BlueCross BlueShield of Tennessee Medical Policy Manual

Edaravone

NDC CODE(S)

70510-2171-XX Radicava 30 MG/100ML SOLN (MT PHARMA AMERICA)

DESCRIPTION

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Amyotrophic lateral sclerosis (ALS)

30 mg/100 mL in a single-dose polypropylene bag - 2 consecutive bags IV infusion:

  • 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) Assessment Categories

Speech
Salivation
Swallowing
Handwriting
Cutting food and handling utensils
Dressing and hygiene
Turning in bed and adjusting bedclothes
Walking
Climbing stairs
Dyspnea
Orthopnea
Respiratory insufficiency

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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION 

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).

SOURCES

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.

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.

U. S. Food and Drug Administration. (2017, May). Center for Drug Evaluation and Research. Radicava (edaravone injection), for intravenous use. Retrieved May 10, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209176lbl.pdf.

ORIGINAL EFFECTIVE DATE:  7/28/2017

MOST RECENT REVIEW DATE:  7/28/2017

ID_MRxEx

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.

Pharmaceutical Decision Support Tree

Edaravone (Radicava®)

  1. Is this the initial request for the agent?

If yes, go to question #2

If no, go to question #7

  1. Is the individual 18 years of age with a diagnosis of amyotrophic lateral sclerosis (ALS), clinically definite or probable based on Awaji criteria or El Escorial revised criteria?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a Baseline ALS Functional Rating Scale – Revised (ALSFRS-R)(required for determining efficacy of treatment) or functionality retained in most activities of daily living?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have normal respiratory function (defined as percent-predicted forced vital capacity values of [%FVC] ≥ 80%)?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the individual’s disease duration 2 years or less?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for a treatment schedule of the following?

60 mg (two consecutive 30 mg infusion bags) IV infusion over 60 minutes for an initial authorization period of six months:

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have absence of unacceptable toxicity from the agent, including hypersensitivity reactions, anaphylaxis or sulfite allergic reactions which occurs more frequently in individuals with asthma?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Has there been maintenance of baseline ALSFRS-R score or minimal decline?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is respiratory function maintained or prior documented decline is slowed?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.