scholarly journals COST-EFFECTIVENESS ANALYSIS OF AVELUMAB TREATMENT FOR PATIENTS WITH METASTATIC MERKEL CELL CARCINOMA

2020 ◽  
Vol 66 (2) ◽  
pp. 109-119
Author(s):  
Nikolay Avksentev ◽  
Lev Demidov ◽  
Maksim Frolov ◽  
Aleksandr Makarov

Merkel cell carcinoma (MCC) is a rare primary malignant skin tumor with epithelial and neuroendocrine differentiation. According to the Russian clinical recommendations, MCC accounts for around 650 new cases per year in Russia. Avelumab is a human IgG1 monoclonal antibody that targets cancer cells through the inhibition of the immune checkpoint protein PD-L1 and can be used as a 2nd line treatment of metastatic MCC (mMCC). The aim of the study is to conduct a clinical and economic evaluation of avelumab as a second-line treatment in patients with mMCC from the perspective of Russian health care. Methods. Standard chemotherapy regimens were considered as a comparator for avelumab. We proposed a mathematical model of MCC progression and calculated direct medical costs during 6 years of treatment. Incremental cost-effectiveness ratios for avelumab (vs chemotherapy) were compared with the corresponding ratios for another PD-1 inhibitor included in Vital and Essential Drug List (VEDL). Results. Life-years gained (LYG) for avelumab were 2.21 years, compared to 0.39 LYG for chemotherapy. The average costs of using avelumab were 9 156 731 RUB per patient, compared to 60 743 RUB when using chemotherapy. Incremental cost-effectiveness ratio (ICER) for avelumab (vs chemotherapy) was 5 012 867.70 RUB per one LYG, which was 54.8% lower than ICER for pembrolizumab (vs docetaxel) as a second-line treatment in patients with non-small cell lung cancer. ICER for avelumab vs chemotherapy was 11,940,043.38 RUB per one progression-free LYG, which was 40.9% lower than ICER for pembrolizumab (vs chemotherapy) as a treatment in patients with ipilimumab-refractory advanced melanoma.

2021 ◽  
Vol 12 ◽  
Author(s):  
Hongfu Cai ◽  
Baohua Xu ◽  
Na Li ◽  
Bin Zheng ◽  
Zhiwei Zheng ◽  
...  

Background: This study aimed to analyze the cost effectiveness of camrelizumab in the second-line treatment of advanced or metastatic esophageal squamous cell carcinoma in China.Methods: On the basis of the ESCORT clinical trial, a partitioned survival model was constructed to simulate the patient’s lifetime quality-adjusted life years (QALYs), lifetime costs, and incremental cost-effectiveness ratio (ICER). One-way sensitivity and probability sensitivity analyses were performed to test the stability of the model.Results: Treatment of esophageal squamous cell carcinoma with camrelizumab added 0.36 QALYs and resulted in an incremental cost of $1,439.64 compared with chemotherapy, which had an ICER of $3,999 per QALY gained. The ICER was far lower than the threshold of willingness to pay for one time the GDP per capita in China. Sensitivity analysis revealed that the ICERs were most sensitive to the cost of drugs, but the parameters did not have a major effect on the results of the model.Conclusion: Camrelizumab is likely to be a cost-effective option compared with chemotherapy for patients with advanced or metastatic esophageal squamous cell carcinoma. This informs patient selection and clinical path development.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21104-e21104
Author(s):  
Nimer S. Alkhatib ◽  
Briana Choi ◽  
Hala Halawah ◽  
Matthias Calamia ◽  
Dexter Gulick ◽  
...  

e21104 Background: Crizotinib, alectinib, ceritinib, and brigatinib are approved as second line treatment for ALK+ NSCLC. Crizotinib was the first ALK inhibitor for first line therapy approved by Food and Drug Administration (2011) then ceritinib (2014), alectinib (2015), and brigatinib (2017) were approved as second line drugs. Following more data, these agents were approved as the first line therapy (2017 for ceritinib and alectinib; 2020 for brigatinib). These remain as a treatment option in patients who fail the first line therapy. Cost-effectiveness/utility analyses were conducted to assess clinical efficacy with varying costs of the agents. Methods: A three state Markov model were assumed (progression free, progression and death). Progression free survival (PFS) curves were digitized and fitted with exponential function. US payer perspective, a lifetime horizon, and discount rate of 3% were applied. Drug costs were Redbook wholesale acquisition cost. Other costs included were monitoring, adverse events and disease progression from published data (US$ 2020). Adverse events reported >5% in patients were included. Measured outcomes were PFS life years (PFSLY) and quality adjusted life years (PFSQALY). Crizotinib was the reference drug. Incremental cost-effectiveness and utility ratios (ICER/ICUR) of PFSLY and PFSQALY gained (PFSLYG, PFSQALYG) and lost were estimated. Base case (BCA) and probabilistic sensitivity analyses (PSA) were conducted. Results: Crizotinib was the reference drug for the following outcomes. For alectinib, with the decremental cost of -$14,653 (-$14,712), the incremental PFSLY of 0.16 (0.16) and PFSQALY of 0.05 (0.05) resulted in an ICER / PFSLYG of -$89,337 (-$88,604) and an ICUR / PFSQALYG of -$269,835 (-$266,510). For brigatinib, with the decremental cost of -$14,975 (-$14,954), the incremental PFSLY of 0.01 (0.01) and PFSQALY of ̃0.01 (0.02) yielded an ICER / PFSLYG of -$1,982,962 (-$1,431,631) and an ICUR / PFSQALYG of -$2,140,534 (-$570,538). For ceritinib, with the incremental cost of $7,590 ($7,514), there were decremental PFSLY of -0.01 (-0.01) and PFSQALY of -0.03 (-0.03). Conclusions: As second line treatment, crizotinib, ceritinib, and brigatinib had comparable PFSLYs and PFSQALYs while alectinib had the most PFSLY and PFSQALY and the lowest cost. Therefore, alectinib is the most cost-effective treatment for treating ALK+ NSCLC as the second line therapy.[Table: see text]


2019 ◽  
Vol 22 ◽  
pp. S511
Author(s):  
N.A. Avxentyev ◽  
M. Frolov ◽  
A. Makarov ◽  
R. Palencia ◽  
O.V. Kudelya ◽  
...  

Author(s):  
Costantino Ricci ◽  
Luca Morandi ◽  
Francesca Ambrosi ◽  
Alberto Righi ◽  
Dino Gibertoni ◽  
...  

AbstractMerkel cell carcinoma (MCC) is an aggressive skin tumor with neuroendocrine differentiation, mainly affecting elderly population or immunocompromised individuals. As methylation of the human telomerase reverse transcriptase (mhTERT) has been shown to be a prognostic factor in different tumors, we investigated its role in MCC, in particular in intron 4–5 where rs10069690 has been mapped and recognized as a cancer susceptibility locus. DNA methylation analysis of hTERT gene was assessed retrospectively in a cohort of 69 MCC patients from the University of Bologna, University of Turin and University of Insubria. Overall mortality was evaluated with Kaplan-Meier curves and multivariable Royston-Parmar models. High levels of mhTERT (mhTERThigh) (HR = 2.500, p = 0.015) and p63 (HR = 2.659, p = 0.016) were the only two clinico-pathological features significantly associated with a higher overall mortality at the multivariate analysis. We did not find different levels of mhTERT between MCPyV (+) and (−) cases (21 vs 14, p = 0.554); furthermore, mhTERThigh was strongly associated with older age (80.5 vs 72 years, p = 0.026), no angioinvasion (40.7% vs 71.0%, p = 0.015), lower Ki67 (50 vs 70%, p = 0.005), and PD-L1 expressions in both tumor (0 vs 3%, p = 0.021) and immune cells (0 vs 10%, p = 0.002). mhTERT is a frequently involved epigenetic mechanism and a relevant prognostic factor in MCC. In addition, it belongs to the shared oncogenic pathways of MCC (MCPyV and UV-radiations) and it could be crucial, together with other epigenetic and genetic mechanisms as gene amplification, in determining the final levels of hTERT mRNA and telomerase activity in these patients.


Author(s):  
V. N. Vysotskaya ◽  
Y. V. Karpova ◽  
E. S. Sukhovskaya ◽  
A. V. Babushkin ◽  
Ni. V. Boriskin

Merkel cell carcinoma is a rare malignant primary skin tumor with epithelial and neuroendocrine differentiation. In the presented diagnostic case, the possibility of a cytological method in this material is a scarification biopsy.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18338-e18338
Author(s):  
Michal Sarfaty ◽  
Moshe Leshno ◽  
Noa Gordon ◽  
Assaf Moore ◽  
Victoria Neiman ◽  
...  

e18338 Background: In recent years, new drugs have been introduced to the second line setting of advanced renal cell carcinoma (RCC). Nivolumab increases overall survival and is associated with less toxicity compared to everolimus in this setting based on the Checkmate 025 study. However, due to nivolumab's high cost there is a need to define its value by considering both efficacy and cost. The objective of this study was to estimate the cost-effectiveness of nivolumab for the second-line treatment of advanced RCC from the US payer perspective. Methods: A Markov model was developed to compare the costs and effectiveness of nivolumab with those of everolimus or placebo in the second-line treatment of advanced RCC. Health outcomes were measured in life-years and quality-adjusted life-years (QALYs). Drug costs were based on Medicare reimbursement rates in 2016. Model robustness was addressed in univariable and probabilistic sensitivity analyses. We addressed the controversial issue of the extensive duration of immunotherapy treatment amongst long term survivors, which may or may not be approved by payers. Results: The total mean cost per-patient of nivolumab versus everolimus was $101,070 and $50,935, respectfully. Nivolumab generated a gain of 0.24 LYs (0.34 QALYs) over everolimus and 0.89 LYs (0.96 QALYs) over placebo. The incremental cost-effectiveness ratio (ICER) for nivolumab was $146,532/QALY versus everolimus and $105,232/QALY versus placebo. Limiting the maximal treatment duration of nivolumab to two years lowered the ICER to $121,788/QALY versus everolimus and $96,418/QALY versus placebo. Conclusions: Our analysis established an ICER of $146,532/QALY for nivolumab versus everolimus in second-line advanced RCC treatment.


2020 ◽  
Vol 16 (17) ◽  
pp. 1189-1198
Author(s):  
Peng-Fei Zhang ◽  
Dan Xie ◽  
Qiu Li

Background: To investigate the cost–effectiveness of nivolumab versus chemotherapy in the second-line treatment for advanced esophageal squamous cell carcinoma. Materials & methods: A Markov model reflecting the patients in the ATTRACTION-3 trial was established. Weibull survival model was employed to fit the Kaplan–Meier progression-free survival and overall survival probabilities of the nivolumab and chemotherapy strategy, respectively. Meanwhile, one-way and PSA were performed to test the uncertainty in the model. Results: Overall, the incremental effectiveness and cost of nivolumab versus chemotherapy were 0.107 quality-adjusted life-years and $14,627.90, resulting in an incremental cost–effectiveness ratio of $136,709.35/quality-adjusted life-year. Conclusion: Nivolumab is not a cost-effective treatment option compared with chemotherapy from the perspective of Chinese society.


2021 ◽  
Vol 12 ◽  
Author(s):  
SiNi Li ◽  
JianHe Li ◽  
LiuBao Peng ◽  
YaMin Li ◽  
XiaoMin Wan

Background: In a recent randomized, phase 3 trial (CheckMate 9ER), nivolumab combined with cabozantinib significantly improved patient outcomes compared with sunitinib. However, the cost-effectiveness of these novel agents for untreated advanced renal cell carcinoma (aRCC) remains unknown.Materials and Methods: We constructed a microsimulation decision-analytic model to measure the healthcare costs and outcomes of nivolumab plus cabozantinib compared with those of sunitinib for patients with aRCC. The transition probability of patients was calculated from CheckMate 9ER using parametric survival modeling. Lifetime direct medical costs, life years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were estimated for nivolumab-plus-cabozantinib treatment compared with sunitinib from a US payer perspective. We conducted one-way and probabilistic sensitivity analyses and a series of scenario analyses to evaluate model uncertainty.Results: Nivolumab plus cabozantinib was associated with an improvement of 0.59 LYs and 0.56 QALYs compared with sunitinib. However, incorporating nivolumab plus cabozantinib into first-line treatment was associated with significantly higher lifetime costs ($483,352.70 vs. $198,320.10), causing the incremental cost-effectiveness ratio for nivolumab plus cabozantinib to be $508,987/QALY. The patients’ age of treatment, first-line utility, and cost of nivolumab had the greatest influence on the model. The outcomes were robust when tested in sensitivity and scenario analyses.Conclusion: For aRCC, substituting nivolumab plus cabozantinib in the first-line setting is unlikely to be cost-effective under the current willingness-to-pay threshold ($150,000/QALY). Significant price decreases for nivolumab used in first-line therapy would be needed to drop ICERs to a more diffusely acceptable value.


2019 ◽  
Vol 46 (8) ◽  
Author(s):  
Shiho Hanai ◽  
Takatoshi Shimauchi ◽  
Reiko Kageyama ◽  
Masahiro Aoshima ◽  
Taisuke Ito ◽  
...  

10.36469/9834 ◽  
2015 ◽  
Vol 3 (2) ◽  
pp. 180-193
Author(s):  
Gabriel Tremblay ◽  
Unnati Majethia ◽  
Ilias Kontoudis ◽  
Jesús De Rosendo

Background: Two thirds (62%) of metastatic breast cancer (MBC) patients in Western Europe have human epidermal growth factor receptor 2 (HER2)-negative disease, for which anthracyclines and taxanes are recommended as first-line treatments, followed by microtubule-targeting agents such as capecitabine, vinorelbine and/or eribulin. The study objective was to compare the cost-effectiveness of eribulin in Spain as a second-line treatment for HER2-negative MBC with its current status as a third-line treatment for patients who have received capecitabine. Methods: A Markov model was developed from the perspective of the Spanish healthcare system. The model had three health states: Stable; Progression and Death. In Stable, patients received eribulin or: capecitabine and vinorelbine for HER2-negative patients; primary treatment of physician’s choice (TPC) for post-capecitabine patients. In Progression, all patients received secondary TPC. Model inputs were overall survival, progression-free survival and costs relating to chemotherapies, grade 3/4 adverse events and healthcare utilization. Sensitivity analyses were conducted to identify uncertainty. Results: As second-line treatment, Eribulin was associated with a greater incremental benefit in life years (LYs) and quality-adjusted life years (QALYs) than capecitabine and vinorelbine. Erubilin as third-line treatment was associated with greater benefit in life years (LYs) and QALYs than TPC. The incremental cost-effectiveness ratios (ICERs) for eribulin were higher in the second-line than the third-line setting in terms of LYs (€35,149 versus €24,884) and QALYs (€37,152 versus €35,484). In both settings, deterministic sensitivity analyses demonstrated that the ICER is most sensitive to the eribulin price. Conclusion: Eribulin is cost-effective as second-line treatment for HER2-negative MBC patients in Spain; albeit, slightly less so than as third-line treatment for MBC patients who have received capecitabine (an ICER per QALY difference of €1,668). This difference may fall within the margin of error for the model and could potentially be addressed by a minor reduction in the eribulin price.


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