Collaborative governance in the Quebec Cancer Network: a realist evaluation of emerging mechanisms of institutionalization, multi-level governance, and value creation using a longitudinal multiple case study design.

BACKGROUND: People living with and beyond cancer (PLC) receive various forms of specialty care at different locations and many interventions concurrently or over time. They are affected by the operation of professional and organizational silos. This results in undue delays in access, unmet needs, sub-optimal care experiences and clinical outcomes, and human and financial costs for PLCs and healthcare systems. National cancer control programs advocate organizing in a network to coordinate actions, solve fragmentation problems, and thus improve clinical outcomes and care experiences for every dollar invested. The variable outcomes of such networks and factors explaining them have been documented. Governance is the "missing link" for understanding outcomes. Governance refers to the coordination of collective action by a body in a position of authority in pursuit of a common goal. The Quebec Cancer Network (QCN) offers the opportunity to study in a natural environment how, why, by whom, for whom, and under what conditions collaborative governance contributes to practices that produce value-added outcomes for PLCs, healthcare providers, and the healthcare system. METHODS/DESIGN: The study design consists of a longitudinal case study, with multiple nested cases (4 local networks nested in the QCN), mobilizing qualitative and quantitative data and mixed data from various sources and collected using different methods, using the realist evaluation approach. Qualitative data will be used for a thematic analysis of collaborative governance. Quantitative data from validated questionnaires will be analyzed to measure relational coordination and teamwork, care experience, clinical outcomes, and health-related health-related quality of life, as well as a cost analysis of service utilization. Associations between context, governance mechanisms, and outcomes will be sought. Robust data will be produced to support decision-makers to guide network governance towards optimized clinical outcomes and the reduction of the economic toxicity of cancer for PLCs and health systems.

Safety Profile and Costs of Related Adverse Events of Trastuzumab Emtansine for the Treatment of HER2-Positive Locally Advanced or Metastatic Breast Cancer Compared to Capecitabine Plus Lapatinib from the Perspective of the Canadian Health-Care System.

BACKGROUND AND OBJECTIVES: Trastuzumab emtansine (T-DM1, KADCYLA(®)) is an antibody-drug conjugate comprised of the cytotoxic agent DM1 and trastuzumab (HERCEPTIN(®)). The safety profile of T-DM1 in human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer previously treated with trastuzumab and a taxane was investigated in the phase III EMILIA trial. The trial demonstrated clinically and statistically meaningful differences in the safety profile between T-DM1 and capecitabine plus lapatinib (CAP + LAP). The objective of this study was to estimate the costs of managing treatment-related grade ≥ 3 adverse events (AEs) that occurred in ≥ 2% of patients and grade 2 AEs that occurred in ≥ 5% of patients taking T-DM1 compared with patients taking CAP + LAP based on the EMILIA trial, from the perspective of Canadian public payers. METHODS: An Excel-based model was utilized to estimate the relevant costs. Clinical data were obtained from the EMILIA trial. Cost information was obtained from the literature, clinical experts, and standard cost sources. The analysis was conducted from the Canadian public-payer perspective and reported in 2014 Canadian dollars (CAD). RESULTS: The management of included treatment-related AEs resulted in higher estimated per-patient costs of CAD6901 for CAP + LAP versus CAD3380 for T-DM1, resulting in savings of CAD3521. CONCLUSIONS: From a Canadian perspective, this analysis demonstrated that utilizing T-DM1 for the management of HER2-positive metastatic breast cancer results in substantial savings to the public health-care system when considering the costs of treatment-related AEs, due to fewer amount of toxicities compared with CAP + LAP. Results of various sensitivity analyses investigating changes in number and costs of AEs confirmed the findings; however, the magnitude of cost savings varied. Further analyses are necessary to determine whether these cost savings would occur in other countries and health-care systems.