Evidence for benefits and risks of tadalafil as a non-prescription medicine: review and evaluation using the Group Delphi technique to achieve consensus amongst clinical experts

Kurt Miller; Uwe May; Wolf-Dietrich Beecken; Georgios Hatzichristodoulou; Michael Böhm; Stefan Fink

doi:10.3389/fphar.2023.1254706

Evidence for benefits and risks of tadalafil as a non-prescription medicine: review and evaluation using the Group Delphi technique to achieve consensus amongst clinical experts

Front Pharmacol. 2023 Oct 9:14:1254706. doi: 10.3389/fphar.2023.1254706. eCollection 2023.

Authors

Kurt Miller¹, Uwe May², Wolf-Dietrich Beecken³, Georgios Hatzichristodoulou⁴, Michael Böhm⁵, Stefan Fink⁶

Affiliations

¹ Department of Urology, Charité Campus Benjamin Franklin, Berlin, Germany.
² Department of Health Economics and Pharmacoeconomics, Fresenius University of Applied Sciences, Wiesbaden, Germany.
³ Department of Urology, Goethe University, Frankfurt, Germany.
⁴ Martha-Maria Hospital Nuremberg, Nuremberg, Germany.
⁵ Department of Internal Medicine, University of the Saarland, Homburg Saar, Germany.
⁶ State Pharmacists' Association of Thuringia, Erfurt, Germany.

Abstract

An evidence-based consensus meeting was held with urologists, a pharmacist and a cardiologist to perform a structured benefit-risk analysis of reclassifying tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor for treatment of erectile dysfunction (ED), to be available without prescription in Germany. As per the Brass process endorsed by regulatory authorities, an evidence-based Brass value tree was developed, which identified the incremental benefits and risks that should be considered above the safety and efficacy evidence required for prescription medicines. During the Group Delphi consensus meeting, the expert panel rated the likelihood and clinical impact of each benefit and risk on a scale of 0 (none) to 3 (high). Overall attribute scores were calculated from the product of the mean likelihood and mean clinical impact scores giving a possible score of 0-9. The overall benefit attribute scores ranged from 2.8 to 5.4. The overall risk attribute scores ranged from 0.2 to 2.2 though most were 1.0 or less (3 or more is generally considered to be of concern). On balance, the independent meeting scored the benefits of reclassification of tadalafil higher than the risks and considered the risk mitigation strategies of the packaging label and patient information leaflet (PIL) sufficient.

Keywords: erectile dysfunction; non-prescription; phosphodiesterase type 5 inhibitor (PDE5 inhibitor); reclassification; tadalafil.

Grants and funding

The process was sponsored by Sanofi who provided funding to support the extensive literature review, allowed access to their post-marketing safety data, clinical trial data and clinical pharmacology data and provided funding to facilitate the meeting. However, the Group Delphi process and evaluation of the benefits/risks was independent of Sanofi. No members of Sanofi actively participated in the meeting and discussion of the evidence or interacted with the clinical experts. Editorial support was provided by Fiona Hammond and Alison Carr of Hamell Communications, United Kingdom, and was funded by Sanofi.