It is common practice for developers of new health care technologies to engage in early dialogue with the major regulatory 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 3 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 phase 3 clinical trial designs for their key development compounds have been finalized, may be beneficial. This article reports on the pioneering efforts of one technology developer in seeking early dialogue with seven pricing and reimbursement agencies in five countries globally in 2007-2008 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, through a face-to-face meeting with prior circulation of a briefing book. 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. The conclusion of this study, however, was that early dialogue can be a worthwhile process for all parties and can lead to a common understanding about evidence development for market access.

The results of the model suggest that, on the basis of current evidence, laparoscopic fundoplication represents a cost effective means of treating GORD rather than lifelong medical management.

The sessions proved highly informative and permitted better alignment of the possible positioning of new medicines with the clinical evidence that regulators and HTA agencies might subsequently require for favorable assessment. The process provided early and clear signals to inform major development investments and the probability of successful market access. A number of challenges need to be addressed before tripartite scientific advice can be provided on continual basis.

The results indicate that outcome-based schemes are better suited to deal with uncertainties surrounding cost effectiveness, while non-outcome-based schemes are more appropriate for pricing and budget impact challenges.