Lu Christine Y, Lupton Caitlin, Rakowsky Shana, Babar Zaheer-Ud-Din, Ross-Degnan Dennis, Wagner Anita K
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, USA.
Jefferson Medical School, Philadelphia, USA.
J Pharm Policy Pract. 2015 Feb 16;8(1):6. doi: 10.1186/s40545-014-0019-x. eCollection 2015.
Patient access (or risk-sharing) schemes are alternative market access agreements between healthcare payers and medical product manufacturers for conditional coverage of promising health technologies. This study aims to identify and characterize patient access schemes to date in the Asia-Pacific region.
We reviewed the literature on patient access schemes over the last two decades using publicly available databases, Internet, and grey literature searches. We extracted key features of each scheme identified, including the drug, clinical indication, stakeholders involved, and details of the scheme. We categorized schemes according to a previously published taxonomy of scheme types and by country.
We identified 3 schemes in South Korea, 5 in New Zealand, and 98 in Australia. Most (97.2%; n = 103) schemes focused on pharmaceuticals, few on medical technologies. More than half of the schemes related to treatments for cancer and inflammatory diseases such as rheumatoid arthritis. The majority (77.4%; n =82) involved pricing arrangements. Evidence generation schemes were rarely used. About half (41.8%; n = 41) of schemes in Australia were hybrid by nature, consisting of pricing arrangements with a conditional treatment continuation component.
Australia has the most experience with patient access schemes and its experience may provide useful insights for other Asia-Pacific countries. The main targets are pharmaceuticals likely to have high budget impact (due to high per-patient costs and/or large volumes of use), and pharmaceuticals that may be adopted more widely than indicated. With the proliferation of high-cost medicines, the use of schemes may increase to address rising cost pressures, consumer demands, and uncertainties, while attempting to provide patient access to innovative care within finite budgets. Future research is warranted to evaluate the performance of patient access schemes.
患者准入（或风险分担）计划是医疗保健支付方与医疗产品制造商之间达成的替代性市场准入协议，用于有条件地覆盖有前景的健康技术。本研究旨在识别并描述亚太地区迄今为止的患者准入计划。
我们使用公开可用数据库、互联网以及灰色文献检索，回顾了过去二十年中关于患者准入计划的文献。我们提取了所识别的每个计划的关键特征，包括药物、临床适应症、涉及的利益相关者以及计划细节。我们根据先前发表的计划类型分类法并按国家对计划进行了分类。
我们在韩国识别出3个计划，在新西兰识别出5个，在澳大利亚识别出98个。大多数（97.2%；n = 103）计划聚焦于药品，很少涉及医疗技术。超过一半的计划与癌症及类风湿关节炎等炎症性疾病的治疗有关。大多数（77.4%；n = 82）计划涉及定价安排。很少使用证据生成计划。澳大利亚约一半（41.8%；n = 41）的计划本质上是混合型的，由带有条件性治疗延续部分的定价安排组成。
澳大利亚在患者准入计划方面经验最为丰富，其经验可能为其他亚太国家提供有益的见解。主要目标是那些可能对预算有高影响的药品（由于每位患者成本高和/或使用量大），以及可能比获批适应症更广泛被采用的药品。随着高成本药品的激增，为应对不断上升的成本压力、消费者需求和不确定性，同时试图在有限预算内让患者获得创新治疗，计划的使用可能会增加。有必要开展未来研究以评估患者准入计划的绩效。
