第一类药物的起源:创新与临床益处对比
Leeza Osipenko1,2, Philippe Potey3, Bernardo Perez1,4
1Department of Health Policy, LSE, London, UK.
Clinical pharmacology and therapeutics
|November 20, 2023
概括
第一类 (FIC) 药物虽然具有创新性,但往往缺乏经过证明的临床益处. 进入法国市场的FIC药物中,超过一半没有为患者提供任何额外的益处,尽管它们代表着科学进步.
科学领域:
- 药物经济学 药物经济学
- 药物开发 药物开发
- 卫生政策 卫生政策
背景情况:
- 第一类 (FIC) 标志着新药开发,但对实际的临床实用性提供了有限的洞察力.
- 对医疗保健系统来说,在营销许可时评估FIC药物的实际临床益处至关重要.
研究的目的:
- 调查2008年至2018年期间在法国市场上销售的FIC药物的来源和临床益处.
- 为了比较HAS和Prescrire分配的临床益处分级.
主要方法:
- 对法国批准的135种FIC药物 (2008-2018) 的回顾性分析.
- 药物来源 (工业,学术界,合资企业) 和治疗领域的分类.
- 将药物与来自HAS和Prescrire的临床益处评估相匹配.
主要成果:
- 大多数FIC药物 (71.1%) 来自工业. 抗瘤,抗感染和代谢剂是最常见的治疗领域.
- 在临床益处分级方面,HAS和Prescrire表现出中度一致 (60.74%).
- 很大一部分FIC药物被评估为没有或仅有一些临床益处 (例如,45.9%的HAS没有益处;68.2%的处方没有益处).
- 只有3%至5%的FIC药物被认为具有实质性的附加益处.
结论:
- FIC药物主要来源于工业发展,而不是学术研究.
- 超过50%的评估FIC药物没有为患者提供可证明的临床益处,这表明科学创新和治疗价值之间存在差距.
- 这些发现强调了需要严格评估临床效用与药物开发中的新性.
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