Policies and availability of orphan medicines in outpatient care in 24 European countries
Policies and availability of orphan medicines in outpatient care in 24 European countries
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DOI：
10.1007/s00228-018-2457-x
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发表时间：
2018-07-01
影响因子：
2.9
通讯作者：
Timonen, Johanna
中科院分区：
文献类型：
--
作者：
Sarnola, Kati;Ahonen, Riitta;Timonen, Johanna
评估孤儿药的具体定价和报销政策，以及最近授权的十种适合门诊护理的孤儿药和欧洲集中营销授权的药品的可用性和分销环境，以及患者是否免费获得这些产品，还是必须自己支付部分或全部费用。2016年4月，对药品定价和报销信息（PPRI）网络中的当局和第三方付款人代表进行了网络调查。在24个国家中的大多数国家，评估中没有实施特殊政策孤儿药的报销状况（22 个国家）或定价（20 个国家）。每个国家最近授权的十种产品中平均有五种可用于门诊治疗。产品由八个国家的社区药房和五个国家的医疗保健单位分发。在四个国家中，使用了两种分发设置。当社区药房配发产品时，患者通常会自己支付部分费用。医疗机构发放的产品通常免费提供给患者。大多数欧洲国家尚未实施针对孤儿药的定价和报销政策。孤儿产品的可用性因国家而异。讨论是否应将孤儿药视为报销法规中的一个单独组以确保患者获得这些药物非常重要。
To assess pricing and reimbursement policies specific to orphan medicines and the availability and distribution settings of ten recently authorised medicinal products suitable for outpatient care with orphan status and centralised marketing authorisation in Europe, and whether patients receive these products free of charge or have to pay some or all of the costs themselves.Web survey to authorities and representatives of third party payers in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network in April 2016.In most of the 24 countries, special policies were not implemented in the assessment of reimbursement status (22 countries) or in the pricing (20 countries) of orphan medicines. An average of five of the ten recently authorised products per country were available for outpatient care. Products were dispensed from community pharmacies in eight countries and from health care units in five countries. In four countries, both distribution settings were used. When products were dispensed from community pharmacies, patients typically paid some of the price themselves. Products dispensed from health care units were often free of charge for patients.Most European countries had not implemented pricing and reimbursement policies specific to orphan medicines. The availability of orphan products varied between countries. It is important to discuss whether orphan medicines should be considered as a separate group in the reimbursement regulations in order to secure patient access to these medicines.