Clinical Drug Investigation

, Volume 35, Issue 8, pp 487–493 | Cite as

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

  • Charles Piwko
  • Catherine Prady
  • Simon Yunger
  • Erika Pollex
  • Aurelie Moser
Original Research Article


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.


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).


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.


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.


Trastuzumab Metastatic Breast Cancer Capecitabine Lapatinib Pertuzumab 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Compliance with Ethical Standards

Source of funding

F. Hoffmann-La Roche AG., Basel, Switzerland.

Conflicts of interest

Charles Piwko—Consultant for Hoffmann-La Roche. Catherine Prady—Clinical expert—was reimbursed for the time spent on the study and manuscript. Simon Yunger—Employee of Hoffmann-La Roche. Erika Pollex—was an employee of Hoffmann-La Roche at the time of preparing the manuscript. Aurelie Moser—Employee of Hoffmann-La Roche.

Ethical Approval

The EMILIA study (Verma et al 2012, N Engl J Med, from which data were taken for this analysis) was conducted in accordance with the International Conference on Harmonization Good Clinical Practice standards and the Declaration of Helsinki. Patients provided written informed consent; the study was approved by the relevant institutional review board or independent ethics committee.


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Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  • Charles Piwko
    • 1
  • Catherine Prady
    • 2
  • Simon Yunger
    • 4
  • Erika Pollex
    • 3
  • Aurelie Moser
    • 5
  1. 1.CHP Pharma IncThornhillCanada
  2. 2.CICM-CISS Montérégie centreMontrealCanada
  3. 3.GenentechSouth San FranciscoUSA
  4. 4.Hoffmann-La Roche LimitedMississaugaCanada
  5. 5.F. Hoffmann-La Roche AG.BaselSwitzerland

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