TRENDS IN APPROVALS AND PRICES OF ONCOLOGY DRUGS IN THE US (1990-2013)
Author(s)
Greene N1, Turkistani FA2, Seoane-Vazquez E3, Rodriguez-Monguio R4
1Massachusetts College of Pharmacy and Health Sciences, Boston, MA, USA, 2Massachusetts College of Pharmacy and Health Sciences University, Boston, MA, USA, 3International Center for Pharmaceutical Economics and Policy, Massachusetts College of Pharmacy and Health Sciences, Boston, MA, USA, 4University of Massachusetts Amherst, Amherst, MA, USA
OBJECTIVES: Manufacturer listed prices do not represent real transactions prices but are often used to set up reimbursement rates for third-party payers. This study evaluates approvals, discontinuations, and price trends of oncology drugs approved by the US Food and Drug Administration (FDA) in the period 1990-2013. METHODS: Drug regulatory information derived from the FDA. Average wholesaler prices (AWP) per unit were collected from the RedBook. Annual average price changes were calculated for each drug as the increase in prices from market entry to Dec-31-2013 divided by the number of years between the effective dates of those prices. Prices were converted to 2013 year dollars using the consumer price index (CPI). Descriptive statistics and 95% confidence intervals and t-tests were performed in the analysis. RESULTS: The FDA listed 165 approved oncology therapeutic drugs (44 biologics and 121 chemical entities) in the period of analysis. The FDA approved 31 products (18% of total) before the 1980s, 11 (6.7%) in the 1980s, 50 (30.3%) in the 1990s, 48 (29.1%) in the 2000s, and 25 (15.2%) in 2010-2103. There were 45 (27.3%) products with at least one FDA approved orphan indication. There were 10 products (6.1% of approvals) discontinued. There were 45 products with complete price history from approval to January 1,2014, and 2 had generic competition. The CPI adjusted average annual AWP price increase was 10.2%±21.0% (95%CI:8.2%-12.1%); with an average 9.18±6.59 years in the market. The average annual AWP increase was higher for products approved in the 1990s (20.9%±34.8%) than for those approved in the 2000’s (5.0%±5.2%) and 2000-2013 (6.3%±9.8%). Chemical entities and drugs with orphan indications had higher AWP price increases than biologics and non-orphan drugs, respectively. CONCLUSIONS: Manufacturer listed prices of oncology products approved in the period 1990-2013 grew faster than the inflation. Price increases were higher for orphan drugs and chemical entities.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PCN80
Topic
Economic Evaluation
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies
Disease
Oncology