One World, One Evidence-base, Many Decisions

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One World, One Evidence-base, Many Decisions Bevacizumab

Background Metastatic Colorectal Cancer Treatment

1 One World, One Evidence-base, Many Decisions Bevacizumab for the Treatment of Metastatic Colorectal Cancer Shawn Bugden B.Sc.(Hons), B.Sc.Pharm, M.Sc. 2 Pharmacoeconomics Pharmacist Outline Colorectal Cancer Background Metastatic Colorectal Cancer Treatment Bevacizumab Efficacy Bevacizumab Economics USA Case Example United Kingdom NICE Approach Canadian Federation Reflections and Ethics Colorectal Cancer - Background Background Treatment Treatment 1

Bevacizumab Recombinant humanized monoclonal antibody to VEGF- A ligand Based on Phase III study

4 months (p<0.001) Extended median survival by 4.7 months (p<0.001) Actual median survival 20.

combination with intravenous 5-flourouracil based combination chemotherapy Hurwitz, H. et al. 2004.

Bevacizumab Efficacy in Context Incremental Cost Effectiveness Ratio (ICER) ICER = [C b C a ] / [E

2 Bevacizumab Recombinant humanized monoclonal antibody to VEGF- A ligand Based on Phase III study by Hurwitz, et al. IFL (bolus 5-FU) + bevacizumab vs. IFL alone Improved time to progression by 4.4 months (p<0.001) Extended median survival by 4.7 months (p<0.001) Actual median survival 20.3 months with IFL and bevacizumab Indication: First line treatment of metastatic CRC in combination with intravenous 5-flourouracil based combination chemotherapy Hurwitz, H. et al NEJM 250:2335. Bevacizumab Efficacy in Context Incremental Cost Effectiveness Ratio (ICER) ICER = [C b C a ] / [E b E a ] The drug itself has no side effects but the number of health economists needed to prove its value may cause dizziness and nausea Bevacizumab Incremental Cost Bevacizumab Incremental Cost 2

Bevacizumab Efficacy Bevacizumab Economics Hurwitz, H. et al. 2004. NEJM 250:2335. Fernando NH, et al. Semin Oncol 2003;30(3)(Suppl Tappenden, 6):39-50.; Ferrara P. N. et Semin al. 2007.

3 Bevacizumab Efficacy Bevacizumab Economics Hurwitz, H. et al NEJM 250:2335. Fernando NH, et al. Semin Oncol 2003;30(3)(Suppl Tappenden, 6):39-50.; Ferrara P. N. et Semin al Oncol 2002;29(6)(Suppl Health Technol 16):10-14.; Assess Avastin 11(12) package insert. South San Francisco, CA: Genentech; Feb 2004; Hurwitz H, et al. NEJM, Bevacizumab Economics The Cost-Effectiveness Plane Cost NW SW lose/lose clinically ineffective may be costeffective win/win NE SE Health Effects Bevacizumab Economics Bevacizumab Economic Model 3

Bottom Line Texas, USA Central Point Estimates of Cost Effectiveness: Cost per LYG = $93 707 Cost per QALY = $124 457 Despite using favourable estimates for the benefits of bevacizumab, the estimates

Anderson Cancer Center Incorporation of cost effectiveness and budget impact into formulary management system bevacizumab case study Economic Model Bevacizumab until tumor progression Included only

4 Bottom Line Texas, USA Central Point Estimates of Cost Effectiveness: Cost per LYG = $ Cost per QALY = $ Despite using favourable estimates for the benefits of bevacizumab, the estimates of its cost effectiveness suggest that it is likely to exceed acceptable cost effectiveness thresholds. M. D. Anderson Cancer Center Incorporation of cost effectiveness and budget impact into formulary management system bevacizumab case study Economic Model Bevacizumab until tumor progression Included only direct medical costs Budget Impact Predicted 250 patients (50% FOLFIRI/50% FOLFOX4) Incremental cost 25 million per year LYS by adding bevacizumab MD Anderson Economic Model Inputs 0.39 years FOLFOX + BV (Proposed) $270,049 FOLFOX (Standard-STD) $140,114 Incremental cost of bevacizumab $129,935 FOLFIRI + BV (Proposed) $165,330 FOLFIRI (Standard-STD) $68,519 Incremental cost of bevacizumab $96,811 Results: Cost-Effectiveness Analysis Incremental Cost-Effectiveness Ratio (ICER) (COST PROPOSED COST STD ) ICER = = COST ( LYS PROPOSED LYS STD ) LYS ICER FOLFOX4+BV = $ 333,167 per LYS ICER FOLFIRI+BV = $ 248,233 per LYS Recommended for addition to formulary First-line treatment of metastatic CRC in combination with intravenous fluorouracil-based chemotherapy regimens (FDAlabel) Physician discretion advised for use outside its FDAapproved indication Texas A Closer Look 4

What happened in Texas What happened in Texas Patients Receiving Bevacizumab, by Service (Jan-May 2006, N = 411) Chemotherapy Regimen for GI Cancer Patients (Jan - May 2006, n = 240) Thoracic/H&N 4%

5 What happened in Texas What happened in Texas Patients Receiving Bevacizumab, by Service (Jan-May 2006, N = 411) Chemotherapy Regimen for GI Cancer Patients (Jan - May 2006, n = 240) Thoracic/H&N 4% Breast 3% Mel/Sarc 5% Gyn-Onc 7% Phase I 1% Other 46% FOLFOX 20% Neuro-oncology 8% GU 14% GI 58% FOLFOX/ FOLFIRI 6% FOLFIRI 28% Farewell to Texas UK Naughty or NICE Charges $39 M Reimbursement 22 M Model did not capture 72% of patients Bevacizumab was not stopped upon disease progression - only the chemo was changed Chemotherapy for metastatic colorectal cancer varied by practitioner Standards of care changed Capecitabine Off label utilization challenging NICE Final Appraisal Determination Company Cost per QALY of for bevacizumab plus irinotecan/5fu vs irinotecan/f5u alone PSA,willingness to pay per QALY likelihood of cost effectiveness 0.16 NICE Cost per QALY of and for bevacizumab plus irinotecan/5fu vs irinotecan/f5u alone PSA,willingness to pay per QALY likelihood of cost effectiveness 0 NICE Says NO Bevacizumab in combination with 5- fluorouracil plus folinic acid, with or without irinotecan, is not recommended for the first-line treatment of metastatic colorectal cancer. People currently receiving bevacizumab should have the option to continue until they and their consultants consider it appropriate to stop NICE Final Appraisal Determination August

Canada Oh, Canada Canada Advocacy in Canada 2007 Report Card

Saskatchewan Newfoundland British Columbia Quebec Ontario

. by the letter E Economic Limits Evidence Efficacy

are scarce in relation to wants alternate use = opportunity

medicine Joint Oncology Drug Review Accountability and

6 Canada Oh, Canada Canada Advocacy in Canada 2007 Report Card on Cancer in Canada Canada s Middle Ground The Way Forward Saskatchewan Newfoundland British Columbia Quebec Ontario Manitoba PEI, NB, NS, Alberta Brought to you.. by the letter E Economic Limits Evidence Efficacy Effectiveness Economics Efficiency Ethics Equity Resources are scarce in relation to wants alternate use = opportunity cost Economic evaluations address one dimension of health care decisions. Problems with cost utility age, disability, palliative medicine Joint Oncology Drug Review Accountability and Reasonableness (revision, enforcement, empowerment, relevance, publicity) Gibson, Martin and Singer. (2005) Healthcare Quarterly 8:50-59 Daniels and Sabin

7 The End - Alpha/Omega Questions? shawn.bugden@cancercare.mb.ca 7

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Technology Appraisals. Patient Access Scheme Submission Template

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Technology Appraisals Patient Access Scheme Submission Template Bevacizumab in combination with fluoropyrimidine-based chemotherapy for the first-line