Clearing up the hazy road from bench to bedside: a framework for integrating the fourth hurdle into translational medicine.
BACKGROUND
New products evolving from research and development can only be translated to medical practice on a large scale if they are reimbursed by third-party payers. Yet the decision processes regarding reimbursement are highly complex and internationally heterogeneous. This study develops a process-oriented framework for monitoring these so-called fourth hurdle procedures in the context of product development from bench to bedside. The framework is suitable both for new drugs and other medical technologies.


METHODS
The study is based on expert interviews and literature searches, as well as an analysis of 47 websites of coverage decision-makers in England, Germany and the USA.


RESULTS
Eight key steps for monitoring fourth hurdle procedures from a company perspective were determined: entering the scope of a healthcare payer; trigger of decision process; assessment; appraisal; setting level of reimbursement; establishing rules for service provision; formal and informal participation; and publication of the decision and supplementary information. Details are given for the English National Institute for Health and Clinical Excellence, the German Federal Joint Committee, Medicare's National and Local Coverage Determinations, and for Blue Cross Blue Shield companies.


CONCLUSIONS
Coverage determination decisions for new procedures tend to be less formalized than for novel drugs. The analysis of coverage procedures and requirements shows that the proof of patient benefit is essential. Cost-effectiveness is likely to gain importance in future.
Rogowski
Wolf H
WH
Helmholtz Zentrum München, German Research Center for Environmental Health, Institute of Health Economics and Health Care Management, PO Box 1129, D-85758 Neuherberg, Germany. Rogowski@helmholtz-muenchen.de
Hartz
Susanne C
SC
John
Jürgen H
JH
D001690:Biological Science Disciplines / Q000458:organization & administration; D003659:Decision Making, Organizational; D004739:England; D005858:Germany; D006302:Health Services Research; D006801:Humans; D007407:Interviews as Topic; D017146:Models, Organizational; D012051:Reimbursement Mechanisms / Q000458:organization & administration; D018581:Technology Transfer; D014481:United States