Moderator: Keith Tolley, MPhil, Research Director, Mapi Values, Bollington, Cheshire, UK

Panelist(s): Carole Longson, PhD, Director, NICE, London, UK; Michael Barry, MD, PhD, Clinical Director (NCPE) Senior Lecturer in Clinical Pharmacology (TCD), National Centre for Pharmacoeconomics, Dublin 8, Ireland; Hilda Bastian, PhD, Head of Department; Health Information, IQWiG, Institute for Quality and Efficiency in Health Care, Cologne, Germany

ISSUE: To investigate whether in the future formal cost-effectiveness methods will be routinely applied to appraise new pharmaceuticals seeking market access in European countries?

OVERVIEW: A number of countries in Europe already use formal cost-effectiveness evidence to support reimbursement and pricing decisions. For this issue contrasting perspectives will be put forward from panelists covering countries with institutions that perform appraisals of pharmaceuticals and other technologies on behalf of their respective Ministries of Health, but with differing approaches to the use of formal cost-effectiveness methods. In the UK cost-effectiveness evidence is routinely used by NICE, adopting a cost-utility ‘reference case' approach, and indirect comparisons performed where necessary to compare new interventions with the current standard. In Germany cost-effectiveness evidence has not been routinely used to date in IQWiG appraisals, although new plans to take greater account of such evidence have been put in place. But what form should that data take to inform decisions? The requirements for cost-effectiveness evidence in Ireland and the rapid HTA approach adopted in this country provide a further contrast with the UK and German perspectives. The role of pharmaceutical companies and consultancy agencies in the evidence generation, submission and review process and the future use of economic evaluation methods and HTA in UK, Germany and Ireland and other countries around Europe will be a key topic for audience debate. Also, the issue of timeliness of cost-effectiveness evidence in relation to product launch will be debated. There will be discussion as to whether the “NICE approach” to cost-effectiveness is likely to be increasingly adopted for guideline development or reimbursement purposes in other European countries, and whether applying explicit cost-effectiveness thresholds are useful.