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HTA from an Industry Perspective

HTA from an Industry Perspective. Janey Shin, Director of Medical Affairs Johnson & Johnson Medical Companies CADTH, 2015. Industry Challenges in Canada. Lack of pharma-grade evidence: Current regulatory requirements for medical devices are less stringent compared to pharmaceuticals.

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HTA from an Industry Perspective

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

  2. Industry Challenges in Canada • 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 • 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 • Engagement and Partnerships: • Early engagement between HTA and medical technology organizations to ensure: • appropriate and effective design and use of HTA for new technologies • 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 Janey Shin Director, Medical Affairs Johnson and Johnson Medical Companies jshin2@its.jnj.com

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