Lack of access to CDK4/6 inhibitors for premenopausal patients with metastatic breast cancer in Brazil: estimation of the number of premature deaths

Abstract

Purpose: A CDK4/6 inhibitor (CDK4/6i) combined with endocrine therapy is the standard of care for patients with hormone receptor-positive (HR+) and HER2-negative (HER2-) metastatic breast cancer (MBC). However, the incorporation of these agents into clinical practice remains challenging. This study aims to estimate the impact of the lack of access to ribociclib on mortality of premenopausal patients with MBC in Brazil. Methods: Based on published epidemiological studies and national cancer registries, we estimated the number of premenopausal patients with potential indication of ribociclib as first-line treatment for MBC. Efficacy estimates were based on results from the Monaleesa-7 trial. Our analysis is made under the unrealistic assumption that all premenopausal MBC patients would be candidates for the treatment. To estimate the number of yearly premature deaths that could be prevented, we considered the largest absolute effect on mortality when sequentially applying the observed hazard ratio. Results: We estimated an annual incidence of 4,294 premenopausal HR+, HER2-MBC patients in Brazil. Considering these patients, at 12, 24 and 60 months, the number of surviving subjects would be 3,504, 2,859 and 1,553 for endocrine therapy (ET) alone; and 3,717, 3,217 and 2,086 for ET plus ribociclib. The largest difference between both groups was observed at the end of the sixth year when the use of ribociclib would prevent 538 premature deaths (survival of 1,805 versus 1,267 patients by the 72nd month). Conclusion: We estimate that lack of access to CDK4/6i for patients with HR+, HER2-, MBC will cause the premature death of a significant number of premenopausal women with MBC. The unavailability of effective therapies has measurable consequences. Progress in this area demands a concerted effort to prevent further loss of lives.

Cost-effectiveness of ribociclib for premenopausal or perimenopausal women with HR+/HER2− advanced breast cancer: a Brazilian public health care system perspective

“…In Brazil, it is estimated that 39% of all BC cases occur in premenopausal women. 31,32 Clinical manifestations in this population differ from those in older women, with worse prognostic features and more aggressive tumors, suggesting that younger age is an independent predictor of adverse outcomes. 33,34 Young premenopausal women also experience age-specific issues that significantly impair their quality of life.…”

Breast Cancer Priorities in Limited-Resource Environments: The Price-Efficacy Dilemma in Cancer Care

“…A recent study from Brazil estimated that lack of access to CDK4/6 inhibitors for patients with metastatic breast cancer will cause the premature death of a considerable number of premenopausal women with metastatic breast cancer (approximately 30% of premature deaths). 49 This will be difficult to prevent without incorporation of CDK4/6 inhibitors into the WHO EML, coupled with drug-pricing interventions.…”

Effect of ribociclib on productivity losses due to breast cancer in young women in Brazil

“…Considering its efficacy, the inaccessibility to ribociclib in Brazil will lead to higher mortality and impaired quality of life in patients with metastatic breast cancer. Reinert et al 19 estimated that administering ribociclib combined with endocrine therapy to one-year incident cases of HR+/HER2-metastatic breast cancer in Brazil would prevent 538 deaths over six years, compared with endocrine therapy alone. Our study complements Reinert et al 19 by estimating productivity gains that would benefit the Brazilian society due to access to ribociclib.…”

“…Presenteeism was defined as the percentage of time formally employed participants spent away from work tasks while at work due to illness 20 . Absenteeism, presenteeism and workforce dropout figures from the MONALEESA-7 trial were subsequently extrapolated to a premenopausal population-based 11 cohort of the prevalence of women with HR+/HER2-metastatic breast cancer in Brazil in 2020, representing 39% of breast cancer prevalent cases in Brazil (n = 10,936) 19 . All costs were estimated in Brazilian reals and converted to 2020 U.S. dollars at the prevailing exchange rate of USD $1 = BRL 5.3, obtained from the Brazilian Central Bank website calculator 22 .…”

“…We applied the rate of workforce dropout obtained in the MONALEESA-7 trial to a Brazilian population-based cohort of 10,936 premenopausal women with HR+/HER2metastatic breast cancer 11,19 . Table 2 shows the results over the treatment period in both comparator arms.…”