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首页> 美国卫生研究院文献>Pharmacology Research Perspectives >Bridging the gap: Can International Consortium of Health Outcomes Measurement standard sets align outcomes accepted for regulatory and health technology assessment decision‐making of oncology medicines
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Bridging the gap: Can International Consortium of Health Outcomes Measurement standard sets align outcomes accepted for regulatory and health technology assessment decision‐making of oncology medicines

机译：弥补差距：国际财团的健康结果可以测量标准套装对肿瘤医学药物的监管和健康技术评估决策的符合结果

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Standard outcome sets developed by the International Consortium for Health Outcomes Measurement (ICHOM) facilitate value‐based health care in healthcare practice and have gained traction from regulators and Health Technology Assessment (HTA) agencies that regularly assess the value of new medicines. We aimed to assess the extent to which the outcomes used by regulators and HTA agencies are patient‐relevant, by comparing these to ICHOM standard sets. We conducted a cross‐sectional comparative analysis of ICHOM standard sets, and publicly available regulatory and HTA assessment guidelines. We focused on oncology due to many new medicines being developed, which are accompanied by substantial uncertainty regarding the relevance of these treatments for patients. A comparison of regulatory and HTA assessment guidelines, and ICHOM standard sets showed that both ICHOM and regulators stress the importance of disease‐specific outcomes. On the other hand, HTA agencies have a stronger focus on generic outcomes in order to allow comparisons across disease areas. Overall, similar outcomes are relevant for market access, reimbursement, and in ICHOM standard sets. However, some differences are apparent, such as the acceptability of intermediate outcomes. These are recommended in ICHOM standard sets, but regulators are more likely to accept intermediate outcomes than HTA agencies. A greater level of alignment in outcomes accepted may enhance the efficiency of regulatory and HTA processes, and increase timely access to new medicines. ICHOM standard sets may help align these outcomes. However, some differences in outcomes used may remain due to the different purposes of regulatory and HTA decision‐making.
机译：国际财团制定的卫生成果衡量（ICHOM）制定的标准成果套装促进了医疗保健实践的价值的医疗保健，并从监管机构和卫生技术评估（HTA）机构获得了定期评估新药物价值的牵引力。我们旨在评估监管机构和HTA机构所使用的结果的程度，通过将这些与ICHOM标准集进行比较。我们对ICHOM标准集进行了横截面比较分析，以及公开的监管和HTA评估指南。我们专注于由于许多正在开发的新药物而致力于伴随着关于这些治疗对患者的相关性的实质性不确定性。监管和HTA评估指南和ICHOM标准组的比较表明，ICHOM和调节因子都强调了疾病特异性结果的重要性。另一方面，HTA各机构对通用结果具有更强的重点，以便在疾病区域进行比较。总体而言，类似的结果与市场准入，报销和ICHOM标准集相关的相关结果。然而，一些差异是显而易见的，例如中间结果的可接受性。这些建议在ICHOM标准套装中，但监管机构更有可能接受比HTA机构的中间结果。接受的结果的更大程度的对准可能提高调节和HTA过程的效率，并及时增加对新药。 Ichom标准集可能有助于对齐这些结果。然而，由于监管和HTA决策的不同目的，所使用的结果可能存在一些差异。

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