Fogacci Federica, Giovannini Marina, Grandi Elisa, Imbalzano Egidio, Degli Esposti Daniela, Borghi Claudio, Cicero Arrigo F G
Hypertension and Atherosclerosis Research Group, Medical and Surgical Sciences Department, Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.
Cardiovascular Medicine Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.
J Clin Med. 2022 Aug 11;11(16):4701. doi: 10.3390/jcm11164701.
Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are effective and safe lipid-lowering treatments (LLT). The primary endpoint of the study was to assess the prevalence of patients eligible for treatment with PCSK9 inhibitors in a real-life clinical setting in Italy before and after the recent enlargement of reimbursement criteria. For this study, we consecutively considered the clinical record forms of 6231 outpatients consecutively admitted at the Lipid Clinic of the University Hospital of Bologna (Italy). Patients were stratified according to whether they were allowed or not allowed to access to treatment with PCSK9 inhibitors based on national prescription criteria and reimbursement rules issued by the Italian Medicines Agency (AIFA). According to the indications of the European Medicines Agency (EMA), 986 patients were candidates to treatment with PCSK9 inhibitors. However, following the prescription criteria issued by AIFA, only 180 patients were allowed to access to PCSK9 inhibitors before reimbursement criteria enlargement while 322 (+14.4%) with the current ones. Based on our observations, low-cost tailored therapeutic interventions for individual patients can significantly reduce the number of patients potentially needing treatment with PCSK9 inhibitors among those who are not allowed to access to the treatment. The application of enlarged reimbursement criteria for PCSK9 inhibitors could mildly improve possibility to adequately manage high-risk hypercholesterolemic subjects in the setting of an outpatient lipid clinic.
前蛋白转化酶枯草溶菌素/kexin 9型（PCSK9）抑制剂是有效且安全的降脂治疗药物。本研究的主要终点是评估在意大利现实临床环境中，近期报销标准扩大前后符合PCSK9抑制剂治疗条件的患者比例。在本研究中，我们连续查看了意大利博洛尼亚大学医院脂质门诊连续收治的6231名门诊患者的临床记录表格。根据意大利药品管理局（AIFA）发布的国家处方标准和报销规定，患者被分为是否允许使用PCSK9抑制剂进行治疗两类。根据欧洲药品管理局（EMA）的指征，986名患者符合PCSK9抑制剂治疗条件。然而，按照AIFA发布的处方标准，在报销标准扩大前只有180名患者被允许使用PCSK9抑制剂，而目前有322名患者（增加了14.4%）。基于我们的观察，针对个体患者的低成本定制化治疗干预措施可显著减少那些不被允许接受治疗的患者中可能需要使用PCSK9抑制剂治疗的人数。扩大PCSK9抑制剂报销标准的应用可能会在一定程度上改善门诊脂质门诊环境中对高危高胆固醇血症患者进行充分管理的可能性。
