Trastuzumab Treatment of Early Stage Breast Cancer Is Cost-Effective From the Perspective of the Belgian Health Care Authorities

Abstract

Trastuzumab (Herceptin, Roche) is a recombinant, humanized monoclonal antibody directed against the neu-HER2 protein, since May 2002 reimbursed in Belgium for the treatment of metastatic HER2+ breast cancer and since June 2007 also in adjuvant therapy of HER2+ early stage breast cancer. The purpose of this study was to estimate the cost-effectiveness from the Belgian health care payer perspective of reimbursing trastuzumab in the Latter indication. A Markov state transition model was designed to adequately capture the natural history and course of disease for early stage breast cancer patients, and to simulate cost and disease progression over a life time perspective. The model estimates differences in outcomes for patients treated with adjuvant trastuzumab during 1 year compared to current therapy, and captures cost consequences and health benefits of trastuzumab treatment. Health benefits were expressed in terms of quality-adjusted life years gained, and future benefits were discounted at 1.5%. Costs were calculated from the perspective of the Belgian authorities' health care budget, and future costs were discounted at 3%. Where relevant, the costs per Markov state were obtained from the IMS Hospital Disease database. Additionally, an expert opinion analysis on resource use during the follow-up of treated early breast cancer patients provided the cost estimates for states with minor or without hospital costs. The incremental cost-effectiveness ratio based on a life time simulation was estimated at Euro 10,315 per quality-adjusted life year gained. It can be concluded that trastuzumab treatment of HER2+ early stage breast cancer patients is cost-effective from the perspective of the Belgian health care authorities.

Modeling companion diagnostics in economic evaluations of targeted oncology therapies: systematic review and methodological checklist

“…In another study, a range of HER2-positive prevalence values were used to determine the number of tests required to identify one positive patient [52]. In the other six studies, either the HER2-positive prevalence was not included in the model [53] or its impact was not tested in sensitivity analyses [49,50,[54][55][56] BC: Breast cancer; ICER: Incremental cost-effectiveness ratio; IHC: Immunohistochemistry; NE: Tested but no effect; NSCLC: Non-small-cell lung cancer; NT: Not tested. particularly decreasing the prevalence can increase the ICER whereas increasing the prevalence may only moderately decrease the ICER, especially when drug costs are high.…”

“…The secondary synthesis included 18 studies for 4 test and therapy combinations. The number of studies for each combination was slightly larger (except for crizotinib) than that of the primary synthesis with: six studies for cetuximab and KRAS testing in colorectal cancer [39][40][41][42][43][44], one study for crizotinib and ALK testing in lung cancer [45], three studies for erlotinib and EGFR testing in lung cancer [46][47][48] and eight studies for trastuzumab and HER2 testing in breast cancer [49][50][51][52][53][54][55][56].…”

Bridging Trial and Decision: A Checklist to Frame Health Technology Assessments for Resource Allocation Decisions

“…All studies extrapolated the trial data. The time horizon was lifetime in eight studies [38,[41][42][43][44][45][46][47], two studies analyzed costs and effects over 15 years [37,40]. One study used a not specified long-term time horizon [39].…”

“…A total of 11 publications met the inclusion criteria [37][38][39][40][41][42][43][44][45][46][47]. All studies used decision-analytic modeling.…”

An exploratory analysis of the factors leading to delays in cancer drug reimbursement in the European Union: The trastuzumab case

“…Cost-effectiveness analyses were performed in eight EU countries in the adjuvant setting (France [28], Belgium [29,30], United Kingdom [31], Portugal [32], Finland [33], Sweden [34], Italy [35] and The Netherlands [36]) with results favoring the incorporation of trastuzumab. In all these countries, trastuzumab reimbursement was approved within the 180 day deadline versus around half of the countries where no such study was available (100% versus 53%, p = 0.026).…”