CurrentCareSourcePolicy N/A

Qalsody (tofersen) — Prior Authorization Coverage Criteria

Defines prior authorization, medical necessity, dosing, and renewal criteria for Qalsody (tofersen) for treatment of adults with SOD1 mutation-associated amyotrophic lateral sclerosis for CareSource Arkansas PASSE members.

Policy Summary

PayerCareSource

PolicyQalsody (tofersen) — Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation including neurologist consultation, SOD1 genetic test results, and baseline ALSFRS-R; approve initial requests for 6 months when criteria are met.

SourceLink

18+minimum member age for coverage

6 moinitial approval duration

6 moreauthorization approval duration

100 mg ITdose and route

SOD1 mutationrequired genetic finding

Coverage Criteria for Qalsody (tofersen)

Initial Authorization

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

Initial Authorization: Member is at least 18 years of age.

Initial Authorization: Medication is prescribed by or in consultation with a neurologist or neuromuscular specialist.

Initial Authorization: Documented diagnosis of amyotrophic lateral sclerosis (ALS) with signs or symptoms of weakness.

Initial Authorization: Genetic test results demonstrating a mutation in the SOD1 gene.

Policy Summary

PayerCareSource

PolicyQalsody (tofersen) — Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2026

Next Review DateN/A

SourceLink

On This Page

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Initial Authorization: Documentation of a baseline ALSFRS-R score.

Initial Authorization: Dosage: 100 mg (15 mL) intrathecally every 14 days for three loading doses, then every 28 days for maintenance (quantity limit: 1 vial per 28 days maintenance).100 mg per dose

If all requirements met, approve for 6 months.

Reauthorization

Reauthorization covered when ALL of the following are met:

Reauthorization: Chart notes document a positive clinical response, such as reduced plasma neurofilament light chain (NfL) level or a reduced rate of disease progression/functional decline.

If requirement met, approve for an additional 6 months.

CareSource considers the use of Qalsody (tofersen) for any condition not expressly listed in this policy to be not medically necessary. Such off‑label uses are outside the scope of coverage defined here and may be denied.

Qalsody (tofersen) is not medically necessary for indications not listed in this policy. For requests for other uses, refer to the payer’s Off‑Label policy for consideration and documentation requirements.

Initial Therapy

Initial Therapy: Adult (≥18 years) with ALS and confirmed SOD1 mutation; prescribed by or in consultation with a neurologist or neuromuscular specialist; documented ALS with signs/symptoms of weakness; baseline ALSFRS-R documented; dosing 100 mg intrathecally every 14 days for three loading doses then every 28 days for maintenance (QL: 1 vial per 28 days maintenance).

Approve for 6 months if met.

Reauthorization / Continuation Criteria

Reauthorization / Continuation

Continuation: For reauthorization/continuation, chart notes must document positive clinical response (e.g., reduced plasma NfL or reduced rate of functional/clinical decline).

Approval for additional 6 months if met.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Qalsody (tofersen) is prior authorization required and will be considered when specified clinical and documentation criteria are met.

Benefit type: Medical
Policy status: Prior Authorization Required
Approved FDA indication: treatment of ALS in adults with a SOD1 mutation (accelerated approval)

Step Therapy

No step therapy requirements are specified for Qalsody.

Documentation Required

Documentation Expectations

Prescribing clinician must provide documentation to support the request. Required documentation includes: prescribing clinician note, documentation that the prescriber is a neurologist or neuromuscular specialist (or consultation note), genetic test results confirming a SOD1 mutation, baseline ALSFRS-R score, and for reauthorization chart notes showing positive clinical response such as reduced plasma neurofilament light chain (NfL) level or reduced rate of disease progression/functional decline.

Prescriber: neurologist or neuromuscular specialist (or documented consultation)
Genetic test results: confirm SOD1 mutation
Baseline ALSFRS-R score: must be documented
Reauthorization evidence: reduced plasma NfL or slowed functional decline

Denial Risk

Not Medically Necessary for Unlisted Indications

Use of Qalsody for indications not listed in this policy is considered not medically necessary and may be denied. For other indications, refer to the Off‑Label policy.

Administration and Site of Care

Note

Administration route — intrathecal

Qalsody is administered intrathecally; the policy does not specify or limit the site of care beyond this route of administration.

Dose/route: 100 mg intrathecally (loading: every 14 days ×3; maintenance: every 28 days).

Quantity and Dosing Limits

Qalsody (tofersen) — quantity

Quantity limit1 vial per 28 days (maintenance)

Applicable phaseMaintenance (after 3 loading doses)

Unit periodPer 28 days

Qalsody (tofersen) — dose

Dose per administration100 mg (15 mL) intrathecally per dose

RouteIntrathecal (IT)

Dose scheduleEvery 14 days for 3 loading doses, then every 28 days for maintenance

Step Therapy

Step	Requirement
No step therapy steps specified for Qalsody in this policy.	No step therapy requirements are defined in the policy; prior authorization is required and coverage is determined by meeting the clinical criteria for initial authorization and reauthorization.

Definitions

Accelerated approval — definition

DefinitionFDA approval based on a surrogate marker (reduction in plasma neurofilament light chain [NfL]) that is reasonably believed to predict clinical benefit; confirmatory clinical trials are pending.

ContextQalsody's indication for SOD1-ALS was approved under accelerated approval based on NfL reduction.

ImplicationContinued approval may depend on results of confirmatory trials.

ALSFRS-R — definition

DefinitionALS Functional Rating Scale Revised (ALSFRS-R): a measure of clinical function used as a baseline and outcome assessment.

Role in policyDocumentation of baseline ALSFRS-R score is required for initial authorization.

Use in reauthorizationChart notes documenting reduced rate of functional decline (ALSFRS-R) may support reauthorization.

Background

Qalsody (tofersen) is an antisense oligonucleotide therapy indicated for adults with amyotrophic lateral sclerosis (ALS) caused by a confirmed SOD1 gene mutation. The agent received accelerated approval based on a surrogate biomarker—reduction in plasma neurofilament light chain (NfL)—with confirmatory trials pending. Per the policy, treatment is provided under prior authorization with specific clinical and documentation requirements including age ≥ 18, neurologist involvement, genetic confirmation of SOD1 mutation, baseline ALSFRS‑R, and specified intrathecal dosing (100 mg) and monitoring; reauthorization requires documentation of a positive clinical response (for example, reduced plasma NfL or slowed functional decline).