Developing a Framework for the Incorporation of Real World Evidence into Cancer Drug Funding Decisions in Canada

Project number: 
20-036
Approval date: 
Wednesday, March 11, 2020
Principal Investigator: 
Peacock,Stuart
Institution: 
BC Cancer
Funding Agency: 
Canadian Institutes of Health Research(CIHR)
Datasets requested: 
Hospital Separations (BC Ministry of Health)
consolidation - census geocodes
bc cancer-external
PharmaNet
Medical Services Plan (BC Ministry of Health)
Consolidation - demographic (Ministry of Health)
Consolidation file (BC Ministry of Health)
Deaths (BC Vital Statistics Agency)
NACRS
Research objective: 

Objective 1: to determine the effectiveness (as survival benefit) of adding pertuzumab to trastuzumab + taxane therapy for patients with advanced breast cancer, as part of real-world clinical practice.
Objective 2: to determine the impact on safety and toxicity outcomes of adding pertuzumab to trastuzumab + taxane therapy for patients with advanced breast cancer, as part of real-world clinical practice.
Objective 3: to determine the cost-effectiveness of adding pertuzumab to trastuzumab + taxane therapy for patients with advanced breast cancer, as part of real-world clinical practice.
Objective 4: to evaluate the overall budget impact of introducing pertuzumab therapy to clinical practice

Hypothesis 1: the survival benefit of pertuzumab therapy will be smaller than what was seen in clinical trials, due to the less controlled nature of regular clinical practice
Hypothesis 2: safety and toxicity events will be rare, but will be more likely with the addition of pertuzumab to trastuzumab + taxane.
Hypothesis 3: pertuzumab will be less cost-effective than what was originally estimated, due to a possible reduction in survival benefit and the appearance of unanticipated costs
Hypothesis 4: the impact on the systemic therapy budget will be roughly as anticipated in the original budget projection


Page last revised: July 14, 2020