CurrentViva HealthPolicy IC-0305

Radicava (edaravone) (Intravenous) — Prior Authorization Coverage Criteria

Prior authorization policy for intravenous edaravone (Radicava) for treatment of amyotrophic lateral sclerosis (ALS). Specifies initial and renewal authorization lengths, dosing units, eligibility criteria, and required documentation.

Policy Summary

PayerViva Health

PolicyRadicava (edaravone) IV — Prior authorization coverage criteria

Policy CodePolicy IC-0305

Change TypeRoutine review — no material changes

Effective DateJul 1, 2025

Next Review DateJul 1, 2025

Key ActionObtain prior authorization: initial approval up to 6 months with renewals available every 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization duration

12 monthsrenewal prior authorization duration

J1301HCPCS code billed (1 mg/unit)

G12.21Covered diagnosis code (ALS)

≥80%%FVC eligibility threshold

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Initial Therapy

Covered when ALL of the following are met

Age: Patient is at least 18 years of age18+

Formulation: Will not be used in combination with other formulations of edaravone (i.e., oral)

Diagnosis of clinically definite or probable ALS based on El Escorial revised criteria, Gold Coast criteria, or Awaji criteria

FDA-approved indication

Disease duration of 2 years or less≤ 2 years

Respiratory function: Percent-predicted forced vital capacity (%FVC) ≥ 80%%FVC ≥ 80%

Functional status: Baseline documentation of retained functionality for most activities of daily living (score of 2 or better on each individual ALSFRS-R item)item score ≥2 (implies total ≥24)

Renewal Therapy

Renewal covered when ALL of the following are met

Continued criteria: Patient continues to meet the universal and indication-specific relevant criteria identified for initial approval

Toxicity: Absence of unacceptable toxicity from the drug (examples: hypersensitivity reactions, anaphylaxis, sulfite allergic reactions)

Examples provided in policy

Clinical response: Patient has responded to therapy compared to pretreatment baseline with disease stability or mild progression indicating a slowing of decline on the ALSFRS-R (no rapid progression)

Severe impairment threshold: Patient does not have a cumulative ALSFRS-R score of ≤ 3total ALSFRS-R > 3

Use of intravenous edaravone (Radicava) in combination with other formulations of edaravone is not permitted. Edaravone must not be used in combination with oral edaravone or any other formulation of the same active agent.

Eligibility for initiation requires documentation that the patient meets diagnostic and functional thresholds: a diagnosis of clinically definite or probable ALS per the El Escorial revised, Gold Coast, or Awaji criteria; disease duration of ≤ 2 years; baseline respiratory function with percent-predicted forced vital capacity (%FVC ≥ 80%); and baseline functional status demonstrating retained activities of daily living with a score of 2 or better on each ALSFRS‑R item (which corresponds to a minimum total ALSFRS‑R score of 24).

For renewal, the patient must continue to meet the universal and indication-specific criteria, show absence of unacceptable drug-related toxicity (for example, hypersensitivity, anaphylaxis, or sulfite allergic reactions), and demonstrate clinical benefit defined as disease stability or slowed decline on the ALSFRS‑R compared with pretreatment baseline. Renewal is not appropriate for patients with rapid progression or unacceptable toxicity.

Coding, Dosing, and Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

J1301

Injection, edaravone, 1 mg; 1 billable unit = 1 mg

NDCsNDC

70510-2171-xx

Radicava 30 mg/100 mL single-dose bag

Covered Diagnosis CodesICD-10Covered

G12.21

Amyotrophic lateral sclerosis

%FVC

%FVC eligibility thresholdPercent-predicted forced vital capacity (%FVC) ≥ 80%

Documentation requirementBaseline %FVC must be documented prior to initiation

Renewal implicationPatients with %FVC < 80% do not meet coverage criteria

Initial dosing units and schedule

Initial dosing schedule (units)60 billable units daily for 14 days, followed by 14 days off per 28-day cycle (1 billable unit = 1 mg; initial cycle = 60 mg IV over 60 minutes)

Subsequent dosing (units per cycle)600 billable units per 28-day cycle (subsequent cycles: daily dosing 10 days out of each 14-day period with 14-day drug-free periods)

Administration detailsEach 60 mg dose administered as an intravenous infusion over 60 minutes

Provider Requirements, Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial prior authorization will be provided for 6 months; renewals may be approved for 12 months.

Initial authorization: 6 months
Renewal authorization: 12 months

Note

Formulation Restriction

Edaravone must not be used in combination with other formulations of edaravone (e.g., oral formulations).

Documentation Required

Required Clinical Documentation

For initial and renewal requests provide complete clinical documentation: diagnostic criteria used to establish ALS (El Escorial revised, Gold Coast, or Awaji), disease duration, baseline and ongoing ALSFRS‑R item scores (documentation that most ADLs retained: score ≥2 on each ALSFRS‑R item at baseline), and percent‑predicted FVC (must be ≥80% at baseline). For renewals include documentation of continued meeting of universal and indication‑specific criteria, absence of unacceptable toxicity, and objective evidence of clinical benefit or disease stabilization (ALSFRS‑R trajectory showing stability or slowed decline).

Diagnosis: clinically definite or probable ALS per El Escorial revised, Gold Coast, or Awaji criteria
Disease duration documented and ≤ 2 years (initial)
Baseline %FVC documented (≥ 80%)
Baseline ALSFRS‑R documented with score ≥2 on each item (minimum total ≥24 implied)
For renewals: documentation patient continues to meet criteria and has absence of unacceptable toxicity (e.g., hypersensitivity, anaphylaxis, sulfite reactions)
For renewals: documentation of response — disease stability or slowed decline on ALSFRS‑R compared to pretreatment baseline (not rapid progression)
For renewals: ensure cumulative ALSFRS‑R score is not ≤3 (indicating profound impairment)

Denial Risk

Renewal Denial Triggers

Renewal requests may be denied if any of the following apply: unacceptable toxicity attributable to edaravone (e.g., severe hypersensitivity, anaphylaxis, sulfite allergic reaction); lack of clinical benefit (no evidence of stabilization or slowed decline on ALSFRS‑R compared with pretreatment baseline or evidence of rapid progression); or the patient no longer meets universal or indication‑specific criteria (for example %FVC < required threshold, or ALSFRS‑R cumulative score ≤3).

Unacceptable toxicity (hypersensitivity reactions, anaphylaxis, sulfite allergy)
Lack of benefit: no stabilization or slowing of decline on ALSFRS‑R vs pretreatment baseline; rapid disease progression while on therapy
Failure to meet criteria: %FVC below required threshold or ALSFRS‑R cumulative score ≤ 3

Definitions and Assessment Scales

ALSFRS-R

InstrumentAmyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R): 12-item questionnaire assessing bulbar, fine motor, gross motor, and respiratory function; items scored 0–4; total range 0–48.

Item-level threshold for initiationBaseline score of ≥2 on each individual ALSFRS-R item (corresponds to minimum total score of 24)

Renewal severity thresholdCumulative ALSFRS-R score must be > 3 for renewal eligibility (a score of ≤3 is exclusionary)

Diagnostic criteria

Referenced diagnostic criteriaEl Escorial revised criteria

Referenced diagnostic criteriaGold Coast criteria

Referenced diagnostic criteriaAwaji criteria

Background

Edaravone (Radicava) is an intravenous therapy indicated for amyotrophic lateral sclerosis (ALS). This policy limits coverage to adults with relatively early disease and preserved function: patients must have disease duration ≤ 2 years, preserved respiratory function (%FVC ≥ 80%), and retained activities of daily living as documented by the ALS Functional Rating Scale‑Revised (ALSFRS‑R). The ALSFRS‑R is a 12‑item scale (items scored 0–4; total 0–48) assessing bulbar, fine motor, gross motor, and respiratory domains and is used to establish baseline function and monitor response to therapy.

Coverage and dosing follow the intravenous formulation billing units (HCPCS J1301 billed per mg) and align with prior authorization requirements and renewal criteria described elsewhere in the policy.

OpenPayer

Radicava (edaravone) (Intravenous) — Prior Authorization Coverage Criteria

Coverage Criteria for Radicava (edaravone)

Coding, Dosing, and Clinical Thresholds

Provider Requirements, Authorization and Documentation

Definitions and Assessment Scales

Background