CurrentMass General Brigham Health PlanPolicy N/A

Qalsody (tofersen) — Medical-benefit prior authorization for SOD1-ALS

Medical-benefit prior authorization policy for Qalsody (tofersen) for adults with ALS due to SOD1 mutation; applies to MassHealth members covered by Mass General Brigham Health Plan medical benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyQalsody (tofersen) — Prior authorization for adults with SOD1-ALS

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with ALS diagnosis, genetic test confirming SOD1 mutation, prescriber specialty or consult notes, and ALSFRS-R scores within the past 12 weeks.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum age for coverage

6 moInitial approval duration

1 yrReauthorization duration

NeurologistPrescriber requirement

Coverage criteria for Qalsody (tofersen)

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Coding and measurement requirements

Benefit classificationmixed

medical benefit

Indicates coverage through medical benefit (not pharmacy)

inv-06: ALSFRS-R timing

Required timing for initial ALSFRS-RPre-treatment ALSFRS-R questionnaire score must be dated within the past 12 weeks

Required timing for reauthorization ALSFRS-RCurrent ALSFRS-R questionnaire including scores for each individual domain must be within the past 12 weeks

Completed questionnaire requirementA completed ALSFRS-R must include scores for each individual domain

Provider requirements and actions

Prior Authorization

Prior Authorization Required

Prior authorization required under the medical benefit. Requests will be reviewed case-by-case; prior authorization is required for members new to the plan who are currently receiving therapy and for all new starts.

Medical benefit prior authorization required
Contact: Medical Benefit phone 833-895-2611, fax 888-656-6671

Documentation Required

Riluzole Requirement

Either the requested agent must be used concurrently with riluzole, or there must be documentation of an adverse reaction or a contraindication to riluzole.

Concurrent use with riluzole preferred
If riluzole is not used, provide documentation of adverse reaction or contraindication

Denial Risk

Required documentation and potential denial triggers

Provide diagnosis of Amyotrophic Lateral Sclerosis (ALS), genetic test confirming SOD1 mutation, prescriber specialty or consult notes (neurologist, neuromuscular specialist, or other ALS specialist), and a completed ALSFRS-R questionnaire (with individual domain scores) performed within the past 12 weeks. Authorization may be denied if member is <18 years of age, lacks documented ALS diagnosis, lacks documented SOD1 mutation, or is dependent on invasive mechanical ventilation (intubation or tracheostomy).

Diagnosis of ALS
Genetic test confirming SOD1 mutation
Prescriber specialty or consult notes
Completed ALSFRS-R questionnaire with individual domain scores (within 12 weeks)
Member ≥18 years of age
Member not dependent on invasive mechanical ventilation by intubation or tracheostomy

Clinical background

Qalsody (tofersen) is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults with a confirmed SOD1 mutation. The agent received accelerated approval based on a biomarker endpoint (reduction in plasma neurofilament light chain); clinical use under this policy requires baseline and ongoing functional assessment with the ALSFRS-R questionnaire and management by an appropriate specialist (neurologist or neuromuscular specialist) or documented specialist consultation.

Definitions and scales

inv-12: ALSFRS-R

DefinitionAmyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R): a multi-domain questionnaire used to assess function in ALS

Submission requirementSubmit the ALSFRS-R questionnaire with scores for each individual domain

PurposeUsed for baseline and ongoing functional assessment to support initial authorization and reauthorization decisions

Timing requirementScores must be current — within the past 12 weeks for both initial and reauthorization