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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:

scott.gavura@cancercare.on.ca

lyndee.yeung@cancercare.on.ca

lisa.milgram@cancercare.on.ca

Thank you. Questions?

18