chander sehgal, md, mba director, common drug review (cdr) · chander sehgal, md, mba director,...
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Chander Sehgal, MD, MBA
Director, Common Drug Review (CDR)
Taipei, Taiwan
July 23‐26, 2012
CANADIAN PERSPECTIVE
Common Drug review: A *pan-Canadian processCANADA: 33 M people; area 10 M km2
* includes all publicly funded drug plans except Quebec
DIVERSITY!
Submission of Clinical & Economic Evidence to CADTH
CDR Review
CDEC recommendation to drug plans
Manufacturer ResponsibilityManufacturer Responsibility
CADTH ResponsibilityCADTH Responsibility
Drug Plan ResponsibilityDrug Plan Responsibility
Market Access Continuum (drugs): Canada
Listing Decision
Listing Decision
ListingDecision
Listing Decision
Market AuthorizationMarket AuthorizationHealth Canada ResponsibilityHealth Canada Responsibility
PMPRBPMPRB
Drug PlansDrug Plans
Patient Input
Submission
Patient Input
Submission
Where HTA Fits
HTADecision support
Evidence-based reviews, recommendationsand optimal use tools
FEDERAL GOVERNMENTRegulation of drugs and devices in Canada
FUNDERSUptake and coverage decision
PHYSICIANS AND PATIENTS
Health Canada - Regulatory Perspective
*Safety
*Efficacy
Quality
*In many cases, compared with placebo
CDR Reviews – HTA perspective
*Comparative Effectiveness
*Cost and Cost Effectiveness
Patient Groups input
*Compared with best (publicly) funded alternative
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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)
Benefit-Risk AssessmentHTA perspective
Benefit considerations Real world health gain
Health gain at a societal level
Risk considerations Harms (safety)
Opportunity cost of the decision
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
How Patient Input Evidence is Used
Patient evidence summarised, used to inform protocol &
included review report
Patient input presented, used in deliberations & reflected in
recommendations
CADTH ReviewTeamCADTH ReviewTeam
Expert Committee Expert Committee
Drug PlansDrug PlansPatient
evidence shared
Patient Input SubmissionPatient Input SubmissionCanadian Patient GroupsCanadian Patient Groups
Reasons & recommendations
published
Original & summary input sent to CDEC
Patient evidence shared
Patient evidence shared
Patient evidence shared
Patient evidence shared
Patient evidence shared
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?
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
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
