Budget impact analysis of the use of oral and intravenous anti-cancer drugs for the treatment of HER2-positive metastatic breast cancer

Abstract

Objectives:

Two anti-cancer drugs are currently approved for the treatment of HER2-positive metastatic breast cancer (MBC): trastuzumab-based therapy (TBT) administered intravenously as first line therapy until disease progression and lapatinib, an oral self-administered dual therapy with capecitabine (L+C) as second intention for patients who continue to progress despite TBT. In current practice, TBT is still prescribed beyond disease progression. In addition to medical reasons, the difficulty to switch eligible patients to oral drugs may also be explained by economic reasons. Thus, we aimed at comparing the budgetary impact of TBT and L+C for progressing HER2+MBC after TBT from the French Health Insurance perspective.

Methods:

A budget impact analysis was performed on a 3-year time horizon (2012–2014) to simulate a dynamic cohort of 4182 HER2-positive patients with a progressing MBC treated with TBT (73%) and L + C (27%). The model was adjusted on progression-free survival (PFS). Office visits, clinical evaluations, drug acquisition, administration costs, and transportation costs obtained from the literature and published databases were considered.

Results:

In the base case analysis (2012), the annual treatment cost per patient for TBT (€36,077) was 2-times higher than that of L + C (€17,165). Using L + C for all patients (n = 4182) would avoid €34.8 million of drug administration and transportation costs. Hospital costs represented 1% vs 88%, while community costs represented 99% vs 12% of L + C and TBT treatment costs, respectively. The lack of direct comparison PFS and treatment dosage modification data were the main limitations. However, no major changes from baseline results were observed from sensitivity analyses.

Conclusions:

Despite a slightly higher acquisition cost, the treatment cost of L + C remains lower than that of TBT, and it is the only approved anti-HER2 treatment for HER2-positive patients with progressing MBC. Based on this, it seems important to consider the potential savings for Health Insurance with the use of oral drug due to the reduction of outpatient hospitalizations. Such reductions may result in a subsequent budget reduction for hospitals, but may also provide those facing acute medical activity with opportunities to better manage other diseases whose treatment cannot be externalized.

Keywords::

• Breast cancer
• HER2-positive
• Trastuzumab
• Lapatinib
• Budget impact
• Preventable hospitalizations
• Cost savings

Transparency

Declaration of funding

Funding for the study was provided by GSK and had no influence on the study design, execution, and publication of results.

Ethics

The study was conducted according to international guidelines on budget impact analysis. Data included in the model were drawn from the published literature, when available, and no data on specific patients or hospitals centers were included. No specific consultation or authorization from ethic committees was required. GlaxoSmithKline (GSK) is the purveyor of lapatinib, a small-molecule inhibitor of the HER2/ErbB2 tyrosine kinase receptor for use in the treatment of HER2-positive advanced or metastatic breast cancer.

Declaration of financial/other interests

LB is a doctoral fellow whose researches are financed by the ANRT (Association Nationale pour la Recherche et la Technologie, Paris, France) and GSK. LB is also an employee of GSK. VB, CR, and GVT were members of the steering committee (SC) of the study and perceived fees for their participation to the SC. MI and BF are employees of PharmIdeas, a Contract Research Organization.

Authors’ contributions

LB was responsible for the study conception and monitoring, literature review, data collection, face-to-face interviews with healthcare professionals, construction of the model framework, cost analysis, interpretation of the results, and manuscript writing. VB, CR, and GVT helped in the study design, results interpretation, data reviewing, and manuscript review. BF and MI helped in the model development, created a user-friendly interactive analytic interface, and contributed to interpretation of the results. All authors reviewed and approved the manuscript.

Acknowledgments

The authors wish to thank all healthcare professionals for their time and help in the data collection and review of the model, especially Pr Jean-Pierre Durand (Département d’Oncologie, Hôpital Cochin, Paris, France) and the nurses in oncology of the outpatient hospital service of the Hôpital Paul Brousse (Villejuif, France), Vincent Navarro (PharmIdeas, Lyon, France) for assistance in the study coordination, and Gaëlle Nachbaur (GlaxoSmithKline, Marly le Roi, France) for support in the study conception and funding and for the reviewing of the manuscript.

Notice of Correction

The version of this article published online ahead of print on 26th September 2012 contained a single graph (Figure 1) on page 6. To clarify the presentation of the data this figure has been presented as two separate graphs side by side. This has been corrected for this version.