Almirall Announces Expanded CVS Caremark Coverage and New Clinical Data for Tirbanibulin at AAD 2026

Leading up to the 2026 American Academy of Dermatology (AAD) Annual Meeting, Almirall announced that tirbanibulin (KLISYRI) has been added to several CVS Caremark commercial formularies, including Standard Control, Advanced Control, and Performance Standard plans.¹ This expansion increases potential access to approximately 26 million commercially insured patients in the US. Coverage includes utilization management criteria such as prior authorization and step-through of a prior topical field therapy.

The company emphasized continued patient support through the Almirall Advantage Program, aimed at reducing out-of-pocket costs. This development represents a meaningful step toward improving real-world access to a short-course, field-directed therapy for actinic keratosis (AK), particularly as treatment adherence and tolerability remain key considerations in clinical practice.

At AAD, Dermatology Times’ editor in chief and associate professor of dermatology at Yale School of Medicine, Christopher Bunick, MD, PhD, spoke with Johnny Im, head of US marketing at Almirall, to discuss the significance of expanded patient access of tirbanibulin.

Im highlighted efforts to improve dermatologic care access and portfolio expansion. He emphasized that, “Patient access is at the forefront of what we’ve been striving to do,” noting the formulary win with CVS Caremark that expands access to tirbanibulin. He also mentioned renewed focus on legacy therapies, stating, “We’re very excited to bring back some of the oldies but goodies,” including topical agents such as 20% azelaic acid cream and flurandrenolide tape in response to clinician demand.

“As we come together at AAD to share new science and strengthen our commitment to dermatology, the expanded CVS Caremark coverage for tirbanibulin represents another important milestone for patients with actinic keratosis. By broadening access to innovative treatments for millions of people in the US, we are advancing our purpose to help people living with skin disease,” said Paul Ritman, President and General Manager of Almirall US, in the news release.¹

Along with the announcement of expanded coverage, the company presented several posters reinforcing the clinical utility and accessibility of tirbanibulin 1% ointment for the treatment of AK.

Tolerability and Complete Clearance

Lain et al explored the relationship between tolerability and treatment success through a pooled post hoc analysis of three phase 3 studies.² Investigators compared local skin reactions (LSRs), also referred to as local tolerability signs (LTS), in patients who achieved complete clearance (CC) at day 57 vs those who did not.

Among 213 patients achieving CC and 242 who did not, the overall tolerability profile was similar between groups. Composite LTS scores peaked at day 8 and returned to baseline by day 29 in both cohorts. Patients who achieved CC had slightly higher mean peak LTS scores (4.5 vs 3.6), but these reactions were predominantly mild to moderate in severity.

The most common reactions included erythema and flaking/scaling, again largely mild to moderate, with similar distributions observed regardless of treatment outcome. Importantly, the majority of patients—both those achieving and not achieving CC—experienced absent to moderate LSRs, supporting a favorable tolerability profile overall.

Tirbanibulin's Efficacy Beyond Complete Clearance

Bhatia et al analyzed the clinical relevance of the percent reduction in AK lesion count as an alternative to CC.³ Drawing on pooled analyses from phase 3, phase 4, and real-world studies across both 25 cm² and 100 cm² treatment fields, the microtubule inhibitor ointment demonstrated consistent efficacy regardless of baseline lesion count or treatment area.

Following a single 5-day treatment course, mean lesion reductions ranged from approximately 72% to 82% at day 57, with sustained reductions of over 80% observed at later time points. Real-world evidence and phase 4 data supported these findings, showing reductions of approximately 70% to 83% across multiple studies. Importantly, investigators noted that percent reduction provides a more clinically meaningful and comparable metric across trials with varying baseline characteristics. Overall, approximately three-quarters of lesions were cleared after a single treatment cycle, underscoring the robustness of tirbanibulin’s effect across diverse study settings.

Expanded Treatment Fields up to 100 cm²

Another poster by Welzel et al reported results from a randomized, double-blind, vehicle-controlled phase 3 trial evaluating tirbanibulin in treatment fields larger than 25 cm² and up to approximately 100 cm².⁴ A total of 280 patients were randomized in a 2:1 ratio to tirbanibulin or vehicle, with the option for a second 5-day treatment course in patients without CC at day 57.

At the primary end point, tirbanibulin achieved a significantly greater reduction in lesion count compared with vehicle (least squares mean reduction: 64.2% vs 25.2%; p < 0.001), with a median reduction of 84.5% versus 20.0%. CC rates at day 113 reached 56.1% in the tirbanibulin group compared with 23.7% in the vehicle arm (p < 0.001).

Safety and tolerability were consistent with prior studies. Most treatment-emergent adverse events were mild to moderate local skin reactions, including erythema and scaling, which peaked early and resolved by approximately day 29. Notably, no squamous cell carcinoma events were reported in the tirbanibulin group, and cosmetic outcomes were highly favorable, with over 80% of both patients and investigators rating results as good or excellent at follow-up.

References

1. Almirall together with CVS Caremark expand U.S. access for KLISYRI (tirbanibulin) ointment for the treatment of actinic keratosis. News release. Almirall. March 27, 2026. Accessed April 1, 2026. Exclusive media statement.

2. Lain E, Issa N, Patel V, et al. Achieving complete clearance (CC) in actinic keratosis (AK) after treatment with tirbanibulin 1% with mild to moderate local skin reactions (LSRs): a pooled post-hoc analysis of three phase III studies. Poster presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, Colorado.

3. Bhatia N, Welzel J, Gilaberte Y, et al. Efficacy of tirbanibulin 1% beyond complete clearance (CC): percent reduction of actinic keratosis (AK) lesions as a clinically meaningful endpoint. Poster presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, Colorado.

4. Welzel J, Szepietowski J, Ferrándiz Pulido C, et al. A phase 3 study assessing the efficacy, safety and tolerability of up to two 5-day treatment courses of tirbanibulin 1% ointment in patients with actinic keratosis (AK) over a treatment field up to 100 cm². Poster presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, Colorado.