Holistic Value Assessment of Tirbanibulin for Actinic Keratosis: European Multi-Criteria Decision Analysis

Introduction: Actinic keratosis (AK) is a prevalent, chronic skin condition and a precursor to cutaneous squamous cell carcinoma. Effective, patient-friendly therapies that target both visible and subclinical lesions are essential. Tirbanibulin, a topical microtubule inhibitor, is the latest treatment approved in the USA and European Union (EU) for treating non-hyperkeratotic, non-hypertrophic AK on the face and scalp. This study aimed to assess the overall value of tirbanibulin for treating AK on the face or scalp across Germany, Italy, and Spain and to identify key value drivers using a multi-stakeholder perspective. Methods: This study used a multi-criteria decision analysis (MCDA) to assess the holistic value of tirbanibulin compared with 5-fluorouracil 4% (5FU-4%) across Germany, Italy, and Spain. The validated EVIDEM MCDA framework (tenth edition) included eleven criteria related to disease burden, treatment benefits, evidence quality, and comparative outcomes. A total of 18 participants-dermatologists, payers, and patients-evaluated the treatments in a two-phase process. Phase 1 involved weighing the criteria, and phase 2 involved scoring clinical, economic, and patient-reported evidence for both treatments. Results from both phases were used to calculate an estimated value. The approach supports transparent, stakeholder-informed decision-making for AK treatment. Results: All criteria were rated as relevant, with the greatest importance assigned to "comparative safety/tolerability," "quality of evidence," and "comparative efficacy." Tirbanibulin received positive scores across all criteria, particularly for "expert consensus/guidelines," "quality of evidence," and "size of the affected population." The final estimated value of tirbanibulin was 0.622 on a -1 to +1 scale, indicating high perceived value. Value estimations were consistent across stakeholder types, with slight country-level variations. Conclusions: Overall, participants recognized tirbanibulin as a valuable treatment for AK, on the basis of robust evidence, favorable safety/tolerability and patient-reported outcomes (PRO) profiles, and alignment with clinical guidelines, with similar efficacy compared with 5FU-4%.