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Review
. 2024 Jan 29;40(1):e13.
doi: 10.1017/S0266462324000047.

Early technology review: towards an expedited pathway

Leslie Levin  1 , Murray Sheldon  2 , Robert S McDonough  3 , Naomi Aronson  4 , Maroeska Rovers  5   6 , C Michael Gibson  7 , Sean Robert Tunis  8 , Richard E Kuntz  9
Affiliations
Review

Early technology review: towards an expedited pathway

Leslie Levin et al. Int J Technol Assess Health Care. .

Abstract

Objectives: Evidence development for medical devices is often focused on satisfying regulatory requirements with the result that health professional and payer expectations may not be met, despite considerable investment in clinical trials. Early engagement with payers and health professionals could allow companies to understand these expectations and reflect them in clinical study design, increasing chances of positive coverage determination and adoption into clinical practice.

Methods: An example of early engagement through the EXCITE International model using an early technology review (ETR) is described which includes engagement with payers and health professionals to better inform companies to develop data that meet their expectations. ETR is based on an early evidence review, a framework of expectations that guides the process and identified gaps in evidence. The first fourteen ETRs were reviewed for examples of advice to companies that provided additional information from payers and health professionals that was thought likely to impact on downstream outcomes or strategic direction. Given that limitations were imposed by confidentiality, examples were genericized.

Results: Advice through early engagement can inform evidence development that coincides with expectations of payers and health professionals through a structured, objective, evidence-based approach. This could reduce the risk of business-related adverse outcomes such as failure to secure a positive coverage determination and/or acceptance by expert health professionals.

Conclusions: Early engagement with key stakeholders exemplified by the ETR approach offers an alternative to the current approach of focusing on regulatory expectations. This could reduce the time to reimbursement and clinical adoption and benefit patient outcomes and/or health system efficiencies.

Keywords: biomedical; device approval; diffusion of innovation; evidence-based medicine; investigational; technology assessment; therapies.

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Conflict of interest statement

EXCITE is a nonprofit organization set up as a voluntary collaboration. All the coauthors are EXCITE Board members or members of Board committees. The lead author derives a salary from the organization as chief executive and scientific officer in addition to being a Board member. None of the other authors receive salaries or honoraria from EXCITE, which has stringent conflict of interest guidelines with which they are all compliant. Panelists are offered honoraria by EXCITE for their participation in ETRs. One coauthor is the President of a nonprofit academic research organization (ARO) which has a special relationship with EXCITE as the preferred favored vendor for undertaking clinical trials resulting from the early engagement mentioned above. The aforementioned ARO is invited to attend ETR Panel meetings as a way of establishing continuity between the ETR and any subsequent clinical trial. Early technology reviews are confidential to EXCITE and its appointed panelists and becomes the intellectual property of the company on its completion. The company may divulge content at its discretion. EXCITE insists on an objective evidence-based approach and explicitly states that it cannot and will not promote any of the technologies it is asked to evaluate.

Figures

Figure 1.
Figure 1.
EXCITE evidence technology review process.
See this image and copyright information in PMC

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