• Edaravone (Radicava^® ) intravenous infusion for administration by a healthcare professional

• For treatment of amyotrophic lateral sclerosis (ALS)

The restricted product(s) may be considered medically necessary when the following criteria are met: 

Initial Criteria for Approval: 

1. The patient is 18 years of age or older; AND
2. The patient has a diagnosis of amyotrophic lateral sclerosis (ALS) [medical record documentation required]; AND 
3. The patient has been diagnosed within the last 2 years [medical record documentation required]; AND 
4. The patient has normal respiratory function (i.e., FVC ≥ 80%) [medical record documentation required]; AND
5. The patient is able to live independently [medical record documentation required]; OR 
6. The patient has retained most activities of daily living, defined as scores of 2 points or better on each individual item of the ALS Functional Rating Scale – Revised (ALSFRS-R) [medical record documentation required]; AND
7. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
8. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

Duration of Approval: 180 days (6 months)

Continuation Criteria for Approval: 

1. The patient was approved through Blue Cross NC initial criteria for approval; OR 
2. The patient would have met initial criteria for approval at the time they started therapy; AND
3. The patient has had continued clinical benefit while on edaravone (Radicava^® ) therapy, indicated by slowing of the progression of symptoms relative to that of the projected natural course of ALS (e.g., disease stability or mild progression demonstrating a slowing of decline on the ALSFRS-R, absence of rapid disease progression while on therapy) [medical record documentation required]; AND 
4. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
5. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)* 

Duration of Approval: 365 days (1 year)

1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR 
2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met:
   1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR 
   2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR 
   3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR 
      1. Re-initiation of therapy, defined as ONE of the following:
      2. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR
   4. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR e. Requirement of a change in the requested restricted product formulation; AND
3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional.

All information referenced is from FDA package insert unless otherwise noted below.

1. Cedarbaum JM, Stambler N, Malta E, et al. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. J Neurol Sci. 1999;169(1-2):13-21. 

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

June 2022: Criteria update: Updated length of authorization for continuation criteria to 365 days (1 year) and adjusted maximum units for continuation.

June 2021: Criteria change: Added maximum units; added clarification of continued clinical benefit for continuation section; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.