Garattini Livio, Padula Anna
CESAV, Centre for Health Economics, IRCCS Institute for Pharmacological Research 'Mario Negri', 24020 Ranica, Italy.
J R Soc Med. 2017 Feb;110(2):57-64. doi: 10.1177/0141076816681951. Epub 2017 Jan 13.
Long-term use of statin therapy is essential to obtain clinical benefits, but adherence is often suboptimal and some patients are also reported to fail because of 'statin resistance'. The identification of PCSK9 as a key factor in the LDL clearance pathway has led to the development of new monoclonal antibodies. Here we critically review the economic evaluations published in Europe and focused on statins. We searched the PubMed database to select the studies published from July 2006 to June 2016 and finally selected 19 articles. Overall, the majority of studies were conducted from a third-party payer's viewpoint and recurred to modelling. Most studies were sponsored by industry and funding seemed to play a pivotal role in the study design. Patients resistant to LDL-C level reduction were considered only in a few studies. The place in therapy of the new class of biologic should be considered a kind of 'third line' for cholesterol-lowering, after patients have failed with restricted dietary regimens and then with current drug therapies. Otherwise they could result in hardly sustainable expenses even for developed countries.
长期使用他汀类药物治疗对于获得临床益处至关重要，但依从性往往不理想，而且据报道一些患者因“他汀抵抗”而治疗失败。前蛋白转化酶枯草溶菌素9（PCSK9）被确定为低密度脂蛋白清除途径中的关键因素，这促使了新型单克隆抗体的研发。在此，我们对欧洲发表的聚焦于他汀类药物的经济学评价进行批判性综述。我们检索了PubMed数据库，以选取2006年7月至2016年6月发表的研究，最终选定了19篇文章。总体而言，大多数研究是从第三方支付方的角度进行的，并采用了建模方法。大多数研究由行业赞助，资金似乎在研究设计中起着关键作用。只有少数研究考虑了对低密度脂蛋白胆固醇水平降低有抵抗的患者。在患者采用严格饮食方案失败，继而当前药物治疗也失败后，新型生物制剂在治疗中的地位应被视为降低胆固醇的一种“三线”治疗方法。否则，即使对发达国家而言，它们可能导致难以承受的费用。
