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. 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. 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. 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%. Actinic keratosis is a very common skin condition caused by many years of sun exposure; while it is not always serious, it can sometimes develop into a type of skin cancer called squamous cell carcinoma, and because actinic keratosis often returns after treatment, there is a real need for safe and effective options that can help manage it over the long term. To address the limited evidence available on how newer treatments compare with existing alternatives, this study in Germany, Italy, and Spain explored the overall value of a topical treatment called tirbanibulin versus an older option, 5-fluorouracil 4%, for people with actinic keratosis on the face or scalp. Researchers used a structured approach called multi-criteria decision analysis, which looks beyond effectiveness alone and considers multiple factors such as safety, quality of evidence, and how well a treatment fits into everyday clinical practice; 18 participants—dermatologists, payers, and patients with actinic keratosis—reviewed the evidence and scored both treatments across these criteria. Overall, tirbanibulin was rated positively across all areas and was particularly valued for being safe and well tolerated, supported by strong scientific evidence, and recommended in expert guidelines, achieving a high overall value score of 0.62 on a scale from −1 to +1. These findings suggest that tirbanibulin is a valuable option for managing actinic keratosis, giving patients and clinicians an evidence-backed, clinically supported treatment choice that can help address the ongoing challenge of long-term disease control.
Berking et al. (2026) studied this question.