Abstract

Abstract BACKGROUND: A phase III randomized clinical trial demonstrated significantly longer progression-free survival of everolimus and exemestane combination therapy compared to exemestane alone in postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor-2 negative (HER2−) metastatic breast cancer (MBC) who failed letrozole or anastrozole. This study estimates the budget impact of adding everolimus as the first or second treatment after failure of letrozole or anastrozole for post-menopausal, ER+ HER2− MBC patients from a third-party payer perspective in the United States. METHODS: Pharmacy and medical budget impacts were estimated over the first year of everolimus use in this indication. Published epidemiology data were used to estimate target population size. Market share was assumed to be divided between exemestane, fulvestrant and tamoxifen before everolimus entry based on market research data on file. Market share of combination therapy of everolimus and exemestane was assumed to increase linearly during the one-year period and replace 10% of overall market share by the end of the year, proportional to the pre-entry market share distribution of the other three treatments. Pharmacy budget inputs (wholesale acquisition cost of the therapies, daily dose, treatment duration, dispensing fee and copayment) were obtained from published and unpublished sources. Patients were assumed to be on treatment until progression or death. Medical costs were estimated as the average costs before and after progression, weighted by time in each state and adjusted for survival. Pre- and post-progression costs, time to progression and survival rates were derived from published literature. Compliance was assumed to be 100% until progression and adverse events were not considered. All costs were reported in 2011 US dollars. RESULTS: In a hypothetical health plan with 1 million members, there would be 72 patients expected to use one of the study drugs (exemestane, tamoxifen, fulvestrant or everolimus+exemestane) as the first treatment option immediately after letrozole or anastrozole failure, and 159 expected to use one of the study drugs as the second treatment option after letrozole or anastrozole failure. For the first treatment option after letrozole or anastrozole failure, total budget impact was $0.013 per member per month (PMPM), including a $0.017 PMPM increase to the pharmacy budget and $0.004 PMPM decrease to the medical budget one year after everolimus entry. For the second treatment option after letrozole or anastrozole failure, total budget impact was $0.029 PMPM, including a $0.037 PMPM increase to the pharmacy budget and $0.009 PMPM decrease to the medical budget one year after everolimus entry. Total budget impact was $0.042 PMPM, including a $0.055 PMPM increase to the pharmacy budget and $0.013 PMPM decrease to the medical budget one year after everolimus entry. CONCLUSION: Use of everolimus for ER+, HER2− MBC is expected to reduce the medical budget due to improved efficacy but increase the pharmacy budget due to higher drug cost. The total budget impact is relatively small. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P5-15-05.

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