title: Price analysis of multiple sclerosis disease-modifying therapies marketed in the United States.
abstract: 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.
  
  
  
  DMT regulatory information was derived from the FDA website. The AWPs per unit at market entry data were derived from the Red Book (Truven Health Analytics Inc.). The AWP history for each DMT was collected from its date of approval to 31 December 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, and multiple linear regression were performed. The statistical significance level was set at 0.05.
  
  
  
  The FDA approved 12 multiple sclerosis (MS) DMTs, including five new drug applications (NDAs) and seven biologic license applications (BLAs) as of 31 December 2014. The FDA granted orphan designation to five DMTs. There was one DMT approved by the FDA in the 1980s, three in the 1990s, three in 2000s, and five 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).
  
  
  
  The AWP per DDD for DMTs at market entry increased substantially over time. The increase in DMTs prices exceeded the general consumer price index.
authors.affiliation: a International Center for Pharmaceutical Economics and Policy, MCPHS University , Boston , MA , USA.|b Department of Clinical Pharmacy , Umm Al-Qura University , Makkah , Kingdom of Saudi Arabia.
authors.forename: Aseel
authors.initials: A
authors.lastname: Bin Sawad
authors.affiliation: a International Center for Pharmaceutical Economics and Policy, MCPHS University , Boston , MA , USA.
authors.forename: Enrique
authors.initials: E
authors.lastname: Seoane-Vazquez
authors.affiliation: c Department of Health Policy and Management , University of Massachusetts Amherst , Amherst , MA , USA.
authors.forename: Rosa
authors.initials: R
authors.lastname: Rodriguez-Monguio
authors.affiliation: a International Center for Pharmaceutical Economics and Policy, MCPHS University , Boston , MA , USA.|d Department of Clinical Pharmacy , Taibah University , Medina , Kingdom of Saudi Arabia.
authors.forename: Fatema
authors.initials: F
authors.lastname: Turkistani
mesh_terms: D000328:Adult; D003132:Commerce; D016527:Drug Costs; D006801:Humans; D009103:Multiple Sclerosis / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
keywords: Analysis; cost; disease-modifying drugs; disease-modifying therapies; multiple sclerosis; price