How reliable are ICER's results published in current pharmacoeconomic literature? The controversial issue of price confidentiality.

Pharmacoeconomic data are widely used along drug life cycle for supporting decision-making processes on research and development, pricing and reimbursement, and market access. In this context, the incremental cost-effectiveness ratio (ICER) is the gold standard of either cost-effectiveness analyses (CEAs) or cost-utility analyses (CUAs) of pharmaceuticals and health technologies. However, the widespread use of confidentiality clauses in the agreements between pharmaceutical companies and the payers may affect the reliability of ICER value based on transparent price. The aim of this article is to evaluate a case study and simulate the impact of price confidentiality and other managed-entry agreement conditions on the ICER value. The case study was conducted selecting a CEA submitted to the Health Economic Evaluations Office of the Italian Medicines Agency by the pharmaceutical company, which specifically compared two alternative options reimbursed by the Italian NHS using confidential managed-entry agreements. So, a real model was used to collect the output of ICERs generated by the simulation model, considering price inputs of alternative options ranging from the transparent prices to the confidential net price. The simulation showed that price confidentiality may affect the estimated value of the ICER of a new medicine and, consequently, its interpretation. From a different point of view, the published ICER values may also give a completely false economic evidence if non-disclosure agreements are not taken into account. A proposal for editors of pharmacoeconomic journals to improve reliability of CEA is also discussed.