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临床试验/NCT05848219
NCT05848219终止不适用

Healthcare Resource Utilization and Costs in Metastatic Melanoma Patients Initiated Dabrafenib + Trametinib and Encorafenib + Binimetinib

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 543 人开始时间: 2021年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
543
试验地点
1
主要终点
All-cause healthcare costs among patients treated with dab/tram versus enco/bini

研究概览

简要总结

This was a retrospective cohort study using the MarketScan health care administrative claim databases: Truven Health Analytics' MarketScan Commercial Claims and Encounters; MarketScan Medicare Supplement and Coordination of Benefit. We conducted this analysis using the most recent available data from the MarketScan database at the time of analysis, which was 01 June 2018 to 31 December 2020. We initiated this analysis from 01 June 2018 as encorafenib + binimetinib (enco/bini) was approved for patients with unresectable or metastatic melanoma with BRAF mutation at this time.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least one diagnosis of malignant melanoma (The International Classification of Diseases, 9th Revision [ICD-9] codes: 172.0-172.9 or V10.82; ICD-10 codes: C43.0 C43.10 C43.20 C43.30 C43.31 C43.39 C43.4 C43.59 C43.60 C43.70 C43.8 C43.9 D03.0 D03.10 D03.11 D03.12 D03.20 D03.21 D03.22 D03.30 D03.39 D03.4 D03.51 D03.52 D03.59 D03.60 D03.61 D03.62 D03.70 D03.71 D03.72 D03.8 D03.9 Z85.820) in the study period.
  • A diagnosis of metastasis (ICD-9 196.x, 197.x, 198.x, 199.x & ICD-10 C77.xx, ICD-10 C78.xx, ICD-10 C79.xx, ICD-10 C80.xx) within 30 days before or 60 days after their malignant melanoma diagnosis.
  • A prescription (pharmacy or medical claim) of enco/bini or dab/tram as a 1L therapy after the metastatic melanoma diagnosis date.
  • At least ≥18 years as of the index date.
  • At least 6 months of continuous enrollment before index date and 6 months after index date.

排除标准

  • Patients with a diagnosis of other primary malignancy (ICD-9: 140.xx-165.xx, 170.xx-171.xx, 173.xx-195.xx, 200.xx-208.xx; ICD-10: C00.x - C14.x, C41.x, C49.x, C50, C51) during the 6 months pre-index period.
  • Patients with pregnancy (ICD-9: 630.xx-679.xx, V22.xx-V24.xx, V27.xx-V28.xx; ICD-10: O00 - O99) any time during the study period.
  • Patients with more than one melanoma-related drug prescription other than the index drug, on the index date.

结局指标

主要结局

All-cause healthcare costs among patients treated with dab/tram versus enco/bini

时间窗: Up to 2.5 years

All-cause healthcare resource utilization (HCRU) among patients treated with dab/tram versus enco/bini

时间窗: Up to 2.5 years

Melanoma-specific HCRU among patients treated with dab/tram versus enco/bini

时间窗: Up to 2.5 years

Melanoma-specific healthcare costs among patients treated with dab/tram versus enco/bini

时间窗: Up to 2.5 years

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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