MEDICAL COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 11/14/17 SECTION: DRUGS LAST REVIEW DATE: LAST CRITERIA REVISION DATE: ARCHIVE DATE:

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1 RADICAVA (edaravone) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Medical Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. O1029.docx Page 1 of 6

2 Description: Radicava (edaravone) was approved by the U.S. Food and Drug Administration (FDA) in May 2017 for the treatment of amyotrophic lateral sclerosis (ALS). It has been characterized as a free radical scavenger and antioxidant that may provide neuroprotection against oxidative stress. It is administered via intravenous infusions. Definitions: Adult: Age 18 years and older Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig s disease, is a rare disease that affects nerve cells in the brain and the spinal cord leading to progressive muscle weakness and premature death. Rilutek (riluzole) is the first FDA approved drug to treat ALS. It is an oral medication that acts to slow the progression ALS symptoms and prolong life. It protects motor nerves from further deterioration by reducing glutamate levels in the brain and spinal cord by blocking its release from nerve terminals. The ALS Functional Rating Scale-Revised (ALSFRS-R) is a questionnaire that measures and evaluates the decline in physical function over time. The scale consists of 12 questions that evaluate the fine motor, gross motor, bulbar, and respiratory function of individuals with ALS. Each item is scored from 0 to 4, with higher scores representing greater functional ability. The clinical standard for the diagnosis of ALS is the revised El Escorial World Federation of Neurology criteria. The degree of certainty of diagnosis is increased by the number of body regions that demonstrate upper motor neuron (UMN) and lower motor neuron (LMN) signs. The body is divided into 4 regions: cranial, cervical, thoracic, and lumbosacral. The categories of ALS are the following: Clinically Definite ALS: UMN and LMN signs in at least 3 body regions Clinically Probable ALS: UMN and LMN signs in at least 2 regions with UMN in a region above LMN signs Clinically Probable-Laboratory-Supported ALS: UMN and LMN signs in 1 region or UMN signs in 1 region coupled with LMN signs by electromyography (EMG) in at least 2 limbs Clinically Possible ALS: UMN and LMN signs in 1 body region, UMN signs alone in at least 2 regions, or LMN signs in regions above UMN signs Clinically Suspected ALS: Pure LMN syndrome with other causes of LMN disease adequately excluded. O1029.docx Page 2 of 6

3 Criteria: All requests for Radicava will be reviewed by the medical director(s) and/or clinical advisor(s). See Resources section for FDA-approved dosage. Initiation of Radicava, used in combination with Riluzole, is considered medically necessary for the treatment of adults with ALS with documentation of ALL of the following: 1. Functionality retained in 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) 2. Normal respiratory function defined by a percent-predicted forced vital capacity value (%FVC) of greater than or equal to 80% 3. Definite or probable ALS diagnosis based on El Escorial revised criteria 4. Disease duration of 2 years or less 5. No evidence of hypersensitivity reactions (e.g., redness, wheals, or erythema multiforme) to edaravone or any of the inactive ingredients 6. No evidence of sulfite allergic reactions (e.g., hives, wheezing, trouble breathing or swallowing, asthma exacerbation in individuals with asthma) Continuation of Radicava, used in combination with Riluzole, is considered medically necessary with documentation of ALL of the following: 1. Normal respiratory function retained with FVC of greater than or equal to 80% 2. Documented evidence of efficacy, disease stability and/or improvement by continuing to have scores of 2 points or better on each individual item of the ALSFRS-R score. Radicava for all other indications not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Lack of final approval from the Food and Drug Administration, and 2. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 3. Insufficient evidence to support improvement of the net health outcome, and 4. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 5. Insufficient evidence to support improvement outside the investigational setting. These indications include, but are not limited to: Treatment with dosing or frequency outside the FDA-approved dosing and frequency O1029.docx Page 3 of 6

4 Resources: Literature reviewed 11/14/17. We do not include marketing materials, poster boards and nonpublished literature in our review. 1. Abe K, Itoyama Y, Sobue G, et al. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. Dec 2014;15(7-8): Castrillo-Viguera C, Grasso DL, Simpson E, Shefner J, Cudkowicz ME. Clinical significance in the change of decline in ALSFRS-R. Amyotroph Lateral Scler. 2010;11(1-2): Costa J, Swash M, de Carvalho M. Awaji criteria for the diagnosis of amyotrophic lateral sclerosis:a systematic review. Arch Neurol. Nov 2012;69(11): Hardiman O, van den Berg LH. Edaravone: a new treatment for ALS on the horizon? Lancet Neurol. Jul 2017;16(7): Medscape, Armon C. Amyotrophic Lateral Sclerosis. 05/22/ UpToDate.com. Disease modifying treatment of amyotrophic lateral sclerosis. 06/01/ Writing G, Edaravone ALSSG. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. Jul 2017;16(7): Radicava Package Insert: - FDA-approved indication and dosage: Indication For the treatment of adult individuals with amyotrophic lateral sclerosis (ALS). Recommended Dose RADICAVA is for intravenous (IV) use only. Recommended dosage is 60 mg administered IV over 60 minutes as follows: Initial treatment cycle: daily dosing for 14 days followed by a 14 day drug-free period. Subsequent treatment cycles: daily dosing for 10 days out of 14- day periods, followed by 14-day drug free periods. O1029.docx Page 4 of 6

5 Non-Discrimination Statement: Blue Cross Blue Shield of Arizona (BCBSAZ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability or sex. BCBSAZ provides appropriate free aids and services, such as qualified interpreters and written information in other formats, to people with disabilities to communicate effectively with us. BCBSAZ also provides free language services to people whose primary language is not English, such as qualified interpreters and information written in other languages. If you need these services, call (602) for Spanish and (877) for all other languages and other aids and services. If you believe that BCBSAZ has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability or sex, you can file a grievance with: BCBSAZ s Civil Rights Coordinator, Attn: Civil Rights Coordinator, Blue Cross Blue Shield of Arizona, P.O. Box 13466, Phoenix, AZ , (602) , TTY/TDD (602) , crc@azblue.com. You can file a grievance in person or by mail or . If you need help filing a grievance BCBSAZ s Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 509F, HHH Building, Washington, DC 20201, , (TDD). Complaint forms are available at Multi-Language Interpreter Services: O1029.docx Page 5 of 6

6 Multi-Language Interpreter Services: (cont.) O1029.docx Page 6 of 6