Health and Economic Outcomes of Pembrolizumab in the Treatment of Metastatic Non-small Cell Lung Cancer (mNSCLC) and Melanoma in Italy.

IF 2.9 3区 医学 Q2 PHARMACOLOGY & PHARMACY Clinical Drug Investigation Pub Date : 2024-08-01 Epub Date: 2024-08-08 DOI:10.1007/s40261-024-01366-y
Martina Paoletti, Chiara Bini, Andrea Marcellusi, Francesco Saverio Mennini
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Abstract

Background and objective: In Italy, the management of metastatic non-small cell lung cancer and melanoma leads to significant healthcare challenges, necessitating cost-effective treatment strategies and offering valuable insights for healthcare policymakers and stakeholders. This study was designed to assess the costs, quality-adjusted life-years (QALYs) and disability-adjusted life-years (DALYs) associated with the health and economic outcomes of (1) pembrolizumab-combined chemotherapy administered as a first-line treatment for metastatic non-squamous and squamous non-small cell lung cancer (NSCLC) where the tumour presents with a programmed death-ligand 1 expression level < 50% and of (2) adjuvant pembrolizumab treatment for stage III melanoma.

Methods: Three cost-effectiveness models developed by MSD were investigated for each treatment indication. A unique model was built to assess the overall effect of pembrolizumab versus chemotherapy or watchful waiting in patients with lung cancer or melanoma, respectively. Theoretical cohorts of patients with metastatic squamous and non-squamous NSCLC were followed over time using a partitioned survival model with weekly cycles. A weekly cycle Markov model was employed for melanoma. The analysis was conducted from the Italian National Health Service perspective, considering a time horizon of 40 years (lifetime). A single closed cohort of treatable patients was followed over time for each indication (4000, 7000 and 900 for NSCLC squamous, non-squamous and melanoma, respectively). The costs evaluated included those for adverse drug events, non-drug disease management, subsequent treatment and terminal care. Drug acquisition and administration costs were excluded.

Results: For each treatment indication assessed, pembrolizumab produced downstream direct cost offsets (- €122,498,568, - €133,369,076 and - €32,993,242 for NSCLC squamous, non-squamous and melanoma indications, respectively), increased quality of life (+2088, +5317 and +2307 QALYs for NSCLC squamous, non-squamous and melanoma indications, respectively) and reduced disability (- 2658, - 7202 and - 3029 DALYs for NSCLC squamous, non-squamous and melanoma indications, respectively). Across indications, the total cost offsets of pembrolizumab were - €288,860,885, with 9712 QALYs gained and 12,889 DALYs avoided.

Conclusions: The analysis demonstrated that, compared with chemotherapy, pembrolizumab is more cost effective in Italy as a first-line treatment in patients with metastatic squamous or non-squamous NSCLC and, if compared with watchful waiting, as adjuvant treatment in patients with stage III melanoma. The present analysis suggested that pembrolizumab use could lead to important health benefits for patients while offsetting a portion of cancer care costs.

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意大利 Pembrolizumab 治疗转移性非小细胞肺癌 (mNSCLC) 和黑色素瘤的健康和经济效益。
背景和目的:在意大利,转移性非小细胞肺癌和黑色素瘤的治疗带来了巨大的医疗挑战,需要采取具有成本效益的治疗策略,并为医疗决策者和利益相关者提供有价值的见解。本研究旨在评估与以下健康和经济结果相关的成本、质量调整生命年(QALYs)和残疾调整生命年(DALYs):(1)pembrolizumab-联合化疗作为转移性非鳞状和鳞状非小细胞肺癌(NSCLC)的一线治疗,肿瘤出现程序性死亡配体 1 表达水平 方法:针对每种治疗适应症,研究了 MSD 开发的三种成本效益模型。在肺癌或黑色素瘤患者中,分别建立了一个独特的模型来评估pembrolizumab与化疗或观察等待的总体效果。使用周周期分区生存模型对转移性鳞状和非鳞状 NSCLC 患者的理论队列进行长期随访。黑色素瘤采用的是周周期马尔可夫模型。分析从意大利国家医疗服务的角度进行,考虑的时间跨度为 40 年(终生)。针对每种适应症(NSCLC 鳞癌、非鳞癌和黑色素瘤分别为 4000 人、7000 人和 900 人),对可治疗患者的单一封闭队列进行了长期跟踪。评估的成本包括药物不良事件、非药物疾病管理、后续治疗和临终关怀的成本。不包括药物采购和管理成本:结果:在评估的每个治疗适应症中,pembrolizumab都产生了下游直接成本抵消(NSCLC鳞癌、非鳞癌和黑色素瘤适应症分别为-122,498,568欧元、-133,369,076欧元和-32,993,242欧元),提高了生活质量(+2088、+5317和+2307)、在 NSCLC 鳞癌、非鳞癌和黑色素瘤适应症中分别为+2088、+5317 和+2307 QALYs),残疾程度降低(在 NSCLC 鳞癌、非鳞癌和黑色素瘤适应症中分别为-2658、-7202 和-3029 DALYs)。在所有适应症中,pembrolizumab的总成本抵消为-288,860,885欧元,获得9712 QALYs,避免12,889 DALYs:分析表明,在意大利,与化疗相比,pembrolizumab 作为转移性鳞状或非鳞状 NSCLC 患者的一线治疗更具成本效益,如果与观察等待相比,作为 III 期黑色素瘤患者的辅助治疗也更具成本效益。本分析表明,使用 pembrolizumab 可以为患者带来重要的健康益处,同时抵消部分癌症治疗费用。
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来源期刊
CiteScore
5.90
自引率
3.10%
发文量
108
审稿时长
6-12 weeks
期刊介绍: Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.
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