Are Priority Review Vouchers Really Worth the Hype? May be Not.  
​[Posted on: Thursday, October 13, 2016]

The Priority Review Vouchers or PRVs are a much coveted incentive from FDA with an estimated value of over $300 million, but a close review of the case studies shows it may be more hype than benefit to the owners. It has been almost 10 years since the PRV program was implemented and so far 11 of these were awarded; 8 for the development of treatments for tropical diseases and 3 for rare pediatric diseases. The program was created to incentivize development of new treatments for diseases for which there is no reasonable market in the US and hence companies will not develop such treatments unless there was an alternate mechanism for returns on the investment to embark on such development. The PRV has some obvious benefit to the owner. A PRV can be used to speed-up the review of an NDA or BLA by 4-6 months which could mean returns of hundreds of millions of dollars for blockbuster products. If the owner of the PRV cannot use it, they can be sold to anyone, who in turn can sell it further, giving it enormous cash value. Of the 11 PRVs awarded so far, only one was used by the original owner, Novartis. Three other PRVs were sold by the original owners, and used by the new owners. Of the four times PRVs were used for an NDA review, three times the users were able to get faster market approval. Six of the PRVs have not been sold yet, and one was sold by United Therapeutics to AbbVie for $350 million but has not been used so far. Despite the financial windfall that a PRV award could mean for the original owners, the true benefit of pursuing a product solely to get a PRV is probably not a smart venture. First, PRVs are awarded only after the drug is successfully approved by the FDA, meaning that the developers have to dedicate the resources and time needed for the full approval. The data needed for the approval of a PRV-eligible product is no different from that for another product. Second, using a PRV does not guarantee faster approval of the product for which it is used. Per the law, FDA assures that in 90% of the time, it will make a decision within 6 months of accepting an application for review, compare to 10 months for standard review. Additionally, the first decision may not be the approval decision, as was the case with Novartis where in 6 months the company received a rejection notice and did not see the benefit of the PRV. Third, only 4 of the 11 PRVs awarded have been sold. It is predicted in the next few years, as many as 3-4 PRVs may be awarded per year. As more PRVs become available in the market, the price of each PRV is likely to go down. Fourth, there are multiple other mechanisms available now to speed approval such as Fast Track designation, Priority Review designation, Orphan Product designation and the Breakthrough designation, that are designed to expedite the overall development process and not just the NDA review cycle, translating to much larger benefits than the 4-6 months seen with PRV use. Lastly, with the advent of newer project management tools that could reduce waste and increase efficiency of the development process, developers will see much improved development cycles and review cycles, making saving a few months on the NDA review a moot point. FDA has often criticized the PRV program for limited benefit to the patients and increased pressure to review drugs that are only been prioritized for financial gains of the applicant. Also, drugs for tropical diseases and rare pediatric diseases could end up being very profitable despite the smaller market size so it has been argued that the PRV program may not even be needed to develop such products. However, there is significant industry and political support to keep the PRV program for the near future. PRVs are unique to the US as no other country has such incentive. It should be considered more like an added benefit post-approval rather than the only benefit.