欧洲跨境准入机会简化atmp准入的可行性

IF 3.4 3区 医学 Q1 HEALTH POLICY & SERVICES
Luigi Angelillo , Cécile van Steen , Kirsty Ross-Stewart , Justus Dehnen , Walter Colasante
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引用次数: 1

摘要

目的在新的《卫生技术评估条例》(HTA)的背景下,调查几种跨境获取机会的可行性,以简化患者获得高级治疗药品(ATMP)的途径。该法规由欧盟委员会提出,并于2021年12月通过,强烈主张欧洲联合合作,使ATMP等创新、改变生活的疗法更广泛地提供给欧洲患者。ATMP为治疗各种疾病提供了开创性的新机会。然而,在允许接触患者之前,医疗保健系统通常需要在基础设施开发、通过新立法或实施替代报销解决方案方面进行重大调整。这就需要新的跨境准入途径来简化准入,尤其是在非欧盟4国+英国国家。方法进行案头研究,并与监管机构和付款人专家进行60分钟访谈,以评估ATMPs的新获取途径。结果一些途径,如跨国合作(如联合治疗中心)有可能提供长期ATMPs。然而,发现了一些重要的挑战,这些挑战目前阻碍了跨境接入成为常规接入ATM的可行选择,尤其是对中小企业而言。结论通过制造商、付款人和政策制定者之间的公开沟通和合作,克服与当前可用的ATM接入途径相关的挑战,跨境解决方案可能是包括中小企业在内的制造商加快报销患者使用ATM的真正机会。公共利益峰会2021年12月,欧洲层面通过了一项新法规,以促进跨欧洲合作,使创新治疗更广泛地提供给患者。确保患者能够获得创新的、可能改变生活的治疗与许多挑战有关。因此,患者,尤其是居住在欧盟四大国家(也称为欧盟4国:法国、德国、意大利和西班牙)和英国以外的患者,在获得所需的创新治疗方面可能会遇到困难。我们对专家(付款人和监管机构)进行了采访,以评估新的途径,确保(非欧盟4+英国)患者能够更好地获得创新疗法。国家、制造商、支付方和监管机构之间的合作和公开沟通是实现这一目标的可行途径。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Viability of European cross-border access opportunities to streamline access to ATMPs

Objectives

To investigate the viability of several cross-border access opportunities to streamline patient access to advanced therapy medicinal products (ATMPs) in the context of the new Regulation on Health Technology assessment (HTA). The regulation, proposed by the European Commission and adopted in December 2021strongly advocates joint European collaboration to make innovative, life-changing therapies, such as ATMPs, more widely available to patients in Europe. ATMPsoffer ground-breaking new opportunities for the treatment of various diseases. However, healthcare systems are often required to undergo significant adaptation in terms of infrastructure development, adoption of new legislation or implementation of alternative reimbursement solutions before access to patients can be granted. This calls for new cross-border access pathways to streamline access, especially in non-EU4+UK countries.

Methods

Desk research and 60-minute interviews with regulatory and payer experts were conducted to evaluate new access pathways for ATMPs.

Results

Some pathways, such as cross country collaborations (e.g. joint treatment centers) have the potential to provide long-term access to ATMPs. However, several important challenges were identified that currently prevent cross-border access from being viable options for routine access to ATMPs, especially for SMEs.

Conclusions

Through open communication and collaboration between manufacturers, payers and policy makers to overcome challenges associated with currently available access pathways for ATMPs, cross-border solutions could represent real opportunities for manufacturers, including SMEs, to expedite reimbursed patient access to ATMPs.

Public Interest Summary

In December 2021, a new regulation was adopted on a European level to promote cross-European collaboration to make innovative treatments more widely available to patients. Making sure patients have access to innovative, potentially life-changing, treatments is associated with many challenges. As a result, patients, especially those who live outside of the four biggest countries in the European Union (EU), also known as the EU4:  (France, Germany, Italy and Spain) and the UK where the necessary infrastructure is often lacking, can experience difficulty accessing the innovative treatments they need. We conducted interviews with experts (payers and regulators) to evaluate new pathways to make sure (non-EU4 + UK) patients get better access to innovative therapies. Collaboration and open communication between countries, manufacturers, payers and regulators presents a viable way of achieving this.

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来源期刊
Health Policy and Technology
Health Policy and Technology Medicine-Health Policy
CiteScore
9.20
自引率
3.30%
发文量
78
审稿时长
88 days
期刊介绍: Health Policy and Technology (HPT), is the official journal of the Fellowship of Postgraduate Medicine (FPM), a cross-disciplinary journal, which focuses on past, present and future health policy and the role of technology in clinical and non-clinical national and international health environments. HPT provides a further excellent way for the FPM to continue to make important national and international contributions to development of policy and practice within medicine and related disciplines. The aim of HPT is to publish relevant, timely and accessible articles and commentaries to support policy-makers, health professionals, health technology providers, patient groups and academia interested in health policy and technology. Topics covered by HPT will include: - Health technology, including drug discovery, diagnostics, medicines, devices, therapeutic delivery and eHealth systems - Cross-national comparisons on health policy using evidence-based approaches - National studies on health policy to determine the outcomes of technology-driven initiatives - Cross-border eHealth including health tourism - The digital divide in mobility, access and affordability of healthcare - Health technology assessment (HTA) methods and tools for evaluating the effectiveness of clinical and non-clinical health technologies - Health and eHealth indicators and benchmarks (measure/metrics) for understanding the adoption and diffusion of health technologies - Health and eHealth models and frameworks to support policy-makers and other stakeholders in decision-making - Stakeholder engagement with health technologies (clinical and patient/citizen buy-in) - Regulation and health economics
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