Division of Clinical Pharmacology, Karolinska University Hospital Huddinge Stockholm, Sweden ; Mario Negri Institute for Pharmacological Research Milan, Italy ; Prescribing Research Group, University of Liverpool Management School Liverpool, UK.
Front Pharmacol. 2013 Jan 7;3:198. doi: 10.3389/fphar.2012.00198. eCollection 2012.
Scrutiny over pharmaceutical expenditure is increasing leading to multiple reforms. This includes Austria with measures to lower generic prices and enhance their utilization. However the situation for newer antidepressants and atypical antipsychotic medicines (AAPs) is different to PPIs, statins, and renin-angiotensin inhibitor drugs with greater tailoring of therapy and no wish to switch products in stable patients. Authorities welcome generics though given the high costs particularly of single-sourced AAPs.
Assess (a) changes in utilization of venlafaxine versus other newer antidepressants before and after availability of generics, (b) utilization of generic versus originator venlafaxine, (c) price reductions of venlafaxine over time and their influence on total expenditure, (d) utilization of risperidone versus other AAPs, (e) suggest potential additional reforms that could be introduced if pertinent to further enhance the use of generics.
A quasi-experimental study design with a segmented time series and an observational study. Utilization measured in defined daily doses (DDDs) and total expenditure per DDD and over time.
No appreciable changes in the utilization of venlafaxine and risperidone after generics. The reduction in expenditure/DDD for venlafaxine decreased overall expenditure on newer antidepressants by 5% by the end of the study versus just before generics despite a 37% increase in utilization. Expenditure will further decrease if reduced prescribing of duloxetine.
Depression, schizophrenia, and bipolar diseases are complex diseases. As a result, specific measures are needed to encourage the prescribing of generic risperidone and venlafaxine when multiple choices are appropriate. Authorities cannot rely on a "Hawthorne" effect between classes to enhance the use of generics. Measures may include prescribing restrictions for duloxetine. No specific measures planned for AAPs with more multiple-sourced AAPs becoming available.
对药品支出的审查日益加强,导致了多项改革。奥地利也采取了降低仿制药价格和提高其利用率的措施。然而,与质子泵抑制剂 (PPIs)、他汀类药物和肾素-血管紧张素抑制剂药物不同,新型抗抑郁药和非典型抗精神病药物 (AAPs) 的情况有所不同,对于稳定患者,治疗方案更具针对性,且不希望更换产品。尽管当局对 AAPs 的高成本,特别是单一来源的 AAPs 持欢迎态度,但还是接受了仿制药。
评估 (a) 在仿制药可用之前和之后,文拉法辛与其他新型抗抑郁药的使用率变化,(b) 仿制药与文拉法辛原研药的使用率,(c) 文拉法辛的价格随时间的降低及其对总支出的影响,(d) 利培酮与其他 AAPs 的使用率,(e) 提出如果相关,可能会引入的进一步增强仿制药使用的潜在改革措施。
采用准实验研究设计,分段时间序列和观察性研究。利用限定日剂量 (DDD) 和随时间变化的每个 DDD 的总支出来衡量使用率。
仿制药可用后,文拉法辛和利培酮的使用率没有明显变化。尽管文拉法辛的使用率增加了 37%,但由于文拉法辛的每个 DDD 支出/DDD 减少,到研究结束时,新型抗抑郁药的总支出减少了 5%,而在仿制药上市之前则减少了 5%。如果减少度洛西汀的处方量,支出将进一步减少。
抑郁症、精神分裂症和双相情感障碍等疾病较为复杂。因此,需要采取具体措施来鼓励在有多种选择时开处方使用仿制药利培酮和文拉法辛。当局不能依赖于不同药物类别之间的“霍桑效应”来提高仿制药的使用率。措施可能包括对度洛西汀进行处方限制。对于有更多多源 AAPs 上市的 AAPs,没有具体的措施计划。