Comparison of healthcare resource utilization and costs of patients with HR+/HER2- advanced breast cancer treated with ribociclib versus other CDK4/6 inhibitors

Burne, Rebecca; Balu, Sanjeev; Guérin, Annie; Bungay, Rebecca; Sin, Roxana; Paul, Mary Lisha

doi:10.1080/13696998.2021.1939705

Cited by 6 publications

(3 citation statements)

References 46 publications

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“…In conclusion, to our knowledge, this study has the longest follow up of any abemaciclib observational study, and is the first one, outside of the clinical trial setting, to obtain OS data with abemaciclib [ 18 , 19 ]. Baseline characteristics of women treated within the NPU program suggest an advanced disease course and worse prognosis than in patients enrolled in abemaciclib clinical trials, with a heavily pre-treated population, a high tumor load, and a high proportion of patients with bone and visceral disease.…”

Section: Discussionmentioning

confidence: 99%

Observational study of HR+/HER2− metastatic breast cancer patients treated with abemaciclib in Spain in the Named Patient Use Program (AbemusS)

et al. 2023

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Introduction/objectives To describe abemaciclib use in patients with hormone receptor-positive, human epidermal growth factor receptor-negative (HR+/HER2−) metastatic breast cancer (mBC) who participated in the Named Patient Use program (NPU) in Spain. Material and methods This retrospective study was based on medical record review of patients across 20 centers during 2018/2019. Patients were followed up until death, enrolment in a clinical trial, loss of follow-up or study end. Clinical and demographic characteristics, treatment patterns and abemaciclib effectiveness were analyzed; time-to-event and median times were estimated using the Kaplan–Meier (KM) method. Results The study included 69 female patients with mBC (mean age 60.4 ± 12.4 years), 86% of whom had an initial diagnosis of early BC and 20% had an ECOG ≥ 2. Median follow-up was 23 months (range 16–28). Metastases were frequently observed in bone (79%) and visceral tissue (65%), with 47% having metastases in > 2 sites. Median number of treatment lines before abemaciclib was 6 (range 1–10). Abemaciclib monotherapy was received by 72% of patients and combination therapy with endocrine therapy by 28% of patients; 54% of patients required dose adjustments, with a median time to first adjustment of 1.8 months. Abemaciclib was discontinued in 86% of patients after a median of 7.7 months (13.2 months for combination therapy and 7.0 months for monotherapy) mainly due to disease progression (69%). Conclusion These results suggest that abemaciclib is effective, as monotherapy and in combination, for patients with heavily pretreated mBC, consistent with clinical trial results.

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Section: Discussionmentioning

confidence: 99%

Observational study of HR+/HER2− metastatic breast cancer patients treated with abemaciclib in Spain in the Named Patient Use Program (AbemusS)

et al. 2023

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“…In this study, we observed that palbociclib, the first approved medicine of the 3 CDK4/6 inhibitors, remained the predominant medicine that was prescribed. This preference for palbociclib was also seen in other high-income countries, although there is no clear evidence that palbociclib is superior to ribociclib and abemaciclib . Possibly the pattern of use can be explained by physician preferences, the marketing strategies of the manufacturers, hospital policies, or differences in price rebates.…”

Section: Discussionmentioning

confidence: 90%

“…This preference for palbociclib was also seen in other high-income countries, although there is no clear evidence that palbociclib is superior to ribociclib and abemaciclib. [38][39][40][41][42] Possibly the pattern of use can be explained by physician preferences, the marketing strategies of the manufacturers, hospital policies, or differences in price rebates. We also observed that the CDK4/6 inhibitors were mainly combined with fulvestrant, which likely reflects the recommendation in the Netherlands to primarily prescribe CDK4/6 inhibitors in the second line of treatment.…”

Section: Jama Network Open | Health Policymentioning

confidence: 99%

Regulatory Approval, Reimbursement, and Clinical Use of Cyclin-Dependent Kinase 4/6 Inhibitors in Metastatic Breast Cancer in the Netherlands

et al. 2023

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ImportanceThe number of new cancer medicines that are being approved by regulatory agents is increasing exponentially. Yet little is known about the pace at which these medicines reach eligible patients in daily clinical practice during different phases of the postapproval access pathway.ObjectiveTo describe the entire postapproval access pathway of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in the Netherlands, from regulatory approval to reimbursement and to investigate the adoption of these medicines in clinical practice among patients with metastatic breast cancer.Design, Setting, and ParticipantsThis cohort study reviewed approval and reimbursement decisions of the CDK4/6 inhibitors palbociclib, ribociclib, and abemaciclib and estimated the number of patients with metastatic breast cancer who were eligible for these medicines compared with the actual use in clinical practice. The study used nationwide claims data that were obtained from the Dutch Hospital Data. Claims and early access data for patients with hormone receptor–positive and ERBB2 (formerly HER2)–negative metastatic breast cancer who were treated with CDK4/6 inhibitors from November 1, 2016, to December 31, 2021, were included.Main Outcomes and MeasuresDescription of the postapproval access pathway, monthly number of patients who were treated with CDK4/6 inhibitors in clinical practice, and estimated number of patients who were eligible for treatment. Aggregated claims data were used, and patient characteristics and outcomes data were not collected.ResultsThree CDK4/6 inhibitors have received European Union–wide regulatory approval for the treatment of HR-positive and ERBB2-negative metastatic breast cancer since November 2016. In the Netherlands, the number of patients who have been treated with these medicines increased to approximately 1847 (based on 1 624 665 claims over the entire study period) from approval to the end of 2021. Reimbursement for these medicines was granted between 9 and 11 months after approval. While awaiting reimbursement decisions, 492 patients received palbociclib, the first approved medicine of this class, via an expanded access program. By the end of the study period, 1616 patients (87%) were treated with palbociclib, whereas 157 patients (7%) received ribociclib, and 74 patients (4%) received abemaciclib. The CKD4/6 inhibitor was combined with an aromatase inhibitor in 708 patients (38%) and with fulvestrant in 1139 patients (62%). The pattern of use over time appeared to be somewhat lower compared with the estimated number of eligible patients (1847 vs 1915 in December 2021), especially in the first 2.5 years after approval.Conclusions and RelevanceThis study found that CDK4/6 inhibitors rapidly reached many eligible patients with metastatic breast cancer and were adopted gradually over time in the Netherlands. Adoption of innovative medicines may be further optimized, and better transparency of the availability of new medicines during different phases of the postapproval access pathway is needed.

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Integrated budget impact model to estimate the impact of introducing selpercatinib as a tumor-agnostic treatment option for patients with RET -altered solid tumors in the US

Bhandari,

Gilligan,

Myers

et al. 2024

Journal of Medical Economics

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Comparison of healthcare resource utilization and costs of patients with HR+/HER2- advanced breast cancer treated with ribociclib versus other CDK4/6 inhibitors

Cited by 6 publications

References 46 publications

Observational study of HR+/HER2− metastatic breast cancer patients treated with abemaciclib in Spain in the Named Patient Use Program (AbemusS)

Observational study of HR+/HER2− metastatic breast cancer patients treated with abemaciclib in Spain in the Named Patient Use Program (AbemusS)

Regulatory Approval, Reimbursement, and Clinical Use of Cyclin-Dependent Kinase 4/6 Inhibitors in Metastatic Breast Cancer in the Netherlands

Integrated budget impact model to estimate the impact of introducing selpercatinib as a tumor-agnostic treatment option for patients with RET -altered solid tumors in the US

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