|55566-8303-XX Firmagon 80 MG SOLR (FERRING)|
|55566-8403-XX Firmagon 120 MG SOLR (FERRING)|
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
Degarelix for the treatment of prostate cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Degarelix for the treatment of other conditions/diseases is considered investigational.
Degarelix is considered medically appropriate if ALL of the following criteria are met:
Individual is diagnosed with advanced prostate cancer
Degarelix for the treatment of advanced prostate cancer is considered medically appropriate for continued treatment if ALL of the following:
Individual continues to meet initial medical appropriateness criteria
Tumor response with stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the agent. Examples of unacceptable toxicity include the following: prolongation of the QT-interval, severe hypersensitivity, etc.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Advanced prostate cancer||
Loading Dose: 240 mg subcutaneously (SQ) x 1 doseRoutine Dose: 80 mg subcutaneously (SQ) once every 28 days
LENGTH OF AUTHORIZATION
Coverage will be provided for twelve months and may be renewed.
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).
Lexi-Comp Online. (2018). AHFS DI. Degarelix. Retrieved January 4, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018 December). Cetuximab. Retrieved January 4, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Degarelix. Retrieved January 4, 2019 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 January 4, 2019 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022201s011lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 2/12/2019
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