Hammerman Ariel, Lipschitz Yoel, Pliskin Joseph, Greenberg Dan
Department of Health Systems Management, Ben-Gurion University of the Negev, Beer Sheba.
Harefuah. 2011 Feb;150(2):163-7, 204.
Off-label use of drugs is common in all areas of medicine, but is specifically prevalent in pediatrics, oncology and in treating rare diseases. Such use may benefit patients, but on the other hand, there is concern about the safety aspects of these treatments. Besides the legal, ethical and safety issues associated with off-label use, arises the issue of whether such prescribing should be reimbursed by public funds. According to Ministry of Health (MoH) guidelines, the committee in charge of updating the National List of Health Services (NLHS) did not discuss, from its inception and until its deliberations at the end of 2008, off-label indications. This policy was to protect the Israeli pharmaceutical registration mechanism, prevent registration bypass mechanisms and not grant use of public funds for reimbursing treatments for which there were insufficient evidence on safety and efficacy. The patients most affected by this policy were the ones that could not benefit from a drug that was not in the NLHS for their medical condition and had to pay for it out of pocket. Occasionally, health plans agreed to subsidize critically needed off-label treatments, although they did not receive public funding for off-label indications. In this article we review the problems associated with off-label prescribing, the reasons why the MoH changed its policy at the beginning of 2009 to permit, in very special circumstances, reimbursement of off-label treatment. We also provide a brief summary of off-label policies in a few western countries.
药物的非标签使用在医学的各个领域都很常见，但在儿科、肿瘤学和罕见病治疗中尤为普遍。这种使用可能使患者受益，但另一方面，人们也担心这些治疗的安全性。除了与非标签使用相关的法律、伦理和安全问题外，还出现了这种处方是否应由公共资金报销的问题。根据卫生部的指导方针，负责更新《国家卫生服务清单》（NLHS）的委员会从成立之初到2008年底进行审议期间，都没有讨论非标签适应症。这项政策是为了保护以色列的药品注册机制，防止注册绕过机制，并且不批准使用公共资金报销那些在安全性和有效性方面证据不足的治疗。受这项政策影响最大的患者是那些因病情而无法从不在NLHS中的药物中受益，并且不得不自掏腰包支付费用的患者。偶尔，健康计划会同意补贴急需的非标签治疗，尽管它们没有获得非标签适应症的公共资金。在本文中，我们回顾了与非标签处方相关的问题，卫生部在2009年初改变政策以在非常特殊的情况下允许报销非标签治疗的原因。我们还简要总结了一些西方国家的非标签政策。
