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基于价值的定价、研究与开发以及患者准入方案。英国会做对还是做错?

Value based pricing, research and development, and patient access schemes. Will the United Kingdom get it right or wrong?

机构信息

Office of Health Economics, 12 Whitehall, London, UK.

出版信息

Br J Clin Pharmacol. 2010 Sep;70(3):360-6. doi: 10.1111/j.1365-2125.2010.03740.x.

DOI:10.1111/j.1365-2125.2010.03740.x
PMID:20716236
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2949908/
Abstract

The National Health Service (NHS) should reward innovation it values. This will enable the NHS and the United Kingdom (UK) economy to benefit and impact positively on the Research and Development (R&D) decision making of companies. The National Institute for Health and Clinical Excellence (NICE) currently seeks to do this on behalf of the NHS. Yet the Office of Fair Trading proposals for Value Based Pricing add price setting powers--initially for the Department of Health (DH) and then for NICE. This introduces an additional substantial uncertainty that will impact on R&D and, conditional on R&D proceeding, on launch (or not) in the UK. Instead of adding to uncertainty the institutional arrangements for assessing value should seek to be predictable and science based, building on NICE's current arrangements. The real challenge is to increase understanding of the underlying cost-effectiveness of the technology itself by collecting evidence alongside use. The 2009 Pharmaceutical Price Regulation Scheme sought to help do this with Flexible Pricing (FP) and Patient Access Schemes (PASs). The PASs to date have increased access to medicines, but no schemes proposed to date have yet helped to tackle outcomes uncertainty. The 2010 Innovation Pass can also be seen as a form of 'coverage with evidence development.' The NHS is understandably concerned about the costs of running such evidence collection schemes. Enabling the NHS to deliver on such schemes will impact favourably on R&D decisions. Increasing the uncertainty in the UK NHS market through government price setting will reduce incentives for R&D and for early UK launch.

摘要

英国国民医疗服务体系(NHS)应该奖励其重视的创新。这将使 NHS 和英国(UK)经济受益,并对公司的研发(R&D)决策产生积极影响。国家卫生与临床优化研究所(NICE)目前代表 NHS 进行此项工作。然而,公平贸易办公室(Office of Fair Trading)提出的基于价值的定价提案增加了定价权力——最初是为卫生部(DH),然后是为 NICE。这引入了一个额外的重大不确定性,将对 R&D 产生影响,并在 R&D 进行的情况下,对英国的推出(或不推出)产生影响。评估价值的制度安排不应增加不确定性,而应寻求具有可预测性和科学性,在此基础上建立 NICE 当前的安排。真正的挑战是通过在使用的同时收集证据,增加对技术本身潜在成本效益的理解。2009 年药品价格监管计划(Pharmaceutical Price Regulation Scheme)试图通过灵活定价(Flexible Pricing,FP)和患者准入计划(Patient Access Schemes,PAS)来帮助实现这一目标。迄今为止,PAS 增加了药品的可及性,但迄今为止,没有任何计划有助于解决结果的不确定性。2010 年的创新通行证(Innovation Pass)也可以被视为一种“证据开发覆盖”。NHS 对运行此类证据收集计划的成本感到担忧是可以理解的。使 NHS 能够实施这些计划将对 R&D 决策产生有利影响。通过政府定价增加英国 NHS 市场的不确定性将降低 R&D 和早期在英国推出的激励。

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