The market access landscape has changed substantially since the introduction of the National Institute for Health and Care Excellence (NICE) in 1999 and the Pharmaceutical Price Regulation Scheme (PPRS) in 2009 (updated in 2014). Increasingly formalised pricing mechanisms were introduced in the 2009 PPRS to allow a range of options to industry, including Patient Access Schemes (PAS). These PAS have since evolved; currently simple discount (confidential upon request), and complex schemes are available. However, the introduction of NHS England also brought Commercial Access Agreements (CAAs) and Market Access Arrangements (MAAs), and the range of options in the future may be even more innovative, albeit with simplicity at their core, relative to complex PAS. A key driver for more innovative approaches comes from ground-breaking new regenerative therapies, such as CAR T-cell therapy in oncology. CAR T-cell therapy is administered once, and patients who remain in remission for over 5 years are considered cured. The University of York and NICE assessed various pricing models and considered a leasing payment model for CAR T-cell therapy worthy of further exploration. This model would spread the cost of providing patient treatment over time; however, there are potential barriers, including the standing operating protocol and standing financial flows within the NHS. While CAR T-cell therapy is likely to be provided by only a small number of specialist centres, this would not be the case for less-specialised treatments that follow a similar model of high upfront costs for long-term benefits. Other solutions may be required for routinely commissioned treatments that are approved through the NICE Technology Appraisal process. This provides the potential for industry and the NHS to collaborate to identify strategies that while innovative are both acceptable and implementable. These concepts will be explored further and summarised.
