Abstract P5-12-02: Long Term Cardiac Toxicity after Adjuvant Trastuzumab for Early Breast Cancer: Implications for Life-Expectancy and Cost-Effectiveness

Introduction: This study is one of the first real-world cost-effectiveness analyses of one-year adjuvant trastuzumab used in HER2-positive early female breast cancer in comparison to chemotherapy alone. It is just the second one in Europe, the first one in Cyprus, and the fourth one worldwide ever carried out using real-world data. Methods: Using a Markov model (four health states), a cost-effectiveness analysis was carried out both over 20 years and for a lifetime horizon. The sampling method used in this study was the randomized sampling of 900 women. Results: The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY]. For the lifetime horizon, with thresholds of €20,000, €40,000, and €60,000/QALY, all trastuzumab arms were found to be more cost-effective (ICER: €17,753.85/QALY). Moreover, for the 20-year and the lifetime horizons, with thresholds of €20,000/QALY, €40,000/QALY, and €60,000/QALY, the most cost-effective of the three subgroups (anthracyclines and then trastuzumab, no anthracyclines and then trastuzumab, and anthracyclines, taxanes, and trastuzumab) was that of anthracyclines and then trastuzumab (ICER: €18,301.55/QALY and €8954.97/QALY, respectively). Conclusions: The study revealed that adjuvant trastuzumab for one year in female HER2-positive early breast cancer can be considered cost-effective.

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Budget impact analysis of trastuzumab in early breast cancer: A hospital district perspective

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462310000103 ◽

2010 ◽

Vol 26 (2) ◽

pp. 163-169 ◽

Cited By ~ 12

Author(s):

Timo T. Purmonen ◽

Päivi K. Auvinen ◽

Janne A. Martikainen

Keyword(s):

Breast Cancer ◽

Sensitivity Analysis ◽

Cost Effectiveness ◽

Early Breast Cancer ◽

Probabilistic Sensitivity Analysis ◽

Budget Impact ◽

Base Case ◽

Adjuvant Trastuzumab ◽

Hospital District ◽

Number Of Patients

Objectives:Adjuvant trastuzumab is widely used in HER2-positive (HER2+) early breast cancer, and despite its cost-effectiveness, it causes substantial costs for health care. The purpose of the study was to develop a tool for estimating the budget impact of new cancer treatments. With this tool, we were able to estimate the budget impact of adjuvant trastuzumab, as well as the probability of staying within a given budget constraint.Methods:The created model-based evaluation tool was used to explore the budget impact of trastuzumab in early breast cancer in a single Finnish hospital district with 250,000 inhabitants. The used model took into account the number of patients, HER2+ prevalence, length and cost of treatment, and the effectiveness of the therapy. Probabilistic sensitivity analysis and alternative case scenarios were performed to ensure the robustness of the results.Results:Introduction of adjuvant trastuzumab caused substantial costs for a relatively small hospital district. In base-case analysis the 4-year net budget impact was €1.3 million. The trastuzumab acquisition costs were partially offset by the reduction in costs associated with the treatment of cancer recurrence and metastatic disease.Conclusions:Budget impact analyses provide important information about the overall economic impact of new treatments, and thus offer complementary information to cost-effectiveness analyses. Inclusion of treatment outcomes and probabilistic sensitivity analysis provides more realistic estimates of the net budget impact. The length of trastuzumab treatment has a strong effect on the budget impact.

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Long-term cardiac toxicity after adjuvant epirubicin-based chemotherapy in early breast cancer: French Adjuvant Study Group Results

Annals of Oncology ◽

10.1093/annonc/mdj034 ◽

2006 ◽

Vol 17 (1) ◽

pp. 85-92 ◽

Cited By ~ 71

Author(s):

P. Fumoleau ◽

H. Roché ◽

P. Kerbrat ◽

J. Bonneterre ◽

P. Romestaing ◽

...

Keyword(s):

Breast Cancer ◽

Early Breast Cancer ◽

Cardiac Toxicity ◽

Study Group

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Multi-arm Cost-Effectiveness Analysis (CEA) comparing different durations of adjuvant trastuzumab in early breast cancer, from the English NHS payer perspective

PLoS ONE ◽

10.1371/journal.pone.0172731 ◽

2017 ◽

Vol 12 (3) ◽

pp. e0172731 ◽

Cited By ~ 6

Author(s):

Caroline S. Clarke ◽

Rachael M. Hunter ◽

Ian Shemilt ◽

Victoria Serra-Sastre

Keyword(s):

Breast Cancer ◽

Cost Effectiveness ◽

Early Breast Cancer ◽

Cost Effectiveness Analysis ◽

Adjuvant Trastuzumab ◽

Effectiveness Analysis ◽

Payer Perspective

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The cost-effectiveness issue of adjuvant trastuzumab in early breast cancer

Expert Opinion on Pharmacotherapy ◽

10.1517/14656566.7.12.1617 ◽

2006 ◽

Vol 7 (12) ◽

pp. 1617-1625 ◽

Cited By ~ 7

Author(s):

Jan Norum

Keyword(s):

Breast Cancer ◽

Cost Effectiveness ◽

Early Breast Cancer ◽

Adjuvant Trastuzumab ◽

The Cost

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Trastuzumab As an Adjuvant Therapy for Early Breast Cancer: Economic Evaluation From a Malaysian Perspective

Journal of Global Oncology ◽

10.1200/jgo.18.12800 ◽

2018 ◽

Vol 4 (Supplement 2) ◽

pp. 72s-72s

Author(s):

F.K. Hanin ◽

L. Sit Wai ◽

J. Sabirin ◽

W.P. Sharifa Ezat ◽

D. Maznah

Keyword(s):

Breast Cancer ◽

Cost Effectiveness ◽

Early Breast Cancer ◽

Adjuvant Treatment ◽

Cost Effective ◽

Effective Strategy ◽

Her2 Positive ◽

Adjuvant Trastuzumab ◽

Common Cancer ◽

The Cost

Background: In Malaysia, breast cancer is the most common cancer in females and also the first most common cancer among population regardless of gender. The percentage of breast cancer detected at stage I and II was 61%, another 27% with locally advanced cancer and 11% with late stage metastatic cancer. From the total, 28% are human epidermal growth factor receptor 2 (HER2) positive and access to targeted therapy (trastuzumab) was very limited; only 19% of eligible patients could be treated. Aim: To determine the incremental cost-effectiveness ratio (ICER) between chemotherapy plus trastuzumab and chemotherapy alone as adjuvant treatment of early breast cancer from Malaysian perspective. Methods: A Markov cohort simulation was developed using Microsoft Excel Workbook 2007 to estimate the cost-utility of adjuvant trastuzumab compared with chemotherapy alone for treatment of early breast cancer with HER2 positive status. Two adjuvant treatment strategies were evaluated: 1) chemotherapy plus trastuzumab and 2) chemotherapy alone as adjuvant treatment. This Markov model was projected to lifetime horizon. All costs and outcomes were discounted at 3% and the cost-effectiveness result was expressed in ICER. One-way sensitivity analysis was performed to address the uncertainty. Results: The base case analysis indicated that 1-year adjuvant trastuzumab treatment generates a deterministic ICER of RM 83,544.59 per QALY gained. Over the lifetime, there is a marginal cost increase of RM 85,659.10 and a marginal benefit of 1.025 QALYs per patient when trastuzumab is added to standard chemotherapy compared with no trastuzumab strategy. Based on one-way sensitivity analysis, these components have shown to be a sensitive parameter for ICER determination: discount rate, disease-free state utility, route of trastuzumab administration and cost of trastuzumab. Conclusion: Addition of 1-year treatment with trastuzumab on top of standard adjuvant chemotherapy is considered as a cost-effective strategy for early breast cancer with HER2 positive, yielding an ICER of RM 83,544.59 per QALY gained, which is within the suggested value of cost-effectiveness threshold by WHO (1-3 times GDP per capita). However, if suggested threshold for Malaysia is taken into consideration, this treatment may not be a cost-effective strategy.

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Epirubicin Increases Long-Term Survival in Adjuvant Chemotherapy of Patients With Poor-Prognosis, Node-Positive, Early Breast Cancer: 10-Year Follow-Up Results of the French Adjuvant Study Group 05 Randomized Trial

Journal of Clinical Oncology ◽

10.1200/jco.2005.05.059 ◽

2005 ◽

Vol 23 (12) ◽

pp. 2686-2693 ◽

Cited By ~ 123

Author(s):

Jacques Bonneterre ◽

Henri Roché ◽

Pierre Kerbrat ◽

Alain Brémond ◽

Pierre Fumoleau ◽

...

Keyword(s):

Breast Cancer ◽

Early Breast Cancer ◽

Poor Prognosis ◽

Cardiac Toxicity ◽

Study Group ◽

Term Survival ◽

Long Term Survival ◽

Patients With Poor Prognosis

Purpose The French Adjuvant Study Group 05 (FASG-05) showed that fluorouracil 500 mg/m2, cyclophosphamide 500 mg/m2, and epirubicin 100 mg/m2 (FEC 100) was superior to the same regimen with epirubicin 50 mg/m2 (FEC 50) in terms of disease-free survival (DFS) and overall survival (OS) in adjuvant treatment of early breast cancer. We report 10-year data on efficacy, and long-term side effects for FASG-05. Patients and Methods We randomly assigned 565 patients to treatment with FEC 50 or FEC 100 after surgery. Postmenopausal patients also received tamoxifen for 3 years, and almost all patients (96%) also received radiotherapy. Results Median follow-up was 110 months. The 10-year DFS was 45.3% (95% CI, 41.9% to 48.7%) with FEC 50 and 50.7% (95% CI, 47.3% to 54.1%) with FEC 100 (Wilcoxon P = .036; log-rank P = .08). The 10-year OS was 50.0% (95% CI, 46.7% to 53.3%) with FEC 50 and 54.8% (95% CI, 51.3% to 58.3%) with FEC 100 (Wilcoxon P = .038; log-rank P = .05). Delayed cardiac toxicity (before relapse) occurred in four patients (1.5%) in the FEC 50 arm and three patients (1.1%) in the FEC 100 arm. Cardiac toxicity after relapse occurred in six (4.3%) and five (4.1%) patients treated with FEC 50 and FEC 100, respectively. Conclusion Treatment with adjuvant FEC 100 demonstrated superior DFS and OS versus FEC 50 at 10 years of follow-up. This survival advantage was not offset by long-term complications such as cardiac toxicity and second malignancy. Given the risk-benefit ratio, FEC 100 is a more optimal regimen for long-term survival in patients with poor prognosis.

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Cost Effectiveness of Adjuvant Trastuzumab in Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2006.06.4220 ◽

2007 ◽

Vol 25 (6) ◽

pp. 625-633 ◽

Cited By ~ 97

Author(s):

Nicola Lucio Liberato ◽

Monia Marchetti ◽

Giovanni Barosi

Keyword(s):

Breast Cancer ◽

Cost Effectiveness ◽

Early Breast Cancer ◽

Growth Factor Receptor ◽

Local Relapse ◽

Her2 Positive ◽

Adjuvant Trastuzumab ◽

Life Years ◽

Epidermal Growth ◽

The Cost

Purpose To evaluate the cost-effectiveness of 12-month adjuvant trastuzumab therapy in women with high-risk human epidermal growth factor receptor 2 (HER2) –positive early breast cancer. Methods A Markov model tracked quarterly patients’ transitions between five health states: disease free, local relapse, disease free after local relapse, metastatic disease, and death. Patients were allowed to incur symptomatic or asymptomatic transient cardiac dysfunction during trastuzumab administration. Probabilities were derived mainly from the combined report of the National Surgical Adjuvant Breast and Bowel Project B-31 and the North Central Cancer Treatment Group N9831 trials (95% node positive) and a meta-analysis by the Early Breast Cancer Trialists’ Collaborative Group. Costs were estimated from the perspective of the Italian and US health care systems. The analysis was run during a 15-year time horizon. A 3% yearly discount rate was applied to both costs and life-years. Second-order Monte-Carlo and probabilistic sensitivity analyses were performed. Results Adjuvant trastuzumab increases life expectancy by 1.54 (1.18 discounted) quality-adjusted life-years (QALYs). At a cost of €675 and $767 per weekly dose in the Italian and US setting, respectively, trastuzumab achieves its clinical benefit at a cost of €14,861 (95% CI, €3,917 to €44,028) and $18,970 (95% CI, $6,014 to $45,621) per QALY saved. The incremental cost effectiveness was higher than €50,000/QALY (or $60,000/QALY) at time horizons shorter than 7.8 years and for patients older than 76 years or with a 10-year risk of relapse lower than 15%. The results confirmed the cost effectiveness when simulating a Herceptin Adjuvant Trial (HERA) -like scenario at multiway sensitivity analysis. Conclusion In a long-term horizon, adjuvant trastuzumab is a cost-effective therapy for patients with HER2-positive, high-risk, early breast cancer.

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