在瘤学药物中的后续指示:途径,时间表和通货膨胀减缓法案
Julie A Patterson1, James Motyka2, Rayan Salih2
1National Pharmaceutical Council, 1717 Pennsylvania AVE NW Ste 800, Washington, DC, 20006, USA. jpatterson@npcnow.org.
Therapeutic innovation & regulatory science
|October 5, 2024
概括
减少通货膨胀的法律.
科学领域:
- 瘤学 药物开发 药物开发
- 卫生经济学和研究成果研究成果
- 监管科学 监管科学
背景情况:
- 人们担心通货膨胀减缓法案 (IRA) 的药物价格谈判计划 (DPNP) 可能会降低制造商对批准后研究的激励.
- 瘤药物开发严重依赖于多种迹象,以扩大患者的治疗选择.
- 了解药物开发时间表对于评估政策变化对癌症治疗的影响至关重要.
研究的目的:
- 分析2008年至2018年间批准的瘤药物后续指示的多样化开发途径和时间表.
- 描述药物开发步伐 (快速到测量) 以及它与随后的指示批准的关系.
- 探索IRA的DPNP对瘤学研发的潜在意外后果.
主要方法:
- 一项对56种癌症药物的横截面研究,至少有一种随后获得FDA批准.
- 收集关于批准后标志的数量,类型和时间的数据.
- 药物根据批准后开发的速度被分为四分之一.
主要成果:
- 评估的瘤药物中有65.1%获得了针对新癌症类型,治疗线,组合,突变或阶段的后续指示.
- 批准之间的中位时间因开发速度而有很大差异,从0.6年 (快速) 到4.9年 (测量).
- 25%的药物在DPNP资格时间表之后获得了最新的后续指示批准.
结论:
- 批准后的指示对于扩大瘤学治疗选择至关重要.
- 不同质的药物开发时间表凸显了IRA的DPNP对研发激励的潜在影响.
- 需要进一步的研究才能充分了解政策变化对癌症药物创新的长期影响.
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