PRICE ANALYSIS OF MULTIPLE SCLEROSIS DISEASE-MODIFYING THERAPIES MARKETED IN THE US

Author(s)

Bin Sawad A1, Seoane-Vazquez E1, Rodriguez-Monguio R2
1MCPHS University, Boston, MA, USA, 2School of Public Health and Health Sciences, UMASS, Amherst, MA, USA

OBJECTIVES: To assess the trends in average wholesaler prices at market entry for multiple sclerosis (MS) disease-modifying therapies (DMTs) approved by the US Food and Drug Administration (FDA) in the period 1987-2014. METHODS: DMTs regulatory information was derived from the FDA website. Average wholesaler prices (AWP) per unit at market entry data were derived from the RedBook (Truven Health Analytics, Inc.). The AWP history was collected from year of approval to October 2014. The daily defined dosage (DDD) for adult patients was obtained from FDA approved labels. AWP per DDD and the AWP per year were computed. Descriptive statistics and Wilcoxon tests were performed. Statistical significance level was set at 0.05.  RESULTS: The National Multiple Sclerosis Society listed 11 FDA approved DMTs (5 new drug applications [NDA] and 6 biological license applications [BLA]) as of October 2014. Two products were approved by the FDA using priority review. The FDA granted orphan designation to 5 DMTs. Only one DMT had generic competition in the study period. There was one DMT approved by US FDA in the 1980s, three in the 1990s and 2000s, respectively, and 4 in the period 2010-2014. The median AWP per DDD was $5.88 in the 1980s, $7.13 in the 1990s, $217.52 in the 2000s, and $274.76 in the period 2010–Oct 2014. Statistically significant differences were found in median AWP per DDD prices between NDAs and BLAs. The median AWP per DDD was not significantly different for FDA priority review drugs compared to standard review drugs, and for orphan compared to non-orphan drugs.   CONCLUSIONS: The median AWP per DDD for DMTs at market entry increased substantially over time. No statistically significant differences were found in the median AWP per DDD between priority and standard review drugs, and between orphan and non-orphan drugs.

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

PND24

Topic

Economic Evaluation

Topic Subcategory

Cost/Cost of Illness/Resource Use Studies, Cost-comparison, Effectiveness, Utility, Benefit Analysis

Disease

Neurological Disorders

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