70510-2171-xx Radicava 30 MG/100ML SOLN (MITSUBISHI TANABE PHARMA AMERI)
Edaravone is a member of the substituted 2-pyrazolin-5-one class. The agent must be protected from oxygen degradation until time of use and is packaged with an oxygen indicator which will turn blue or purple if the oxygen has exceeded acceptable levels. The solution also includes sodium bisulfite. The way in which it exerts its therapeutic effect in individuals with amyotrophic lateral sclerosis (ALS) is unknown
Edaravone for the treatment of amyotrophic lateral sclerosis (ALS) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Edaravone for the treatment of other conditions/diseases is considered investigational.
Edaravone is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older
Diagnosis of amyotrophic lateral sclerosis (ALS), clinically definite or probable based on Awaji criteria or El Escorial revised criteria
Disease duration of 2 years or less
Normal respiratory function, defined as percent-predicted forced vital capacity values of [%FVC] ≥ 80%
Baseline documentation of functionality retained for most activities of daily living (i.e., score of 2 points or better on each individual item of the ALS Functional Rating Scale - Revised [ALSFRS-R]) required for determining efficacy of treatment
Edaravone is considered medically appropriate for renewal ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the agent, including hypersensitivity reactions, anaphylaxis or sulfite allergic
Responded to therapy compared to pretreatment baseline with disease stability or mild progression indicating a slowing of decline on the ALSFRS-R (individual has not experienced rapid disease progression while on therapy)
Individual does not have a cumulative score on the ALSFRS-R of ≤ 3
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Amyotrophic lateral sclerosis (ALS)||
60 mg /100 mL in a single-dose polypropylene bag administered as an intravenous infusion over 60 minutes
• 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
|Do not use if the oxygen indicator has turned blue or purple before opening the package. Once the overwrap package is opened, use within 24 hours.|
ALS Functional Rating Scale - Revised (ALSFRS-R)
|Cutting food and handling utensils|
|Dressing and hygiene|
|Turning in bed and adjusting bedclothes|
LENGTH OF AUTHORIZATION
Coverage will be provided initially for 6 months and may be renewed
Refer to DOSAGE LIMITS below
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
Costa, J., Swash, M., de Carvalho, M. (2012, November). Awaji criteria for the diagnosis of amyotrophic lateral sclerosis. Journal of the American Medical Association Archives of Neurology, 69 (11), 1410-1416.
Lexicomp Online. (2019, February). AHFS DI. Edaravone. Retrieved June 5, 2019 from Lexicomp Online with AHFS.
Ludolph, A., Drory, V., Hardiman, O., Nakano, I., Ravits., J., Robberecht, W., Shefner, J. (2015, April). A revision of the El Escorial criteria – 2015. Informa Healthcare. Retrieved June 7, 2017 from http://www.wfnals.org/downloads/A%20revision%20of%20the%20El%20Escorial%20criteria%202015.pdf.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, November). Edaravone. Retrieved June 5, 2019 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2015, November). Center for Drug Evaluation and Research. Radicava (edaravone injection), for intravenous use. Retrieved June 5, 201918 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209176Orig1s007lbl.pdf.
ORIGINAL EFFECTIVE DATE: 7/28/2017
MOST RECENT REVIEW DATE: 7/9/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 mg = 1 billable unit