Title: Payers perspective
Other Titles: Matching p-values to Clinical Needs: Statistical Significance vs Clinical Relevance.
Authors: De Nys, Katelijne
Issue Date: 2013
Publisher: Pergamon
Host Document: European Journal of Cancer vol:49 pages:S31-S31
Conference: 17th ECCO / 38th ESMO / 32nd ESTRO European Cancer Congress on Reinforcing Multidisciplinarity location:Amsterdam: NETHERLANDS date:SEP 27-OCT 01, 2013
Abstract: Payers are facing challenging times. Not only the economic crisis but also the aging population, suffering from various chronic diseases, and the high prices of new drugs increase the pressure on drug reimbursement systems. Moreover and especially in the oncology area, launch volumes are expected to increase when considering the current pipeline1. With the sustainability of health care systems at stake, most parties involved realize that a change of mentality, not only in drug development plans, but also in the pricing and reimbursement policies imposes. From a payers perspective, some suggestions can be made.
At the registration level, adding values such as clinical relevance to the classical registration parameters could be considered, as relatively little attention seems to have been paid to the availability of (good) alternative treatment options until recently2. In order to better define the best Standard of Care, academic head-to-head trials comparing available treatments, objective registers or trials challenging the optimal dose or duration of treatment offer an important added value to the registration trials, and should therefore be promoted. In the set-up of such trials, participation of the reimbursement systems, defining the current gaps and the research questions, is absolutely necessary.
Reimbursement systems need guidelines, which should be – at least partly – based on the results of these academic studies. The scope of those guidelines can be international especially in the field of the mentioned scientific assessments, but since reimbursement decisions are taken on the national level, national guidelines adapted to the local situation can be helpful. Organizations editing these guidelines should be as independent as possible and free of Conflict of Interest.
Payers need more than statistical significant endpoints. In order to maintain equity, an important basis of our current health care system, they will need extra information such as the clinical and societal relevance of these endpoints, the actual real medical need, the price society is willing or able to pay for parameters such as a life year gained or, in the expanding area of oncology, a month of progression free.
1. Berggen R. et al. Outlook for the next 5 years in drug innovation. Drug Discov. 11, 435-436 (2012)
2. Putzeist M., et al. Factors influencing non-approval of new drugs in Europe. Nature Rev. Drug Discov. 11, 903-904 (2012)
ISSN: 0959-8049
Publication status: published
KU Leuven publication type: IMa
Appears in Collections:Clinical Pharmacology and Pharmacotherapy

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