Design of patient access schemes in the UK
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Appl Health Econ Health Policy 2011; 9 (4): 209-215 1175-5652/11/0004-0209/$49.95/0
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Design of Patient Access Schemes in the UK Influence of Health Technology Assessment by the National Institute for Health and Clinical Excellence Szymon Jaros!awski1 and Mondher Toumi2 1 Creativ-Ceutical, Paris, France 2 University Claude Bernard Lyon I, UFR of Odontology, Lyon, France
Abstract
Background: Patient Access Schemes (PAS) are alternative market access agreements between the UK Department of Health and drug manufacturers. They are implemented to enable the UK National Institute for Health and Clinical Excellence (NICE) to recommend expensive medicines for use in the UK NHS. Objective: We aimed to analyse the extent to which NICE drug appraisals influence the construction of PAS and what rationale underlies the variety of approaches to their design. Methods: We analysed publicly available documentation on PAS developed as a part of the NICE Health Technology Assessment process. Results: We demonstrate how the design of PAS is determined by the kind of evidence that is available to model cost effectiveness of a drug and by the incremental cost-effectiveness ratio that is deemed acceptable in a given patient population. PAS aimed to reduce drug cost to the NHS by means of various discounts or rebates on a per-patient basis rather than by lowering the list price of drugs. While almost all schemes were proposed by the industry in reply to negative draft recommendations by NICE, motivations of the stakeholders to implement PAS are not disclosed in the publicly available documentation. Conclusion: A more transparent process might be necessary to protect against a perverse impact of PAS on international reference pricing that uses list prices rather than the real cost of purchasing medicines that the NHS incurs.
Jaros!awski & Toumi
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Key messages NICE HTA is the key driver of Patient Access Scheme (PAS) design, with the schemes constructed to address uncertainty surrounding cost effectiveness All PAS were financially based but, rather than reducing list prices, cost reductions were via various discounts or rebates on a per-patient basis Manufacturers’ motivations to put forward PAS are unclear, and a more transparent process might be necessary to protect against a perverse impact of PAS on international reference pricing and to enable impartial monitoring and evaluation of the schemes
Introduction In England and Wales, many expensive medicines are only recommended for use in the UK NHS if the National Institute for Health and Clinical Excellence (NICE) finds that they are a good use of (limited) financial resources. While the prices of medicines are not regulated in the UK (a list price is set by the manufacturer) and price negotiation is not practiced between the industry and the Department of Health (DoH), NICE assessments act as a gatekeeper of patients’ access to such medicines. NICE uses modelling of cost effectiveness of interventions to aid its decision maki
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