Mapping policy instruments and challenges in health innovation development: implications for the role of early HTA - an umbrella review.

Abstract

Objectives: Health innovation encounters challenges across the innovation lifecycle. Although various policy instruments aim to support innovation, their alignment with stage-specific challenges remains unclear. This study synthesizes evidence to examine how innovation challenges and policy responses are distributed across the health innovation lifecycle, with particular attention to the role of early Health Technology Assessment (early HTA).

Methods: We conducted an umbrella review of review-level studies that examined health innovation challenges and related policy instruments. A comprehensive literature search was performed across five databases, including PubMed, Web of Science, Embase, Scopus, and CINAHL. Twenty-four eligible studies were included and synthesized using a well-established analytical framework. Innovation challenges and policy instruments were mapped across stages of the development pathway and linked to the contributions of early HTA.

Results: Innovation challenges were most pronounced in product design and clinical trial stages. Institutional barriers, including lengthy approval processes, became more prominent during regulatory approval and market access. Eighty policy responses were identified and clustered into economic, regulatory, and informational instruments. Economic measures were concentrated in product design and clinical trial stages, while regulatory instruments focused on regulatory approval and market access. Early HTA emerged as a complementary decision-support approach that may help address product design and clinical trial stages challenges.

Conclusions: There is a clear misalignment between where innovation challenges arise and where policy responses are applied. Integrating early HTA more systematically into innovation policy frameworks could help address challenges in product design and clinical trial stages and improve the likelihood of successful innovation adoption.