Last Review Date: 07/02/2024

Date of Origin: 05/30/2017

Dates Reviewed: 05/2017, 06/2017, 04/2018, 08/2018, 08/2019, 08/2020, 12/2021, 07/2022, 12/2023, 07/2024

1. Length of Authorization

Initial coverage will be provided for 6 months and may be renewed annually thereafter.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Radicava 30 mg/100 mL single-dose bag: 2 bags per day for 14 days of a 28 day cycle initially, followed by 2 bags per day for 10 days of a 28 day cycle

2. Max Units (per dose and over time) [HCPCS Unit]:

• Initial dose: 60 billable units daily for 14 days, followed by 14 days off per 28-day cycle
• Subsequent doses: 60 billable units daily for 10 days out of 14 days, followed by 14 days off per 28-day cycle

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria

• Will not be used in combination with other formulations of edaravone (i.e., oral); AND

Amyotrophic Lateral Sclerosis (ALS) † Ф ^1-3,5,7,8

• Patient has a diagnosis of clinically definite or probable ALS based on El Escorial revised criteria or Awaji criteria; AND
• Patient has a disease duration of 2 years or less; AND
• Patient has a percent-predicted forced vital capacity (%FVC) ≥ 80%; AND
• Baseline documentation of retained functionality for most activities of daily living [i.e., score of 2 or better on each* individual item of the ALS Functional Rating Scale – Revised (ALSFRS-R)]

*Note: The ALSFRS-R is a 12-item questionnaire assessing functional disease progression across four domains including bulbar, fine motor, gross motor, and respiratory. Each item is scored on a five-point ordinal scale from 0 (loss or significant impairment) up to 4 (normal function) with a possible cumulative score of 48. A score of 2 or better on each item would correspond to a minimum ALSFRS-R score of 24.

† FDA Approved Indication(s); ‡ Compendium Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,3

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: hypersensitivity reactions (e.g., redness, wheals, and erythema multiforme), anaphylaxis (e.g., urticaria, decreased blood pressure, and dyspnea), sulfite allergic reactions, etc.; AND
• Patient has responded to therapy compared to pretreatment baseline with disease stability or mild progression indicating a slowing of decline on the ALSFRS-R (patient has not experienced rapid disease progression while on therapy); AND
• Patient does not have a cumulative score* on the ALSFRS-R of ≤ 3 (The cumulative possible score on the ALSFRS-R is 48; a cumulative score of 3 indicates loss/significant impairment [i.e., item score of zero] in nine or more items on the 12-item questionnaire)

*Note: The ALSFRS-R is a 12-item questionnaire assessing functional disease progression across four domains including bulbar, fine motor, gross motor, and respiratory. Each item is scored on a five-point ordinal scale from 0 (loss or significant impairment) up to 4 (normal function) with a possible cumulative score of 48. A score of 2 or better on each item would correspond to a minimum ALSFRS-R score of 24.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J1301 - Injection, edaravone, 1 mg; 1 billable unit = 1 mg

NDC:

• Radicava 30 mg/100 mL single-dose bag: 70510-2171-xx

7. References

1. Radicava [package insert]. Jersey City, NJ; Mitsubishi Tanabe Pharma America, Inc.; December 2023. Accessed May 2024.
2. Tanaka M, Sakata T, Palumbo J, et al. A 24-Week, Phase III, Double-Blind, Parallel-Group Study of Edaravone (MCI-186) for Treatment of Amyotrophic Lateral Sclerosis (ALS). Neurology April 5, 2016 vol. 86 no. 16 Supplement P3.189.
3. Cedarbaum JM, Stambler N, Malta E, et al. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999 Oct 31;169(1-2):13-21.
4. Miller RG, Jackson CE, Kasarskis EJ, et al. Practice parameter update: the care of the patient with amyotrophic lateral sclerosis: drug, nutritional, and respiratory therapies (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2009 Oct 13;73(15):1218-26.
5. Siddique N, Siddique T. Amyotrophic Lateral Sclerosis Overview. GeneReviews. Initial Posting: March 23, 2021; Last Revision: September 28, 2023; Accessed on May 28, 2024. http://www.ncbi.nlm.nih.gov/books/NBK1450/.
6. Hardiman O, van den Berg LH, Kiernan MC. Clinical diagnosis and management of amyotrophic lateral sclerosis. Nat Rev Neurol. 2011 Oct 11;7(11):639-49.
7. Costa J, Swash M, de Carvalho M. Awaji criteria for the diagnosis of amyotrophic lateral sclerosis: a systematic review. Arch Neurol. 2012 Nov;69(11):1410-6.
8. Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16(7):505-512. doi:10.1016/S1474-4422(17)30115-1.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A