Creativ-Ceutical, ul. Przemysłowa 12, 30-701, Krakow, Poland.
Alimera Sciences Ophthalmologie GmbH, Cicerostraße 21, Handelsregister Amtsgericht Berlin, (Charlottenburg) HRB 165580 B, 10709, Berlin, Germany.
BMC Health Serv Res. 2019 Jan 9;19(1):22. doi: 10.1186/s12913-018-3804-4.
Diabetic macular oedema (DMO) may lead to visual loss and blindness. Several pharmacological treatments are available on the National Health Service (NHS) to United Kingdom patients affected by this condition, including intravitreal vascular endothelial growth factor inhibitors (anti-VEGFs) and two types of intravitreal steroid implants, releasing dexamethasone or fluocinolone acetonide (FAc). This study aimed to assess the value for money (cost-effectiveness) of the FAc 0.2 μg/day implant (ILUVIEN®) in patients with chronic DMO considered insufficiently responsive to other therapies.
We developed a Markov model with a 15-year time horizon to estimate the impact of changes in best-corrected visual acuity in DMO patients on costs and quality-adjusted life years. The model considered both eyes, designated as the "study eye", defined at model entry as phakic with an ongoing cataract formation or pseudophakic, and the "fellow eye". The model compared the FAc 0.2 μg/day implant with a 700 μg dexamethasone implant (pseudophakic patients only) or with usual care, defined as a mixture of laser photocoagulation and anti-VEGFs (phakic and pseudophakic patients). Costs were estimated from the perspective of the NHS and Personal Social Services; full NHS prices were used for drugs.
In patients who were pseudophakic at baseline, at 36 months, the FAc implant provided an additional gain of 4.01 and 3.64 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with usual care and the dexamethasone implant, respectively. Over the 15-year time horizon, this translated into 0.185 additional quality-adjusted life years (QALYs) at an extra cost of £3066 compared with usual care, and 0.126 additional QALYs at an extra cost of £1777 compared with dexamethasone. Thus, incremental cost-effectiveness ratios (ICERs) were £16,609 and £14,070 per QALY gained vs. usual care and dexamethasone, respectively. In patients who were phakic at baseline, the FAc 0.2 μg/day implant provided an additional gain of 2.96 ETDRS letters at 36 months compared with usual care, which, over 15 years, corresponded to 0.11 additional QALYs at an extra cost of £3170, resulting in an ICER of £28,751 per QALY gained.
The FAc 0.2 μg/day implant provided good value for money compared with other established treatments, especially in pseudophakic patients.
糖尿病性黄斑水肿（DMO）可导致视力丧失和失明。英国国民保健制度（NHS）为受此疾病影响的患者提供了几种药理学治疗方法，包括玻璃体内血管内皮生长因子抑制剂（抗-VEGF）和两种类型的玻璃体内类固醇植入物，释放地塞米松或氟轻松醋酸酯（FAc）。本研究旨在评估慢性 DMO 患者对其他疗法反应不足时，每天 0.2μgFAc（ILUVIEN®）植入物的性价比（成本效益）。
我们开发了一个具有 15 年时间范围的 Markov 模型，以估计 DMO 患者最佳矫正视力变化对成本和质量调整生命年的影响。该模型考虑了双眼，指定为“研究眼”，在模型进入时定义为正在进行白内障形成或假性白内障的有晶状体眼，或“对侧眼”。该模型将每天 0.2μgFAc 植入物与 700μg 地塞米松植入物（仅适用于假性白内障患者）或与通常的护理（定义为激光光凝和抗-VEGF 的混合）进行比较。成本是从英国国民保健制度和个人社会服务的角度估算的；药物全部采用英国国民保健制度全额价格。
在基线时为假性白内障的患者中，在 36 个月时，FAc 植入物与常规治疗和地塞米松植入物相比，分别提供了 4.01 和 3.64 个早期糖尿病视网膜病变研究（ETDRS）字母的额外增益。在 15 年的时间范围内，与常规治疗相比，这相当于额外获得 0.185 个质量调整生命年（QALY），额外成本为 3066 英镑，与地塞米松相比，额外获得 0.126 个 QALY，额外成本为 1777 英镑。因此，增量成本效益比（ICER）分别为与常规治疗和地塞米松相比，每获得一个 QALY 的额外成本为 16609 英镑和 14070 英镑。在基线时为有晶状体眼的患者中，FAc 0.2μg/天植入物在 36 个月时与常规治疗相比提供了 2.96 个 ETDRS 字母的额外增益，在 15 年内，相当于额外获得 0.11 个 QALY，额外成本为 3170 英镑，ICER 为每获得一个 QALY 的额外成本为 28751 英镑。
与其他已确立的治疗方法相比，FAc 0.2μg/天植入物具有良好的性价比，尤其是在假性白内障患者中。
