TRENDS OF APPROVAL AND PRICES OF BRAND DIABETES MEDICATIONS
Author(s)
Kwon S1, Seoane-Vazquez E2
1MCPHS University, Boston, MA, USA, 2International Center for Pharmaceutical Economics and Policy, Massachusetts College of Pharmacy and Health Sciences, Boston, MA, USA
OBJECTIVES: Diabetes mellitus (DM) is one of the diseases with the largest health care expenditures, with an estimated cost of $245 billion in 2012. We assessed US Food and Drug Administration (FDA) approval trends and manufacturer listed prices at approval of diabetes medications. METHODS: Regulatory data were derived from the FDA website and average wholesaler price (AWP) per unit from the RedBook (Truven Health Analytics, Inc.). Descriptive statistical methods were used in the analysis. RESULTS: There were 104 medications approved for DM as of January 1, 2014. Among them, 53% were insulins and 47% oral antidiabetes drugs (OAD). The FDA designated 8 orphan indications for diabetes, but not orphan designations were approved to date. The number of insulin approvals was higher during the 1980’s and the number of OAD approvals was higher between 2000 and 2009. The rate of market discontinuation was 75.0% for insulins and 18.4% for OAD. There were a total of 23 OADs with generic market competition. The mean time from new drug application approval to abbreviated new drug application approval was 15.4 years. Mean AWP unit prices were $1.25 for insulins and $0.30 for OADs in the 1980’s, and increased to $6.45 and $12.73, respectively in the 2000’s. From the 1980s to the 2000s, OAD manufacturer prices at approval increased by 42 times and insulin prices increased by 5 times. In comparison, the consumer price index increased 2.8 times during the same period. CONCLUSIONS: OAD products represented the largest percentage of new products approved for diabetes after 2000. In contrast, the number of insulin approvals decreased during the same period. There were not orphan approvals indicating the high prevalence of DM in the US. Manufacturer listed prices increased at higher pace than the inflation during the study period.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PDB127
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
Diabetes/Endocrine/Metabolic Disorders