Impact of using real-world outcomes versus clinical evidence and list prices on value assessments

D. Meade, M. Ng, S. Hensley Alford
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Abstract

Abstract Background: To assess value, industry organizations often use list or net prices to calculate average prices per patient or price per QALY. However, this methodology requires numerous assumptions which need to be validated and can be challenging to ascertain. A better approach is to use fully adjudicated net prices and real-world clinical outcomes data for value assessments. Aims: We sought to demonstrate the impact on value analyses of using list vs. net prices. Methods: Using the IBM Access and Value Connect solution, patients in the IBM MarketScan Commercial Database between 1 October 2016 and 30 September 2017 with a psoriasis diagnosis were identified. To demonstrate an example of impact on value assessments, we calculated the mean per-patient-per-month (PPPM) cost associated with apremilast and compared that to the net price calculation reported in the 2018 Plaque Psoriasis Condition Update by the Institute for Clinical and Economic Review (ICER), based on per-unit dosing and discount assumptions. Results: We identified 4169 patients with a psoriasis diagnosis during the study period. The adjudicated claims PPPM cost for US health plans was $20,821 with a mean duration of exposure to apremilast of 243 days and including concomitant psoriasis medications. This is approximately $10,000 less than the net price presented in the 2018 ICER report ($30,807 Year 1, $31,018 Year 2) . Numerous additional differences between the real-world performance data and ICER evidence report were identified. Conclusions: Our analysis found that using a fully adjudicated net price: (1) allowed direct comparison of prices amongst therapies quickly and easily; and (2) facilitated a more accurate reflection of price versus value when used alongside analysis of the real-world clinical outcomes data. We recommend that net prices and real-world data be used for value assessments whenever possible. Value assessment organizations should incorporate the numerous data sets and tools available to improve transparency, accuracy and ease of analysis.
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使用真实世界的结果与临床证据和标价对价值评估的影响
摘要背景:为了评估价值,行业组织通常使用标价或净价来计算每个患者的平均价格或每个QALY的价格。然而,这种方法需要大量的假设,这些假设需要验证,并且很难确定。更好的方法是使用完全裁定的净价和真实世界的临床结果数据进行价值评估。目的:我们试图证明使用标价与净价对价值分析的影响。方法:使用IBM Access和Value Connect解决方案,确定2016年10月1日至2017年9月30日期间IBM MarketScan商业数据库中诊断为银屑病的患者。为了证明对价值评估的影响,我们计算了与阿培司特相关的每位患者每月平均费用(PPPM),并根据单位剂量和折扣假设,将其与临床与经济审查研究所(ICER)在2018年斑块型银屑病病情更新中报告的净价计算进行了比较。结果:在研究期间,我们确定了4169名被诊断为银屑病的患者。已裁定的美国健康计划PPPM费用为20821美元,平均暴露于阿普司特的时间为243 天,包括伴随的银屑病药物。这比2018年ICER报告中的净价(第一年30807美元,第二年31018美元)低了约10000美元。真实世界的性能数据和ICER证据报告之间存在许多其他差异。结论:我们的分析发现,使用完全裁定的净价:(1)可以快速方便地直接比较不同疗法的价格;以及(2)当与真实世界临床结果数据的分析一起使用时,有助于更准确地反映价格与价值的关系。我们建议尽可能使用净价和真实世界的数据进行价值评估。价值评估组织应纳入大量可用的数据集和工具,以提高分析的透明度、准确性和易用性。
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来源期刊
Journal of Drug Assessment
Journal of Drug Assessment PHARMACOLOGY & PHARMACY-
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