1. The HTA-Adoption (missing) Link for Medical Devices: Observations to Date Daria O’Reilly PhD Associate Professor, Dept. of Clinical Epidemiology & Biostatistics, Faculty of Health Sciences, McMaster University Associate Director, PATH Research Institute, St. Joseph’s Healthcare Hamilton. CADTH Symposium Ottawa, ON April 11, 2016

2. Disclosure I have no actual or potential conflict of interest in relation to this topic or presentation.

3. Medical Devices  $6.8 Billion/yr industry  For regulators, challenge to regulate for safety and effectiveness Risk-based approach  For payers, it is to manage the costs as well as the benefits to patients. HTA to determine value for $ 3

4. HTA & Adoption  Adoption can be slow regardless of evidence base Positive recommendation does not ensure successful uptake  HTA does not address adoption  Assumes seamless and costless, beyond the incremental costs of the device itself Even after procurement 4

5.  Uptake depends on the impact on the health system operating costs, HR needs, disruptiveness, readiness, usability, willingness, storage, patient demand, medical need  Reimbursement-who should pay and why? ID payer for device and disposables (e.g. hospital capital budget vs. MOH vs. private). May require shifting of budgets between silos May also require a new payment model for remuneration (new OHIP codes) 5 Factors Affecting Adoption

6. Implications for Traditional HTA  Broader context and impacts of non-drug technologies (HR needs, training, credentialing, system readiness)  HTA should support decision making not only on what to implement, but also on how to implement innovative HTs 6

7. Implications for Traditional HTA  Evaluation should be iterative, tailored to the device and timely Based on type, context, indication, use  Clinical efficacy and CE are necessary but not sufficient Understanding the organizational implications is vital  Innovative methods requires communication between stakeholders (industry, patients, HCP, payers), researchers, procurement and regulatory processes

8. Programs for Assessment of Technology in Health (PATH) Research Institute McMaster University Daria O’Reilly, MSc, PhD Associate Professor Department of Clinical Epidemiology and Biostatistics, McMaster University Associate Director, Programs for Assessment of Technology in Health (PATH) Research Institute, St Joseph’s Healthcare Hamilton Telephone: (905) 523-7284 (PATH) Ext. 5277 Fax: (905) 522-0568 25 Main Street West Email: oreilld@mcmaster.ca 20th floor, Suite 2000 Website: http://www.path-hta.ca Hamilton, ON, L8P 1H1 For further information, please contact: 8

9. 9 The Catalyst--Report of the OHIC