Early access to medicines with added therapeutic value: Measuring and comparing time to medicines access in England, France, Germany, Italy and Spain

IF 3.6 3区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Health Policy Pub Date : 2025-04-28 DOI:10.1016/j.healthpol.2025.105317

Sophie Delcroix-Lopes , Nadia Amer , Christophe Chaignot , Charlotte Pelletan

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Abstract

The scientific breakthroughs over the past few decades have opened up new therapeutic possibilities, transforming the treatment of critical illnesses like cancer and rare diseases. However, delayed access to these innovations can lead to a loss of valuable life years for patients.

The annual European medicines access times Monitor, launched by the French Statutory Health Insurance (CNAM) with the support of the French National Authority for Health (HAS), analysed time to patient access across five countries between 2017 and 2023 (England, France, Germany, Italy and Spain) for a sample of 50 molecules that demonstrate therapeutic improvement.

The results underscore the crucial role of Early Access Schemes-EAS in accelerating patient access to medicines. These schemes are particularly prevalent in countries where national reimbursement is contingent on Health Technology Assessment-HTA assessments and price negotiations—notably France, Italy, and Spain.

These findings indicate that early access schemes, rather than being restricted to compassionate use for patients with no alternative treatment options, can also serve as a strategy to expedite access to essential therapies, particularly cancer drugs, prior to their formal reimbursement.

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早期获得具有附加治疗价值的药物：衡量和比较英国、法国、德国、意大利和西班牙的药物获取时间

过去几十年的科学突破开辟了新的治疗可能性，改变了癌症和罕见疾病等重症的治疗方法。然而，延迟获得这些创新可能导致患者损失宝贵的生命年。由法国法定健康保险公司（CNAM）在法国国家卫生管理局（HAS）的支持下推出的年度欧洲药物获取时间监测报告，分析了2017年至2023年五个国家（英国、法国、德国、意大利和西班牙）患者获得50种分子样本的时间，这些分子显示出治疗效果的改善。这些结果强调了早期获取计划在加速患者获得药物方面的关键作用。这些方案在国家报销取决于卫生技术评估（hta评估和价格谈判）的国家尤其普遍，尤其是法国、意大利和西班牙。这些发现表明，早期获得计划，而不是仅限于对没有其他治疗方案的患者进行同情使用，也可以作为一种战略，在正式报销之前加快获得基本疗法，特别是癌症药物。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Health Policy 医学-卫生保健

CiteScore

6.40

自引率

6.10%

发文量

157

审稿时长

3-8 weeks

期刊介绍： Health Policy is intended to be a vehicle for the exploration and discussion of health policy and health system issues and is aimed in particular at enhancing communication between health policy and system researchers, legislators, decision-makers and professionals concerned with developing, implementing, and analysing health policy, health systems and health care reforms, primarily in high-income countries outside the U.S.A.