Cost-effectiveness analysis of everolimus plus exemestane versus exemestane alone for treatment of hormone receptor positive metastatic breast cancer

Abstract

Everolimus in combination with exemestane significantly improved progression-free survival compared to exemestane alone in patients previously treated with non-steroidal aromatase inhibitors in the BOLERO-2 trial. As a result, this combination has been approved by the food and drug administration to treat postmenopausal women with hormone receptor positive and HER2 negative metastatic breast cancer. A cost-effectiveness analysis was conducted to determine whether everolimus represents good value for money, utilizing data from BOLERO-2. A decision-analytic model was used to estimate the incremental cost-effectiveness ratio between treatment arms of the BOLERO-2 trial. Costs were obtained from the Center for Medicare Services drug payment table and physician fee schedule. Benefits were expressed as quality-adjusted progression-free survival weeks (QAPFW) and quality-adjusted progression-free years (QAPFY), with utilities/disutilities derived from the literature. Deterministic and probabilistic sensitivity analyses were performed. A willingness to pay threshold of 1–3 times the per capita gross domestic product was adopted, as per the definition of the World Health Organization. The U.S. per capita gross domestic product in 2013 was $49,965; thus, a threshold varying between $49,965 and $149,895 was considered. Everolimus/exemestane had an incremental benefit of 11.88 QAPFW (0.22 QAPFY) compared to exemestane and an incremental cost of $60,574. This translated into an ICER of $265,498.5/QAPFY. Univariate sensitivity analyses showed important variations of the ICER, ranging between $189,836.4 and $530,947/QAPFY. A tornado analysis suggested that the key drivers of our model, by order of importance, included health utility value for stable disease, everolimus acquisition costs, and transition probabilities from the stable to the progression states. The Monte-Carlo simulation showed results that were similar to the base-case analysis. This cost-effectiveness analysis showed that everolimus plus exemestane is not cost-effective compared to exemestane alone. Further research is needed to investigate the cost-effectiveness of the drug combination within sub-groups of the population studied in BOLERO-2.

Efficacy and safety of everolimus in Chinese metastatic HR positive, HER2 negative breast cancer patients: a real-world retrospective study

“…14.4% of the discontinuations were up to patients’ choice, mainly because of economic pressure. A cost-effective analysis based on the results of BOLERO-2 shows that the total cost of everolimus/exemestane ($63,584) was 21 times higher than the cost of exemestane alone ($3,010) [ 23 ]. Since everolimus hasn't been covered up by Chinese health insurance, it makes sense that people might find it unable to afford.…”

mTOR inhibitors, a new era for metastatic luminal HER2-negative breast cancer? A systematic review and a meta-analysis of randomized trials

“…In particular, in asymptomatic luminal patients with good prognosis, the combination treatment should be comparable to the HT alone in terms of toxicity to ensure the maintenance of good clinical conditions. Cost-effectiveness analysis demonstrated conflicting results on everolimus plus exemestane compared to exemestane alone in BOLERO-2 [ 20 ]. Long-term results and analysis of post-marketing studies are indeed needed to finally address this important issue.…”

Outcomes research examining treatments, quality of life and costs in HER2 -negative and triple-negative metastatic breast cancer: a systematic literature review

“…Overview of cost studies Findings on costs were reported by three articles [50][51][52] and two conference abstracts (Table 7) [53,54]. These studies varied in aims, designs, data sources and therapies: for example, three were cost-effectiveness analyses [50,51,54], one study was a budget impact model [52] and one study was a retrospective secondary database analysis [53].…”

“…These studies varied in aims, designs, data sources and therapies: for example, three were cost-effectiveness analyses [50,51,54], one study was a budget impact model [52] and one study was a retrospective secondary database analysis [53]. All patients examined were women with HER-negative mBC.…”

“…The study found that introduction of everolimus in combination with exemestane is projected to increase the pharmacy budget while reducing medical service expenditures, yielding a modest net increase of US$522,336 in total budget for the first year from a US payer perspective. Diaby et al [50] conducted a cost-effectiveness analysis (CEA) of everolimus plus exemestane versus exemestane alone for treatment of HR-positive/HER2-negative mBC. Using the BOLERO-2 data and costs obtained from the Center for Medicare Services drug payment table and physician fee schedule, the benefits were expressed as quality-adjusted PFS weeks and quality-adjusted progression-free years, with utilities/disutilities derived from the literature.…”