Novel Humanitarian Aid Program: The Glivec International Patient Assistance Program-Lessons Learned From Providing Access to Breakthrough Targeted Oncology Treatment in Low- and Middle-Income Countries.
Novel Humanitarian Aid Program: The Glivec International Patient Assistance Program-Lessons Learned From Providing Access to Breakthrough Targeted Oncology Treatment in Low- and Middle-Income Countries.
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DOI：
10.1200/jgo.2015.000570
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发表时间：
2015-10-01
影响因子：
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通讯作者：
Epstein, David
中科院分区：
文献类型：
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作者：
Garcia-Gonzalez, Pat;Boultbee, Paula;Epstein, David
伊马替尼是第一个被批准用于治疗癌症的靶向疗法。获得批准后，诺华立即明白，这种突破性疗法需要一种创新的方法，让全世界都能获得，并特别考虑到低收入和中等收入国家。缺乏政府报销、全民医疗保健或健康保险、训练有素的专业医生或诊断服务很少以及卫生保健基础设施差，过去和现在都是阻碍中低收入国家获得治疗的因素。格列卫国际患者援助计划（GIPAP）是诺华制药公司（Novartis Pharma AG）与非营利非政府组织The Max Foundation合作实施的一项国际药品捐赠计划。GIPAP成立于2001年，基本上与伊马替尼首次获批治疗慢性髓性白血病同时进行。自2001年以来，GIPAP使80个国家的所有医疗和经济条件合格的病人都能持续获得伊马替尼，只要他们的医生开了处方，而且没有其他途径可以获得。迄今为止，已有49,000多名患者受益于GIPAP，每月230万剂量的伊马替尼已通过该计划获得批准。GIPAP代表了一种创新的药物捐赠模式，为其他靶向或创新疗法的获取计划设定了标准。本文的目的是描述GIPAP的结构，以及为该计划的成功做出贡献的重要经验教训。本文可以帮助其他公司在未来开发成功且影响深远的患者援助计划。
Imatinib was the first targeted therapy approved for the treatment of cancer. With its approval, it was immediately clear to Novartis that this breakthrough therapy would require an innovative approach to worldwide access, with special consideration of low- and middle-income countries. Lack of government reimbursement, universal health care, or health insurance coverage, few trained specialty physicians or diagnostic services, and poor health care infrastructure were, and continue to be, contributing barriers to access to treatment in low- and middle-income countries. The Glivec International Patient Assistance Program (GIPAP) is an international drug donation program established by Novartis Pharma AG and implemented in partnership with The Max Foundation, a nonprofit, nongovernmental organization. GIPAP was established in 2001, essentially in parallel with the first approval of imatinib for chronic myeloid leukemia. Since 2001, GIPAP has made imatinib accessible to all medically and financially eligible patients within 80 countries on an ongoing basis as long as their physicians prescribe it and no other means of access exists. To date, more than 49,000 patients have benefited from GIPAP, and 2.3 million monthly doses of imatinib have been approved through the program. GIPAP represents an innovative drug donation model that has set the standard for access programs for other targeted or innovative therapies. The purpose of this article is to describe the structure of GIPAP, as well as important lessons that have contributed to the success of the program. This article may assist other companies with the development of successful and far-reaching patient assistance programs in the future.