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    v1.0.28
    OpenPayerPolicy UpdatesNeurology/NeurosurgerySierra Health and Life Qalsody Coverage | OpenPaye…
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    Currentsierra health and lifePolicy 2026D0123F

    Qalsody (tofersen) — Coverage Criteria for SOD1‑mutation ALS

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    Medical benefit drug policy governing coverage criteria for Qalsody (tofersen) to treat adults with amyotrophic lateral sclerosis (ALS) who have a SOD1 gene mutation; applies to UnitedHealthcare Commercial and Individual Exchange plans (as adopted by Sierra Health and Life).

    Policy Summary
    Payersierra health and life
    PolicyQalsody (tofersen) — Coverage Criteria for SOD1‑mutation ALS
    Policy CodePolicy 2026D0123F
    Change TypeNo material changes
    Effective DateMay 1, 2026
    Next Review Date
    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.

    Adults w/ SOD1FDA indicated population
    12 monthsinitial/renewal auth period
    J1304

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    HCPCS
    G12.21ICD-10

    Coverage Criteria for Qalsody (tofersen)

    Initial and continuation therapy

    Covered when ALL of the following are met

    Initial therapy criteria: Submission of medical records to support diagnosis of ALS (e.g., chart notes, prior medical history, diagnostic testing including imaging, nerve conduction studies, laboratory values); submission of medical records confirming a SOD1 gene mutation; provider attestation that baseline functional ability has been documented prior to initiating treatment (e.g., speech, walking, climbing stairs); patient is not dependent on invasive ventilation; Qalsody is prescribed by, or in consultation with, a neurologist with expertise in ALS; Qalsody dosing is in accordance with FDA-approved labeling; initial authorization up to 12 months.
    Continuation therapy criteria: Diagnosis of ALS; patient is currently receiving Qalsody therapy; provider attestation that the patient has slowed disease progression from baseline; patient is not dependent on invasive ventilation; Qalsody is prescribed by, or in consultation with, a neurologist with expertise in ALS; Qalsody dosing is in accordance with FDA-approved labeling; authorization up to 12 months.

    Patient dependence on invasive ventilation is an exclusion to coverage under these criteria. The policy requires that, for both initial and continuation therapy, the patient is not dependent on invasive ventilation as a condition of approval.

    Applicable Billing and Diagnosis Codes

    Applicable HCPCSHCPCS
    J1304Injection, tofersen, 1 mg.
    Applicable ICD-10ICD-10
    G12.21Amyotrophic lateral sclerosis

    Provider Actions and Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required. Submit medical records and provider attestations as specified below. Initial and continuation authorizations are each limited to no more than 12 months.

    • Prior authorization required with submitted medical records and provider attestations
    • Initial and continuation authorizations limited to ≤ 12 months
    Documentation Required

    Required documentation for initial therapy

    For initial therapy, submit documentation to confirm the diagnosis and baseline status before starting Qalsody (tofersen). Failure to provide required records may result in denial.

    • Medical records supporting ALS diagnosis (chart notes, prior medical history, diagnostic testing such as imaging, nerve conduction studies, laboratory values)

    Background

    Amyotrophic lateral sclerosis (ALS) is a progressive, fatal motor neuron disease characterized by loss of voluntary muscle control and eventual respiratory failure. Familial forms account for a minority of cases, and the subset caused by mutations in the superoxide dismutase 1 (SOD1) gene is recognized as SOD1‑ALS.

    Qalsody (tofersen) is an antisense oligonucleotide therapy that reduces SOD1 messenger RNA and protein and is intended for adults with ALS who have a confirmed SOD1 gene mutation; coverage under this policy is limited to patients who meet the specified diagnostic and documentation requirements and other criteria.

    Definitions

    inv-11: Qalsody (tofersen) — Antisense oligonucleotide that causes degradation of SOD1 mRNA, reducing SOD1 protein synthesis
    AgentQalsody (tofersen)
    Mechanism of actionAntisense oligonucleotide that binds SOD1 mRNA and causes degradation of SOD1 mRNA, reducing SOD1 protein synthesis
    Indication contextUsed to treat amyotrophic lateral sclerosis in patients with SOD1 gene mutations
    Pharmacologic classAntisense oligonucleotide (ASO)
    Clinical effectReduces production of mutant SOD1 protein implicated in motor neuron degeneration
    inv-12: SOD1-ALS — Form of familial ALS associated with mutations in the superoxide dismutase 1 gene
    Policy Summary
    Payersierra health and life
    PolicyQalsody (tofersen) — Coverage Criteria for SOD1‑mutation ALS
    Policy CodePolicy 2026D0123F
    Change TypeNo material changes
    Effective DateMay 1, 2026
    Next Review Date
    Key ActionObtain prior authorization with submitted medical records confirming ALS diagnosis and SOD1 mutation plus provider attestation of baseline function.
    SourceLink
    On This Page
    Coverage Criteria for Qalsody (tofersen)Applicable Billing and Diagnosis CodesProvider Actions and RequirementsBackgroundDefinitions
  1. Medical records confirming SOD1 gene mutation
  2. Provider attestation that baseline functional ability is documented prior to initiating treatment (e.g., speech, walking, climbing stairs)
  3. Patient is not dependent on invasive ventilation
  4. Qalsody prescribed by or in consultation with a neurologist experienced in ALS diagnosis
  5. Dosing consistent with FDA-approved labeling
  6. Initial authorization duration: up to 12 months
    7. Documentation Required

    Required documentation for continuation

    For continuation therapy, provide current treatment status and a provider attestation of clinical benefit or stabilization to support ongoing authorization.

    • Documentation confirming diagnosis of ALS
    • Evidence the patient is currently receiving Qalsody therapy
    • Provider attestation that disease progression has slowed or stabilized from baseline
    • Patient is not dependent on invasive ventilation
    • Qalsody prescribed by or in consultation with a neurologist experienced in ALS diagnosis
    • Dosing consistent with FDA-approved labeling
    • Authorization duration: up to 12 months
    Denial Risk

    Documentation and specialist requirement

    Missing or incomplete documentation — including lack of medical records confirming ALS diagnosis, absence of documented SOD1 mutation, or missing baseline functional assessment — may result in denial of the prior authorization request. Specialist involvement (neurologist with ALS expertise) is required or consultation must be documented.

    • Denial risk if medical records confirming ALS diagnosis and SOD1 mutation are not submitted
    • Denial risk if baseline functional documentation and provider attestations are not provided
    • Specialist requirement: prescribing or documented consultation with a neurologist experienced in ALS
    TermSOD1-ALS
    DefinitionForm of familial amyotrophic lateral sclerosis associated with mutations in the superoxide dismutase 1 (SOD1) gene
    Prevalence among ALS casesApproximately 2% of ALS cases are associated with SOD1 gene mutations
    Familial ALS shareFamilial ALS accounts for ~5–10% of cases; SOD1 is the second most common familial ALS gene
    Clinical featuresEarlier onset than sporadic ALS (familial ALS generally has onset ~10 years earlier) and progressive motor neuron degeneration leading to respiratory failure