In relation to MS DMTs pricing in the US are Pharma running a covert cartel? #MSBlog #PoliticalSpeak #MSResearch
Bin Sawad et al. Price Analysis of Multiple Sclerosis Disease-Modifying Therapies Marketed in the United States. Curr Med Res Opin. 2016 Jun 30:1-22.
OBJECTIVES: This study assessed trends in the average wholesale price (AWP) at the market entry of disease-modifying therapies (DMTs) approved by Food and Drug Administration (FDA) in the period 1987-2014.
METHODS: DMTs regulatory information was derived from the FDA website. The AWP per unit at market entry data were derived from the RedBook (Truven Health Analytics, Inc.). The AWP history for each DMT was collected from its date of approval to December 31, 2014. The FDA approved label defined daily dose (DDD) for adult patients was obtained from FDA approved labels. The AWP per DDD and the AWP/DDD per year of therapy were computed. Descriptive statistics, Wilcoxon tests, t-test, multiple linear regression were performed. Statistical significance level was set at 0.05.
RESULTS: The FDA approved 12 MS DMTs, including five new drug applications (NDA) and seven biologic license applications (BLA) as of December 31, 2014. The FDA granted orphan designation to 5 DMTs. There was one DMT approved by the FDA in the 1980s, 3 in the 1990s, 3 in 2000s, and 5 in the period 2010-2014. The market entry inflation-adjusted AWP per DDD was $10.23 for the first DMT (mitoxantrone hydrochloride) that was approved in the 1980s. The median market entry inflation-adjusted AWP per DDD was $12.41 (interquartile range [IQR] = 4.51) for DMTs approved in the 1990s, $71.26 (IQR = 58.35) in the 2000s, and $172.56 (IQR = 84.97) in the period 2010-2014. The median AWP per DDD was statistically significantly different (p = 0.011) for orphan (median=$41.82, IQR = 56.077) compared to non-orphan drugs (median=$171.32, IQR = 199.29). Year of market entry was positively associated with DMT prices at US market entry (p = 0.01).
CONCLUSIONS: The AWP per DDD for DMTs at market entry increased substantially over time. The increase in DMTs prices exceeded the general consumer price index.