Early HTA Case Study of Premarket Evaluation

Workshop PM-5

Intermediate. Will be of particular interest to HTA producers.

Presenters: Professor Murray Krahn, Toronto Health Economics and Technology Assessment (THETA) Collaborative/Toronto General Research Institute; Dr. Valeria Rac, Toronto Health Economics and Technology Assessment (THETA) Collaborative/Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto; Dr. Petros Pechlivanoglou, The Hospital for Sick Children (SickKids) Research Institute; Dr. Lusine Abrahamyan, THETA Collaborative/Institute of Health Policy, Management and Evaluation, University of Toronto

Educational Objective: Theoretical and practical knowledge on how to conduct a comprehensive, early HTA to guide future adoption in the health care system.
Early evaluation of health technologies is collaboratively implemented by policy- makers, industry, and academia to select and expedite the development of emerging technologies that may address the needs of patients and health systems. This workshop will provide theoretical and practical knowledge on early HTA using a case study of a Canadian-grown technology, BresoDx ― a portable monitor (PM) for the diagnosis of obstructive sleep apnea (OSA). For the early HTA of BresoDx, our comprehensive premarket evaluation included:

  • a pragmatic, randomized controlled trial, with adult patients with symptoms suggestive of OSA referred to sleep clinics to evaluate the accuracy of the clinical diagnosis of OSA informed by the home sleep study with BresoDx against the clinical diagnosis informed by the in-laboratory sleep study with polysomnography (PSG) as a reference standard
  • an economic evaluation using cost-utility analysis and comparing three strategies: i) testing with BresoDx PM at home, followed by treatment based on these results; ii) testing with BresoDx PM at home, followed by full PSG for patients with negative or indeterminate home test results; iii) current testing policy, or full PSG for all referred patients.
  • systematic review and meta-analysis to synthesize the current evidence on the diagnostic ability of Type IV PMs compared to the PSG to establish diagnosis in patients with suspected OSA. For each evaluation component, we will present applied methodology and discuss any challenges faced. We will complete the session by discussing how this comprehensive evaluation will help to guide the adoption decisions of this technology in Canada.