- James Raftery, professor of health technology assessment
- 1Wessex Institute, School of Medicine, University of Southampton, Southampton SO167NS
- Accepted 16 March 2010
The largest and most ambitious patient access scheme, the UK multiple sclerosis risk sharing scheme, was set up in 2002 after the National Institute for Health and Clinical Excellence (NICE) recommended against use of interferon beta and glatiramer acetate.1 Under the scheme patients were closely monitored to confirm the cost effectiveness of the drugs, with an agreement that prices would be reduced if patient outcomes were worse than predicted.2 The first report on the scheme in 2009 showed patient outcomes were much worse than predicted but judged that it was premature to reduce prices.3 Why did this happen and what can we do to prevent it recurring?
Development of patient access schemes
The high prices charged for many new drugs have led to many health systems requiring proof of cost effectiveness before they are funded. However, decisions often have to be made with limited information: licensing trials are typically short term and of little value for assessing cost effectiveness. Once licensed, drug prices are listed at prices that seldom change. Patient access schemes have developed whereby agreements are made with the manufacturer to vary drug prices according to factors such as the number of patients treated or doses used, the response of the patient, or longer term patient outcomes.
The 2009 Pharmaceutical Price Regulation Scheme, which governs drug pricing, outlined two types of access scheme: those based on finance and those based on outcomes (table⇓).4 Schemes based on finance involve either changes in list price or discounts linked to the number of patients or doses or to patient responses. Schemes based on responses can …