Opposing perspectives on the rapidly growing number of orphan drug designations – as heard from payers, industry leaders, and investors.
Since the Orphan Drug Act (ODA) in 1983, Orphan Drug designation has been increasingly sought after by both industry leaders seeking to gain an upper hand, and investors looking to find the next opportunity. The benefits of the designation are varied and helpful, and over the past few years both big and small pharma have really started to take notice.
Prior to the act, only 38 “orphan drugs” were developed. Since then, 347 have been approved. In 2012, orphan drug sales increased 7.1% to $83 billion, which compares to a 2.1% overall decrease in prescription drug sales. 43 new drugs were approved by the FDA in 2012; 15 of those were orphan drugs, representing 35% of the industry’s output.
With the increasing numbers of orphan drugs in the pipeline, it calls a few aspects into question – including pricing and the sustainability of a designation that has seemingly outgrown its initial necessity.
On one side of the argument, investors, capital markets and industry who are fighting to hold prices firm and make everyone realized that some drugs really are worth $100,000 per year. On the other, payers and some regulators who say that the current system is simply not sustainable, and that if every drug becomes $100,000 per year, then where exactly will the money come from? This eBook highlights arguments from both sides as told by stakeholders in the market.
Download this eBook now to find out the two sides of the sustainability argument by using the form to your right.
Thanks,
World Orphan Drug Congress US team