[Translation] Post-marketing surveillance study of the effectiveness (all-cause mortality) of posaconazole injection and posaconazole enteric-coated tablets in the treatment of invasive aspergillosis in Chinese patients

主要目的：评估接受了至少7天泊沙康唑注射液和/或泊沙康唑肠溶片作为一线方案治疗侵袭性曲霉病的中国成人患者中第42天的全因死亡率。次要目的：1.评估接受一线治疗方案泊沙康唑注射液和/或泊沙康唑肠溶片治疗侵袭性曲霉病的中国成人患者在泊沙康唑治疗结束时（最短治疗持续时间42天，最长治疗持续时间12周，即84天）的总应答率（完全或部分应答）。2.评估接受泊沙康唑注射液和/或泊沙康唑肠溶片作为挽救方案治疗侵袭性曲霉病的两性霉素B、伏立康唑、伊曲康唑或艾沙康唑难治性3或者对上述药物不耐受的中国成人患者在泊沙康唑治疗结束时（最短治疗持续时间7天，最长治疗持续时间12周，即84天）的总应答率（完全或部分应答）。3. 描述接受泊沙康唑注射液和/或泊沙康唑肠溶片作为一线或挽救方案治疗侵袭性曲霉病的中国成人患者的研究人群特征，包括基线、临床特征和治疗模式。

[Translation]

Primary objective: To evaluate the all-cause mortality at day 42 in Chinese adult patients who received at least 7 days of posaconazole injection and/or posaconazole enteric-coated tablets as first-line treatment for invasive aspergillosis. Secondary objectives: 1. To evaluate the overall response rate (complete or partial response) at the end of posaconazole treatment (minimum treatment duration 42 days, maximum treatment duration 12 weeks, i.e. 84 days) in Chinese adult patients who received posaconazole injection and/or posaconazole enteric-coated tablets as first-line treatment for invasive aspergillosis. 2. To evaluate the overall response rate (complete or partial response) at the end of posaconazole treatment (minimum treatment duration 7 days, maximum treatment duration 12 weeks, i.e. 84 days) in Chinese adult patients who received posaconazole injection and/or posaconazole enteric-coated tablets as salvage treatment for invasive aspergillosis who were refractory to amphotericin B, voriconazole, itraconazole or isavuconazole or were intolerant to the above drugs. 3. To describe the characteristics of the study population of Chinese adult patients who received posaconazole injection and/or posaconazole enteric-coated tablets as first-line or salvage therapy for invasive aspergillosis, including baseline, clinical characteristics, and treatment patterns.

Start Date15 Nov 2023

Sponsor / Collaborator

Schering-Plough Corp.

[+3]

CTR20231040 / CompletedPhase 4

接受含多拉韦林的高效联合抗反转录病毒治疗（HAART）HIV-1中国成年患者有效性上市后研究

[Translation] Post-marketing efficacy study of doravirine-containing combination antiretroviral therapy (HAART) in Chinese adults with HIV-1

主要目的：旨在评价含多拉韦林的HAART对HIV-1中国成年患者的效果；次要目的：描述研究人群的人口学特征、临床特征及治疗模式。

[Translation]

Primary objective: To evaluate the effect of HAART containing doravirine on Chinese adult patients with HIV-1; Secondary objective: To describe the demographic characteristics, clinical characteristics and treatment patterns of the study population.

Start Date25 Jul 2023

Sponsor / Collaborator

MSD R&D (China) Co. Ltd.

[+2]

CTR20231216 / CompletedPhase 4

中国常规临床实践中使用诺科飞的上市后安全性监测项目

[Translation] Post-marketing safety monitoring program for using NocoFy in routine clinical practice in China

描述在中国真实使用诺科飞注射液和/或肠溶片的参与者中发生1起或多起不良事件、严重不良事件或不良反应的参与者数量和百分比

[Translation]

Describe the number and percentage of participants who experienced one or more adverse events, serious adverse events, or adverse reactions among participants who actually used NucoFy injection and/or enteric-coated tablets in China

Start Date22 May 2023

Sponsor / Collaborator

Organon Heist BV

[+3]

100 Clinical Results associated with Merck Sharp & Dohme BV

0 Patents (Medical) associated with Merck Sharp & Dohme BV

Literatures (Medical) associated with Merck Sharp & Dohme BV

01 Dec 2020·Cost Effectiveness and Resource AllocationQ4 · MEDICINE

Cost-effectiveness analysis of pembrolizumab compared to standard of care as first line treatment for patients with advanced melanoma in Hong Kong

Q4 · MEDICINE

ArticleOA

Author: Leung, Linda K S ; Loong, Herbert H ; Lee, Mary Y K ; Wong, Carlos K H ; Aguiar-Ibáñez, Raquel ; Wang, Jingshu ; Jen, Jason ; Tan, S C

AbstractBackgroundPembrolizumab has been shown to improve overall survival (OS) and progression free survival (PFS) compared to ipilimumab in patients with ipilimumab-naïve advanced melanoma; however, there are no published data on the cost-effectiveness for pembrolizumab compared to standard-of-care treatments currently used in Hong Kong for advanced melanoma.MethodsA partitioned-survival model based on data from a recent randomized phase 3 study (KEYNOTE-006) and meta-analysis was used to derive time in PFS, OS, and post-progression survival for pembrolizumab and chemotherapy, such as dacarbazine (DTIC), temozolomide (TMZ), and the paclitaxel-carboplatin combination (PC). A combination of clinical trial data, published data, results of meta-analysis, and melanoma registry data was used to extrapolate PFS and OS curves. The base-case time horizon for the model was 30 years with costs and health outcomes discounted at a rate of 5% per year. Individual patient level data on utilities and frequencies of adverse events were obtained from the final analysis of KEYNOTE-006 (cut-off date: 3-Dec-15) for pembrolizumab. Cost data included drug acquisition, treatment administration, adverse event management, and clinical management of advanced melanoma. The distribution of patient weight from the Hong Kong population was applied to calculate the drug costs. Analyses were performed from a payer’s perspective. The incremental cost effectiveness ratio (ICER) expressed as cost in US Dollars (USD) per quality-adjusted life years (QALYs) was the main outcome.ResultsIn base-case scenario, the ICER for pembrolizumab as a first-line treatment for advanced melanoma was USD49,232 compared to DTIC, with the ICER values lower than cost-effectiveness threshold in Hong Kong. Results comparing pembrolizumab to TMZ and to PC were similar to that when compared to DTIC. Probability sensitivity analyses showed that 99% of the simulated ICERs were below three times the Gross Domestic Product (GDP) per capita for Hong Kong (currently at $119,274//QALY threshold). In a scenario analysis comparing pembrolizumab with ipilimumab, the estimated ICER was USD8,904.ConclusionsPembrolizumab is cost-effective relative to chemotherapy (DTIC, TMZ and PC), and highly-cost-effective compared to ipilimumab, for the first-line treatment of advanced melanoma in Hong Kong.

01 Jul 2020·Clinical Drug InvestigationQ4 · MEDICINE

An Economic Evaluation of Pembrolizumab Versus Other Adjuvant Treatment Strategies for Resected High-Risk Stage III Melanoma in the USA

Q4 · MEDICINE

Article

Author: Krepler, Clemens ; Gao, Wei ; Jenkins, Madeline ; Wang, Jingshu ; Signorovitch, James ; Bensimon, Arielle G ; Scherrer, Emilie ; Song, Yan ; Zhou, Zheng-Yi ; Aguiar-Ibáñez, Raquel

BACKGROUND AND OBJECTIVEOver the past 5 years, adjuvant treatment options for surgically resected stage III melanoma have expanded with the introduction of several novel immune checkpoint inhibitors and targeted therapies. Pembrolizumab, a programmed cell death protein 1 inhibitor, received US Food and Drug Administration approval in 2019 for resected high-risk stage III melanoma based on significantly longer recurrence-free survival versus placebo. This study evaluated the cost-effectiveness of pembrolizumab versus other adjuvant treatment strategies for resected high-risk stage III melanoma from a US health system perspective.METHODSA Markov cohort-level model with four states (recurrence-free, locoregional recurrence, distant metastases, death) estimated costs and quality-adjusted life-years (QALYs) for pembrolizumab versus routine observation and other adjuvant comparators: ipilimumab in the overall population; and dabrafenib + trametinib in the BRAF-mutation positive (BRAF+) subgroup. Transition probabilities starting from recurrence-free were estimated through parametric multi-state modeling based on phase 3 KEYNOTE-054 (NCT02362594) trial data for pembrolizumab and observation, and network meta-analyses for other comparators. Post-recurrence transitions were modeled based on electronic medical records data and trials in advanced/metastatic melanoma. Utilities were derived using quality-of-life data from KEYNOTE-054 and literature. Costs of treatment, adverse events, disease management, and terminal care were included.RESULTSOver a lifetime, pembrolizumab, ipilimumab, and observation were associated with QALYs of 9.24, 7.09, and 5.95 and total costs of $511,290, $992,721, and $461,422, respectively (2019 US dollars). Pembrolizumab was thus dominant (less costly, more effective) versus ipilimumab, with an incremental cost-effectiveness ratio of $15,155/QALY versus observation. In the BRAF+ subgroup, pembrolizumab dominated dabrafenib + trametinib and observation, decreasing costs by $62,776 and $11,250 and increasing QALYs by 0.93 and 3.10 versus these comparators, respectively. Results were robust in deterministic and probabilistic sensitivity analyses.CONCLUSIONSAs adjuvant treatment for resected stage III melanoma, pembrolizumab was found to be dominant and therefore cost-effective compared with the active comparators ipilimumab and dabrafenib + trametinib. Pembrolizumab increased costs relative to observation in the overall population, with sufficient incremental benefit to be considered cost-effective based on typical willingness-to-pay thresholds.

03 Oct 2019·Journal of Medical EconomicsQ4 · MEDICINE

Cost-effectiveness of pembrolizumab for the adjuvant treatment of resected high-risk stage III melanoma in the United States

Q4 · MEDICINE

Article

Author: Krepler, Clemens ; Bensimon, Arielle G. ; Gao, Wei ; Jenkins, Madeline ; Wang, Jingshu ; Signorovitch, James ; Song, Yan ; Zhou, Zheng-Yi ; Aguiar-Ibáñez, Raquel ; Liu, Frank Xiaoqing

Aims: To evaluate the cost-effectiveness of adjuvant pembrolizumab relative to observation alone following complete resection of high-risk stage III melanoma with lymph node involvement, from a US health system perspective. Materials and methods: A Markov cohort model with four health states (recurrence-free, locoregional recurrence, distant metastases, and death) was developed to estimate costs, life-years, and quality-adjusted life-years (QALYs) associated with pembrolizumab vs observation over a lifetime (46-year) horizon. Using a parametric multi-state modeling approach, transition probabilities starting from recurrence-free were estimated based on patient-level data from KEYNOTE-054 (NCT02362594), a direct head-to-head phase 3 trial. Post-recurrence transition probabilities were informed by real-world retrospective data and clinical trials in advanced melanoma. Health state utilities and adverse event-related disutility were derived from KEYNOTE-054 trial data and published literature. Costs of drug acquisition and administration, adverse events, disease management, and terminal care were estimated in 2018 US dollars. Deterministic and probabilistic sensitivity analyses were conducted to assess robustness. Results: Over a lifetime horizon, adjuvant pembrolizumab and observation were associated with total QALYs of 9.24 and 5.95, total life-years of 10.54 and 7.15, and total costs of $489,820 and $440,431, respectively. The resulting incremental cost-effectiveness ratios (ICERs) for pembrolizumab vs observation were $15,009/QALY and $14,550/life-year. Across the range of input values and assumptions tested in deterministic sensitivity analyses, pembrolizumab ranged from being a dominant strategy to having an ICER of $57,449/QALY vs observation. The ICER was below a willingness-to-pay threshold of $100,000/QALY in 90.2% of probabilistic simulations. Limitations: Long-term extrapolation of outcomes was based on interim results from KEYNOTE-054, with a median follow-up of 15 months. Conclusions: Based on common willingness-to-pay benchmarks, pembrolizumab is highly cost-effective compared with observation alone for the adjuvant treatment of completely resected stage III melanoma in the US.

100 Deals associated with Merck Sharp & Dohme BV

100 Translational Medicine associated with Merck Sharp & Dohme BV

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