title: EARLY EVALUATION OF NEW HEALTH TECHNOLOGIES: THE CASE FOR PREMARKET STUDIES THAT HARMONIZE REGULATORY AND COVERAGE PERSPECTIVES.
abstract: With an increasing awareness that active engagement between policy decision makers, HTA agencies, regulators and payers with industry in the premarket space is needed, a disruptive comprehensive approach is described which moves the evidentiary process exclusively into this space. Single harmonized studies pre-market to address regulatory and coverage needs and expectations are more likely to be efficient and less costly and position evidence to drive rather than test innovation. An example of such a process through the MaRS EXCITE program in Ontario, Canada, now undergoing proof of concept, is briefly discussed. Other examples of dialogue between decision makers and industry pre-market are provided though these are less robust than a comprehensive evidentiary approach.
authors.affiliation: MaRS EXCITEandUniversity of Torontollevin@marsdd.com.
authors.forename: Leslie
authors.initials: L
authors.lastname: Levin
mesh_terms: D003132:Commerce; D033161:Government Regulation; D011050:Policy Making; D013673:Technology Assessment, Biomedical; D013997:Time Factors
keywords: Health technology; Premarket evaluation