More Unnecessary Imaginary Worlds - Part 2: The ICER Evidence Report on Modeling Oral Semaglutide for Type 2 Diabetes.

On 9 December2019, the Institute for Clinical and Economic Review (ICER) released its final evidence report to establish the value of oral semaglutide (Novo Nordisk) for Type 2 diabetes (T2DM). A key element in this report was the development of a lifetime cost effectiveness microsimulation model based on a small sample of NHANES diabetes respondents. The model contrasted oral semaglutide added to current antihyperglycemic treatment for T2DM. The purpose of the model was to estimate outcomes that included life years (LYs) gained, an estimate of equal value life years gained (evLYGs), QALYs gained, clinical events, cost per major adverse cardiovascular events (MACE) avoided and total costs for each intervention over a lifetime time horizon. Previous commentaries in INNOVATTIONS in Pharmacy have provided detailed critiques of the ICER modeling framework. While this model differs from previous ICER models, the result is still a framework that constructs a so-called evidence base that fails the demarcation test. It is best described as pseudoscience. The model creates, by assumption, an imaginary world. The claims made for oral semaglutide by ICER should not be taken seriously by health care decision makers. The purpose of this commentary is to point to the limitations of the model with particular reference to the utility metrics employed, the resulting claims for quality adjusted life years (QALYs) and consequent recommendations for price discounting and affordability.