Measuring Survival Benefit in Health Technology Assessment in the Presence of Nonproportional Hazards
| Autor: | Mingshu Zhu, J McKendrick, Yun Su, Giles Monnickendam |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Technology Assessment Biomedical Time Factors Cost effectiveness Endpoint Determination media_common.quotation_subject Antineoplastic Agents Excellence Neoplasms Medicine Humans Intensive care medicine Survival analysis media_common Proportional Hazards Models Clinical Trials as Topic business.industry Health Policy Hazard ratio Public Health Environmental and Occupational Health Health technology Clinical trial Survival Rate Treatment Outcome Data Interpretation Statistical RMST Practice Guidelines as Topic Health Policy & Services Metric (unit) business |
| Zdroj: | Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 22(4) |
| ISSN: | 1524-4733 |
| Popis: | © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research Background: Proportional hazards (PH) is an assumption often made by researchers, despite evidence of nonproportionality in a significant proportion of clinical trials. In the presence of non-PH, the interpretation of hazard ratios, medians, and landmark survival as summary measures of treatment effect can become problematic. Several recent studies have recommended restricted mean survival time (RMST) as an alternative metric for survival analysis, particularly where non-PH may apply. Objectives: To determine the current approaches of health technology assessment (HTA) agencies to value assessment in the presence of non-PH, and the extent to which RMST is accepted as an alternative measure of treatment benefit. Methods: Methodological guidelines published by 10 HTA agencies were reviewed to establish recommended approaches for presenting survival benefit from clinical trials. Published HTA reports for 23 oncology agents approved by the US Food and Drug Administration and the European Medicines Agency since 2014 were reviewed to determine how guidelines are implemented in practice and identify instances where the PH assumption was tested and RMST analyses reported. Results: Testing for non-PH is not widely incorporated into HTA except by the UK National Institute for Health and Care Excellence. RMST is used infrequently but has been used in a number of countries, particularly by agencies that focus on cost effectiveness. Conclusions: HTA agencies vary in their approaches to non-PH. Most do not routinely check the PH assumption. RMST has played a role in assessing clinical benefit within HTA, although not consistently within countries (across drugs) or across countries (for the same drug). |
| Databáze: | OpenAIRE |
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