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Institute for Clinical and Economic Review (ICER) VS. Health Technology Assessment (HTA) Agencies: The Case of Multiple Myeloma and PCSK9S

      Objectives

      ICER, a newly established HTA organization in the U.S., has been both praised and criticized for its drug assessments. Manufacturers and patient groups have been critical of ICER, but is this criticism justified? ICER’s goal is similar to other established HTA agencies: to inform payers and policymakers on a drug’s value and better tie drug prices to value. How does the ICER’s decisions compare to those of more established HTA agencies?

      Methods

      We compared ICER’s multiple myeloma and PCSK9 evaluations with the corresponding HTAs from NICE, SMC, pCODR/CADTH, G-BA, and HAS to determine how consistent the agencies were in their decision making. We focused on their overall clinical effectiveness and cost-effectiveness conclusions.

      Results

      ICER’s assessments were published before all the corresponding HTAs; a comparison of all drugs was not possible. This is because ICER times their reviews based on FDA approvals, which are issued before EMA approvals. There were few differences between ICER and the HTA agencies in their conclusions on clinical efficacy. For example, ICER determined that panobinostat (third-line multiple myeloma) did not demonstrate a net clinical benefit, while both NICE and SMC determined the drug was clinically effective. All three agencies noted the same toxicity issue, which would likely be mitigated by the route of administration used in clinical practice. The uncertainty around toxicity lead ICER to determine there was no net clinical benefit.

      Conclusions

      Using established HTA agencies as a benchmark, ICER’s clinical evaluations were similar to other HTA agencies, however, there was a lack of data for comparisons of all drugs. The criticism in the U.S. might be due to the newness of HTA in the US healthcare system and not a deviation from well-established HTA decisions. While HTA decisions from the agencies evaluated have immediate impact on their healthcare systems, the impact of ICER is less well known.