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Access to anticancer drugs: Many evidence-based treatments are off-label and unfunded by the Pharmaceutical Benefits Scheme

机译:获得抗癌药物:许多循证治疗均已脱离标签,并且没有药品福利计划的资助

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Background: The off-label use of a drug refers to a use outside the terms of its approval by the Therapeutic Goods Administration (TGA). It is also possible to prescribe unlicensed drugs under the TGA's special access scheme. A high rate of off-label prescribing has previously been reported in cancer. Our study aimed to document the disparity between evidence-based clinical guidelines for anticancer therapy, product approval and funding status of these agents within an academic tertiary/quaternary cancer centre. Methods: All chemotherapy protocols approved for use in our specialist oncology centre were assessed to determine if the drugs were off-label or unlicensed for that indication based on review of their current product information. The Pharmaceutical Benefits Scheme (PBS) funding status for each protocol was subsequently assessed. Results: A total of 448 protocols containing 82 different drugs across 15 tumour groups was identified. Overall, 189 (42.2%) of protocols were off-label, and three (0.7%) were unlicensed. This resulted in all 192 protocols being unfunded by the PBS. Of the 189 off-label protocols, 132 (69.9%) were based on established evidence-based treatment guidelines, and a further 39 (20.6%) was based on phase II or III clinical trial data. Conclusion: Over 90% of off-label protocols are supported by established treatment guidelines or published peer-reviewed research even though the medications are not approved for that particular use by the TGA. However, these off-label protocols are unfunded by the PBS; this results in a marked inequality of access to appropriate medications for cancer patients across Australia.
机译:背景:药物的标签外使用是指超出治疗药物管理局(TGA)批准的使用条款。根据TGA的特殊获取计划,也可以开出无牌药品。先前已经报道了在癌症中高比例的处方外处方。我们的研究旨在证明在第三级/第四级癌症研究中心中抗癌治疗的循证临床指南,产品批准以及这些药物的资金状况之间的差异。方法:根据对当前产品信息的审查,评估了所有批准在我们的专科肿瘤中心使用的化疗方案,以确定该药物是超标药物还是无牌药物。随后评估了每种方案的药品福利计划(PBS)资金状况。结果:共鉴定出448个方案,其中包含15个肿瘤组中的82种不同药物。总体而言,有189个协议(占42.2%)是不合规的,三个(0.7%)是未经许可的。这导致PBS没有资助所有192个方案。在189种标签外治疗方案中,有132种(69.9%)基于既定的循证治疗指南,另外39种(20.6%)基于II或III期临床试验数据。结论:即使TGA并未批准将药物用于特定用途,但超过90%的标签外治疗方案得到了既定的治疗指南或已发表的同行评审研究的支持。但是,这些标签外协议没有PBS的资助;这导致澳大利亚各地癌症患者获得适当药物的明显不平等。

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