生物仿制药的地方政策:是否旨在优化释放资源的利用?

Pub Date : 2020-12-15 DOI:10.5639/GABIJ.2020.0904.027
A. Bertolani, C. Jommi
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引用次数: 6

摘要

研究目的:已经实施了不同的政策来提高生物仿制药的吸收。关于侧重于需求侧的政策,文献主要集中于国家或地区政策制定者发布的互换性和可替代性建议。关于医疗保健组织(HCOs)针对处方行为采取的行动的信息有限。此外,没有证据表明地方当局是否实施了旨在适当重新分配通过专利到期获得的资源的政策框架。本文旨在填补这些空白,调查在意大利国家卫生服务的地方一级实施的生物仿制药政策。材料和方法:通过结构化的、有效的问卷收集数据,对所有199家公立hco进行在线管理。结果:意大利21个地区中的16个地区的76个组织完成了调查,89%的hco实施了生物仿制药的信息/教育举措。分别在62%和75%的hco中引入了生物仿制药与原研药、非专利分子与专利内分子的处方靶点。达到目标的处方者大多通过金钱激励来奖励。75%的hco对生物仿制药进行了系统的影响评估。然而,由于预算限制和如何获得更便宜的药物可以提供帮助,只有21%的hco发现患者治疗不足。此外,根据25%的受访者,他们的HCO参与了生物仿制药的研究,但受访者没有提供这些研究的任何证据。讨论和结论:该研究表明意大利hco对非专利生物制剂处方行为的行动具有高度的主动性。然而,似乎仍然缺乏旨在适当重新分配通过专利到期获得的资源的结构化行动。
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Local policies on biosimilars: are they designed to optimize use of liberated resources?
Study Objectives: Different policies have been implemented to enhance uptake of biosimilars. Regarding policies focussing on the demand-side, the literature has mainly concentrated on interchangeability and substitutability recommendations, issued by national or regional policymakers. Information on actions taken by healthcare organisations (HCOs) regarding prescribing behaviour is limited. Furthermore, there is no evidence on whether local authorities implemented a policy framework aimed to appropriately reallocate resources gained through patent expiration. This paper aims to fill these gaps, investigating policies on biosimilars implemented at the local level in the Italian National Health Service. Materials and Methods: Data were retrieved through a structured, validated questionnaire, administered online to all 199 public HCOs. Results: Seventy-six organizations in 16 of 21 Italian regions completed the survey, 89% of HCOs implemented information/educational initiatives on biosimilars. Prescription targets on biosimilars versus originators and off-patent versus in-patent molecules were introduced in 62% and 75% of HCOs, respectively. Prescribers reaching targets are mostly rewarded through monetary incentives. 75% of HCOs performed systematic impact evaluation of biosimilars. However, only 21% of HCOs detect patient under-treatment due to budget constraints and how availability of cheaper drugs could help. Furthermore, according to 25% of respondents, their HCO is involved in studies on biosimilars, but respondents did not provide any evidence of these studies. Discussion and conclusions: The study shows a high level of proactivity by Italian HCOs regarding actions on prescribing behaviour for off-patent biologicals. However, it seems that structured actions aimed at appropriately reallocating resources gained through patent expiration are still lacking.
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