关键词: Access to treatment Availability Drug and Therapeutics Committee Drug reimbursement Formulary Health technology assessment Hospital Innovative National Orphan Patient access Unmet need

Mesh : Belgium Hospitals Humans Pharmacy and Therapeutics Committee Research Design Retrospective Studies

来  源:   DOI:10.1007/s11096-022-01384-w

Abstract:
Background New therapies that do not reach patients in need, have not achieved their goal. Drug and Therapeutics Committees in hospitals ensure access to patients by compiling a formulary on rational grounds. An evolving landscape of innovative molecules challenges timely formulary adaptation after national reimbursement. Aim To integrate national reimbursement reports in the hospital\'s appraisal, thereby promoting access for patients without delay. Method For 2019, the rationale for new molecules at Ghent University Hospital, Belgium, was compared with the public assessment report of the National Institute for Health and Disability Insurance, assessing a medicine in a specific indication following a reimbursement request by the manufacturer. Decision criteria (therapeutic value and cost) between matching medicines in both databases (national & hospital) were retrospectively compared [no (%), mean (SD)]. Results Two-hundred public reports and 30 formulary decisions were analysed (with antineoplastic & immunomodulating as most prevalent class: 41.0% resp. 36.7%). National decision often concerned hospital-only medicines (89; 44.5%) without patient co-payment (101; 50.5%). Of 13 matched medicines (same indication), time delay between national decision and formulary admission was on average 3.1 (SD 2.3) months. Comparative analysis showed that assessment in both committees was mostly based on the efficacy endpoints of Randomised Controlled Trials. Literature used in hospital appraisals was of more recent publication date: + 0.78 (SD 2.2) years. Using public reports as a horizon scan could enable quick identification of new indications. Conclusion To speed up patient access, the scientific evidence of national reimbursement reports can be used for the purpose of hospital formulary decisions.
摘要:
背景:新的治疗方法不适合需要的患者,没有实现他们的目标。医院的药物和治疗委员会通过合理的理由编制处方来确保与患者接触。不断发展的创新分子景观挑战了国家报销后及时的配方适应。目的将国家报销报告整合到医院的评估中,从而促进患者毫不拖延地进入。方法2019年,根特大学医院新分子的基本原理,比利时,与国家健康和残疾保险研究所的公共评估报告进行了比较,在制造商提出报销要求后,评估特定适应症的药物。回顾性比较两个数据库(国家和医院)中匹配药物之间的决策标准(治疗价值和成本)[无(%),平均值(SD)]。结果分析了200份公开报告和30份处方决定(抗肿瘤和免疫调节是最普遍的类别:41.0%。36.7%)。国家决定通常涉及仅在医院使用的药物(89;44.5%),而没有患者自付费用(101;50.5%)。在13种匹配的药物(相同的适应症)中,国家决定和处方组入院之间的时间延迟平均为3.1个月(SD2.3).比较分析表明,两个委员会的评估主要基于随机对照试验的疗效终点。医院评估中使用的文献最近发表日期:0.78(SD2.2)年。使用公共报告作为地平线扫描可以快速识别新的适应症。结论为了加快患者进入,国家报销报告的科学证据可用于医院处方集决策。
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