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Abstract：
BACKGROUND: To evaluate the impact of reimbursement criteria change on the utilization pattern of anti-vascular endothelial growth factor (anti-VEGF) among patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) separately in Taiwan.
METHODS: An interrupted time series analysis (ITSA) was performed using Taiwan\'s National Health Insurance (NHI) database, and patients with wAMD or DME diagnosis at the first injection of anti-VEGF agents was identified from 2011 to 2019. The outcome of interest was treatment gaps between injections of anti-VEGF. This outcome was retrieved quarterly, and the study period was divided into three phases in wAMD (two criteria changed in August 2014 [intervention] and December 2016 [intervention]) and two phases in DME (three consecutive criteria changed in 2016 [intervention]). Segmented regression models adjusted for autocorrelation were used to estimate the change in level and the change in slope of the treatment gaps between each anti-VEGF injection.
RESULTS: The treatment gaps between each anti-VEGF injection decreased from 2011 to 2019. The cancellation of the annual three needles limitation was associated with significantly shortened treatment gaps between the third and fourth needles (wAMD change in level: -228 days [95% CI -282, -173], DME change in level: -110 days [95% CI -141, -79]). The treatment gap between the fifth and sixth needles revealed a similar pattern but without significant change in DME patients. Other treatment gaps revealed considerable change in slopes in accordance with criteria changes.
CONCLUSIONS: This is the first nationwide study using ITSA to demonstrate the impact of reimbursement policy on treatment gaps between each anti-VEGF injection. After canceling the annual limitation, we found that the treatment gaps significantly decreased among wAMD and DME patients. The shortened treatment gaps might further link to better visual outcomes according to previous studies. The different impacts from criteria changes can assist future policy shaping. Future studies were warranted to explore whether such changes are associated with the benefits of visual effects.
METHODS: An interrupted time series analysis (ITSA) was performed using Taiwan\'s National Health Insurance (NHI) database, and patients with wAMD or DME diagnosis at the first injection of anti-VEGF agents was identified from 2011 to 2019. The outcome of interest was treatment gaps between injections of anti-VEGF. This outcome was retrieved quarterly, and the study period was divided into three phases in wAMD (two criteria changed in August 2014 [intervention] and December 2016 [intervention]) and two phases in DME (three consecutive criteria changed in 2016 [intervention]). Segmented regression models adjusted for autocorrelation were used to estimate the change in level and the change in slope of the treatment gaps between each anti-VEGF injection.
RESULTS: The treatment gaps between each anti-VEGF injection decreased from 2011 to 2019. The cancellation of the annual three needles limitation was associated with significantly shortened treatment gaps between the third and fourth needles (wAMD change in level: -228 days [95% CI -282, -173], DME change in level: -110 days [95% CI -141, -79]). The treatment gap between the fifth and sixth needles revealed a similar pattern but without significant change in DME patients. Other treatment gaps revealed considerable change in slopes in accordance with criteria changes.
CONCLUSIONS: This is the first nationwide study using ITSA to demonstrate the impact of reimbursement policy on treatment gaps between each anti-VEGF injection. After canceling the annual limitation, we found that the treatment gaps significantly decreased among wAMD and DME patients. The shortened treatment gaps might further link to better visual outcomes according to previous studies. The different impacts from criteria changes can assist future policy shaping. Future studies were warranted to explore whether such changes are associated with the benefits of visual effects.
摘要：
背景：评估在台湾分别患有湿性年龄相关性黄斑变性（wAMD）和糖尿病性黄斑水肿（DME）的患者中，报销标准的变化对抗血管内皮生长因子（anti-VEGF）使用模式的影响。
方法：使用台湾国民健康保险（NHI）数据库进行了中断时间序列分析（ITSA），2011年至2019年首次注射抗VEGF药物时诊断为wAMD或DME的患者。感兴趣的结果是注射抗VEGF之间的治疗间隙。这个结果是每季度检索一次，研究期间分为wAMD三个阶段(2014年8月[干预]和2016年12月[干预]两个标准更改)和DME两个阶段(2016年连续三个标准更改[干预]).使用自相关调整的分段回归模型来估计每次抗VEGF注射之间的治疗间隙的水平变化和斜率变化。
结果：从2011年到2019年，每种抗VEGF注射之间的治疗差距有所减少。取消年度三针限制与第三针和第四针之间的治疗间隙显着缩短有关（wAMD水平变化：-228天[95％CI-282，-173]，DME水平变化：-110天[95%CI-141，-79])。在DME患者中，第五针和第六针之间的治疗间隙显示出相似的模式，但没有显着变化。其他治疗差距显示，根据标准变化，斜率发生了相当大的变化。
结论：这是首次使用ITSA进行的全国性研究，以证明报销政策对每种抗VEGF注射液之间治疗差距的影响。取消年度限制后，我们发现,wAMD和DME患者的治疗差距显著缩小.根据先前的研究，缩短的治疗差距可能进一步与更好的视觉结果联系在一起。标准变化的不同影响可以帮助未来的政策制定。未来的研究有必要探索这种变化是否与视觉效果的好处有关。
方法：使用台湾国民健康保险（NHI）数据库进行了中断时间序列分析（ITSA），2011年至2019年首次注射抗VEGF药物时诊断为wAMD或DME的患者。感兴趣的结果是注射抗VEGF之间的治疗间隙。这个结果是每季度检索一次，研究期间分为wAMD三个阶段(2014年8月[干预]和2016年12月[干预]两个标准更改)和DME两个阶段(2016年连续三个标准更改[干预]).使用自相关调整的分段回归模型来估计每次抗VEGF注射之间的治疗间隙的水平变化和斜率变化。
结果：从2011年到2019年，每种抗VEGF注射之间的治疗差距有所减少。取消年度三针限制与第三针和第四针之间的治疗间隙显着缩短有关（wAMD水平变化：-228天[95％CI-282，-173]，DME水平变化：-110天[95%CI-141，-79])。在DME患者中，第五针和第六针之间的治疗间隙显示出相似的模式，但没有显着变化。其他治疗差距显示，根据标准变化，斜率发生了相当大的变化。
结论：这是首次使用ITSA进行的全国性研究，以证明报销政策对每种抗VEGF注射液之间治疗差距的影响。取消年度限制后，我们发现,wAMD和DME患者的治疗差距显著缩小.根据先前的研究，缩短的治疗差距可能进一步与更好的视觉结果联系在一起。标准变化的不同影响可以帮助未来的政策制定。未来的研究有必要探索这种变化是否与视觉效果的好处有关。
