical records and confirmatory documentation with the prior authorization request. Include clear attestations where indicated (baseline functional status for initial therapy; evidence of slowed disease progression for continuation). Requests lacking these elements risk denial or processing delays.

Submit medical records and chart notes supporting the ALS diagnosis
For initial therapy: documentation of SOD1 gene mutation and provider attestation of documented baseline functional ability prior to treatment
For continuation therapy: documentation that patient is currently receiving Qalsody and provider attestation that disease progression has slowed from baseline
Confirm patient is not dependent on invasive ventilation
Include documentation that Qalsody dosing aligns with FDA-approved labeling
Indicate neurologist involvement or consultation

Documentation Required

Required Documentation

Specific documentation must be included with the authorization request to support medical necessity. Provide copies of the listed records and test results — do not submit summaries without source documentation.

Medical records and chart notes supporting ALS diagnosis
Genetic testing report confirming SOD1 mutation (for initial therapy)
Baseline functional status documentation (initial therapy)
Progress notes documenting clinical status and evidence of slowed disease progression (continuation therapy)
Relevant diagnostic testing: imaging, nerve conduction studies, laboratory values
Treatment history showing current receipt of Qalsody (for continuation)
Consultation notes from neurologist when treatment was initiated or when requested

Denial Risk

Documentation Missing — Denial Risk

If required documentation or attestations are missing or incomplete, the authorization request may be denied or returned for additional information, which will delay care. Denials may be issued if genetic confirmation, functional baseline (initial), or evidence of slowed progression (continuation) are not provided, or if the patient is ventilator dependent.

Missing SOD1 mutation report (initial) — denial risk
Missing baseline functional status attestation (initial) — denial risk
Missing documentation of slowed progression or current receipt of Qalsody (continuation) — denial risk
Documentation showing dependence on invasive ventilation — not eligible
Incomplete dosing information or lack of neurologist involvement — may result in denial or request for more information

OpenPayer

Qalsody (tofersen) (for Louisiana Only)

Coverage Criteria for Qalsody (tofersen)

Coding and Patient Eligibility

Provider Actions and Authorization Requirements

Background

Definitions