Early Dialogue Between the Developers of New Technologies and Pricing and Reimbursement Agencies: a pilot study

M. Backhouse, M. Wonder, E. Hornby, A. Kilburg, M.F. Drummond, F.K. Mayer

Research output: Contribution to journalArticlepeer-review


It is common practice for developers of new health care technologies to engage in early dialogue with the major regulator agencies; such discussions frequently center around the proposed clinical trial designs to support the registration of new interventions and suggestions on their improvement. Pricing and reimbursement agencies are increasingly using the results from health technology assessments to inform their decision-making for new technologies. Such assessments are invariably underpinned by the Phase III clinical trial evidence which may not provide answers to the key questions. Technology developers are beginning to realize that direct, early dialogue on the evidence requirements of the major pricing and reimbursement agencies before the Phase III clinical trial designs for their key development compounds have been finalised may be beneficial. Until recently, this has not been possible. This paper reports on the pioneering efforts of one technology developer in seeking early dialogue with seven pricing and reimbursement agencies in five countries in 2007-8 on their likely evidence requirements for a new oral treatment for patients with chronic plaque psoriasis. The pilot project demonstrated that a feasible process of early dialogue could be established. Although there was some variation in the advice the similarities far outweighed the differences. More experience of early dialogue needs to be accumulated, involving a wider range of pricing and reimbursement agencies and compounds.
Original languageUndefined/Unknown
Pages (from-to)608-615
Number of pages8
JournalValue in Health
Issue number4
Publication statusPublished - Jun 2011


  • cost-effectiveness analysis, clinical research, pharmaceuticals, decision-making

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