Chander Sehgal, MD, MBA Director, Common Drug Review (CDR) Taipei, Taiwan July 23 26, 2012

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1 Chander Sehgal, MD, MBA Director, Common Drug Review (CDR) Taipei, Taiwan July 23 26, 2012

2 CANADIAN PERSPECTIVE

3 Common Drug review: A *pan-canadian process CANADA: 33 M people; area 10 M km 2 DIVERSITY! * includes all publicly funded drug plans except Quebec

4 Market Access Continuum (drugs): Canada Health Canada Responsibility Market Authorization Manufacturer Responsibility Submission of Clinical & Economic Evidence to CADTH Drug Plans CADTH Responsibility CDR Review CDEC recommendation to drug plans Patient Input Submission PMPRB Drug Plan Responsibility Listing Decision Listing Decision Listing Decision Listing Decision

5 Where HTA Fits FEDERAL GOVERNMENT Regulation of drugs and devices in Canada HTA Decision support Evidence-based reviews, recommendations and optimal use tools FUNDERS Uptake and coverage decision PHYSICIANS AND PATIENTS

6 Health Canada - Regulatory Perspective *Safety *Efficacy Quality *In many cases, compared with placebo

7 CDR Reviews HTA perspective *Comparative Effectiveness *Cost and Cost Effectiveness Patient Groups input *Compared with best (publicly) funded alternative

8 CDR reviews: Dealing with Uncertainty Clinical Uncertainty RCTs vs. appropriate comparator (not placebo) correct target population ( first line vs. second line use) surrogate vs. clinical endpoint Economic Uncertainty not necessarily evidence-based based on (often) unsubstantiated assumptions problems with limited/poor quality data (e.g., lack of head-to-head trials, translation from surrogate to clinical endpoint, wrong comparator, wrong patient group) 8

9 Benefit-Risk Assessment HTA perspective Benefit considerations Real world health gain Health gain at a societal level Risk considerations Harms (safety) Opportunity cost of the decision

10 Drug Plans listing decisions Affordability (impact on budget and available financial resources) Current funding status of comparators *Local context and Other Factors (Ethical, Legal, Societal preferences etc.) *Each jurisdiction will have different constraints and will make different choices

11 How Patient Input Evidence is Used Canadian Patient Groups Patient Input Submission CADTH Review Team Patient evidence summarised, used to inform protocol & included review report Original & summary input sent to CDEC Expert Committee Patient input presented, used in deliberations & reflected in recommendations Reasons & recommendations published Drug Plans Patient evidence shared Patient evidence shared Patient evidence shared Patient evidence shared

12 CDEC/CDR Recommendations Framework Based on established criteria: safety, efficacy and effectiveness of the drug compared to alternatives therapeutic advantages and disadvantages relative to current accepted therapy cost-effectiveness relative to current accepted therapy patient and public perspectives on impact of the drug No Weights! How to apply weights across different disease areas? %Weights for patients input versus comparative effectiveness versus cost-effectiveness?

13 Future Directions: Transparency and Patient Group input Intent to make CDR review reports public Principle of complete transparency and minimum redaction What is disclosable information or not and why? Need co-operation fro m the industry Evaluation of patient groups input underway Explore parallel review mechanisms with Health Canada pre-noc reviews

14 Drug Review Issues Limited data typically fewer patients, more limited Canadian expertise Trial durations short term trials, limited long-term data yet lifelong conditions Trial designs observational studies rather than randomized controlled trials limited comparative data Outcome measures often surrogate markers relationship with clinical benefit unclear often don t include outcomes of importance identified by patients

15 For More Information Contact:

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