Godman Brian, Petzold Max, Bennett Kathleen, Bennie Marion, Bucsics Anna, Finlayson Alexander E, Martin Andrew, Persson Marie, Piessnegger Jutta, Raschi Emanuel, Simoens Steven, Zara Corinne, Barbui Corrado
Department of Laboratory Medicine, Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital Huddinge, SE-141 86 Stockholm, Sweden.
BMC Med. 2014 Jun 13;12:98. doi: 10.1186/1741-7015-12-98.
Generic atypical antipsychotic drugs offer health authorities opportunities for considerable savings. However, schizophrenia and bipolar disorders are complex diseases that require tailored treatments. Consequently, generally there have been limited demand-side measures by health authorities to encourage the preferential prescribing of generics. This is unlike the situation with hypertension, hypercholaesterolaemia or acid-related stomach disorders.The objectives of this study were to compare the effect of the limited demand-side measures in Western European countries and regions on the subsequent prescribing of risperidone following generics; to utilise the findings to provide future guidance to health authorities; and where possible, to investigate the utilisation of generic versus originator risperidone and the prices for generic risperidone.
Principally, this was a segmented regression analysis of retrospective time-series data of the effect of the various initiatives in Belgium, Ireland, Scotland and Sweden following the introduction of generic risperidone. The study included patients prescribed at least one atypical antipsychotic drug up to 20 months before and up to 20 months after generic risperidone. In addition, retrospective observational studies were carried out in Austria and Spain (Catalonia) from 2005 to 2011 as well as one English primary care organisation (Bury Primary Care Trust (PCT)).
There was a consistent steady reduction in risperidone as a percentage of total selected atypical antipsychotic utilisation following generics. A similar pattern was seen in Austria and Spain, with stable utilisation in one English PCT. However, there was considerable variation in the utilisation of generic risperidone, ranging from 98% of total risperidone in Scotland to only 14% in Ireland. Similarly, the price of generic risperidone varied considerably. In Scotland, generic risperidone was only 16% of pre-patent loss prices versus 72% in Ireland.
Consistent findings of no increased prescribing of risperidone post generics with limited specific demand-side measures suggests no 'spillover' effect from one class to another encouraging the preferential prescribing of generic atypical antipsychotic drugs. This is exacerbated by the complexity of the disease area and differences in the side-effects between treatments. There appeared to be no clinical issues with generic risperidone, and prices inversely reflected measures to enhance their utilisation.
非专利的非典型抗精神病药物为卫生当局提供了大幅节省开支的机会。然而，精神分裂症和双相情感障碍是复杂的疾病，需要量身定制的治疗方案。因此，卫生当局在需求方采取的鼓励优先开处非专利药物的措施通常有限。这与高血压、高胆固醇血症或胃酸相关胃部疾病的情况不同。本研究的目的是比较西欧国家和地区有限的需求方措施对非专利利培酮后续处方的影响；利用研究结果为卫生当局提供未来指导；并在可能的情况下，调查非专利利培酮与原研利培酮的使用情况以及非专利利培酮的价格。
主要是对比利时、爱尔兰、苏格兰和瑞典在引入非专利利培酮后各项举措效果的回顾性时间序列数据进行分段回归分析。该研究纳入了在非专利利培酮引入前20个月及引入后20个月内至少开具过一种非典型抗精神病药物的患者。此外，2005年至2011年在奥地利和西班牙（加泰罗尼亚）以及一个英国初级医疗保健机构（伯里初级医疗保健信托基金（PCT））开展了回顾性观察研究。
非专利利培酮在所选非典型抗精神病药物总使用量中的占比持续稳定下降。在奥地利和西班牙也观察到类似模式，在一个英国初级医疗保健机构中使用情况稳定。然而，非专利利培酮的使用情况存在很大差异，从苏格兰非专利利培酮占利培酮总量的98%到爱尔兰仅占14%。同样，非专利利培酮的价格差异也很大。在苏格兰，非专利利培酮仅为专利期损失前价格的16%，而在爱尔兰为72%。
有限的特定需求方措施下，非专利利培酮处方量未增加的一致研究结果表明，不存在一类药物对另一类药物的“溢出”效应以鼓励优先开处非专利非典型抗精神病药物。疾病领域的复杂性以及不同治疗方法副作用的差异加剧了这种情况。非专利利培酮似乎不存在临床问题，价格与提高其使用率的措施呈反比。
