e5 cadth ebp intro - yeung - salon d
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Evidence Building and Evaluating Real-World
Effectiveness: From Concept to Action
May 7, 2013
Lyndee Yeung, Program Manager, Provincial Drug Reimbursement Programs,
Cancer Care Ontario
Presented to: CADTH Symposium, St. John’s, Newfoundland
Acknowledgements
Cancer Care OntarioOntario Public Drug
ProgramsPharmacoeconomics Research Unit, CCO
Provincial Disease Site Groups
Committee to Evaluate Drugs
(CED)
Stakeholders we’ve consulted with
2
A special thanks toScott Gavura, Director, Provincial Drug Reimbursement Programs, Cancer Care OntarioSherry O’Quinn, Senior Pharmacist, Ontario Public Drug Programs
Agenda
Item Presenter Time (minutes)
Introduction Lyndee Yeung 3
Perspectives
Funder Lyndee YeungSherry O’Quinn
715
Researcher, CED Member, Clinician Dr. Kelvin Chan 20
Health Economist Dr. Jeffrey Hoch 20
Conclusion Lyndee Yeung 5
Question & Answer All 20
3
Overview
How are drugs reviewed and approved in Ontario?
Why an Evidence Building Program?
What are the program principles, criteria, and process?
What are the challenges, lessons learned, and opportunities?
Perspectives
What is the status of the program?
What additional work is underway?
4
Drug Review & Funding Process for Cancer
Drugs in Ontario
Health Canada issues market authorization
Manufacturer or Disease/Tumour Group submits topan-Canadian Oncology Drug Review(Ontario context contributed to review)
Ontario Public Drug Programs evaluates recommendation and makes final funding decision
pan-Canadian Oncology Drug Review (pCODR)Makes recommendation to drug plans
Why have an Evidence Building Program?
Why
• New therapies but new challenges for funding
• No means to fund where evidence is preliminary
• Funding gap compared to other provinces
What
• Conditional funding while real-world data are collected to resolve uncertainty and to inform a final funding decision
• Not intended to be a catch-all for every “No” decision
How• Implemented funding for Herceptin (trastuzumab)
• Published policy; working to add more drugs to the EBP
6
Drug Review & Funding Process for Cancer
Drugs in Ontario
Health Canada issues market authorization
Manufacturer or Disease/Tumour Group submits topan-Canadian Oncology Drug Review(Ontario context contributed to review)
Ontario Public Drug Programs evaluates recommendation and makes final funding decision
pan-Canadian Oncology Drug Review (pCODR)Makes recommendation to drug plans
The Evidence-Building Program
consideration process begins after a
drug has been reviewed for funding.
Program Principles
Enhance Review Integrity
• Enhance existing process and decision-making
Use Real-World Data
• Collect data during periods of conditional reimbursement to inform future funding decision
Transparency
• Transparent, equitable, defendable and timely policies and processes
Performance Reporting
• Measure and report on efficiency and effectiveness on an ongoing basis
Continued Evaluation
• Ongoing evaluation
• Informed by each funding request considered
8
Inclusion Criteria
Potential EBP
Candidate
Reviewed for
funding
Extension / Expansion of
current funding
Resolvable Uncertainty
Real-world data collection can inform future
funding decision
No trials underway that might answer
question
Supported by Disease Site Group
9
10
Site
Final Proposal
C
A B
CCO Ministry Manufacturers
EAG
PE
Administration &Reimbursement
EAG = External Analytics Group
The process
Patients & Clinicians
Application & Review
DSG proposal
Screen
Initial Review
Executive Officer
(EO) Review & Approval
Detailed work-up
SC & CED Review
EO Final Approval
11
DSG = Disease Site GroupSC = Steering CommitteeCED = Committee to Evaluate Drugs
Implementation
Product Listing
Knowledge Transfer & Adoption
Data Collection & Tracking
Interim Analysis
Final Analysis
Evaluation
Decision
12
Reporting
CHALLENGES, LESSONS LEARNED, AND
OPPORTUNITIES
13
EBP Herceptin – May 2011 to March 2013
14
0
20
40
60
80
100
120
140
Cumulative By month
Resectable or Potentially
Resectable Liver metastases
NDFP
FOLFOX + Surgery
(curative)
Extensive or Unresectable Metastases
NDFP
mCRC regimens
(palliative)
15
Lung, Liver & Lung,Liver & non-pulmonary
EHM
EBPFOLFOX+surg
(curative)
NDFP = New Drug Funding ProgramEBP = Evidence Building ProgramEHM = Extrahepatic Metastases
Oxaliplatin with Curative Surgery (Jan 2013)
16
Hospital agreements & data collection
processes
Evaluation framework & KPIs
Analysis & reporting framework (including feasibility of oral drug
data collection)
Communication, stakeholder engagement, &
governance
DSG engagement in proposal
development EBPPOLICY
The journey continues….
For more informationEvidence Building Program
http://www.cancercare.on.ca/toolbox/drugs/ebprogram/
Contacts:
Thank you. Questions?
18