Proposing a health-specific organizational impact framework to evaluate organizational impacts in health technology assessments.

OBJECTIVES: Health technology assessments (HTAs) have traditionally included clinical and cost-effectiveness evaluation of new health technologies (HTs). However, new HTs can generate important organizational impacts (OIs) that influence their overall value. OIs are currently not clearly identified and evaluated in HTA procedures and tools are limited. To address this issue, a comprehensive framework that allows to assess OIs of new HTs in HTAs is proposed. METHODS: A working and methodological group identified the Oslo Manual 2018, 4th edition, OECD/Eurostat, on the objectives and outcomes of commercial innovations as the basis for the OIs framework for HTAs. The Oslo Manual was translated to the healthcare sector and adapted to HTA procedures through a three-step process. RESULTS: The framework is composed of three main parts. Part I tackles the context of the evaluation, Part II the categories of impacts and the specific impacts - in total, 16 OIs were identified - and Part III the stakeholders involved. The central part of the framework is Part II, and consists of three categories of impacts: (i) on the care process, (ii) on the stakeholders' capabilities and skills, and (iii) on society or the community. CONCLUSIONS: This framework provides a comprehensive and structured basis to document OIs of new HTs. It thus contributes to the extension of HTA evaluation criteria to other dimensions than clinical and economic aspects, that is, organizational aspects. Some of its intrinsic limitations and the questions they raise in the field for policy-makers, practitioners, and researchers are discussed.