Objectives: The US Institute for Clinical and Economic Review (ICER) began assessing innovative drugs in 2014, applying a cost-effectiveness threshold of USD100,000-150,000. While its guidance is not binding, ICER's recommendations are considered by private health insurers and, since 2017, by the Department of Veterans Affairs. Understanding ICER's pricing recommendations and whether in arriving at them ICER consistently applies its assessment framework would be beneficial for pharmaceutical companies when they set US prices.

Methods: All ICER's decisions for pharmaceuticals between the inception of assessments in 2014 and the end of August 2021 were reviewed to assess the price level recommendations by ICER and also whether the assessment process adhered to ICER’s assessment framework.

Results: Over the 2014-2021 period examined, ICER evaluated 170 products/indications (across 48 evidence reports), including 117 active pharmaceutical ingredients (APIs). Around 37% of products/indications had no clear “value” determination (that is, “No Vote”). Conversely, there were multiple cases of voting for medicines that should have automatically qualified as low or high value, which deviates from ICER’s value assessment framework. ICER's assessments resulted in a recommendation to reduce list prices by more than 80% for 15% of reviewed drugs, by 50-80% for 38% of drugs and by less than 50% for 37% of drugs.

Conclusions: The vast majority of ICER's assessments result in recommendations for substantial price cuts to meet the cost-effectiveness threshold. The threshold itself of USD100,000-150,000 has been criticised for being too high, but ICER maintained its level in the January 2020 revision of its assessment framework. While the framework gives some predictability to pharma, it is worrying that it was not consistently applied in 37% of assessments. Conducting assessments as prescribed in the framework should help create a more transparent and predictable HTA process for pharmaceutical companies and for the eventual users of ICER’s cost-effectiveness reports.