1. Developing a multi-criteria approach for drug reimbursement decision making: an initial step forward Francois Dionne- Centre for Clinical Epidemiology and Evaluation Farzad Ali- Pfizer

2. Plan 1. Why this initial step 2. How was the work done 3. Where do we stand now 4. What’s next

3. Why this initial step Industry is evolving PAST Regulatory Need PRESENT Regulatory Need Payer Need

4. What could HTA/Payers consider? Cost-Effectiveness Safety Efficacy (Comparator, endpoint) Patient Preference Ethical and equity consideration Budget Impact & Affordability Unmet need $ Burden of Disease Reward future innovation (dynamic efficiency) Severity Price

5. How was the work done Two workshops- November 2013, April 2014 Key stakeholders involved Report is a summary of the discussions

6. Where do we stand now Overarching context Seven guiding principles Ten criteria Dionne F, Mitton C, Dempster B, Lynd LD. Developing a multi-criteria approach for drug reimbursement decision making: an initial step forward. J Popul Ther Clin Pharmacol. 2015;22(1):e68-77. Epub 2015 Feb 12.

7. What’s next The next steps involve: Finalization of the criteria selection Refinement of the criteria definitions to ensure clarity and minimize potential overlap between criteria Criteria weights have to be set, and each criterion needs a rating scale Finally, the completed framework should be tested for validity with some past submissions to examine the robustness of the entire rating tool