OBJECTIVES

: Early-stage Health Technology Assessment (HTA) is increasingly advocated to support health-care decision making during the R&D process of new non-drug medical technologies. However, such analyses are mostly performed in later stages, when no further refinements are possible without considerable time and resource inputs, with negative consequences for companies, governments, and the whole society.

The main aim of this study was to systematically describe and assess how Early Economic Evaluation (3E) techniques have been conducted in practice in order to identify methodological gaps. We also aimed to investigate which drivers might influence the choice of a specific methodology for conducting a 3E.

METHODS

: Related to the period 2006-2017, original research presenting case studies in 3E of two broad device categories (i.e. Medical Devices (MDs) and In Vitro Diagnostics (IVDs)) were searched using MEDLINE (via Pubmed), Embase, Scopus.

RESULTS

: Out of 2,826 publications identified, 240 were assessed for eligibility and 69 (35 on MDs, 30 on IVDs, and 4 on both categories) met the inclusion criteria. We used the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist supplemented by additional categories, defined through an iterative process, which culminated in a structured focus group with several experts, to assess the quality of the studies included. As 10 publications (14.49%) investigated more than one case study in MD and/or IVD, we distinguished two types of framework according to the application level: study-level and case study-level. The paper shows a unique overview of the 88 case studies in 3E.

CONCLUSIONS

: Our study provides recommendations for consideration in best-practice approaches to developers and decision makers for identifying and choosing the 3E methodology according to the device type and other key technology features, in addition to its development stage. Well-conducted pre-market analyses should lead to effective and affordable technology to adopt for the benefit of patients and society more rapidly.