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European Biopharmaceutical Review

Shared Risk

 

Risk sharing schemes in the UK are offered to the National Health Service (NHS) by manufacturers in order to provide timely patient access to innovative treatments, which link payment to clinical benefit or cost-effectiveness. Historically, these schemes were introduced after a technology was not recommended for use in the NHS in England and Wales by the National Institute for Health and Clinical Excellence (NICE). The proposed schemes were discussed by the Department of Health (DoH) with input from NICE, and were agreed on the basis of a variety of conditions, such as payments made to the manufacturer according to patient outcomes, or payments only made when the technology was considered costeffective relative to other available treatments (1,2).

The Pharmaceutical Price Regulation Scheme (PPRS) is the UKwide price regulation scheme for branded prescription medicines supplied to the NHS. The 2009 scheme includes, for the first time, a formalised process for the implementation of patient access schemes and flexible pricing arrangements (where companies are allowed to increase or decrease the price of a technology when further evidence or a new indication becomes available) (3). A separate press release was issued highlighting the additional value that flexible pricing and patient access schemes are expected to bring to patients, indicating the importance of these new elements (4). The change in process outlined by the PPRS has been mirrored by a consultation by NICE on its single and multiple appraisals process where discussion of patient access schemes is included in the suggested reforms (5,6). This article examines patient access schemes both past and present, and provides insight on the implications of new and evolving processes for risk sharing for manufacturers, patients and the NHS in the future.

PATIENT ACCESS SCHEMES IN THE UK

Pre-2009

The provision of beta interferons and glatiramer for multiple sclerosis was the first risk sharing scheme prompted by a NICE technology appraisal (TA), and was introduced in 2002 (7).


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Ruth McAllister recently joined Abacus International from the National Institute for Health and Clinical Excellence (NICE), where she was a Technical Analyst involved in both technology appraisals and clinical guidelines. Ruth completed her MSc in Health Economics from the University of York, and has over five years’ experience in health outcomes research. Ruth has been involved in designing, building and presenting the results of health economic models and has best-practice knowledge of health economic evaluations in local, national and international environments. As a Consultant Health Economist at Abacus International, Ruth has responsibility for managing and providing advice on projects with a health economic and health technology assessment focus.

Linda Harrison moved into the health economic arena in 1999 when she joined Abacus International. She has worked on a wide variety of health economic projects, and has completed a post-graduate certificate in health economics from Aberdeen University. In her current role as Associate Director, Linda has overall responsibility for the sourcing and delivery of health technology assessments.

Christie Niziol joined Abacus International in 2000, with a first class BSc degree and clinical nursing experience in the UK and US. Her career at Abacus has progressed from researching and writing for a variety of health economic and health technology assessment (HTA) projects, to editing, designing and managing projects. In the last nine years, she has gained a wealth of experience in the HTA arena, and now provides related consultancy advice to the pharmaceutical industry. In her current role as Associate Director of Global Services, she has a specific remit for understanding international HTA processes and expanding related Abacus services globally.

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Ruth McAllister
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Linda Harrison
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Christie Niziol
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