CurrentMass General Brigham Health PlanPolicy N/A

Radicava (edaravone injection) — Medical‑Benefit Prior Authorization for ALS

Medical-benefit prior authorization criteria for Radicava (edaravone injection) for members with amyotrophic lateral sclerosis (MassHealth). Affects providers requesting medical-administered edaravone under Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRadicava (edaravone injection) — Medical‑Benefit prior authorization for ALS

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation including prescriber specialty, El Escorial diagnostic evidence, pre-treatment ALSFRS-R within 12 weeks, and pre-treatment FVC ≥ 80%.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsapproval duration

≥80%FVC threshold

Within 12 wksALSFRS-R timing

Neurologist/ALS specialistPrescriber specialty

Coverage Criteria for Radicava (edaravone injection)

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Initial Therapy

Covered when ALL of the following are met:

Prescriber is a neurologist, neuromuscular specialist, or other specialist in the treatment of ALS, or consult notes from specialist are provided

Diagnosis: Medical records supporting the diagnosis of definite, probable, or probable‑laboratory supported ALS per El Escorial criteria

Pre-treatment ALSFRS-R questionnaire score within the past 12 weeks

Functional items and respiratory status

Functional items: Pre-treatment ALSFRS-R questionnaire score of ≥ 2 on each individual item≥ 2 per item
Respiratory function: Pre-treatment FVC ≥ 80%≥ 80%
Ventilation: Member is not dependent on invasive mechanical ventilation by intubation or tracheostomy

Dosing: Appropriate dosing

Policy specifies appropriate dosing is required

Riluzole requirement: Either Radicava will be used in combination with riluzole OR there is an adverse reaction/contraindication to riluzole

Continuation of Therapy

Reauthorization may be granted when BOTH of the following are met:

Current ALSFRS-R: A current ALSFRS-R questionnaire including scores on each individual domain (within the past 12 weeks)

Ventilation: Member is not dependent on invasive mechanical ventilation by intubation or tracheostomy

Members who are dependent on invasive mechanical ventilation by intubation or tracheostomy are excluded from approval under these coverage criteria.

Requests for initiation do not meet criteria when the member has a pre-treatment forced vital capacity (FVC) of < 80% or when any individual item on the pre-treatment ALSFRS‑R questionnaire is scored < 2.

Coding and Measurement Requirements

Covered/Referenced Codesmixed

NDC/HCPCS not listed

No specific HCPCS, CPT, or NDC codes are listed in the document; policy notes both brand and A-rated generic require PA.

Pre-treatment FVC

Pre-treatment FVC threshold≥ 80%

When measuredBaseline (pre-treatment) evaluation

Role in decisionRequired for initial authorization; FVC < 80% does not meet initiation criteria

ALSFRS-R timing

Required timingALSFRS-R must be performed within the past 12 weeks for initial authorization and for reauthorization

DocumentationMedical records must include the ALSFRS-R questionnaire scores (including individual item scores) dated within 12 weeks

Reauthorization useA current ALSFRS-R within 12 weeks is required to support continuation of therapy

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Radicava (edaravone injection) when billed under the medical benefit. Ensure authorization is obtained before initiating therapy.

Medical benefit only (Radicava is also available on the pharmacy benefit; see MassHealth Drug List for pharmacy criteria).
Contact for medical benefit prior authorization: Phone: 833-895-2611; Fax: 888-656-6671.

Step Therapy

No step therapy requirements are specified for Radicava under this policy.

Documentation Required

Required Documentation

Documentation must be provided to support the request. Include objective diagnostic criteria, baseline and ongoing functional scores, and treatment rationale.

Prescriber specialty: treating neurologist, neuromuscular specialist, or other specialist in ALS; or include consult notes from an ALS specialist.
Medical records confirming diagnosis meeting El Escorial criteria (definite, probable, or probable-laboratory supported ALS).
Pre-treatment ALSFRS‑R questionnaire score obtained within the past 12 weeks.
Individual item scores on the ALSFRS‑R (each item score must be documented).
Pre-treatment forced vital capacity (FVC) value (must be documented and ≥ 80% for initial authorization).
Documentation that the member is not dependent on invasive mechanical ventilation (intubation or tracheostomy).
For continuation/reauthorization: a current ALSFRS‑R (including each individual domain score) within the past 12 weeks and documentation member remains not dependent on invasive mechanical ventilation.
If requesting Radicava in lieu of or instead of riluzole, include documentation of adverse reaction or contraindication to riluzole; otherwise note intended use in combination with riluzole.

Denial Risk

Triggers for Denial

Requests may be denied if required documentation or clinical thresholds are not met.

Missing or incomplete documentation of diagnosis per El Escorial criteria.
No ALSFRS‑R score available within the past 12 weeks (pre-treatment for initial requests; current for reauthorization).
Individual ALSFRS‑R item scores not documented or any individual item score < 2 at baseline (initial therapy requirement).
Pre-treatment FVC < 80% for initial authorization.
Member is dependent on invasive mechanical ventilation (intubation or tracheostomy).
Prescriber is not a neurologist/neuromuscular specialist or no specialist consult notes provided when required.
Inadequate documentation regarding concomitant use with riluzole or valid contraindication/allergy to riluzole when not used in combination.

Definitions and Measurement Tools

El Escorial criteria

DefinitionEl Escorial criteria: diagnostic standards used to confirm definite, probable, or probable‑laboratory supported ALS

Required evidenceMedical records must support diagnosis per El Escorial criteria for initial authorization

Reference sourcesPolicy references World Federation of Neurology / El Escorial diagnostic standards (see references)

ALSFRS-R

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

What it measuresFunctional status across multiple domains including respiratory function; includes individual item scores

Use in policyRequired questionnaire for baseline and ongoing assessment; individual item scores must be ≥ 2 for initiation