REGULATORY APPROVAL AND PRICE ANALYSIS OF ANTI-ANDROGEN DRUGS MARKETED IN THE UNITED STATES AND USED IN HORMONAL THERAPY IN ADVANCED PROSTATE CANCER
Author(s)
Alsahali S1, Alzarea AI1, Seoane-Vazquez E2, Al yahya S1, Eguale T1
1MCPHS University, Boston, MA, USA, 2Massachusetts College of Pharmacy and Health Sciences, Boston, MA, USA
OBJECTIVES: To assess the drug prices’ and drug approval trends of Anti-androgen drugs approved for advanced prostate cancer until December 2016. METHODS: Luteinizing-hormone releasing hormone (LHRH) agonists, LHRH antagonists and Non-Steroidal Anti-Androgen drugs were included and information on approval of these drugs, approval date, type of review, active ingredient, route of administration, and indication were collected from Food and Drug Administration website. Drug prices were collected from Redbook issued by Truven Health Analytics. RESULTS: There are 4 medications of LHRH agonists in The US market and all of these medications are given parenterally. LHRH agonists’ prices are based on frequency (Monthly, 2-months, 3-months, 4-months and 6-months) and route of administration (subcutaneous, intramuscular and subcutaneous implant). The price of Leuprolide given subcutaneously amount to only 37% of price of the drug given intramuscular for the same strength. Based on Defined Daily Dose, Histrlin has the lowest price of LHRH agonist (336 $/month) and is given by subcutaneous implant. There is only one drug from LHRH antagonist group in the US market (degarlix) (594 $/ month) after the discontinuation of abarelix in 2005 due to low sales. Non-Steroidal anti-androgen class includes 4 drugs taken orally and have more than 21 approved generics and represent about 53% of drugs approved for hormone therapy for prostate.CONCLUSIONS: The route of administration and frequency of taking medication may explain the variation in prices between LHRH agonists.Implant dosage form is the highest price over LHRH agonists, but its the lowest price based on defined daily dose per month. High number of generics approved may explain low price for non-steroidal anti-androgens compared to other groups of anti-androgen classes.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PCN74
Topic
Economic Evaluation
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies, Cost-comparison, Effectiveness, Utility, Benefit Analysis
Disease
Oncology