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健康经济学与结果研究在产品生命周期中的重要性。

Importance of Health Economics and Outcomes Research in the Product Lifecycle.

作者信息

Dang Amit

机构信息

Founder and CEO, MarksMan Healthcare Communications, J1309, Amethyst Tower, PBEL City, Peeramcheruvu Village, Rajendra Nagar Mandal, Hyderabad, Telangana, 500091, India.

出版信息

Pharmaceut Med. 2025 Apr 14. doi: 10.1007/s40290-025-00564-z.

Abstract

Health economics and outcomes research (HEOR) has become an integral part of healthcare systems, through its ability to authentically demonstrate the value of the product. HEOR provides healthcare stakeholders with important insights to make informed decisions regarding healthcare delivery. This review aims to highlight the pivotal role of HEOR across the product lifecycle and the value of integrating HEOR activities during the various phases of drug development. Pharmaceutical companies are increasingly realizing that the integration of HEOR activities from early phases of product development through product launch, also during the postmarketing phase, to generate real-world evidence (RWE) can be crucial for their product's continued commercial success. HEOR helps validate the value of a pharmaceutical product, enabling its success in distinct regulatory and health technology assessment (HTA) landscapes across varied geographies. Regardless of several challenges in data collection and analysis, technological advancements facilitate opportunities to improve the value of HEOR. With rising demands for robust clinical evidence by global regulators and economic evidence by HTA agencies and payers, HEOR will become even more crucial in establishing long-lasting value of a pharmaceutical product for all stakeholders, including regulators, patients, prescribers, and payers.

摘要

卫生经济学与结果研究(HEOR)已成为医疗保健系统不可或缺的一部分,因为它能够切实证明产品的价值。HEOR为医疗保健利益相关者提供重要见解,以便他们在医疗保健服务提供方面做出明智决策。本综述旨在强调HEOR在产品生命周期中的关键作用,以及在药物开发各个阶段整合HEOR活动的价值。制药公司越来越意识到,从产品开发的早期阶段到产品上市,甚至在上市后阶段整合HEOR活动以生成真实世界证据(RWE),对其产品的持续商业成功至关重要。HEOR有助于验证药品的价值,使其在不同地区的不同监管和卫生技术评估(HTA)环境中取得成功。尽管在数据收集和分析方面存在一些挑战,但技术进步为提高HEOR的价值提供了机会。随着全球监管机构对有力临床证据以及HTA机构和支付方对经济证据的需求不断增加,HEOR在为包括监管机构、患者、开处方者和支付方在内的所有利益相关者确立药品的持久价值方面将变得更加关键。

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