Department of Pharmacy,Hospital Universitario Virgen
Omakase Consulting S. L.
Int J Technol Assess Health Care. 2018 Jan;34(5):519-526. doi: 10.1017/S0266462318000569. Epub 2018 Oct 23.
The aim of this study was to develop and to assess a specific Multi-Criteria Decision Analysis (MCDA) framework to evaluate new drugs in an hospital pharmacy and therapeutics committee (P&TC) setting.
A pilot criteria framework was developed based on the EVIDEM (Evidence and Value: Impact on DEcisionMaking) framework, together with other relevant criteria, and assessed by a group of P&TC's members. The weighting of included criteria was done using a 5-point weighting technique. Two drugs were chosen by evaluation: an orphan-drug for Gaucher disease, and a nonorphan drug for the treatment of inflammatory bowel disease. Evidence matrices were developed, and value contribution of each drug was evaluated by P&TC's members. An agreed final framework was obtained through a discussion between the P&TC's members.
After criteria assessment, the pilot framework included eight quantitative criteria: "disease severity," "unmet needs," "comparative efficacy/effectiveness," "comparative safety/tolerability," "comparative patient-reported outcomes," "comparative cost consequences-cost of treatment," "comparative cost consequences-other medical costs," and "quality of evidence"; and one contextual criterion: "opportunity costs and affordability." The most valued criteria were: "comparative safety/tolerability," "disease severity," and "comparative efficacy/effectiveness." When assessing the drugs most valued characteristics of the MCDA were the possibility that all team may contribute to drug assessment by means of scoring the matrices and the discussion to reach a consensus in drug positioning and value decision making.
The reflective MCDA would integrate quantitative and qualitative criteria relevant for a P&TC setting, allowing reflective discussions based on the criteria weighting score.
本研究旨在开发并评估一种特定的多准则决策分析(MCDA)框架,以便在医院药剂和治疗学委员会(P&TC)中评估新药。
基于 EVIDEM(证据和价值:对决策的影响)框架,以及其他相关标准,开发了一个试点标准框架,并由一组 P&TC 成员进行评估。所包括标准的权重采用 5 分权重技术进行。通过评估选择了两种药物:一种用于戈谢病的孤儿药,一种用于治疗炎症性肠病的非孤儿药。为每种药物制定了证据矩阵,并由 P&TC 成员评估其价值贡献。通过 P&TC 成员之间的讨论获得了达成一致的最终框架。
在标准评估后,试点框架包括八项定量标准:“疾病严重程度”、“未满足的需求”、“比较疗效/效果”、“比较安全性/耐受性”、“比较患者报告的结果”、“比较成本后果-治疗成本”、“比较成本后果-其他医疗成本”和“证据质量”;以及一个背景标准:“机会成本和负担能力”。最有价值的标准是:“比较安全性/耐受性”、“疾病严重程度”和“比较疗效/效果”。在评估药物时,MCDA 最有价值的特征是所有团队都可以通过评分矩阵和讨论为药物评估做出贡献,从而达成药物定位和价值决策的共识。
反思性 MCDA 将整合与 P&TC 环境相关的定量和定性标准,允许基于标准权重评分进行反思性讨论。