CurrentCignaPolicy N/A

Edaravone (Radicava) prior authorization for ALS — Coverage Criteria

This form governs prior authorization requests for IV Radicava (edaravone) and Radicava ORS for patients, primarily addressing use for amyotrophic lateral sclerosis (ALS), and outlines required clinical documentation and site-of-care considerations for Cigna-covered members and providers.

Policy Summary

PayerCigna

PolicyEdaravone (Radicava) prior authorization for ALS — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionAttach supportive clinical documentation (chart notes, lab/test results) demonstrating a definite or probable ALS diagnosis per El Escorial or revised Airlie House criteria when requesting edaravone.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for prescription drug coverage requests

requires supportive documentationclinical documentation requirement (chart notes, labs, tests)

AccredoCigna's nationally preferred specialty pharmacy

ALSexplicit diagnosis option on form

Coverage Criteria for Edaravone (Radicava)

Initial therapy

Covered when ALL of the following are met (documented on form and with attachments):

Initial therapy ALS criteria: Patient has a definite or probable diagnosis of ALS per El Escorial or revised Airlie House diagnostic criteria (documentation attached).all must be true

The prior authorization form asks whether documentation is being provided that the patient has a 'definite' or 'probable' ALS diagnosis; supportive documentation (chart notes, labs, tests) must be attached.

Functional status: Patient retains most or all activities of daily living, defined as a score of 2 points or better on each item of the ALSFRS-R (answer 'Yes' on form).all must be true

The form queries ALSFRS-R functional status for initial therapy; documentation should support the response.

Policy Summary

PayerCigna

PolicyEdaravone (Radicava) prior authorization for ALS — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Continuation therapy

Continuation therapy requires documentation:

Current therapy status: Prescriber indicates the patient is currently receiving Radicava IV (edaravone) or Radicava ORS on the form.all must be true

The medication request section captures whether the request is for initial therapy or the patient is currently receiving therapy.

Attestation of benefit: Prescriber attests that the patient continues to benefit from therapy (answer 'Yes' when asked if the patient continues to benefit).all must be true

If the prescriber answers 'No', the form requests supporting rationale for continued use.

Ventilation status: Prescriber documents whether the patient requires invasive ventilation (form asks 'Does your patient require invasive ventilation?').all must be true

Continuation requests must note invasive ventilation status as queried on the form.

Supporting documentation attached: Documentation to support continued clinical benefit is attached (chart notes, lab/test results, and other relevant records).all must be true

The form states that supportive documentation for all answers must be attached; failure to attach documentation may result in denial.

A request may be denied if the documentation does not confirm a definite or probable diagnosis of ALS using the El Escorial or revised Airlie House criteria, or if the required supportive clinical documentation is not attached. The form explicitly states that supportive documentation (for example, chart notes, laboratory tests, claims records, or other pertinent information) must be attached with the request and that medical documentation specific to the diagnostic question must be included or the request could be denied. When documentation is missing or does not meet the referenced diagnostic criteria, submitters should provide the required attachments or additional clinical information to avoid denial.

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for edaravone products. Submit a prior authorization request when prescribing Radicava IV or Radicava ORS and include medication name, dose, quantity, duration of therapy, J‑code (if applicable), frequency of administration, and ICD‑10 diagnosis code.

A completed prior authorization form for Radicava IV or Radicava ORS
Medication, dose, quantity, and duration fields completed

Documentation Required

Required Supportive Clinical Documentation

Attach all supportive clinical documentation with this request. Failure to provide chart notes, laboratory or test results, or other required documentation may result in denial.

Attach chart notes documenting diagnosis and course of illness
Attach relevant lab/test results and specialist consultation notes
Include documentation that diagnosis meets El Escorial or revised Airlie House criteria when ALS is the indication

Documentation Required

Continuation Therapy Attestation

If this is continuation therapy, the prescriber must attest that the patient continues to benefit from edaravone and indicate whether the patient requires invasive ventilation. For patients currently receiving therapy, include documentation of ongoing clinical benefit and current ventilation status.

Prescriber attestation of ongoing benefit for patients currently receiving Radicava IV or Radicava ORS
Document whether the patient requires invasive ventilation (Yes/No)

Documentation Required

Riluzole Prior Therapy Documentation

Document prior use of riluzole before approving edaravone for initial therapy. Indicate whether the patient has received or is currently receiving riluzole (tablets), Tiglutik (oral suspension), or Exservan (oral film).

Indicate prior or current use of riluzole tablets, Tiglutik (riluzole oral suspension), or Exservan (riluzole oral film)
If yes, include dates and documentation of response or intolerance

Denial Risk

Documentation-Dependent Denial Risk

Failure to attach required documentation or to demonstrate that the diagnosis meets the specified diagnostic criteria (e.g., definite/probable ALS per El Escorial or revised Airlie House) or to provide required attestation may result in denial of the request.

Missing chart notes, labs, or diagnostic criteria documentation increases denial risk
Omissions in prescriber attestation for continuation therapy may lead to denial

Background

Edaravone (Radicava) is listed on the form for treatment of amyotrophic lateral sclerosis (ALS). For initial therapy the form requires documentation that the patient meets a definite or probable ALS diagnosis per the El Escorial or the revised Airlie House diagnostic criteria, and it requests assessment of functional status and respiratory function (including ALSFRS-R scoring and whether invasive ventilation is required). The form also asks whether the patient has received riluzole and whether the medication was prescribed by or in consultation with a neurologist or ALS specialist. Supportive documentation (chart notes, lab/test results, etc.) must be attached to the request.

Definitions and Clinical Scales

Definite or probable ALS (El Escorial or revised Airlie House criteria)

Required diagnostic categoryDocumented 'definite' or 'probable' diagnosis of ALS per El Escorial or revised Airlie House criteria (documentation attached)

Documentation types acceptedChart notes, laboratory tests, claims records, and/or other supporting information must be attached

When requiredRequested for initial therapy authorization (explicit question on the form)

Consequence of missing documentationMedical documentation must be attached or the request could be denied

ALSFRS-R functional status

Definition of retained ADLsPatient retains most or all activities of daily living defined as a score of 2 points or better on each item of the ALSFRS-R

When assessedAsked for initial therapy requests (explicit question on the form)

Answer options on formYes / No response required on the prior authorization form

Documentation requirementSupportive documentation (chart notes, lab/tests) must be attached with the request

OpenPayer

Edaravone (Radicava) prior authorization for ALS — Coverage Criteria

Coverage Criteria for Edaravone (Radicava)

Billing and Diagnosis Codes

What Providers Must Do

Background

Definitions and Clinical Scales