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爱尔兰药品定价和报销的最新进展。

Recent developments in pricing and reimbursement of medicines in Ireland.

机构信息

National Centre for Pharmacoeconomics, St. James's Hospital, Dublin 8, Ireland.

出版信息

Expert Rev Pharmacoecon Outcomes Res. 2007 Dec;7(6):605-11. doi: 10.1586/14737167.7.6.605.

DOI:10.1586/14737167.7.6.605
PMID:20528322
Abstract

In 2006, the drugs bill exceeded euro1.84 billion or approximately 15% of total healthcare expenditure in Ireland. The majority of this expenditure (85%) related to community prescribing. An agreement between the Health Service Executive (HSE) and the Irish Pharmaceutical Healthcare Association (IPHA) on the pricing and supply of medicines to the Irish Health Service came into effect on the 1st September 2006. The new agreement links the price of medicines in Ireland to nine EU states including Belgium, Denmark, France, Germany, The Netherlands, Spain, the UK, Finland and Austria. Following receipt of market authorization a new product will be reimbursed within 60 days of the reimbursement application. However, the HSE reserves the right to assess the cost-effectiveness of new and existing technologies that may be high cost or have a significant budget impact. Where such a review is requested the 60-day rule will not apply. Where a new medicine is subjected to pharmacoeconomic assessment the reimbursement decision will be notified within 90 days of receipt of the reimbursement application. Products will be reimbursed within 40 days of a positive decision. Should reimbursement be refused an appeal may be made to an expert committee whose final decision will be made within a further 90 days. A cost-effectiveness threshold in the region of euro45,000/quality-adjusted life year has been adopted. An important component of the IPHA/HSE agreement is the 35% two-stepped price reduction for off-patent substitutable products. The new Health Information and Quality Authority (HIQA) was established under the Health Act 2007 and will lead the development of Health Technology Assessment (HTA) across the health service.

摘要

2006 年,药品支出超过 18.4 亿欧元,约占爱尔兰医疗总支出的 15%。这部分支出的大部分(85%)与社区处方有关。2006 年 9 月 1 日,爱尔兰卫生服务执行局(HSE)与爱尔兰制药医疗保健协会(IPHA)就向爱尔兰卫生服务机构提供药品的价格和供应达成协议。新协议将爱尔兰药品价格与包括比利时、丹麦、法国、德国、荷兰、西班牙、英国、芬兰和奥地利在内的九个欧盟国家挂钩。收到市场授权后,新产品将在报销申请后 60 天内得到报销。然而,HSE 保留评估可能成本高昂或对预算有重大影响的新技术的成本效益的权利。在这种情况下,将不适用 60 天规则。如果新药物需要进行药物经济学评估,将在收到报销申请后 90 天内通知报销决定。在做出积极决定后的 40 天内,产品将得到报销。如果拒绝报销,可以向专家委员会提出上诉,专家委员会将在另外 90 天内做出最终决定。已采用 45000 欧元/质量调整生命年的成本效益阈值。IPHA/HSE 协议的一个重要组成部分是,对非专利替代产品实施 35%的两步降价。根据 2007 年《卫生法案》成立了新的健康信息和质量管理局(HIQA),并将领导整个卫生服务领域的卫生技术评估(HTA)的发展。

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