CurrentColorado Rocky Mountain Health PlansPolicy CS2026D00123J

Qalsody (tofersen) for SOD1-associated ALS — Medical Benefit Drug Policy (Coverage Criteria)

This medical benefit drug policy governs coverage criteria for Qalsody (tofersen) to treat adults with amyotrophic lateral sclerosis (ALS) who have a pathogenic SOD1 mutation and applies to UnitedHealthcare plans except where state-specific guidance overrides.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyQalsody (tofersen) for SOD1-associated ALS — Coverage Criteria

Policy CodePolicy CS2026D00123J

Change TypeNo material change

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with submitted medical records confirming ALS diagnosis and SOD1 mutation plus provider attestation of baseline function.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J1304HCPCS

G12.21ICD-10

12 moMax initial auth

Adults w/ SOD1Indicated population

Coverage Criteria for Qalsody (tofersen)

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Initial Therapy

Covered when ALL of the following are met for initial therapy:

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

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

Initial therapy: Provider attestation that the patient's baseline functional ability has been documented prior to initiating treatment (e.g., speech, walking, climbing stairs).

Initial therapy: Patient is not dependent on invasive ventilation.

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

Initial therapy: Qalsody dosing for ALS is in accordance with the United States Food and Drug Administration approved labeling.

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

All conditions required

Continuation Therapy

Continued coverage when ALL of the following are met for continuation of therapy:

Continuation therapy: Diagnosis of ALS.

Continuation therapy: Patient is currently receiving Qalsody therapy.

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

Continuation therapy: Patient is not dependent on invasive ventilation.

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

All conditions required

Qalsody (tofersen) is approved by the FDA for adults with a pathogenic SOD1 mutation under the agency’s accelerated approval pathway based on reduction in plasma neurofilament light chain (NfL). Continued FDA approval may be contingent on verification of a clinical benefit in confirmatory trials; this policy notes that the accelerated approval was granted on the biomarker endpoint and that ongoing confirmation of clinical benefit is required.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Qalsody (tofersen). Providers must submit diagnosis documentation, confirmation of SOD1 gene mutation, baseline functional assessments, and the attestation described below with the prior authorization request.

Required with PA: diagnosis of ALS; confirmation of SOD1 mutation; baseline functional ability documentation; provider attestation; neurologist involvement/consultation; dosing per FDA labeling; initial authorization ≤ 12 months

Step Therapy

There is no step therapy requirement for Qalsody under this policy.

Documentation Required

Required Documentation

Submit medical records to support the diagnosis and clinical need for Qalsody. Acceptable documentation includes chart notes, prior medical history, diagnostic testing (e.g., imaging, nerve conduction studies), laboratory values, genetic testing confirming SOD1 mutation, and documentation of baseline functional status (speech, ambulation, ability to climb stairs, respiratory status).

Chart notes and prior medical history
Diagnostic testing reports (imaging, nerve conduction studies)
Relevant laboratory values and pulmonary/respiratory assessments
Genetic testing report confirming SOD1 mutation
Baseline functional assessments and provider attestation

Denial Risk

Documentation Triggers and Denial Risk

Incomplete or missing supporting records — for example, absence of documented confirmation of an SOD1 mutation or lack of baseline functional assessment — may result in denial of the authorization request. Ensure all required items listed under Prior Authorization and Required Documentation are included to reduce risk of denial.

Missing SOD1 mutation confirmation may trigger denial
Absent baseline functional documentation or attestation may trigger denial
Failure to show neurologist involvement or prescribing consistent with FDA labeling may trigger denial

Definitions

Qalsody (tofersen) — definition and indication

DrugQalsody (tofersen)

Mechanism of actionAntisense oligonucleotide that binds SOD1 mRNA and causes its degradation, reducing SOD1 protein synthesis.

FDA-indicated populationAdults with amyotrophic lateral sclerosis (ALS) who have a mutation in the SOD1 gene (accelerated approval).

Approval basisApproved under the FDA's accelerated approval pathway based on reduction in plasma neurofilament light chain; continued approval may require verification of clinical benefit in confirmatory trials.

Background

Amyotrophic lateral sclerosis (ALS) is a rapidly progressive, ultimately fatal disease of motor neurons that impairs voluntary muscle control. Familial forms account for a minority of cases; mutations in the SOD1 gene are one recognized genetic cause and represent a small proportion of overall ALS patients. Qalsody (tofersen) is an antisense oligonucleotide designed to reduce SOD1 protein synthesis and is indicated specifically for adults with SOD1‑mutation ALS under the FDA’s accelerated approval.