CurrentAvMedPolicy N/A

edaravone IV (Radicava IV) (Medical)

Prior authorization form and medical policy criteria for coverage of edaravone IV (Radicava) for treatment of amyotrophic lateral sclerosis (ALS), including initial and reauthorization clinical requirements, dosing schedules, prescriber qualifications, and utilization limits.

Policy Summary

PayerAvMed

Policyedaravone IV (Radicava IV) (Medical)

Policy CodePolicy N/A

Change TypeNo material change noted

Effective Date

Next Review Date

Key ActionPrescriber must sign and complete the PA form with required member/prescriber/drug information, select El Escorial diagnosis, provide ALSFRS-R item scores, %FVC within 6 months, disease duration documentation, riluzole status, and fax to 1-877-535-1391.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes noted in this brief.

86Max doses per 180-day initial period

6 moInitial authorization duration

12 moReauthorization duration

>=18Minimum age

Coverage Summary

Coverage stance: edaravone IV (Radicava IV) is covered with criteria for outpatient (Part B) when the prior authorization form requirements and clinical criteria are met. This policy is a prior authorization form and medical policy for outpatient (Part B) coverage of edaravone IV and requires completion of the form and submission of supporting documentation as specified.

Eligibility thresholds and authorization limits

%FVC (respiratory function)>= 80% (test within last 6 months; must be attached)

Disease duration<= 2 years (progress notes must document date of onset)

ALSFRS-R item score>= 2 points on each individual item (ALSFRS-R scores must be submitted)

Minimum age>= 18 years

Initial authorization duration6 months (no more than 86 doses over 180 days)

Reauthorization duration12 months (no more than 86 doses over 180 days)

Maximum doses per 180-day period86 doses

Dosing / Treatment Regimens

Utilization limits and dosing cycles: initial authorization duration is up to 6 months with a maximum of 86 doses per 180 days, and reauthorization is 12 months with no more than 86 doses per 180 days. Recommended cycle patterns on the form are: for new starts, 60 mg daily x 14 days then a 14-day drug-free period, then 60 mg daily for 10 days out of the next 14-day period followed by a 14-day drug-free period; for renewals, 60 mg daily for 10 days out of a 14-day period followed by a 14-day drug-free period. These limits and regimens apply in the outpatient (Part B) administration context.

Administrative / Form Requirements

Prior Authorization

Submit completed PA form with required documentation

Submit the completed prior authorization form with all required documentation. Fax the signed and completed form to 1-877-535-1391. Required items to include on the PA form: diagnosis and drug/dosing information, ALSFRS-R item scores, %FVC (within last 6 months), disease duration documentation, riluzole status. Applicable billing code: J1301 (Edaravone, intravenous).

Prescriber signature and printed name (preprinted stamps not valid)
Member and prescriber information, drug name/form/strength, dosing schedule and length of therapy
ALSFRS-R item scores
%FVC result completed within last 6 months
Progress notes documenting disease duration and riluzole status

Documentation Required

Attach objective clinical data

Attach objective clinical data to support the request. Include ALSFRS-R item scores, %FVC results completed within the last 6 months, progress notes documenting date of symptom onset or diagnosis and prior therapies, and an explanation if riluzole is not tolerated or contraindicated.

ALSFRS-R scores (all individual item scores)
%FVC result (test within last 6 months)
Progress notes documenting disease duration (date of onset or diagnosis) and prior therapies
Explanation if riluzole intolerance or FDA-labeled contraindication

Prior Authorization

Prescriber specialty requirement

Prescriber must be a neurologist, a neuromuscular disease specialist, or a physician specializing in the treatment of ALS — or the request must document consultation with one of these specialists.

Neurologist
Neuromuscular disease specialist
Physician specializing in ALS

Denial Risk

Incomplete documentation may delay or result in denial

Incomplete, incorrect, or illegible information or missing signatures may delay processing or result in denial of the authorization request. Ensure all required fields and a valid prescriber signature are provided.

Missing or illegible prescriber signature (preprinted stamps not valid)
Incomplete member, prescriber, or drug information
Unclear or missing documentation attachments

Billing Rule

Utilization limit per authorization period

Utilization limits per authorization period: Initial authorization — up to 86 doses over 180 days (initial duration 6 months). Reauthorization — no more than 86 doses over 180 days with authorization duration 12 months. Applicable billing code: J1301 (Edaravone, intravenous).

Initial: up to 86 doses / 180 days (6-month initial authorization)
Reauthorization: ≤86 doses / 180 days; authorization duration 12 months
Code: J1301

Background & Definitions

Background and form-captured elements: This document is a prior authorization form used to determine medical policy coverage for outpatient (Part B) edaravone IV (J1301). It references Medicare coverage rules and local determinations. The form captures dosing and treatment regimen selection, diagnosis per the El Escorial revised criteria (selecting the appropriate ALS category), detailed ALSFRS-R item scores, %FVC (must be documented within the last 6 months), disease duration (progress notes documenting date of symptom onset or diagnosis), and concomitant riluzole use or documented contraindication/intolerance. Administrative requirements include prescriber signature, complete member and prescriber information, and site of administration or specialty pharmacy details; incomplete information may delay authorization.

El Escorial (revised) Criteria

ALSFRS-R and Other Definitions

Medicare Determinations

Medicare determinations: Medicare coverage for outpatient (Part B) drugs is noted per the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50, and National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) may exist and must be followed where applicable. Local determinations apply as stated on the form and additional indications may be covered at the health plan's discretion.

Revision History

initial_authorization

Initial authorization: up to 6 months (no more than 86 doses over 180 days). Criteria require: prescribed by or in consultation with a neurologist/neuromuscular disease specialist/ALS specialist; patient ≥18 years; diagnosis of 'definite' or 'probable' ALS per the El Escorial criteria; ALSFRS-R item scores of ≥2 on each item (must be submitted); %FVC ≥80% at start of treatment with test within last 6 months; disease duration ≤2 years (progress notes must document date); no history of spinal surgery after ALS onset; and use with riluzole unless contraindicated or intolerant (explanation required). Recommended new-start dosing: 60 mg IV daily x14 days then 14-day drug-free, then 60 mg daily for 10 of 14 days followed by 14-day drug-free. Number of 28-day cycles requested must be specified.

dosing_regimen

Renewal dosing: 60 mg IV daily for 10 days out of a 14-day period followed by a 14-day drug-free period.

reauthorization

Reauthorization: 12 months (no more than 86 doses over 180 days). Criteria require meeting all initial authorization requirements, not requiring invasive ventilation, and prescriber documentation that the member continues to benefit from therapy.

administrative_requirements

Form completion rules: prescribing physician must sign and clearly print name (preprinted stamps not valid); all required member and prescriber information must be provided or authorization can be delayed; use of samples to initiate therapy does not meet preauthorization criteria. Fax completed form to 1-877-535-1391. Medicare Part B coverage and applicable NCDs/LCDs must be followed.