CurrentMass General Brigham Health PlanPolicy N/A

Qalsody (tofersen) — Coverage Criteria for ALS with SOD1 Mutation

Defines prior authorization, eligibility, and continuation criteria for Qalsody (tofersen) for treatment of ALS with SOD1 mutation under Mass General Brigham Health Plan pharmacy benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyQalsody (tofersen) — Coverage Criteria for ALS with SOD1 Mutation

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit genetic test confirming SOD1 mutation plus a pre-treatment ALSFRS-R (within 12 weeks) with individual domain scores.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial approval duration

1 yearReauthorization duration

Adults w/ SOD1Indication population

ALSFRS-R ≤12wRequired assessment

Coverage Criteria for Qalsody (tofersen)

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inv-01: Initial Authorization Criteria

Authorization may be granted when ALL of the following are met:

ALL of the following

Age: Member is ≥18 years of age>= 18
Diagnosis of Amyotrophic Lateral Sclerosis (ALS)
Prescriber is a neurologist; neuromuscular specialist; or other specialist in the treatment of ALS, or consult notes from specialist are provided
Genetic confirmation: Genetic test confirming SOD1 mutation
Pre-treatment ALSFRS-R questionnaire score (within the past 12 weeks)within the past 12 weeks
Include scores for each individual domain
Appropriate dosing (per labeling)
Riluzole use or contraindication: Requested agent will be used in combination with riluzole OR there is an adverse reaction/contraindication to riluzole
Ventilation dependence: Member is not dependent on invasive mechanical ventilation by intubation or tracheostomy

inv-02: Continuation of Therapy

Reauthorization may be approved when ALL of the following are provided:

ALL of the following

ALSFRS-R submission: Prescriber submits a current copy of the ALSFRS-R questionnaire including scores on each individual domain (within the past 12 weeks)within the past 12 weeks
A completed ALSFRS-R should include scores for each individual domain
Ventilation status: Member is not dependent on invasive mechanical ventilation by intubation or tracheostomy

Coding and Assessment Requirements

No codes listedmixed

No codes listed

inv-05: ALSFRS-R — submitted within past 12 weeks; individual domain scores required

RequirementPre-treatment ALSFRS-R submitted within past 12 weeks (must include scores for each individual domain)

PurposeObjective functional assessment to document baseline ALS severity prior to initiating therapy

ReauthorizationPrescriber must submit a current ALSFRS-R (within past 12 weeks) including individual domain scores for continuation of therapy

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Case-by-case review for members new to the plan who are currently receiving treatment.

Prior authorization required
Case-by-case review for members new to plan who are currently receiving treatment

Documentation Required

Riluzole Combination or Contraindication

Member must use riluzole in combination with the requested agent OR have an adverse reaction or contraindication to riluzole.

Requested agent will be used in combination with riluzole
Adverse reaction or contraindication to riluzole

Documentation Required

Required Clinical Documentation

Prescriber must provide genetic test confirming SOD1 mutation, a pre-treatment ALSFRS-R questionnaire (within 12 weeks) including individual domain scores, and related documentation.

Genetic test confirming SOD1 mutation
Pre-treatment ALSFRS-R questionnaire within the past 12 weeks with individual domain scores
Prescriber specialty or consult notes (neurologist, neuromuscular specialist, or other ALS specialist)
Documentation of diagnosis of ALS and age ≥18
Appropriate dosing information
Member not dependent on invasive mechanical ventilation by intubation or tracheostomy

Denial Risk

Documentation Gaps That May Trigger Denial

Failure to provide required documentation may trigger denial of the authorization request.

Missing diagnosis of ALS
Missing documentation that member is ≥18 years of age
No genetic test confirming SOD1 mutation
Absence of prescriber specialty or consult notes
No pre-treatment ALSFRS-R questionnaire or missing individual domain scores
Lack of documentation that requested agent will be used with riluzole or that riluzole is contraindicated
No documentation that member is not dependent on invasive mechanical ventilation

Background

Qalsody (tofersen) is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults with a pathogenic SOD1 gene mutation. The agent received accelerated approval based on a biomarker effect (reduction in plasma neurofilament light chain), and the policy requires specialist prescriber involvement and objective functional assessment prior to and during therapy, including submission of the ALSFRS‑R within the past 12 weeks.

Definitions

inv-11: ALSFRS-R — Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised; required functional assessment to be submitted within the past 12 weeks.

DefinitionAmyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)

RequirementRequired functional assessment to be submitted within the past 12 weeks prior to therapy initiation

Scoring detailA completed ALSFRS-R should include scores for each individual domain; used for initial authorization and reauthorization

inv-12: SOD1 mutation — Pathogenic mutation in the superoxide dismutase 1 gene confirmed by genetic testing required for eligibility.

DefinitionPathogenic mutation in the superoxide dismutase 1 (SOD1) gene confirmed by genetic testing

Indication linkQalsody (tofersen) is indicated for treatment of ALS in adults with a SOD1 gene mutation (accelerated approval)

DocumentationGenetic test confirming SOD1 mutation must be provided with authorization request