The price of the voucher depends on supply and demand. The voucher’s value derives from three factors: shifting sales earlier, longer effective patent life due to earlier entry, and competitive benefits from earlier entry relative to competitors. Top-selling treatments can yield billions in sales each year, so being approved months earlier can be worth hundreds of millions of dollars to the voucher holder (Ridley et al. 2006; Ridley and Régnier 2016). The value of the voucher will depend on the drug’s therapeutic class (Noor 2009).
In 2014, Sanofi/Regeneron purchased the first voucher sold for $67.5 million. In 2015, Sanofi was back in the market with a $245 million voucher purchase. The figure below illustrates voucher prices over time.
In 2015, European regulators approved Amgen’s cholesterol drug Repatha 2 months ahead of Sanofi/Regeneron’s Praluent. But in the US, the order was reversed with Praluent a month ahead of Repatha, because Sanofi/Regeneron used a priority review voucher. Read more at Fierce Pharma.
This web page is maintained by David Ridley, one of the authors of the priority review voucher program.