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  • Cited by 9
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  • International Journal of Technology Assessment in Health Care, Volume 24, Issue 2
  • April 2008, pp. 140-145

Why licensing authorities need to consider the net value of new drugs in assigning review priorities: Addressing the tension between licensing and reimbursement

  • Christopher McCabe (a1), Karl Claxton (a2) and Anthony O'Hagan (a3)
  • DOI:
  • Published online: 01 April 2008

Pharmaceutical regulators and healthcare reimbursement authorities operate in different intellectual paradigms and adopt very different decision rules. As a result, drugs that have been licensed are often not available to all patients who could benefit because reimbursement authorities judge that the cost of therapies is greater than the health produced. This finding creates uncertainty for pharmaceutical companies planning their research and development investment, as licensing is no longer a guarantee of market access. In this study, we propose that it would be consistent with the objectives of pharmaceutical regulators to use the Net Benefit Framework of reimbursement authorities to identify those therapies that should be subject to priority review, that it is feasible to do so and that this would have several positive effects for patients, industry, and healthcare systems.

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2.M Angell . Excess in the pharmaceutical industry. CMAJ. 2004;171:12.

5.K Claxton , PJ Neuman , SS Araki , MC Weinstein . The value of information: An application to a policy model of Alzheimer's disease. Int J Technol Assess Health Care. 2001; 17:3855.

6.K Claxton , M Sculpher , M Drummond . A rational framework for decision making by the National Institute for Clinical Excellence. Lancet. 2002;360:711715.

9.JA DiMasi , RW Hansen , HG Grabowski . The price of innovation: New estimates of drug development costs. J Health Econ. 2003; 22:151185.

16.S Palmer , PC Smith . Incorporating option values into the economic evaluation of health care technologies. J Health Econ. 2000; 19:755766.

18.M Rawlins . Cutting the cost of drug development? Nat Rev Drug Discov. 2004;3:360362.

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International Journal of Technology Assessment in Health Care
  • ISSN: 0266-4623
  • EISSN: 1471-6348
  • URL: /core/journals/international-journal-of-technology-assessment-in-health-care
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