Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers
1 Ministry of Health, Warsaw, Poland
2 Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet at Karolinska University Hospital Huddinge, Stockholm, Sweden
3 Institute for Pharmacological Research 'Mario Negri', Milan, Italy
4 Prescribing Research Group, University of Liverpool Management School, UK
5 Agency for Health Technology Assessment, Warsaw, Poland
6 Kassenärztliche Vereinigung Hessen, Frankfurt, Germany
7 HTA Consulting, Krakow, Poland
8 State Agency of Medicines, Tartu, Estonia
9 Horizon Blue Cross Blue Shield of New Jersey, Newark, USA and Clinical Professor, Rutgers State University of New Jersey, USA
10 IRDES (Institut de Recherche et de Documentation en Économie de la Santé), Paris, France
11 Catalan Health Service, Barcelona, Spain
12 Republic Institute for Health Insurance, Serbia
13 Hospital Pharmacy, Karolinska University Hospital Solna, Stockholm, Sweden
14 Faculty of Medicine, Vilnius, Lithuania
BMC Health Services Research 2010, 10:153 doi:10.1186/1472-6963-10-153Published: 7 June 2010
There has been an increase in 'risk sharing' schemes for pharmaceuticals between healthcare institutions and pharmaceutical companies in Europe in recent years as an additional approach to provide continued comprehensive and equitable healthcare. There is though confusion surrounding the terminology as well as concerns with existing schemes.
Aliterature review was undertaken to identify existing schemes supplemented with additional internal documents or web-based references known to the authors. This was combined with the extensive knowledge of health authority personnel from 14 different countries and locations involved with these schemes.
Results and discussion
A large number of 'risk sharing' schemes with pharmaceuticals are in existence incorporating both financial-based models and performance-based/outcomes-based models. In view of this, a new logical definition is proposed. This is "risk sharing' schemes should be considered as agreements concluded by payers and pharmaceutical companies to diminish the impact on payers' budgets for new and existing schemes brought about by uncertainty and/or the need to work within finite budgets". There are a number of concerns with existing schemes. These include potentially high administration costs, lack of transparency, conflicts of interest, and whether health authorities will end up funding an appreciable proportion of a new drug's development costs. In addition, there is a paucity of published evaluations of existing schemes with pharmaceuticals.
We believe there are only a limited number of situations where 'risk sharing' schemes should be considered as well as factors that should be considered by payers in advance of implementation. This includes their objective, appropriateness, the availability of competent staff to fully evaluate proposed schemes as well as access to IT support. This also includes whether systematic evaluations have been built into proposed schemes.