CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Radicava ORS (edaravone) — Coverage Criteria for Amyotrophic Lateral Sclerosis (ALS)

Defines coverage and authorization criteria for Radicava ORS (oral edaravone) for treatment of amyotrophic lateral sclerosis (ALS) for Medicaid members when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRadicava ORS (edaravone) — Coverage Criteria for ALS

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization with documentation of age ≥18, diagnosis of clinically definite or probable ALS, disease duration ≤2 years, %FVC ≥80%, and baseline ALSFRS‑R item scores of 2 or better.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization period

≥ 80%minimum %FVC

50 ml/28dquantity limit

70 ml/28dinitial post-limit

105 mgoral dose

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inv-01: Initial Therapy (6-month authorization)

Covered when ALL of the following are met:

Initial authorization criteria: 1. Member is 18 years of age or older; 2. Diagnosis of clinically definite or probable amyotrophic lateral sclerosis (ALS); 3. Disease duration of 2 years or less; 4. Percent-predicted forced vital capacity (%FVC) >= 80%; 5. Baseline retained functionality for most activities of daily living, defined as a score of 2 or better on each individual ALSFRS-R item; 6. Radicava ORS will not be used in combination with other formulations of edaravone (e.g., intravenous).

Authorization of 6 months may be granted when all criteria are met.

inv-02: Continuation Therapy (6-month authorization)

Covered when ALL of the following are met:

Continuation authorization criteria: 1. Ongoing diagnosis of clinically definite or probable amyotrophic lateral sclerosis (ALS); 2. Percent-predicted forced vital capacity (%FVC) >= 80%; 3. Member has responded to therapy compared to pretreatment baseline with disease stability or mild progression indicating a slowing of decline on the ALSFRS-R; 4. Cumulative ALSFRS-R score is greater than 3 (not <= 3); 5. No unacceptable toxicity from the drug (examples: hypersensitivity, anaphylaxis, sulfite allergic reactions); 6. Respiratory status does not require invasive ventilation or tracheostomy; 7. Radicava ORS will not be used in combination with other formulations of edaravone (e.g., intravenous).

Authorization of 6 months may be granted for continuation when all criteria met.

inv-03: Not covered / Experimental

Non-FDA indications: All other indications beyond FDA-approved ALS are considered experimental/investigational and not medically necessary.

Use of Radicava ORS in any circumstance that involves concurrent administration with another formulation of edaravone (for example, intravenous edaravone) is excluded. The policy requires that Radicava ORS will not be used in combination with other formulations of edaravone, and documentation confirming absence of combined edaravone therapy is required for authorization and may be a basis for denial if combination therapy is evident.

Radicava ORS is FDA‑approved only for the treatment of amyotrophic lateral sclerosis (ALS). Any use of Radicava ORS for indications other than ALS is considered experimental/investigational and not medically necessary and therefore is excluded from coverage.

Medication Dosing, Quantity Limits, and Key Metrics

Medication dosingmixed

Dose: 105 mg (5 mL)

Oral Radicava ORS dose per administration as specified in policy

inv-07: %FVC — minimum percent-predicted forced vital capacity required for authorization

Minimum %FVC for authorization%FVC ≥ 80%

Applies to initial authorizationRequired as part of initial criteria for 6-month approval

Applies to continuationRequired for continuation approvals as documented in continuation criteria

inv-08: Quantity limit — standard and initial post-limit quantities

Standard quantity limit50 ml per 28 days

Initial post-limit allowance70 ml per 28 days (for initial treatment cycle)

Authorized dosing per administration105 mg (5 mL) per dose

Prescribing, Documentation, and Authorization Requirements

Prior Authorization

Prior Authorization Required — Documentation and Required Clinical Criteria

Prior authorization is required. Submit documentation that meets the clinical criteria listed in the Initial and Continuation authorization callouts. Requests may be denied if required documentation is missing or the indication is not amyotrophic lateral sclerosis (ALS).

Prior authorization required for Radicava ORS (edaravone)
Do not combine with other edaravone formulations (e.g., intravenous)

Documentation Required

Specialist Prescriber Requirement

This medication must be prescribed by or in consultation with a neurologist, neuromuscular specialist, or physician specializing in the treatment of amyotrophic lateral sclerosis (ALS).

Documentation Required

Initial Authorization Documentation

Initial authorization (up to 6 months) — submit documentation of all the following at time of request: 1) Member is ≥ 18 years of age; 2) Diagnosis of clinically definite or probable ALS; 3) Disease duration ≤ 2 years; 4) Percent-predicted forced vital capacity (%FVC) ≥ 80%; 5) Baseline ALS Functional Rating Scale - Revised (ALSFRS-R) demonstrating retained functionality for most activities of daily living (score of 2 or better on each individual item, corresponding to a minimum total score ~24); 6) Statement that Radicava ORS will not be used concurrently with other edaravone formulations (e.g., IV).

Authorization length: up to 6 months
Age: ≥ 18 years
Diagnosis: clinically definite or probable ALS
Disease duration: ≤ 2 years
%FVC: ≥ 80%
ALSFRS-R: score ≥2 on each item (minimum total ≈24)
No concurrent use with IV edaravone

Documentation Required

Continuation Authorization Documentation — Ongoing Approval Requirements

For continuation/renewal, submit documentation demonstrating ongoing benefit and safety: 1) Confirmation of ongoing diagnosis of ALS; 2) Evidence of clinical response compared to pretreatment baseline — disease stability or mild progression indicating slowing of decline on the ALSFRS-R (no rapid progression on therapy); 3) Cumulative ALSFRS-R score > 3 (member does not have a cumulative score ≤ 3); 4) No unacceptable toxicity from drug (e.g., hypersensitivity, anaphylaxis, sulfite allergic reactions); 5) Respiratory status does not require invasive ventilation or tracheostomy; 6) Continued absence of concurrent use with other edaravone formulations (e.g., IV).

Documented clinical response or disease stability vs baseline on ALSFRS-R
Cumulative ALSFRS-R score must be > 3
No unacceptable toxicity
No invasive ventilation or tracheostomy requirement
No concurrent IV edaravone use

Background

Edaravone (Radicava ORS) is approved by the FDA for the treatment of amyotrophic lateral sclerosis (ALS). Clinical assessment for initiation and continuation relies on the ALS Functional Rating Scale—Revised (ALSFRS‑R), a 12‑item instrument that measures functional status across bulbar, fine motor, gross motor, and respiratory domains; each item is scored 0–4 with a maximum total of 48. Continuation decisions require documentation of clinical response as reflected by stability or slowed decline on the ALSFRS‑R compared with pretreatment baseline and avoidance of severe functional loss (the policy specifies that the member must not have a cumulative ALSFRS‑R score of ≤ 3).

Definitions and Measurement Tools

inv-16: ALSFRS-R — description of the 12-item functional rating scale

Scale descriptionALS Functional Rating Scale - Revised (ALSFRS-R): 12-item questionnaire assessing functional progression across bulbar, fine motor, gross motor, and respiratory domains; each item scored 0-4 with total possible 48.

Scoring interpretationEach item scored 0 (loss/significant impairment) to 4 (normal); a score of 2 or better on each item corresponds to a minimum cumulative score of 24.

Use for authorizationBaseline documentation requires score of 2 or better on each individual ALSFRS-R item for initial approval; continuation requires stability or slowed decline compared to pretreatment baseline.

inv-17: %FVC — definition of percent-predicted forced vital capacity and authorization threshold

DefinitionPercent-predicted forced vital capacity (%FVC) is a measure of respiratory function used to assess eligibility for therapy.

Authorization threshold%FVC must be greater than or equal to 80% (%FVC ≥ 80%) for both initial and continuation approvals.

Documentation requirementClinical documentation must include measured percent-predicted FVC meeting the ≥80% threshold at time of request.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRadicava ORS (edaravone) — Coverage Criteria for ALS

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2023

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Radicava ORS (edaravone) — Coverage Criteria for Amyotrophic Lateral Sclerosis (ALS)

Coverage Criteria for Radicava ORS (edaravone)

Medication Dosing, Quantity Limits, and Key Metrics

Prescribing, Documentation, and Authorization Requirements

Background

Definitions and Measurement Tools