Emerging Use of Early Health Technology Assessment in Medical Product Development: A Scoping Review of the Literature

Abstract

Early health technology assessment is increasingly being used to support health economic evidence development during early stages of clinical research. Such early models can be used to inform research and development about the design and management of new medical technologies to mitigate the risks, perceived by industry and the public sector, associated with market access and reimbursement. Over the past 25 years it has been suggested that health economic evaluation in the early stages may benefit the development and diffusion of medical products. Early health technology assessment has been suggested in the context of iterative economic evaluation alongside phase I and II clinical research to inform clinical trial design, market access, and pricing. In addition, performing early health technology assessment was also proposed at an even earlier stage for managing technology portfolios. This scoping review suggests a generally accepted definition of early health technology assessment to be “all methods used to inform industry and other stakeholders about the potential value of new medical products in development, including methods to quantify and manage uncertainty”. The present review also aimed to identify recent published empirical studies employing an early-stage assessment of a medical product. With most included studies carried out to support a market launch, the dominant methodology was early health economic modeling. Further methodological development is required, in particular, by combining systems engineering and health economics to manage uncertainty in medical product portfolios.

Impact of a Global Pandemic on Health Technology Assessment

“…Health economists are no strangers to modelling and extrapolating trial data, or making and testing assumptions to undertake HTAs (see [37] for a COVID-19 modelling example); but assumptions should never replace the opportunity to collect actual data, particularly to go beyond clinical outcomes of hospitalisations to consider quality-adjusted life-years (QALYs). Early HTA can inform research and development during the initial stages of clinical research -potentially important with so many competing treatments being trialled -and help address uncertainty [38]. It is likely that such therapies will be fast tracked through any HTA process (and thereby delay other topics), but faster appraisal may mean drugs are approved that are neither clinically nor cost effective, or there is a greater chance of a negative recommendation as the committee considers there are too many uncertainties.…”

Complexity Stage Model of the Medical Device Development Based on Economic Evaluation—MedDee

“…In this phase, the early health technology assessment has been suggested in the context of iterative economic evaluation alongside phase I and II clinical research to provide information about clinical trial design, market access, and pricing [9]. Within its framework, the results should be calculated based on:…”

“…This obstacle to practical use was discussed by Money et al [8], who devised a relatively simple spreadsheet-based tool intended to lead companies smoothly through the decision-making process and facilitate a common understanding between the companies and the NHS National Innovation Centre. Continuing in the effort to build a bridge between theory and practice, Ijzerman and Steuten [9] researched the question of how likely Health Technology Assesment (HTA) is to be utilized by development companies in the decision-making process. Surveys conducted in selected companies [10] suggest that among commonly used methods informing the decision-making, there are discounted cash flow (DCF), unstructured peer reviews, scoring checklists, and decision tree analyses.…”

Early Health Economic Modelling – Optimizing Development for Medical Device Developers? Comment on "Problems and Promises of Health Technologies: The Role of Early Health Economic Modeling"

“…Given that all products were deemed to have potential value, the use of early economic modelling may have good sensitivity but poor specificity in that regard and may therefore be more useful for directing evidence gathering. 7 The data were based on the first 32 assessments, and may capture an evolving process and learning curve that may not be representative of a steady state process. The relatively small sample size also leaves questions about the generalizability of the findings.…”