CurrentUnitedHealthcarePolicy CS2025D00123H

Qalsody (tofersen) — medical benefit drug coverage criteria for SOD1-associated ALS

Defines UnitedHealthcare's medical benefit drug coverage criteria for Qalsody (tofersen) to treat adults with amyotrophic lateral sclerosis (ALS) who have a SOD1 mutation; applies to members except where state-specific guidance supersedes.

Policy Summary

PayerUnitedHealthcare

PolicyQalsody (tofersen) — coverage criteria for SOD1-associated ALS

Policy CodePolicy CS2025D00123H

Change TypeTemplate update (non-material)

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionPrior authorization required with submission of medical records confirming ALS diagnosis and SOD1 mutation; initial authorization limited to no more than 12 months.

SourceLink

POLICY UPDATE CHANGES

Removed content/language pertaining to the state of Mississippi.

J1304HCPCS code listed for tofersen (1 mg)

G12.21Diagnosis code referenced

12 monthsMax initial auth

SOD1 requiredGenetic confirmation

Not ventilator dependentVentilation status

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Coverage Criteria for Qalsody (tofersen)

Initial Therapy

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

Initial Therapy - ALL required: 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

Initial Therapy - ALL required: Submission of medical records confirming mutation in the superoxide dismutase 1 (SOD1) gene

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

Initial Therapy - ALL required: Patient is not dependent on invasive ventilation

Initial Therapy - ALL required: Qalsody is prescribed by, or in consultation with, a neurologist with expertise in the diagnosis of ALS

Initial Therapy - ALL required: Qalsody dosing for ALS is in accordance with the United States Food and Drug Administration approved labeling

Initial Therapy - ALL required: Initial authorization will be for no more than 12 months<= 12 months

Continuation of Therapy

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

Continuation Therapy - ALL required: Diagnosis of ALS

Continuation Therapy - ALL required: Patient is currently receiving Qalsody therapy

Continuation Therapy - ALL required: Provider attestation that the patient has slowed disease progression from baseline

Continuation Therapy - ALL required: Patient is not dependent on invasive ventilation

Continuation Therapy - ALL required:

This Medical Benefit Drug Policy does not apply to the states listed below; for members in those states, refer to the state-specific policy or guideline identified: Arizona (refer to the state’s Medicaid clinical policy), Indiana (Qalsody® (Tofersen) policy for Indiana only), Kansas (refer to the state’s Medicaid clinical policy), Louisiana (Qalsody® (Tofersen) policy for Louisiana only), and Ohio (Qalsody® (Tofersen) policy for Ohio only). North Carolina: None (no separate state guidance listed).

Coding — HCPCS and Diagnosis Codes

Applicable HCPCS CodesHCPCS

J1304

Injection, tofersen, 1 mg

Referenced Diagnosis CodesICD-10

G12.21

Amyotrophic lateral sclerosis

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Qalsody (tofersen) requires prior authorization. Requests must include submission of supporting medical records (e.g., chart notes, diagnostic testing, imaging, nerve conduction studies, laboratory values) and documentation confirming a pathogenic or likely pathogenic SOD1 gene mutation. Initial authorizations are limited to a maximum duration of 12 months.

Initial authorization duration: up to 12 months
Required submission: medical records to support ALS diagnosis and SOD1 mutation confirmation
Provider attestation: baseline functional status documented prior to treatment initiation

Note

Prescriber Specialty Requirement

Prescriber specialty requirement. Qalsody must be prescribed by, or in consultation with, a neurologist with expertise in the diagnosis and management of ALS. No step therapy requirement is specified in the policy.

Prescriber: neurologist with ALS expertise (or documented consultation)

Background on Condition

Amyotrophic lateral sclerosis (ALS) is a rapidly progressive, fatal neurodegenerative disorder of upper and lower motor neurons that leads to progressive weakness, loss of voluntary motor control, and respiratory failure. Median survival from symptom onset is approximately 3–5 years. A minority of cases (~5–10%) are familial; pathogenic variants in the SOD1 gene account for a subset of familial ALS. Qalsody (tofersen) is an antisense oligonucleotide therapy designed to reduce SOD1 messenger RNA and protein, and is indicated for patients with ALS who have a confirmed SOD1 mutation.

Definitions

Qalsody (tofersen) — definition / mechanism as key-value

Generic nametofersen

Brand nameQalsody

Drug class / mechanismAntisense oligonucleotide that binds SOD1 mRNA and causes degradation of SOD1 mRNA, reducing SOD1 protein synthesis

Indication context in policyUsed for treatment of amyotrophic lateral sclerosis (ALS) in patients with SOD1 mutation

SOD1-ALS — definition

DefinitionA familial form of amyotrophic lateral sclerosis (ALS) caused by pathogenic mutations in the superoxide dismutase 1 (SOD1) gene

Epidemiology

Policy Summary

PayerUnitedHealthcare

PolicyQalsody (tofersen) — coverage criteria for SOD1-associated ALS

Policy CodePolicy CS2025D00123H

Change TypeTemplate update (non-material)

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionPrior authorization required with submission of medical records confirming ALS diagnosis and SOD1 mutation; initial authorization limited to no more than 12 months.

SourceLink

On This Page

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

Step therapy: not required / no step-therapy specified

Documentation Required

Required Documentation for Initial Authorization

Documentation required for initial authorization. Include clinical documentation that confirms the diagnosis of ALS, medical records confirming a pathogenic or likely pathogenic SOD1 mutation, baseline functional status (e.g., speech, ambulation, ability to climb stairs), current respiratory status demonstrating the patient is not dependent on invasive ventilation, prior and current medications, and any relevant diagnostic testing results.

Confirmatory documentation of ALS diagnosis (chart notes, diagnostic testing)
Genetic test results confirming SOD1 mutation
Baseline functional ability documentation (speech, walking, climbing stairs, etc.)
Respiratory status: not dependent on invasive ventilation
Medication history and supporting diagnostic test results

Denial Risk

Documentation-based Denial Risk

Documentation-based denial risk. Requests lacking clear medical records that confirm both an ALS diagnosis and a pathogenic/likely pathogenic SOD1 mutation, or missing baseline functional assessment or respiratory status, are at high risk for denial. Ensure all required records and attestations are submitted with the prior authorization request.

Denial risk if records do not confirm ALS diagnosis
Denial risk if SOD1 mutation confirmation is absent or incomplete
Denial risk if baseline functional status or respiratory dependence documentation is missing

Approximately 2% of ALS cases are associated with SOD1 mutations; SOD1-ALS is the second most common form of familial ALS

Clinical featuresPart of familial ALS which generally has earlier onset (~10 years earlier than sporadic ALS) and involves progressive motor neuron degeneration

PathophysiologyMutations in SOD1 encode a mutated superoxide dismutase protein associated with motor neuron degeneration