PHP79 - PRICE ANALYSIS OF THERAPEUTIC BIOLOGICS APPROVED BY THE US FOOD AND DRUG ADMINISTRATION (1986–OCTOBER 2015)

Abstract

This study assessed trends in average wholesaler prices (AWP) at US market entry for therapeutic biological drugs approved by the US Food and Drug Administration (FDA) in the period 1986–October 2015. Defined daily doses (DDD) for the most common indications for therapeutic biologics approved by the FDA were derived from the FDA-approved labels. AWP trends from the date of market entry to October 2015 were obtained from the RedBook (Truven Health Analytics, Inc.). Consumer Price Index was used to inflate the prices to 2015 US Dollars. The AWP/DDD was computed for therapeutic biologics approved for chronic use and for adult patients. Descriptive statistics and Wilcoxon tests were performed in the analysis (α=0.05). The FDA approved a total of 93 therapeutic biologics in the period of analysis. The FDA approved 45.2% of the therapeutic biologics using the priority review approval process, and 57.0% of the therapeutic biologics had at last one indication with orphan designation at first FDA approval. There were 60 (64.5.% of the total number of approvals) that were indicated for chronic use in adult patients. The median AWP per DDD was significantly lower for priority review ($60.36) than for standard review ($122.27) therapeutic biologics for chronic adult use. Prices were higher from therapeutic biologics approved for use in both adult and children patient population ($130.72), than for therapeutic biologics approved for children ($152.82) and for adults ($89.14). Prices of therapeutic biologics approved by the FDA in the period 1986-October 2015 increased faster than the inflation. There was a substantial variation in the prices of therapeutic biologics marketed in the US. Manufacturer listed prices varied by FDA approval process, orphan designation and targeted population. More studies are needed to assess differences in prices of therapeutic biologics by therapeutic areas.