Dataset Information

Cost-Effectiveness Analysis of Fulvestrant 500 mg in Endocrine Therapy-Naive Postmenopausal Women with Hormone Receptor-Positive Advanced Breast Cancer in the UK.

ABSTRACT:

Introduction

The selective estrogen receptor degrader fulvestrant is approved for the first-line treatment of postmenopausal patients with hormone receptor-positive (HR+), locally advanced or metastatic breast cancer who have not received prior endocrine therapy. We evaluated the cost-effectiveness of fulvestrant versus comparator treatments in endocrine therapy-naïve patients with locally advanced or metastatic breast cancer.

Methods

A three-health-state (progression free, progressed disease, and death) partitioned survival model from the UK National Health Service and Personal Social Services perspective was developed to extrapolate study data for the cumulative probability of progression-free survival and overall survival to a lifetime (30-year) horizon. Relative comparator data were derived from a systematic literature review-informed network meta-analysis. Sensitivity analyses were applied to assess the impact of uncertainty in the parameter input values on the results.

Results

Over a lifetime horizon (30 years), the incremental cost (British pounds sterling) per patient associated with fulvestrant treatment was £18,867 versus anastrozole, £23,097 versus letrozole, and £17,131 versus tamoxifen, with incremental quality-adjusted life-years of 0.55, 0.77, and 0.76, respectively, and incremental cost-effectiveness ratios of £34,109, £29,827, and £22,532, respectively. The largest difference in costs between fulvestrant and the comparators was related to treatment costs.

Conclusions

Results suggest that fulvestrant could potentially be a cost-effective option compared with other endocrine monotherapies (anastrozole, letrozole, and tamoxifen) for treating endocrine therapy-naïve, postmenopausal women with HR+, locally advanced or metastatic breast cancer.

SUBMITTER: Telford C

PROVIDER: S-EPMC6861400 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Publications

Cost-Effectiveness Analysis of Fulvestrant 500 mg in Endocrine Therapy-Naïve Postmenopausal Women with Hormone Receptor-Positive Advanced Breast Cancer in the UK.

Telford Claire C Bertranou Evelina E Large Samuel S Phelps Hilary H Ekman Mattias M Livings Christopher C

PharmacoEconomics - open 20191201 4

<h4>Introduction</h4>The selective estrogen receptor degrader fulvestrant is approved for the first-line treatment of postmenopausal patients with hormone receptor-positive (HR+), locally advanced or metastatic breast cancer who have not received prior endocrine therapy. We evaluated the cost-effectiveness of fulvestrant versus comparator treatments in endocrine therapy-naïve patients with locally advanced or metastatic breast cancer.<h4>Methods</h4>A three-health-state (progression free, progre ...[more]

PMID: 31025302

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Project description:PurposeTo compare overall survival (OS) for fulvestrant 500 mg versus anastrozole as first-line endocrine therapy for advanced breast cancer.Patients and methodsThe Fulvestrant First-Line Study Comparing Endocrine Treatments (FIRST) was a phase II, randomized, open-label, multicenter trial. Postmenopausal women with estrogen receptor-positive, locally advanced/metastatic breast cancer who had no previous therapy for advanced disease received either fulvestrant 500 mg (days 0, 14, 28, and every 28 days thereafter) or anastrozole 1 mg (daily). The primary end point (clinical benefit rate [72.5% and 67.0%]) and a follow-up analysis (median time to progression [23.4 months and 13.1 months]) have been reported previously for fulvestrant 500 mg and anastrozole, respectively. Subsequently, the protocol was amended to assess OS by unadjusted log-rank test after approximately 65% of patients had died. Treatment effect on OS across several subgroups was examined. Tolerability was evaluated by adverse event monitoring.ResultsIn total, 205 patients were randomly assigned (fulvestrant 500 mg, n = 102; anastrozole, n = 103). At data cutoff, 61.8% (fulvestrant 500 mg, n = 63) and 71.8% (anastrozole, n = 74) had died. The hazard ratio (95% CI) for OS with fulvestrant 500 mg versus anastrozole was 0.70 (0.50 to 0.98; P = .04; median OS, 54.1 months v 48.4 months). Treatment effects seemed generally consistent across the subgroups analyzed. No new safety issues were observed.ConclusionThere are several limitations of this OS analysis, including that it was not planned in the original protocol but instead was added after time-to-progression results were analyzed, and that not all patients participated in additional OS follow-up. However, the present results suggest fulvestrant 500 mg extends OS versus anastrozole. This finding now awaits prospective confirmation in the larger phase III FALCON (Fulvestrant and Anastrozole Compared in Hormonal Therapy Naïve Advanced Breast Cancer) trial (ClinicalTrials.gov identifier: NCT01602380).

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