A multi-stakeholder approach in optimising patients’ needs in the benefit assessment process of new metastatic breast cancer treatments

Cardoso, Fátima; Wilking, Nils; Bernardini, Renato; Biganzoli, Laura; Espín, Jaime; Miikkulainen, Kaisa; Schuurman, Susanne; Spence, Danielle; Spitz, Sabine; Ujupan, Sonia; Zernik, Nicole; Gordon, Jenn

doi:10.1016/j.breast.2020.04.011

Cited by 9 publications

(7 citation statements)

References 29 publications

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“…Delaying the initiation of chemotherapy in patients with MBC may translate to improvements in quality of life and a reduction in side effects, while lowering emergency department visits and hospitalizations resulting in healthcare cost savings [ 42 , 43 ]. The ability to delay chemotherapy is considered an important treatment goal for patients, clinicians, and policy makers [ 44 ]. Data from MONARCH 2 and MONARCH 3 trials demonstrated a delay in chemotherapy for abemaciclib in combination with fulvestrant and an aromatase inhibitor [ 45 , 46 ].…”

Section: Discussionmentioning

confidence: 99%

Real-World Patient Characteristics, Utilization Patterns, and Outcomes of US Patients with HR+, HER2− Metastatic Breast Cancer Treated with Abemaciclib

Smyth

Beyrer

Saverno

et al. 2022

Drugs - Real World Outcomes

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Background Abemaciclib is the most recent oral cyclin-dependent kinase 4 and 6 inhibitor (CDK4 & 6i) to receive US Food and Drug Administration (FDA) approval to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced or metastatic breast cancer (MBC). Administrative claims data were used to describe patient characteristics and select clinical and economic outcomes in US patients treated in routine clinical practice. Prior analyses from electronic health records data indicate approximately 25% of patients received either palbociclib or ribociclib for MBC before initiating abemaciclib treatment; this work further explored these findings and associated outcomes. Methods This retrospective study analyzed medical and pharmacy claims from the IBM ® MarketScan ® Research Databases between 1 January 2007 to 31 January 2020. Patients with HR+, HER2− MBC newly initiating abemaciclib between 1 September 2017 and 31 October 2019 were included and grouped by concomitant therapy (+aromatase inhibitor (AI), +fulvestrant (F), 200 mg abemaciclib monotherapy (Mono), or +other), and outcomes were analyzed by prior CDK4 & 6i use. Patient and treatment characteristics were summarized with descriptive statistics. Kaplan-Meier methods assessed time-to-discontinuation (TTD; i.e., persistency) and time-to-chemotherapy (TTC). Adherence (defined by the medication possession ratio) and drug wastage were determined. Results This analysis included 454 patients (mean age 57.7 years), with 35.0% (n = 159) in the +F group, 29.3% (n = 133) in the +AI group, 10.4% (n = 47) in the 200 mg Mono group, and 25.3% (n = 115) in the +other group. Prior chemotherapy and CDK 4 & 6i use were present in 23.8% and 49.8% of all patients, respectively. Visceral metastases were present at abemaciclib initiation in 50.4% in the +AI group; 49.7% in the +F group; and 55.3% in the 200 mg Mono group. Liver metastases were present in 33.7% of the overall population. Among patients without prior CDK4 & 6i use, the median TTD for patients receiving abemaciclib + AI was not reached [95% CI 430-not reached (NR) days], abemaciclib + F [531 days (95% CI 281-NR)], and abemaciclib mono [141 days (95% CI 80-NR)]. Median TTC for abemaciclib + AI and abemaciclib + F groups were not reached and the median TTC for abemaciclib mono was 535 days (95% CI 181-NR). Medication adherence was 88.7% and medication wastage costs among those with at least one dose modification were $808.12 and $452.2 per patient per month based on amount paid and wholesale acquisition cost (WAC), respectively. Mean length of follow-up for all patients was 350 days (SD 187). Conclusion These real-world data complement clinical trial results by examining abemaciclib use among patients treated in routine clinical practice. The sizeable number of patients treated with prior CDK4 & 6i, chemotherapy, and/or visceral metastases at abemaciclib initiation suggest that many patients had very advanced disease and/or were in later stages of their treatment. These data co...

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Section: Discussionmentioning

confidence: 99%

Real-World Patient Characteristics, Utilization Patterns, and Outcomes of US Patients with HR+, HER2− Metastatic Breast Cancer Treated with Abemaciclib

Smyth

Beyrer

Saverno

et al. 2022

Drugs - Real World Outcomes

View full text Add to dashboard Cite

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“…Lack of qualified human resources for optimal delivery of radiotherapy services exacerbates the problem [ 6 ].With regard to treatment, there has been an unprecedented wave of innovations in cancer treatment in the past few years. These developments may have a considerable budget impact and require new pathways and financing mechanisms to ensure timely patient access [ 10 ]. Finally, better political, and societal awareness about cancer is needed: due to demographics and lifestyle change cancer is already in some countries disease burden number one and will soon become that in several other European countries.…”

Section: Main Textmentioning

confidence: 99%

“What’s measured gets done”: a call for a European semester for cancer to improve cancer outcomes in Central and Southeastern Europe

2023

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Cancer mortality varies widely across Europe, and survival depends on where you live. In particular, the inequality between countries in Central and South-Eastern Europe (CEE) and Western Europe (WE) is striking. The COVID-19 pandemic has brought existing inequalities into sharp focus, and the economic disruption it has caused threatens to deepen them. The Central European Cooperative Oncology Group (CECOG) has created a platform with the aim to reduce health inequalities and to improve patient access to cancer care. The subject of discussion is the value of new treatments to create willingness to invest in improving cancer outcomes while managing the budget. The platform includes various stakeholders as scientific leaders, policy makers, payers, patients and industry.

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“…Breast cancer significantly impacts women's lives physically, psychologically, and socially; in 2020, there were 685,000 deaths worldwide from breast cancer [1,2]. Breast cancer is referred to as 'metastatic' or 'advanced' if it cannot be removed with surgery or has travelled to other sites within the body [3].…”

Section: Introductionmentioning

confidence: 99%

Exploring the experiences of women living with metastatic breast cancer [MBC]: A systematic review of qualitative evidence

Lyons-Rahilly,

Meskell,

Carey

et al. 2024

PLoS ONE

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Purpose Metastatic breast cancer [MBC] is the leading cause of cancer death in women globally with no cure. Women diagnosed with MBC endure a catastrophic upheaval to multiple aspects of their life and a radically transformed future landscape. Evidence suggests that the provision of care for women living with metastatic breast cancer is inadequate, socially isolating and stigmatising. To date, this topic has received little research attention. To increase understanding of the experiences of women living with MBC, a synthesis of current evidence is required. This paper presents a review of qualitative evidence on women’s experiences of MBC. Methods A qualitative evidence synthesis [QES] was conducted to synthesise primary qualitative research on the experiences of women living with MBC. Searches were performed of electronic databases Medline, Medline Ovid, PsycINFO, Psych articles, PubMED, CINAHL Complete, Scopus and grey literature databases. The methodological quality of the included studies was appraised using a modified version of the Critical Appraisal Skills Programme [CASP]. Title, abstract, and full-text screening were undertaken. A ‘best fit’ framework approach using the ARC [Adversity, Restoration, Compatibility] framework was used to guide data extraction and synthesis. Confidence in the findings was assessed using the Grading of Recommendations Assessment, Development and Evaluation, Confidence in the Evidence from Reviews of Qualitative research [GRADE-CERQual]. Results 28 papers from 21 research studies containing 478 women’s experiences of living with MBC were deemed suitable for inclusion in this qualitative evidence synthesis. Findings are presented in a new conceptual framework RAAW [adapted from ARC] for women living with MBC under themes: Reality, Adversity, Adjustment and Wellbeing. Findings revealed that a diagnosis of MBC impacted every aspect of women’s lives; this is different to a diagnosis of early breast cancer. An overarching theme of lack of support extended across various facets of their lives. A lack of psychological, emotional, and psychosocial support was evident, with a critical finding that models of care were not fit for purpose. Deficits included a lack of information, knowledge, inclusion in shared decision-making and MDT support, specifically the need for palliative care/oncology support access. Some women living with MBC wanted to be identified as having a chronic illness not a life-limiting illness. Culture and socioeconomic standing influenced the availability of various types of support. The impact of treatment and symptoms had an adverse effect on women’s quality of life and affected their ability to adjust. Conclusion This review synthesised the qualitative literature on the experiences of women living with MBC. The ARC framework used in the synthesis was adapted to develop a revised conceptual framework titled RAAW to represent the evidence from this review on experiences for women living with MBC; Reality & Adversity: A diagnosis of MBC; Adjustment: Living with MBC; Wellbeing: Awareness, meaning, engagement [RAAW; MBC].

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A multi-stakeholder approach in optimising patients’ needs in the benefit assessment process of new metastatic breast cancer treatments

Cited by 9 publications

References 29 publications

Real-World Patient Characteristics, Utilization Patterns, and Outcomes of US Patients with HR+, HER2− Metastatic Breast Cancer Treated with Abemaciclib

Real-World Patient Characteristics, Utilization Patterns, and Outcomes of US Patients with HR+, HER2− Metastatic Breast Cancer Treated with Abemaciclib

“What’s measured gets done”: a call for a European semester for cancer to improve cancer outcomes in Central and Southeastern Europe

Exploring the experiences of women living with metastatic breast cancer [MBC]: A systematic review of qualitative evidence

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