Based on an OHE lunchtime seminar by Professor Henry Grabowski, this seminar briefing explores the lessons learned from Europe’s experience with biosimilars, and provides an analysis of how the US market may evolve.
The cost of R&D for a successful new medicine has been an important policy issue at least since the 1960s. Cost estimates matter not just because of intellectual curiosity or for industry understanding of its performance, but because they are a key aspect of the international debate about the reasonableness of pharmaceutical prices and the magnitude of the long-term investments involved.
Interest is growing in schemes that involve “paying for pills by results”, that is, “paying for performance” rather than merely “paying for pills”. Despite its intuitive appeal, this approach is highly controversial and is disliked by many health care providers, policy makers, and pharmaceutical companies.
Recent reforms to the National Health Service (NHS) in England include important changes in the regulation of prices for new medicines. From January 2014, the existing Pharmaceutical Pricing Regulation Scheme (PPRS) will be replaced by “value based pricing” (VBP) for branded medicines sold to the NHS. This will apply only to new medicines; those marketed before 2014 will continue to be governed by the PPRS.