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Economic Evaluation of Fulvestrant 500 mg Compared to Generic Aromatase Inhibitors in Patients with Advanced Breast Cancer in Sweden.

ABSTRACT: OBJECTIVES:In Sweden, breast cancer (BC) represents 30% of newly diagnosed cancers and is the most common cancer in women. For hormone-dependent BC, endocrine therapies varying in efficacy and price are available. The aim of this study is to assess the cost effectiveness of fulvestrant 500 mg as a second-line hormonal therapy for postmenopausal women with estrogen receptor-positive metastatic or locally advanced BC versus letrozole, anastrozole, and exemestane in Sweden. METHODS:A three-state (pre-progression, post-progression, and death) partitioned-survival model was used to estimate progression-free (PFS) and overall survival (OS) by extrapolating trial results beyond the trial period to capture costs and benefits over a lifetime perspective. The comparative effectiveness was sourced from a network meta-analysis. The evaluation was conducted from a Swedish national payer perspective; costs, resource use, and quality of life were based on published sources and expert opinion. RESULTS:Compared to anastrozole, letrozole, and exemestane the incremental cost-effectiveness ratios (ICERs) were €33,808, €33,883, and €49,225 per QALY with incremental costs of €13,283, €14,986, and €13,862, and incremental QALYs of 0.393, 0.442, and 0.282, respectively. Incremental cost per life-year (LY) gained €21,312 (incremental LY of 0.623), €20,338 (incremental LY of 0.737), and €27,854 (incremental LY of 0.498) for respective comparators. Applying the upper and lower credible intervals for PFS/OS from the meta-analysis had the greatest effect on the ICER in the sensitivity analysis. The results were relatively stable when varying other parameters. CONCLUSIONS:Our results indicate that fulvestrant 500 mg may be a cost-effective alternative to aromatase inhibitors at a threshold of €100,000/QALY.

SUBMITTER: Sabale U

PROVIDER: S-EPMC5711749 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Economic Evaluation of Fulvestrant 500 mg Compared to Generic Aromatase Inhibitors in Patients with Advanced Breast Cancer in Sweden.

Sabale Ugne U Ekman Mattias M Thunström Daniel D Telford Claire C Livings Christopher C

PharmacoEconomics - open 20171201 4

<h4>Objectives</h4>In Sweden, breast cancer (BC) represents 30% of newly diagnosed cancers and is the most common cancer in women. For hormone-dependent BC, endocrine therapies varying in efficacy and price are available. The aim of this study is to assess the cost effectiveness of fulvestrant 500 mg as a second-line hormonal therapy for postmenopausal women with estrogen receptor-positive metastatic or locally advanced BC versus letrozole, anastrozole, and exemestane in Sweden.<h4>Methods</h4>A ...[more]

PMID: 29441507

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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).

Dataset Information

Economic Evaluation of Fulvestrant 500 mg Compared to Generic Aromatase Inhibitors in Patients with Advanced Breast Cancer in Sweden.

Publications

Economic Evaluation of Fulvestrant 500 mg Compared to Generic Aromatase Inhibitors in Patients with Advanced Breast Cancer in Sweden.

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