即使使用完善的技术评估流程，药品价格和报销决策的基础有时也被认为信息不足，有时可能被认为与价值脱节。关于卫生技术评估机构 (HTAb) 应如何报告其决策的决定因素，文献仍没有定论。本研究评估了西班牙在报销决定时肿瘤学和血液学药物目录价格与结构化价值参数之间的关系。该研究包括所有新的肿瘤血液学产品 (22)，在 2017 年 1 月至 2019 年 12 月期间授权了第一个适应症。西班牙和定价决策发布截至 2022 年 10 月。对于每种产品，测量了 56 个反映结构化多标准决策分析 (MCDA) - 循证决策 (EVIDEM) 框架的上下文和非上下文指标。使用单变量统计分析探讨了价格与 MCDA-EVIDEM 框架之间的关系。与疾病进展之前的治疗相比，如果涉及长期反应，当护理标准包括组合治疗时，观察到固定持续时间治疗的价格较高和较低给药频率的治疗；与其他给药途径相比，口服给药的价格较低。在价格和中位治疗持续时间、对患者自主权的影响、药物的易用性以及专家的建议之间观察到统计学上显着的关联。该研究表明，与护理标准类型相关的指标，参考长期反应者、使用药物的便利性、治疗对患者自主权的影响，以及诸如是否存在先前临床共识等背景指标，是西班牙确定肿瘤药物价格的因素。 MCDA-EVIDEM 方法的实施可能有助于捕捉未包含在立法或综合评估框架（例如欧洲卫生技术评估网络 (EunetHTA) 核心模型）中的其他因素对定价决策的影响。在即将修订的西班牙卫生技术评估、定价和报销程序法规中可能会考虑这一点。版权所有 © 2023 Elvira、Torres、Vives、Puig、Obach、Gay、Varón、de Pando、Taberero 和 Pontes。

Even using well-established technology assessment processes, the basis of the decisions on drug price and reimbursement are sometimes perceived as poorly informed and sometimes may be seen as disconnected from value. The literature remains inconclusive about how Health Technology Assessment Bodies (HTAb) should report the determinants of their decisions. This study evaluates the relationship between oncology and hematology drug list prices and structured value parameters at the time of reimbursement decision in Spain.The study includes all new onco-hematological products (22), with a first indication authorized between January 2017 and December 2019 in Spain and pricing decisions published up until October 2022. For each product, 56 contextual and non-contextual indicators reflecting the structured multiple criteria decision analysis (MCDA) - Evidence-based Decision-Making (EVIDEM) framework were measured. The relationship between prices and the MCDA-EVIDEM framework was explored using univariate statistical analyses.Higher prices were observed when the standard of care included for combinations, if there were references to long-lasting responses, for fixed-duration treatment compared to treatment until progression and treatment with lower frequencies of administration; lower prices were observed for oral administration compared to other routes of administration. Statistically significant associations were observed between prices and the median duration of treatment, the impact on patient autonomy, the ease of use of the drug, and the recommendations of experts.The study suggests that indicators related to the type of standard of care, references to long-lasting responders, the convenience of the use of the drug, and the impact of treatment on patient autonomy, as well as contextual indicators such as the existence of previous clinical consensus, are factors in setting oncology drug prices in Spain. The implementation of MCDA-EVIDEM methodologies may be useful to capture the influence on pricing decisions of additional factors not included in legislation or consolidated assessment frameworks such as the European Network for Health Technology Assessment (EunetHTA) core model. It may be opportune to consider this in the upcoming revision of the Spanish regulation for health technology assessments and pricing and reimbursement procedures.Copyright © 2023 Elvira, Torres, Vives, Puig, Obach, Gay, Varón, de Pando, Tabernero and Pontes.