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




Cost-effectiveness, Cost-utility, Incremental cost-effectiveness ratio, Managed-entry agreements, 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.


Langley PC. Focusing pharmacoeconomic activities: reimbursement or the drug life cycle? Curr Med Res Opin. 2004;20(2):181-188. DOI:

Bertram M, Lauer J, Stenberg K, Edejer T. Methods for the economic evaluation of health care interventions for priority setting in the health system: an update from WHO CHOICE. IJHPM; 2021. Available at: Accessed July 5, 2021. DOI:

World Health Organization. Resolution WHA72.8: Improving the transparency of markets for medicines, vaccines, and other health products. Geneva: World Health Assembly 72; 2019. Available at: Accessed July 5, 2021.

Morgan SG, Vogler S, Wagner AK. Payers’ experiences with confidential pharmaceutical price discounts: A survey of public and statutory health systems in North America, Europe, and Australasia. Health Policy. 2017;121(4):354-362. DOI:

Morgan SG, Bathula HS, Moon S. Pricing of pharmaceuticals is becoming a major challenge for health systems. BMJ. 2020;368:14627. PMID:31932289 DOI:

Rintoul A, Colbert A, Garner S, et al. Medicines with one seller and many buyers: strategies to increase the power of the payer. BMJ. 2020;369:m1705. DOI:

Russo P, Carletto A, Németh G, Habl C. Medicine price transparency and confidential managed-entry agreements in Europe: findings from the EURIPID survey. Health Policy. 2021;125(9):1140-1145. PMID:34253396 DOI:

Weinstein MC, Stason WB. Foundations of cost-effectiveness analysis for health and medical practices. N Engl J Med. 1977;296(13):716-721. DOI:

Jommi C, Armeni P, Costa F, Bertolani A, Otto M. Implementation of value-based pricing for medicines. Clin Ther. 2020;42(1):15-24. DOI:

Lakdawalla DN, Doshi JA, Garrison LP Jr, Phelps CE, Basu A, Danzon PM. Defining elements of value in health care – a health economics approach: an ISPOR Special Task Force report [3]. Value Health. 2018;21(2):131-139. DOI:

Russo P, Marcellusi A, Zanuzzi M, et al. Drug prices and value of oncology drugs in Italy. Value Health. 2021;24(9):1273-1278. PMID:34452706 DOI:

Italian Medicines Agency. Technical-scientific reports. Available at: Accessed July 5, 2021.

Italian Medicines Agency. Economic evaluations. Available at: Accessed July 5, 2021.

Carletto A, Zanuzzi M, Sammarco A, Russo P. Quality of health economic evaluations submitted to the Italian Medicines Agency: current state and future actions. Int J Technol Assess Health Care. 2020;36(6):560-568. PMID:32907656 DOI:

Fattore G. Proposta di linee guida per la valutazione economica degli interventi sanitari in Italia. PharmacoEcon Ital Res Artic. 2009;11(2):83-93. DOI:

Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press; 2015.

Weinstein MC, O’Brien B, Hornberger J, et al; ISPOR Task Force on Good Research Practices – Modeling Studies. Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices—Modeling Studies. Value Health. 2003;6(1):9-17. PMID:12535234 DOI:



How to Cite

Russo P. How reliable are ICER’s results published in current pharmacoeconomic literature? The controversial issue of price confidentiality. Grhta [Internet]. 2022 Feb. 25 [cited 2023 May 31];9(1):31-5. Available from:



Point of View