Lege Artis Medicinae

[A practical demonstration of critically assessing health economic analyses]

MERÉSZ Gergô1, DÓCZY Veronika1, HÖLGYESI Áron1, NÉMETH Gergely2

NOVEMBER 30, 2021

Lege Artis Medicinae - 2021;31(11)

DOI: https://doi.org/10.33616/lam.31.039

Journal Article

[During the critical assessment of health economic analyses, it is useful to present their uncertainties within a standardized framework. The aim of this research is to demonstrate how to use the procedural framework to identify, quantify and interpret such uncertainties through the examples of cell and gene therapies. Based on the review of methodological documents used by the Di­vi­sion of Health Technology Assessment at the National Institute of Pharmacy and Nutrition of Hungary (NIPN), and formalizing the current practice in its own framework, first we identify the uncertainty factors of the analysis and then examine their quantification in the submitted health economic model. Subsequently, we interpret their impact on the cost-effectiveness conclusion and determine the significance of all uncertainty factors. By applying the framework on the cost-effectiveness analysis of tisagenlecleucel as our example, we identified the following uncertainty factors. Although it is challenging to quantify, there is significant uncertainty related to the effectiveness of comparator procedure, which is due to single-arm clinical trials and the use of secondary data sources. The discount rate had a quantifiable and significant impact on both health gains and costs. Methods used to estimate relative effectiveness are also quantifiable but have less of an impact on the conclusions. The presented framework proved to be appropriate, with some li­mitations to document and arranging uncertainties of health economic analyses. It is advised to use this framework for reimbursement decisions for public financing. A possible subject of methodological development is the further formalization of identifying factors of uncertainty.]

AFFILIATIONS

  1. Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet, Technológia-értékelő Főosztály
  2. Nemzeti Egészségbiztosítási Alapkezelő, Ártámogatási Főosztály

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