APPROVALS, DISCONTINUATIONS, AND PRICE ANALYSIS OF BRAND BREAST CANCER DRUGS IN THE UNITED STATES (1990-2014)

Author(s)

Greene N1, Seoane-Vazquez E2, Rodriguez-Monguio R3, Harris C4
1Massachusetts College of Pharmacy and Health Sciences University, Medford, MA, USA, 2MCPHS University, Boston, MA, USA, 3University of Massachusetts, Amherst, MA, USA, 4Massachusetts College of Pharmacy and Health Sciences University, Boston, MA, USA

OBJECTIVES: The objectives of this study were to evaluate approvals, discontinuations and trends in prices of US FDA-approved branded breast cancer drugs in the period 1990-2014; and to assess associations between branded breast cancer drug prices at market entry and the characteristics of the drugs. METHODS: Drug regulatory information was derived from the FDA website and the average wholesale prices (AWP) from the RedBook (Truven Health Analytics). Prices were adjusted to 2014 dollars using the consumer price index (CPI). Descriptive statistics were conducted. The AWP compounded annual growth rate (CAGR) was estimated for each drug. A multivariate linear regression model was used to evaluate associations between CPI-adjusted drug prices at market entry and FDA approval date, FDA review process (i.e., standard and priority review system), orphan designation at market entry, and route of administration. RESULTS: The FDA approved 20 breast cancer drugs (16 new molecular entities, 3 biologics and 1 new dosage form) in the period of analysis. Paclitaxel intravenous solution was discontinued from the market. The median CPI-adjusted CARG was 2.9% (IQR=6.2). There were 11 drugs for use in cycles and 9 drugs for chronic use. The median CPI-adjusted AWP per month at market entry for chronic use drugs was $279.82 (IQR=14922.85). The FDA approval date (correlation 0.787, p=0.006) and the FDA priority review process (correlation 0.635, p=0.030) were significantly and positively associated with the CPI-adjusted AWP per DDD at market entry for chronic use drugs. Conversely, orphan designation (correlation -0.317, p=0.203) was non-significantly and negatively associated with CPI-adjusted AWP per DDD at market entry.  CONCLUSIONS: Manufacturer listed prices for most branded breast cancer drugs increased greater than the consumer price index during the study period. New drugs and drugs approved by the FDA using the priority review process were associated with higher manufacturer listed prices at market entry.

Conference/Value in Health Info

2016-05, ISPOR 2016, Washington DC, USA

Value in Health, Vol. 19, No. 3 (May 2016)

Code

PCN67

Topic

Economic Evaluation

Topic Subcategory

Cost/Cost of Illness/Resource Use Studies

Disease

Oncology

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