欧洲转移性激素敏感前列腺癌、非转移性去势抵抗性前列腺癌和转移性去势抵抗性前列腺癌治疗的HTA和报销状况:患者准入景观回顾

Goran Bencina, Elina Petrova, Demet Sönmez, Sonia Matos Pereira, Ioannis Dimitriadis, Stina Salomonsson
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引用次数: 0

摘要

背景:前列腺癌是男性中第二常见的癌症,多达三分之一的男性在其一生中被诊断出来。最近,新的治疗方法获得了监管部门的批准,在转移性去势抵抗性前列腺癌、转移性激素敏感前列腺癌和非转移性去势抵抗性前列腺癌的总生存率方面有显著提高。为了改进有关抗癌治疗价值的决策,并支持卫生技术评估(HTA)机构使用的标准化评估,欧洲肿瘤医学学会(ESMO)制定了临床获益程度量表(MCBS)。目的:本综述旨在绘制2011-2021年间23个欧洲国家3种晚期前列腺癌适应症的HTA状况、报销限制和患者可及性。方法:回顾了26个欧洲国家的HTA、国家报销清单和ESMO-MCBS记分卡的证据和数据。结果:分析表明,只有在希腊、德国和瑞典,所有前列腺癌治疗都可以完全获得。转移性去势抵抗性前列腺癌的治疗得到了广泛的报销,所有国家都可以获得阿比特龙和恩杂鲁胺。在3个国家(匈牙利、荷兰和瑞士),报销状态和ESMO-MCBS“实质性获益”(得分< 5)与“无实质性获益”(得分<4)之间存在统计学显著差异(P< 05)。结论:总体而言,ESMO-MCBS对欧洲报销决策的影响尚不清楚,在本综述中包括的各国之间存在显著差异。
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HTA and Reimbursement Status of Metastatic Hormone‑Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer, and Metastatic Castration-Resistant Prostate Cancer Treatments in Europe: A Patient Access Landscape Review
Background: Prostate cancer is the second most common cancer in men, with up to one-third of men being diagnosed in their lifetime. Recently, novel therapies have received regulatory approval with significant improvement in overall survival for metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and nonmetastatic castration-resistant prostate cancer. To improve decision-making regarding the value of anticancer therapies and support standardized assessment for use by health technology assessment (HTA) agencies, the European Society for Medical Oncology (ESMO) has developed a Magnitude of Clinical Benefit Scale (MCBS). Objective: This review aimed to map HTA status, reimbursement restrictions, and patient access for 3 advanced prostate cancer indications across 23 European countries during 2011-2021. Methods: HTA, country reimbursement lists, and ESMO-MCBS scorecards were reviewed for evidence and data across 26 European countries. Results: The analysis demonstrated that only in Greece, Germany, and Sweden was there full access across all included prostate cancer treatments. Treatments available for metastatic castration-resistant prostate cancer were widely reimbursed, with both abiraterone and enzalutamide accessible in all countries. In 3 countries (Hungary, the Netherlands, and Switzerland), there was a statistically significant difference (P<.05) between status of reimbursement and ESMO-MCBS “substantial benefit” (score of 4 or 5) vs “no substantial benefit” (score <4). Conclusion: Overall, the impact of the ESMO-MCBS on reimbursement decisions in Europe is unclear, with significant variation across the countries included in this review.
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