BMJ  2004;329:972-975 (23 October), doi:10.1136/bmj.329.7472.972

Education and debate

Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle

¹ Department of Public Health and Epidemiology, University of Birmingham, Birmingham B15 2TT, ² Centre for Health Economics, University of York, York, ³ School of Public Health, University of Sydney, Sydney, Australia,, ⁴ Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle, USA

Increasing numbers of countries are considering cost effectiveness in decisions about which drugs to make available for prescription. How do the different approaches work and is it time for standardisation?

The first 150 words of the full text of this article appear below.

Introduction

Licensing is the main method of regulating and controlling access to pharmaceuticals. New drugs cannot receive a product licence until manufacturers provide evidence of their quality, safety, and efficacy. In a world of rapidly escalating global healthcare costs, evidence of a drug's quality, safety, and efficacy is no longer sufficient to ensure reimbursement for use in public markets. Increasingly, new drugs must show evidence of cost effectiveness. In other words, does the drug produce a useful health gain (over and above currently available treatments) for its additional cost? In industry circles this value for money requirement has become known as the fourth hurdle. In this article, we examine the international development of fourth hurdle policies, analyse their effect, and identify some of the future challenges and likely directions.

Emergence of the fourth hurdle

The first healthcare system to develop formal regulations governing the use of cost effectiveness evidence in reimbursement decisions was Australia. Since 1993, . . . [Full text of this article]

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Global development

Europe
United States
Rest of the world
Effect of fourth hurdle
Quality of pharmacoeconomic evidence
Does cost effectiveness information influence reimbursement decisions?

Effect of cost effectiveness analysis on price

Harmonising fourth hurdle systems

Confidentiality and openness

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