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In April 2017, the Institute for Clinical and Economic Review (ICER) issued its evidence report on the value of targeted immune modulators (TIMs) in rheumatoid arthritis. The report made the case that for the TIMs to be accepted for formulary placement in the US, where notional willingness-to-pay thresholds are the ICER gateway criteria, manufacturers should be prepared to offer substantial unit price discounts. The purpose of this commentary is to make the case that the methodology underpinning the ICER claims for value assessment does not meet the required standards of normal science. None of the claims made for clinical and comparative cost-effectiveness are credible, evaluable and replicable. As such, formulary committees have no idea whether ICER recommendations are right or even if they are wrong. They are, in fact, immune to failure and should be rejected. Utilizing ICER claims generated by simulated projections, this review points out that it is entirely possible to justify the current WAC or net pricing structure of TIMS. The review concludes that if ICER is to contribute to the successful formulary placement of drugs and devices the methodology for pricing recommendation should be re-assessed. As it stands, questions must be raised regarding recommendations for, possibly unnecessary, price discounts. ICER needs to develop an assessment framework that focuses on developing claims for competing therapies that are robust, evaluable and replicable together with recommendations on how these claims are to be evaluated in a timeframe meaningful to health care decision makers.   Type: Commentary

Imaginary Worlds and the Institute for Clinical and Economic Review (ICER) Evidence Report: Targeted Immune Modulators for Rheumatoid Arthritis