Leah Z. Rand, D.Phil., is a post-doctoral fellow in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital and a research fellow at Harvard Medical School. Aaron S. Kesselheim, M.D., J.D., M.P.H., is Professor of Medicine at Harvard Medical School, a faculty member of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital, the Director of the Program on Regulation, Therapeutics, and Law (PORTAL), and a primary care physician. He is the Editor-in-Chief of the Journal of Law, Medicine & Ethics.
J Law Med Ethics. 2020 Sep;48(3):583-594. doi: 10.1177/1073110520958885.
In many countries, health technology assessment (HTA) organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries' methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in (1) the methodologies HTA organizations use to conduct their evaluations and (2) considerations they use when making recommendations. We found important differences in the methods, interpretations of HTA findings, and condition-specific carve-outs that HTA organizations use to conduct evaluations and make recommendations. These variations have ethical implications because they influence the recommendations of HTA organizations, which affect access to the drug through national insurance and price negotiations with manufacturers. The differences in HTA approaches result from the distinct political, social, and cultural contexts of each organization and its value judgments. New cost-containment policies in the US should consider the ethical implications of the HTA reviews that they are considering relying on to negotiate drug prices and what values should be included in US pricing policy.
在许多国家，卫生技术评估（HTA）机构确定新药的经济价值，并就国家卫生系统中适当的定价和覆盖范围提出建议。在美国，最近旨在降低药品成本的政策提案将把药品价格与六个国家挂钩：澳大利亚、加拿大、法国、德国、日本和英国。我们审查了这些国家的 HTA 方法和关于价格和覆盖范围建议的指南，分析了方法和指南文件在以下方面的差异：（1）HTA 组织用于进行评估的方法；（2）在提出建议时使用的考虑因素。我们发现 HTA 组织在方法、HTA 结果的解释以及特定条件的细分方面存在重要差异，这些组织用于进行评估和提出建议。这些差异具有伦理意义，因为它们会影响 HTA 组织的建议，而这些建议会影响通过国家保险获得药物的机会和与制造商进行的价格谈判。HTA 方法的差异源于每个组织及其价值判断的独特政治、社会和文化背景。美国的新成本控制政策应考虑到他们正在考虑依赖进行药品价格谈判的 HTA 审查的伦理影响，以及应包括哪些价值观纳入美国定价政策。
