title: Transatlantic convergence with respect to the fourth hurdle?
abstract: There appears to be movement towards convergence between the US and Europe in terms of the objectives of prescription drug cost containment, improvement in and more equitable access to pharmaceuticals, and minimisation of variation in clinical practice. In addition, policymakers in the US and Europe are resorting to the use of similar evidence-based approaches to achieve these policy objectives. However, using the examples of clinical practice guidelines, new drug appraisals for reimbursement, reference pricing and prescription to over-the-counter switching, I illustrate how the development and implementation of such approaches are a function not only of evidence but also of politics. Because all politics is local and differs across countries, and settings within countries, this logically has resulted in instances of divergence in the development and implementation of evidence-based approaches. Evidence improves policy decisions by offering quantitative insight into how well new technologies work, and for whom, but such data do not eliminate vexing trade-offs between the benefits provided and the acceptability of risks and costs incurred to achieve those benefits. Judgments on trade-offs depend in part on the interests and values of stakeholders. And these interests and values help shape how policy makers responsible for drug reimbursement in the US and Europe develop and apply the same types of evidence-based approaches differently.
authors: Tufts Center for Study of Drugs Development, 192 South Street, Suite 550, Boston, Massachusetts 02111, USA. joshua.cohen@tufts.com
authors: Joshua
authors: J
authors: Cohen
mesh_terms: D003363:Cost Control; D016527:Drug Costs; D004345:Drug Industry / Q000191:economics; D005060:Europe; D019317:Evidence-Based Medicine; D006291:Health Policy; D006297:Health Services Accessibility; D006801:Humans; D011050:Policy Making; D017410:Practice Guidelines as Topic; D055553:Prescription Drugs / Q000191:economics*; D012051:Reimbursement Mechanisms; D014481:United States
chemical_list: D055553:Prescription Drugs
references: Health Aff (Millwood). 2004 May-Jun;23(3):10-25
references: 15160799
references: Value Health. 2003 Jul-Aug;6 Suppl 1:S46-51
references: 12846925
references: Health Aff (Millwood). 2004 Jan-Jun;Suppl Web Exclusives:W4-284-96
references: 15451997
references: Health Aff (Millwood). 2003 May-Jun;22(3):42-5
references: 12757270
references: BMJ. 1997 Oct 11;315(7113):943-6
references: 9361548
references: Am J Ther. 2003 Sep-Oct;10(5):370-6
references: 12975722
references: Int J Technol Assess Health Care. 2004 Fall;20(4):415-20
references: 15609789
references: BMJ. 2005 Jan 1;330(7481):39-41
references: 15626806
references: Health Aff (Millwood). 2005 Jan-Feb;24(1):29-40
references: 15647213
references: Pharmacoeconomics. 2006 Dec;24 Suppl 2:55-7
references: 23389488
references: Health Aff (Millwood). 2005 Jan-Feb;24(1):151-62
references: 15647226
references: Health Aff (Millwood). 2003 May-Jun;22(3):16-30
references: 12757268
references: Am J Manag Care. 2004 May;10(5):308-12
references: 15152700