School of Public Health, University College Cork, Cork, Ireland.
Pharmacoepidemiol Drug Saf. 2024 Oct;33(10):e70011. doi: 10.1002/pds.70011.
Prior approval for reimbursement is a policy of cost containment while ensuring oversight and governance of medicines. It has been employed in Ireland to address financial challenges due to the shift from warfarin to direct oral anticoagulants (DOACs). Studies assessing the effectiveness of this policy are limited. Thus, we aimed to examine the effectiveness of prior approval for reimbursement of DOACs (apixaban, rivaroxaban) as a cost containment policy in Ireland.
The Irish Health Service Executive-Primary Care Reimbursement Service database was used in this cross-sectional study. We examined the prescribing frequencies and associated costs of the oral anticoagulants; [(OACs) apixaban, rivaroxaban and warfarin] listed in the top 100 most frequently prescribed drugs, between 2018 and 2021. Time series negative binomial regression was used to assess the impact of removing the approval requirement of apixaban in September 2019 followed by the other DOACs in November 2020.
The prescribing frequency of OACs increased by almost 20% from 2018 to 2021. This study showed there were significant differences in the proportion of OACs prescribed among the Community Drug Schemes. A statistically significant decreased use of apixaban (< 1%, p < 0.05) occurred when prior approval was removed for all DOACs.
The removal of prior approval for reimbursement of DOACs in Ireland had a minimal impact on the prescribing frequency trends of the OACs. Future use of these potentially useful policies by healthcare systems requires careful consideration of drug type, approval criteria and length of time the policy remains in place to minimise any negative effects associated with their use.
在确保对药品进行监督和管理的同时，事先报销审批是一种控制成本的政策。爱尔兰采用这一政策是为了应对因华法林向直接口服抗凝剂（DOACs）转变而带来的财务挑战。评估该政策有效性的研究有限。因此，我们旨在研究事先报销 DOACs（阿哌沙班、利伐沙班）审批作为爱尔兰成本控制政策的有效性。
本横断面研究使用了爱尔兰卫生服务署-初级保健报销服务数据库。我们研究了 2018 年至 2021 年期间，在最常开处方的前 100 种药物中，口服抗凝药（OACs）（阿哌沙班、利伐沙班和华法林）的开处方频率和相关费用。使用时间序列负二项回归评估 2019 年 9 月取消阿哌沙班审批要求后，以及 2020 年 11 月其他 DOACs 审批要求后的影响。
OACs 的开处方频率从 2018 年到 2021 年增加了近 20%。本研究表明，社区药物计划中 OACs 的处方比例存在显著差异。当所有 DOACs 的报销审批都被取消时，阿哌沙班的使用显著减少（<1%，p<0.05）。
在爱尔兰，取消 DOACs 的报销事先审批对 OACs 的开处方频率趋势影响不大。医疗保健系统未来使用这些潜在有用的政策时，需要仔细考虑药物类型、审批标准和政策实施时间，以尽量减少其使用带来的任何负面影响。
