TY - JOUR
T1 - Risk sharing arrangements for pharmaceuticals
T2 - Potential considerations and recommendations for European payers
AU - Adamski, Jakub
AU - Godman, Brian
AU - Ofierska-Sujkowska, Gabriella
AU - Osiska, Bogusawa
AU - Herholz, Harald
AU - Wendykowska, Kamila
AU - Laius, Ott
AU - Jan, Saira
AU - Sermet, Catherine
AU - Zara, Corrine
AU - Kalaba, Marija
AU - Gustafsson, Roland
AU - Garuolienè, Kristina
AU - Haycox, Alan
AU - Garattini, Silvio
AU - Gustafsson, Lars L.
N1 - Funding Information:
NICE (National Institute for Health and Clinical Excellence) has recently entered into a number of patient access programmes to enhance the value of new medicines Examples include cetuximab as first line treatment of metastatic colorectal cancer. Under this scheme, Cetuximab will be rebated as free stock (1 vial per 8 utilised) when used in combination with FOLFOX. Alternative methods will be found if 'free stock' is not suitable. In addition, patient registration is essential to ensure scheme integrity and NICE usage criteria are followed. The Trust pharmacy will carry out a monthly/quarterly audit of usage to make claims from the manufacturer, with free stock delivered directly to the Trust Other examples include Sunitinib for patients with metastatic renal cell carcinoma. Under this scheme, the first treatment cycle (6-weeks costing an average of GB£3139/patient) is provided free via a patient access programme. Subsequent cycles are funded by the NHS until disease progression. The Department of Health considered the scheme did not constitute an excessive administration burden on the NHS Sorafenib for metastatic renal cell carcinoma is another example. Under this scheme, the first pack (200 mg × 112 tablets) is provided free by the manufacturer under the agreed patient access programme. This equates to £2980.47 p excluding VAT
PY - 2010
Y1 - 2010
N2 - Background: 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. Methods: 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. Conclusion: 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.
AB - Background: 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. Methods: 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. Conclusion: 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.
UR - http://www.scopus.com/inward/record.url?scp=77953066585&partnerID=8YFLogxK
U2 - 10.1186/1472-6963-10-153
DO - 10.1186/1472-6963-10-153
M3 - Article
C2 - 20529296
AN - SCOPUS:77953066585
SN - 1472-6963
VL - 10
JO - BMC Health Services Research
JF - BMC Health Services Research
M1 - 153
ER -