Hutton David W, Stein Joshua D, Bressler Neil M, Jampol Lee M, Browning David, Glassman Adam R
Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor2Department of Industrial and Operations Engineering, University of Michigan College of Engineering, Ann Arbor3Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor.
Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor3Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor4Department of Ophthalmology and Visual Sciences, University of Michigan Medical School, Ann Arbor.
JAMA Ophthalmol. 2017 Jun 1;135(6):576-584. doi: 10.1001/jamaophthalmol.2017.0837.
The Diabetic Retinopathy Clinical Research Network Protocol S randomized clinical trial results suggest that ranibizumab is a reasonable treatment alternative to panretinal photocoagulation (PRP) when managing proliferative diabetic retinopathy (PDR), with or without concomitant baseline diabetic macular edema (DME). However, ranibizumab injections are costly. Thus, it would be useful to examine the relative cost-effectiveness of these 2 treatment modalities.
To evaluate incremental cost-effectiveness ratios of 0.5-mg ranibizumab therapy vs PRP for PDR.
DESIGN, SETTING, AND PARTICIPANTS: Preplanned secondary analysis using efficacy, safety, and resource utilization data through 2 years of follow-up at 55 US sites for 213 adults with PDR. Data were collected from February 2012 to January 2015.
Intravitreous 0.5-mg ranibizumab at baseline and as frequently as every 4 weeks based on a structured retreatment protocol or PRP at baseline for PDR. Eyes in both groups could receive ranibizumab for concomitant DME.
Incremental cost-effectiveness ratios of ranibizumab compared with PRP evaluated within 2 prespecified subgroups for the study eye: with baseline vision-impairing (Snellen equivalent 20/32 or worse) DME and without baseline vision-impairing DME.
The study included 305 adults with PDR, the mean age was 52 years, 44% were women, and 52% were white. Of the 46 participants with PDR and vision-impairing DME at baseline, 21 were assigned to the ranibizumab group and 25 to the PRP group (plus ranibizumab for DME). Among the remaining participants without baseline vision-impairing DME, 80 and 87 were in the ranibizumab and PRP groups, respectively. For participants with and without baseline vision-impairing DME, the incremental cost-effectiveness ratios of ranibizumab therapy compared with PRP were $55 568/quality-adjusted life-year and $662 978/quality-adjusted life-year, respectively, over 2 years.
Over 2 years, compared with PRP, 0.5-mg ranibizumab as given in this trial is within the $50 000/quality-adjusted life-year to $150 000/quality-adjusted life-year range frequently cited as cost-effective in the United States for eyes presenting with PDR and vision-impairing DME, but not for those with PDR without vision-impairing DME.
Clinicaltrials.gov Identifier: NCT01489189.
糖尿病视网膜病变临床研究网络方案S随机临床试验结果表明,在治疗增殖性糖尿病视网膜病变(PDR)时,无论是否伴有基线糖尿病性黄斑水肿(DME),雷珠单抗都是全视网膜光凝(PRP)的合理替代治疗方法。然而,雷珠单抗注射费用高昂。因此,研究这两种治疗方式的相对成本效益将很有帮助。
评估0.5毫克雷珠单抗治疗PDR相对于PRP的增量成本效益比。
设计、地点和参与者:使用美国55个地点213例PDR成年患者2年随访的疗效、安全性和资源利用数据进行预先计划的二次分析。数据收集时间为2012年2月至2015年1月。
基线时玻璃体注射0.5毫克雷珠单抗,并根据结构化再治疗方案每4周注射一次,或PDR患者基线时接受PRP治疗。两组患者的眼睛均可接受雷珠单抗治疗伴发的DME。
在研究眼的2个预先指定亚组中评估雷珠单抗与PRP相比的增量成本效益比:伴有基线视力损害(Snellen等效视力20/32或更差)DME和不伴有基线视力损害DME。
该研究纳入305例PDR成年患者,平均年龄52岁,44%为女性,52%为白人。在46例基线时患有PDR和视力损害DME的参与者中,21例被分配到雷珠单抗组,25例被分配到PRP组(DME患者加用雷珠单抗)。在其余无基线视力损害DME的参与者中,雷珠单抗组和PRP组分别有80例和87例。对于有和无基线视力损害DME的参与者,雷珠单抗治疗与PRP相比,2年内的增量成本效益比分别为55568美元/质量调整生命年和662978美元/质量调整生命年。
在2年时间里,与PRP相比,本试验中使用的0.5毫克雷珠单抗对于伴有PDR和视力损害DME的眼睛,其成本效益在每质量调整生命年50000美元至150000美元的范围内,这一范围在美国通常被认为具有成本效益,但对于无视力损害DME的PDR患者则不然。
Clinicaltrials.gov标识符:NCT01489189。