BlueCross BlueShield of Tennessee Medical Policy Manual

Degarelix

NDC CODE(S)

Firmagon® 80 mg SOLR 55566-8303-xx   (Ferring)

 

Firmagon® 120 mg SOLR 55566-8403-xx (Ferring)

DESCRIPTION

Degarelix is a gonadotropin releasing hormone (GnRH) receptor antagonist.  In the pituitary gland it binds reversibly to the GnRH receptors reducing the release of gonadotropins, including testosterone.  A single dose of 240 mg of degarelix decreases plasma concentrations of luteinizing hormone (LH) and follicle stimulation hormone (FSH) and subsequently testosterone.  Sustained use of the agent is effective in achieving and maintaining testosterone suppression below the castration level of 50 ng/dL.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Advanced prostate cancer

Loading Dose: 240 mg subcutaneously (SQ) x 1 dose

Routine Dose: 80 mg subcutaneously (SQ) once every 28 days

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® or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of degarelix for the treatment of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Degarelix. Retrieved July 29, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, July). Cetuximab. Retrieved July 29, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Degarelix. Retrieved July 29, 2016 from National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2015, October). Center for Drug Evaluation and Research. Firmagon® (degarelix for injection) for subcutaneous administration. Retrieved July 29, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022201s011lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  12/1/2016

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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

Degarelix (Firmagon®)

  1. Is this the initial request for treatment with this agent?

If yes, go to question #2

If no, go to question #5

  1. Does the individual have a diagnosis of advanced prostate cancer?

If yes, go to question #3

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

  1. Is the request for a period of 6 months or less with billable units of 80 units every 28 days after a loading dose of 240 units once (720 billable units or less in the first 6 months)?

If yes, go to question #4

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

  1. Is the requested dosage ALL of the following or less?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

  1. Is the request for renewal with ALL of the following?

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.