PCN98 Analysis of Societal Costs Due to Work Productivity Loss and Activity Impairment from the Monaleesa-7 Trial of Ribociclib + Endocrine Therapy (ET) in Premenopausal Women with HR+/HER2− Advanced Breast Cancer (ABC) in the US

2021 ◽  
Vol 24 ◽  
pp. S37
Author(s):  
T. Curteis ◽  
D. Chandiwana ◽  
P. Pathak ◽  
B. Lanoue ◽  
R. Pencheva ◽  
...  
The Breast ◽  
1993 ◽  
Vol 2 (3) ◽  
pp. 203-204 ◽  
Author(s):  
W. Jonat ◽  
M. Kaufmann ◽  
R. Blamey ◽  
A. Howell ◽  
J. Collins ◽  
...  

2017 ◽  
Vol 22 (9) ◽  
pp. 1028-1038 ◽  
Author(s):  
Sibylle Loibl ◽  
Nicholas C. Turner ◽  
Jungsil Ro ◽  
Massimo Cristofanilli ◽  
Hiroji Iwata ◽  
...  

2021 ◽  
Vol 11 ◽  
Author(s):  
Eunae Jeong ◽  
Changjun Wang ◽  
Leslie Wilson ◽  
Lixian Zhong

PurposeTo evaluate the cost-effectiveness of adding ribociclib to endocrine therapy for pre/perimenopausal women with hormone receptor-positive (HR+), human epidermal receptor 2-negative (HER2-) advanced breast cancer from the US payer perspective.MethodsA partitioned survival analysis model with three health states (progression-free, progressed disease, and death) was developed to compare the cost and effectiveness of ribociclib in combination with endocrine therapy versus endocrine therapy alone based on clinical data from the MONALEESA-7 phase 3 randomized clinical trials. Life years (LYs), quality-adjusted life-years (QALYs), and total costs were estimated and used to calculate incremental cost-effectiveness ratio (ICER) over a lifetime. Deterministic and probabilistic sensitivity analyses were conducted to test the uncertainties of model inputs. Additional scenario analyses were performed.ResultsIn the base-case, ribociclib plus endocrine therapy was more effective than endocrine therapy with an additional 1.39 QALYs but also more costly with an ICER of $282,996/QALY. One-way deterministic sensitivity analysis showed that overall survival associated with the treatments and the cost of ribociclib had the greatest impact on the ICER. The probabilistic sensitivity analysis showed that only beyond a willingness-to-pay (WTP) threshold of $272,867, ribociclib plus endocrine therapy would surpass endocrine therapy alone as a cost-effective option.ConclusionsFrom the US payer perspective, ribociclib plus endocrine therapy for pre/perimenopausal patients with HR+/HER2- advanced breast cancer is not cost-effective at a WTP threshold of $100,000 or $150,000 per QALY in comparison of endocrine therapy alone.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Olga Martínez-Sáez ◽  
Tomás Pascual ◽  
Fara Brasó-Maristany ◽  
Nuria Chic ◽  
Blanca González-Farré ◽  
...  

AbstractCirculating tumor DNA (ctDNA) levels may predict response to anticancer drugs, including CDK4/6 inhibitors and endocrine therapy combinations (CDK4/6i+ET); however, critical questions remain unanswered such as which assay or statistical method to use. Here, we obtained paired plasma samples at baseline and week 4 in 45 consecutive patients with advanced breast cancer treated with CDK4/6i+ET. ctDNA was detected in 96% of cases using the 74-gene Guardant360 assay. A variant allele fraction ratio (VAFR) was calculated for each of the 79 detected mutations between both timepoints. Mean of all VAFRs (mVAFR) was computed for each patient. In our dataset, mVAFR was significantly associated with progression-free survival (PFS). Baseline VAF, on-treatment VAF or absolute changes in VAF were not associated with PFS, nor were CA-15.3 levels at baseline, week 4 or the CA-15.3 ratio. These findings demonstrate that ctDNA dynamics using a standardized multi-gene panel and a unique methodological approach predicts treatment outcome. Clinical trials in patients with an unfavorable ctDNA response are needed.


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