Radicava (edaravone) (Intravenous) — Coverage Criteria
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Defines prior authorization, dosing limits, eligibility, renewal, and billing for intravenous edaravone (Radicava) for treatment of amyotrophic lateral sclerosis (ALS) for Eocco members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Intravenous Edaravone (Radicava)
Initial Therapy
Covered when ALL of the following are met
Minimum cumulative score implied = 24
Renewal Criteria
Renewal is allowed when ALL of the following are met
Member has not experienced rapid disease progression while on therapy
A cumulative score of 3 indicates loss/significant impairment in nine or more items
Use of intravenous edaravone (Radicava) in combination with other formulations of edaravone (for example, oral edaravone) is excluded. Therapy must not be prescribed or administered concurrently with any other edaravone formulation.
Therapy is not supported when the member does not meet the documented diagnostic criteria for ALS (clinically definite or probable ALS based on El Escorial revised, Gold Coast, or Awaji criteria).
Treatment is not supported for members with disease duration greater than 2 years, or with impaired respiratory function below the policy threshold of %FVC < 80%.
Baseline functional status must demonstrate retained activities of daily living with item-level scores of 2 or better on each ALSFRS-R item; therapy is not supported when baseline function is not preserved. Additionally, renewal may be denied for unacceptable toxicity (for example, hypersensitivity, anaphylaxis, or sulfite reactions) or for rapid disease progression while on therapy.
Billing and Diagnosis Codes
| J1301 | Injection, edaravone, 1 mg; 1 billable unit = 1 mg |
| 70510-2171-xx | Radicava 30 mg/100 mL single-dose bag: 70510-2171-xx |
| G12.21 | Amyotrophic lateral sclerosis |
Provider Requirements, Documentation, and Denials
Prior authorization validity
Prior authorization is required for Radicava (edaravone). Initial approvals are valid for 6 months (180 days); renewals may be issued every 12 months (365 days) thereafter.
Concomitant formulation restriction
Edaravone intravenous therapy must not be used in combination with other edaravone formulations (for example, oral edaravone).
Required clinical documentation
Required clinical documentation must demonstrate the ALS diagnosis, disease duration, baseline functional and respiratory status, and for renewals, response to therapy.
- Documentation of diagnosis meeting El Escorial revised criteria, Gold Coast criteria, or Awaji criteria (clinically definite or probable ALS).
- Record of disease duration showing ≤ 2 years.
- Baseline ALSFRS-R item scores with a score of 2 or better on each individual ALSFRS-R item.
- Baseline percent-predicted forced vital capacity (%FVC) showing ≥ 80%.
- For renewals, documentation of clinical response on ALSFRS-R demonstrating disease stability or mild progression (no rapid progression) and absence of unacceptable toxicity.
Denial triggers
Prior authorization may be denied when the member does not meet age, diagnostic, duration, respiratory, or other policy requirements, or when universal exclusions apply.
- Member is younger than 18 years of age.
- Diagnosis does not meet El Escorial revised, Gold Coast, or Awaji criteria for clinically definite or probable ALS.
- Disease duration exceeds 2 years.
- Percent-predicted FVC is below 80%.
- Baseline functional status is not preserved (ALSFRS-R item scores < 2 on individual items).
- Concurrent use of other edaravone formulations (e.g., oral) or other universal criteria not met.
- Unacceptable toxicity from the drug (examples: hypersensitivity, anaphylaxis, sulfite allergic reactions) or rapid disease progression while on therapy.
Assessment Tools and Clinical Definitions
Background
Edaravone (Radicava) is indicated for the treatment of amyotrophic lateral sclerosis (ALS) to slow functional decline. The policy addresses the intravenous formulation administered as infusions, with eligibility emphasizing early disease (disease duration ≤ 2 years), preserved respiratory function (percent-predicted forced vital capacity %FVC ≥ 80%), and preserved baseline activities of daily living as measured by the ALSFRS-R (individual item scores ≥ 2).
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