A toolkit of methods of development-focused health technology assessment

Health technology assessment conducted to inform decisions during technology development (development-focused or DF-HTA) has a number of distinct features compared with HTA conducted to inform reimbursement and usage decisions. In particular, there are a broad range of decisions to be informed related to the development of a technology; multiple markets and decision makers to be considered; a limited (and developing) evidence base; and constrained resources for analysis. These features impact upon methods adopted by analysts. In this paper, we (i) set out methods of DF-HTA against a timeline of technology development; (ii) provide examples of the methods' use; and (iii) explain how they have been adapted as a result of the features of DF-HTA. We present a toolkit of methods for analysts working with developers of medical technologies. Three categories of methods are described: literature review, stakeholder consultation, and decision analytic modeling. Literature review and stakeholder consultation are often used to fill evidence gaps. Decision analytic modeling is used to synthesize available evidence alongside plausible assumptions to inform developers about price or performance requirements. Methods increase in formality and complexity as the development and evidence base progresses and more resources are available for assessment. We hope this toolkit will be used in conjunction with the framework of features of DF-HTA presented in our earlier article in order to improve the clarity and appropriateness of methods of HTA used in DF-HTA. We also seek to contribute to a continuing dialogue about the nature of, and the best approach to, DF-HTA.