Evidence-based decision making: when should we wait for more information?

We discuss the challenge of managing innovation in and access to health care interventions in an evidence-based, cost-effective way, and we describe a decision-making framework (using U.S. and U.K. case studies) for health care payers considering the adoption of new technologies. We argue that providing reimbursement for what could be a cost-effective technology "only in the context of research" will be appropriate if the costs of delaying implementation are offset by the value of "keeping one's options open" by waiting for more information. We conclude that there is a need for better integration of health care decision-making processes with research policies.

[1]  S. Tunis,et al.  Using clinical trials as a condition of coverage: lessons from the National Emphysema Treatment Trial , 2004, Clinical trials.

[2]  Sean Tunis,et al.  Reflections On Science, Judgment, And Value In Evidence-Based Decision Making: A Conversation With David Eddy , 2007 .

[3]  E. Emanuel,et al.  Medicare's requirement for research participation as a condition of coverage: is it ethical? , 2006, JAMA.

[4]  J. Skinner,et al.  Is technological change in medicine always worth it? The case of acute myocardial infarction. , 2006, Health affairs.

[5]  Ike Iheanacho,et al.  Testing Treatments: Better Research for Better Healthcare , 2006, BMJ : British Medical Journal.

[6]  Jeffrey M Drazen,et al.  Expression of concern reaffirmed. , 2006, The New England journal of medicine.

[7]  A. Culyer,et al.  Evidence-informed evidence-making , 2008, Journal of health services research & policy.

[8]  S. Tunis,et al.  Coverage options for promising technologies: Medicare's 'coverage with evidence development'. , 2006, Health affairs.

[9]  E. Emanuel,et al.  Does Random Treatment Assignment Cause Harm to Research Participants? , 2006, PLoS medicine.

[10]  A. Oxman,et al.  Systematic review to determine whether participation in a trial influences outcome , 2005, BMJ : British Medical Journal.

[11]  G. Wilensky Developing a center for comparative effectiveness information. , 2006, Health affairs.

[12]  M. Mcgrath Cost Effectiveness in Health and Medicine. , 1998 .

[13]  A Haycox,et al.  Coronary artery stents: a rapid systematic review and economic evaluation. , 2004, Health technology assessment.

[14]  B. Lindsay,et al.  Review of the registry's first year, data collected, and future plans. , 2007, Heart rhythm.

[15]  P. Glasziou,et al.  Testing Treatments: Better Research for Better Healthcare , 2006 .

[16]  R. Brindis,et al.  The National ICD Registry: now and into the future. , 2006, Heart rhythm.

[17]  A. Garber,et al.  Evidence-based coverage policy. , 2001, Health affairs.

[18]  P. Budetti,et al.  Impact of state tort reforms on physician malpractice payments. , 2007, Health affairs.

[19]  J M Grimshaw,et al.  Effectiveness and efficiency of guideline dissemination and implementation strategies , 2004, International Journal of Technology Assessment in Health Care.

[20]  S. Palmer,et al.  Incorporating option values into the economic evaluation of health care technologies. , 2000, Journal of health economics.

[21]  J Chilcott,et al.  The role of modelling in prioritising and planning clinical trials. , 2003, Health technology assessment.

[22]  Peter Littlejohns,et al.  Making a decision to wait for more evidence: when the National Institute for Health and Clinical Excellence recommends a technology only in the context of research. , 2007, Journal of the Royal Society of Medicine.

[23]  Iain Chalmers,et al.  Well informed uncertainties about the effects of treatments , 2004, BMJ : British Medical Journal.

[24]  J. Berger,et al.  Progressive multifocal leukoencephalopathy and natalizumab--unforeseen consequences. , 2005, The New England journal of medicine.

[25]  K Claxton,et al.  The irrelevance of inference: a decision-making approach to the stochastic evaluation of health care technologies. , 1999, Journal of health economics.

[26]  R. Coleman,et al.  The National Oncologic PET Registry: expanded medicare coverage for PET under coverage with evidence development. , 2007, AJR. American journal of roentgenology.

[27]  Nalin Kulatilaka,et al.  Real Options: Managing Strategic Investment in an Uncertain World , 1998 .

[28]  F. Martinez,et al.  Lessons from the national emphysema treatment trial. , 2007, Seminars in thoracic and cardiovascular surgery.

[29]  M. Gillick,et al.  Medicare coverage for technological innovations--time for new criteria? , 2004, The New England journal of medicine.