Division of General Internal Medicine, Center for Research on Healthcare, Department of Medicine, UPMC/University of Pittsburgh, Pittsburgh, PA, United States.
Division of General Internal Medicine, Center for Research on Healthcare, Department of Medicine, UPMC/University of Pittsburgh, Pittsburgh, PA, United States; Center for Pharmaceutical Policy and Prescribing, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States; Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States.
Int J Drug Policy. 2024 Apr;126:104381. doi: 10.1016/j.drugpo.2024.104381. Epub 2024 Mar 8.
Until the end of 2022, a special registration, known as the X-waiver, was required to prescribe buprenorphine in the US. Before its removal, US federal regulations trialed an X-waiver exemption, initiated on April 28, 2021, which permitted buprenorphine prescribing for up to 30 patients without additional training. We aimed to understand if these regulatory changes impacted buprenorphine dispensing.
We conducted an interrupted time series analysis to understand changes in buprenorphine dispensing during the 26 weeks after the X-waiver exemption compared to the expected baseline trend established in the 26 weeks before using the IQVIA Longitudinal Prescription claims database. The primary outcome was number of new buprenorphine prescribers nationwide (defined as no prior buprenorphine prescription dispensed in the last 26 weeks). Segmented regression estimated relative changes in buprenorphine dispensing at 1, 13, and 26 weeks post-X-waiver change.
A total of 15,517,525 prescriptions filled for 1,328,172 patients (43.4 % female) ordered by 62,312 providers were included for analysis. At 26 weeks post-X-waiver change, there was no change in the number of new prescribers compared to the expected baseline trend (-2.7 % [95 % CI:-8.3,2.9]). The number of new (15.2 % [4.6,25.8]) and existing (1.7 % [0.9,2.4]) patients and patients per prescriber (4.3 % [3,5.6]) increased. Buprenorphine prescriptions reimbursed by Medicaid increased (7.5 % [6.6,8.4]) while commercial fills decreased (-3.4 % [-5.3,-1.5]).
The number of new prescribers did not increase six months post-X-waiver exemption while new patients continued to enter treatment at higher-than-expected rates. These findings suggest that additional interventions beyond the recent X-waiver removal may be needed to increase access to buprenorphine.
截至 2022 年底，美国需要特殊注册，即 X 豁免，才能开具丁丙诺啡。在取消之前，美国联邦法规于 2021 年 4 月 28 日试行 X 豁免豁免，允许在没有额外培训的情况下为多达 30 名患者开具丁丙诺啡处方。我们旨在了解这些监管变化是否影响丁丙诺啡的配药。
我们进行了一项中断时间序列分析，以了解 X 豁免豁免后 26 周内丁丙诺啡配药的变化情况，与使用 IQVIA 纵向处方索赔数据库在 26 周前建立的预期基线趋势相比。主要结果是全国范围内新丁丙诺啡处方医生的数量（定义为过去 26 周内没有开出丁丙诺啡处方）。分段回归估计 X 豁免变更后 1、13 和 26 周时丁丙诺啡配药的相对变化。
共纳入 15517525 份处方，涉及 1328172 名患者（43.4%为女性），由 62312 名提供者开出，用于分析。X 豁免变更后 26 周，新处方医生数量与预期基线趋势相比没有变化（-2.7%[-8.3,2.9]）。新（15.2%[4.6,25.8]）和现有（1.7%[0.9,2.4]）患者和每位处方医生的患者人数增加（4.3%[3,5.6]）。医疗补助报销的丁丙诺啡处方增加（7.5%[6.6,8.4]），而商业配药减少（-3.4%[-5.3,-1.5]）。
X 豁免豁免后 6 个月内，新处方医生数量并未增加，而新患者继续以高于预期的速度进入治疗。这些发现表明，可能需要除最近的 X 豁免取消之外的其他干预措施来增加丁丙诺啡的可及性。
