Value Based Reimbursement Do we want it? Do we already have it? CADTH Symposium Vancouver, April 2011

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1 Value Based Reimbursement Do we want it? Do we already have it? CADTH Symposium Vancouver, April 2011 David Shum, PharmD, MBA Director, Reimbursement & Health Economics Roche Pharmaceuticals

2 Agenda 1. Value based reimbursement do we have it? 2. Benefits and challenges with our current VBR framework 3. Do we want it? Future considerations Disclaimer: Viewpoints expressed are of the presenter, not Roche or other organizations

3 The context the business of pharmaceuticals Ref: OECD 2008

4 Key Implications Source: OFT

5 Agenda 1. Value based reimbursement do we have it? 2. Benefits and challenges with our current VBR framework 3. Do we want it? Future considerations Disclaimer: Viewpoints expressed are of the presenter, not Roche or other organizations

6 What is value-based reimbursement? The use of clinical and economic evidence to assess the benefits and value of innovation Countries already using a form of VBR: Canada, UK Australia New Zealand Sweden Norway Germany Italy Belgium Portugal Switzerland

7 There are a number of ways to determine value Soruce: OFT Report 2007

8 HTA markets favour QALYs as the currency for appraisals Mandatory Optional Upcoming None IMS Health

9 Value: Weighing incremental costs vs. incremental benefits

11 Is decision making based on value (as defined by cost/qaly)? Source: 1. Clement, Harris, Li, Yong, Lee, Manns; JAMA Ciapanna, Yunger, Shum, Milliken, Aissa, Longo: ISPOR 2010

12 Value informed reimbursement (VIR) Clinical Value Decision Affordability Others* Patient/Public * E.g. BOI, ethics, precedence, policy, legal, uncertainty, etc

13 Agenda 1. Value based reimbursement do we have it? 2. Benefits and challenges with our current VBR framework 3. Do we want it? Future considerations Disclaimer: Viewpoints expressed are of the presenter, not Roche or other organizations

14 Benefits and challenges with the current VIR approach Benefits Challenges Multi-factorial decision making QALYs are a useful tool, can be used to compare health gains across diverse diseases Patient and public input into decision making a) Value of a drug is dynamic b) QALY limitations may not represent the true value c) Value a broader perspective

15 a) The value of a drug can change over the product life cycle New data Value Indication 1 Indication 2 Time

16 b) QALY limitations: some disease states are disadvantaged Drug Condition (prognosis where available) Survival gain NICE (manufacturer) estimated cost /QALY ( 000) Bevacizumab (1st line) Colorectal cancer (metastatic) 4.7 months 63 (88) Cetuximab (2nd Colorectal cancer (metastatic) 2.6 months TTP 30 (33) Pemetrexed Lung cancer (metastatic) None 60 (19) Fludarabine (1st line) Leukaemia lymphocytic PFS 31% v 23% at 3 years 30 (26) Bevacizumab Renal cancer (metastatic) 5 months PFS 171 (75) Sunitinib Renal cancer (metastatic) 6 months PFS 72 (29) Sorafenib Renal cancer (metastatic) 3.3 months PFS 103 (91) Temsirolimus Renal cancer (metastatic) 3.6 months 94 (102) Lenalidomide Multiple myeloid leukaemia 1.8 months (47) Lapatinib Breast cancer (metastatic) 9.5 weeks PFS (81) Cetuximab (1st line) Colorectal cancer (metastatic) 0.5 week PFS 30 (63) Ref: BMJ 2009;338:b67

17 c) Value a broader perspective Resource-allocation decisions (based on value) are not understood by the public. Value to patients, caregivers, etc? How are societal benefits, preferences, and WTP incorporated into trade-off decisions? Ref: Toronto Star - Nov 2010

18 c) Value a broader perspective WTP for the private / out-of-pocket market Bev mcrc patients enrolling in RPAP 877 With Private Insurance 647 (74%) Without Private Insurance 230 (26%) Approved Coverage 310 (48%) Denied Coverage 337 (52%) Received Therapy 204 patients (65%) Received Therapy (paid cash) 135 (40%) Received Therapy (paid cash) 120 patients (52%) Patients with private insurance: 48% approved Patients with no coverage: 45% elected to pay for bevacizumab Ref: S. Yunger, P. Douglas, P. Anglin, M. Crum, D. Shum, L. Phillips, D. Milliken ASCO 2009

19 c) Value a broader perspective Private market approval for IV oncology agents Source: Roche Patient Assistance Program (RPAP)

20 Agenda 1. Value based reimbursement do we have it? 2. Benefits and challenges with our current VBR framework 3. Do we want it? Future considerations Disclaimer: Viewpoints expressed are of the presenter, not Roche or other organizations

21 VIR, do we want it? Future considerations Maintain reimbursement decision making as a multi-criteria endeavor (where efficiency is not the sole objective) Formally weight inputs that are not captured in the current framework patient / public input into decision making (at the policy level and drug decision level) Broaden the perspective and definition of value e.g. end of life treatments, social value judgments How do we capture the value of innovation beyond health benefits?

22 VIR, do we want it? Future considerations Opportunity to create value in the development process Pre-Clinical Phase I Phase IIa Phase IIb Phase III NDA Filed Launch Post-Launch Target Product Profile Marketing Payer Value Selected Affiliates Early Development Integration & Alignment Full Development & Marketing Idea Key Claims Clinical Technical Successful Product

23 We Innovate Healthcare

European Experience and Perspective on Assessing Value for Oncology Products. Michael Drummond Centre for Health Economics, University of York

European Experience and Perspective on Assessing Value for Oncology Products Michael Drummond Centre for Health Economics, University of York Outline of Presentation The European landscape on access to