CurrentColorado Rocky Mountain Health PlansPolicy CS2026D00123J

Qalsody (tofersen) for SOD1‑mutated amyotrophic lateral sclerosis (ALS) — Coverage Criteria

Defines medical necessity and authorization requirements for Qalsody (tofersen) for treatment of amyotrophic lateral sclerosis (ALS) in patients with a pathogenic SOD1 mutation; applies to Colorado Rocky Mountain Health Plans' medical benefit drug coverage.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyQalsody (tofersen) for SOD1‑mutated amyotrophic lateral sclerosis (ALS) — Coverage Criteria

Policy CodePolicy CS2026D00123J

Change TypeNo material change

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization with submission of medical records confirming ALS diagnosis and SOD1 mutation and documentation that a neurologist prescribes or consults.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J1304HCPCS

G12.21Diagnosis

≤12 moInitial auth

Adults w/ SOD1Indicated population

Coverage Criteria

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Initial Therapy

Covered when ALL of the following are met:

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

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

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

Ventilation status: Patient is not dependent on invasive ventilation.

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

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

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

Continuation of Therapy

Covered when ALL of the following are met:

Ongoing diagnosis: Diagnosis of ALS.

Current therapy: Patient is currently receiving Qalsody therapy.

Clinical benefit attestation: Provider attestation that the patient has slowed disease progression from baseline.

Ventilation status: Patient is not dependent on invasive ventilation.

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

This policy defines coverage for Qalsody (tofersen) under the Medical Benefit Drug Policy for Colorado Rocky Mountain Health Plans. It does not apply to the following states: Arizona, Indiana, Kansas, North Carolina, and Ohio; refer to the state-specific policy or guideline noted for each state where applicable. Providers should follow the state-specific guidance in those jurisdictions rather than this policy.

Qalsody (tofersen) is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults with a pathogenic SOD1 mutation. The U.S. Food and Drug Administration granted this indication under accelerated approval on the basis of a reduction in plasma neurofilament light chain observed in treated patients. Continued approval may be contingent upon verification of clinical benefit in confirmatory trials; FDA approval alone is informational and not a sole basis for coverage decisions.

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required before initiating Qalsody (tofersen). Submit complete medical records including chart notes, prior diagnostic testing (imaging, nerve conduction studies), laboratory values, and documentation confirming an SOD1 mutation. Qalsody must be prescribed by or in consultation with a neurologist with expertise in ALS. Initial authorizations are limited to no more than 12 months; continuation requests must include documentation of slowed disease progression from baseline.

Required for initial and continuation therapy
Include medical records and SOD1 genetic test results
Neurologist involvement required
Initial authorization ≤ 12 months

Step Therapy

No step therapy requirements are specified for Qalsody; members do not need to fail alternative therapies prior to coverage when clinical criteria are met.

Documentation Required

Required Documentation

Providers must submit supporting documentation with the prior authorization request: chart notes, diagnostic testing (e.g., imaging, nerve conduction studies), laboratory values, and genetic test results confirming SOD1 mutation. Include provider attestation of baseline functional status prior to treatment and documentation for ongoing therapy (e.g., notes showing slowed disease progression).

Chart notes and prior medical history
Diagnostic testing: imaging, nerve conduction studies
Laboratory values supporting diagnosis
Genetic test results confirming SOD1 mutation
Provider attestation of baseline functional ability and continued response for continuation requests

Denial Risk

Triggers for Denial

Requests may be denied or delayed if required records are not submitted, if treatment is not prescribed by or in consultation with a neurologist experienced in ALS, if SOD1 mutation confirmation is absent, if the patient is dependent on invasive ventilation, or if dosing/indication are inconsistent with FDA-approved labeling.

Failure to submit required medical records or genetic test results
Lack of neurologist involvement or documented consultation
Patient dependent on invasive ventilation
Dosing or indication not consistent with FDA-approved labeling

Background

Amyotrophic lateral sclerosis (ALS) is a progressive, fatal neurologic disease that causes loss of upper and lower motor neurons, leading to progressive weakness, loss of voluntary muscle control, and eventual respiratory failure. Familial forms of ALS account for a minority of cases; SOD1-associated ALS is a hereditary subset caused by mutations in the superoxide dismutase 1 gene. Qalsody is an antisense oligonucleotide developed to reduce SOD1 protein synthesis by degrading SOD1 mRNA and is indicated specifically for adults with SOD1-mutated ALS.

Definitions

Qalsody (tofersen)

DrugQalsody (tofersen)

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

FDA indicationIndicated for treatment of amyotrophic lateral sclerosis (ALS) in adults with a mutation in the superoxide dismutase 1 (SOD1) gene (accelerated approval based on reduction in plasma neurofilament light chain).

SOD1-associated ALS (SOD1-ALS)

DefinitionFamilial form of ALS associated with mutations in the superoxide dismutase 1 (SOD1) gene.

Prevalence among ALS casesApproximately 2% of all ALS cases are associated with SOD1 gene mutations.

Context within familial ALSSOD1-ALS is the second most common form of familial ALS; familial ALS accounts for about 5–10% of cases and familial forms overall are ~10% of ALS cases.