Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 2008 Sep 24:8:194.
doi: 10.1186/1472-6963-8-194.

Clearing up the hazy road from bench to bedside: a framework for integrating the fourth hurdle into translational medicine

Wolf H Rogowski  1 , Susanne C Hartz, Jürgen H John
Affiliations
Comparative Study

Clearing up the hazy road from bench to bedside: a framework for integrating the fourth hurdle into translational medicine

Wolf H Rogowski et al. BMC Health Serv Res. .

Abstract

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.

Conclusion: 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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
The fourth hurdle within the process of translational medicine.
Figure 2
Figure 2
Increasing heterogeneity of decisions in the process of translational medicine.
See this image and copyright information in PMC

References

    1. Sung NS, Crowley WF, Jr, Genel M, Salber P, Sandy L, Sherwood LM, Johnson SB, Catanese V, Tilson H, Getz K, et al. Central challenges facing the national clinical research enterprise. Jama. 2003;289:1278–1287. doi: 10.1001/jama.289.10.1278. - DOI - PubMed
    1. Plebani M, Marincola FM. Research translation: a new frontier for clinical laboratories. Clin Chem Lab Med. 2006;44:1303–1312. doi: 10.1515/CCLM.2006.238. - DOI - PubMed
    1. Wehling M. Translational medicine: can it really facilitate the transition of research "from bench to bedside"? Eur J Clin Pharmacol. 2006;62:91–95. doi: 10.1007/s00228-005-0060-4. - DOI - PubMed
    1. Taylor RS, Drummond MF, Salkeld G, Sullivan SD. Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle. BMJ. 2004;329:972–975. doi: 10.1136/bmj.329.7472.972. - DOI - PMC - PubMed
    1. Schreyögg J, Stargardt T, Velasco-Garrido M, Busse R. Defining the "Health Benefit Basket" in nine European countries. Evidence from the European Union Health BASKET Project. Eur J Health Econ. 2005;Suppl:2–10. doi: 10.1007/s10198-005-0312-3. - DOI - PMC - PubMed

Publication types

LinkOut - more resources