Anothaisintawee Thunyarat, Leelahavarong Pattara, Ratanapakorn Tanapat, Teerawattananon Yot
Health Intervention and Technology Assessment Program, Ministry of Public Health, Nonthaburi, Thailand ; Family Medicine Department and Section of Clinical Epidemiology and Biostatistics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Clinicoecon Outcomes Res. 2012;4:361-74. doi: 10.2147/CEOR.S37458. Epub 2012 Dec 6.
There is increasing impetus to use pharmaceutical interventions, ie, ranibizumab or bevacizumab, for the treatment of particular macular diseases. This paper describes the evidence and decision-making of the National List of Essential Medicines Committee that recently announced the inclusion of bevacizumab for the treatment of macular diseases in its pharmaceutical benefit package. The findings of a systematic review and meta-analysis in this paper indicate that the intravitreal administration of bevacizumab is superior to nonpharmaceutical treatments for age-related macular degeneration (AMD) and diabetic macular edema (DME), but inconclusive for retinal vein occlusion, given the limited evidence. The study also failed to distinguish among the differences in terms of visual acuity improvement, reduction of central macular thickness, and response to treatment between AMD and DME patients treated with bevacizumab and those treated with ranibizumab. Although bevacizumab was not licensed for AMD and DME, the committee decided to include bevacizumab in the National List of Essential Medicines. It is expected that many patients who are in need of treatment but who are unable to afford the expensive alternative drug, ranibizumab, will be able to receive this effective treatment instead and be prevented from suffering irreversible loss of vision. At the same time, this policy will help generate evidence about the real-life effectiveness and safety profiles of the drug for future policy development in Thailand and other settings.
使用药物干预措施,即雷珠单抗或贝伐单抗,来治疗特定黄斑疾病的推动力日益增大。本文描述了国家基本药物委员会的证据和决策过程,该委员会最近宣布将贝伐单抗纳入其药物福利包中用于治疗黄斑疾病。本文的一项系统评价和荟萃分析结果表明,玻璃体内注射贝伐单抗治疗年龄相关性黄斑变性(AMD)和糖尿病性黄斑水肿(DME)优于非药物治疗,但鉴于证据有限,对于视网膜静脉阻塞的疗效尚无定论。该研究也未能区分接受贝伐单抗治疗的AMD和DME患者与接受雷珠单抗治疗的患者在视力改善、中心黄斑厚度降低以及治疗反应方面的差异。尽管贝伐单抗未被批准用于AMD和DME,但委员会决定将其纳入国家基本药物清单。预计许多需要治疗但无力承担昂贵替代药物雷珠单抗的患者将能够接受这种有效治疗,从而避免不可逆转的视力丧失。同时,该政策将有助于为泰国及其他地区未来的政策制定提供有关该药物实际有效性和安全性的证据。