1. HTA from an Industry Perspective Janey Shin, Director of Medical Affairs Johnson & Johnson Medical Companies CADTH, 2015

2. Industry Challenges in Canada 2 Lack of pharma-grade evidence: Current regulatory requirements for medical devices are less stringent compared to pharmaceuticals. Evidence gap between HTA requirements and those for market licensing Other confounding factors: clinician learning curves and training, patient management Medical device lifecycle is limited: Typically 18 - 24 months No market exclusivity  low value to conduct effectiveness studies Can result in no access to new health technologies in the Canadian market. Canadian market is small: Canadian device market represents 1% of the world market Canadian-based MNEs – requires global budget to invest in risk- sharing medical technology evaluations

3. Barriers to Adoption and Diffusion 3 Procurement Decision-Making: Procurement in healthcare organizations often focus on reducing short-term costs vs. strategic value HTA gap in procurement decisions – not a consideration OHIC (Ontario Health Innovation Council) recommendations on Strategic Value-Based Procurement is promising Healthcare budget and reimbursement systems: Institutional fiscal constraints Disruptive technologies that have overall system benefits such as: improving quality of life shifting resources shifting site of care may not get implemented if the conditions for adoption are not considered

4. Looking Forward 4 Engagement and Partnerships: Early engagement between HTA and medical technology organizations to ensure: 1)appropriate and effective design and use of HTA for new technologies 2)better understanding of the needs of its customers Recognition that industry is a key stakeholder during HTA consultations Harmonization of HTAs: Better understanding of the various HTA organizations Consistency in HTA recommendations Alignment of evaluation framework (transparency in device selection and priority setting) Innovation could be stifled unless the health technology assessment process recognizes the risk of manufacturers.

5. Contact 5 Janey Shin Director, Medical Affairs Johnson and Johnson Medical Companies jshin2@its.jnj.com