Klisyri Shortage: What Providers and Prescribers Need to Know in 2026

Dermatologists and other prescribers who regularly recommend Klisyri (tirbanibulin) for actinic keratosis are increasingly encountering a familiar problem: patients can't fill their prescriptions. While Klisyri is not experiencing an FDA-designated shortage, access barriers are real and impacting patient adherence to treatment. This article gives prescribers a comprehensive understanding of the current availability landscape and actionable strategies to help their patients get treatment.

The Regulatory and Market Context in 2026

Klisyri received initial FDA approval in December 2020. In June 2024, the FDA approved a supplemental NDA expanding the treatment area from 25 cm² to up to 100 cm², with new 350 mg packet sizes. The drug's manufacturer, Almirall, LLC (Malvern, PA), has not reported any supply disruptions to the FDA.

Despite adequate manufacturing supply, pharmacy-level availability remains inconsistent. As a brand-name-only medication with a retail price exceeding $1,900 per course, Klisyri is not routinely stocked at most retail pharmacies. Prescribers should understand this landscape to set accurate expectations with patients and streamline the prescription-filling process.

Insurance Coverage and Step Therapy Requirements

Prior authorization and step therapy are among the most significant barriers to Klisyri access. UnitedHealthcare (as of November 2025) requires documented failure, contraindication, or intolerance to two of the following prior to Klisyri approval:

Diclofenac sodium 3% gel (generic Solaraze)

Topical fluorouracil (e.g., generic Efudex)

Imiquimod 5% cream (e.g., generic Aldara)

Other commercial plans have similar step therapy requirements. Prescribers should document prior treatment history thoroughly in the patient record to expedite prior authorization. When step therapy can be waived (contraindication to 5-FU, intolerance, or prior documented failure), include this documentation in the PA submission. When prior authorization is denied, appeal if the clinical rationale supports Klisyri as first-line therapy (e.g., patient compliance concerns with longer treatment regimens).

The Almirall Advantage Patient Access Program

Almirall has established a pharmacy access program — the Almirall Advantage Network — that can significantly ease access for your commercially insured patients:

Commercially insured patients: copay as low as $25 per fill

Uninsured/self-pay through network pharmacy: as low as $95

Uninsured/self-pay at retail pharmacy: as low as $150

NOT available for Medicare or Medicaid patients

When you prescribe Klisyri, routing prescriptions to an Almirall Advantage Network pharmacy dramatically improves the chance the prescription gets filled. These pharmacies reliably carry Klisyri and can also provide home delivery. Ask your Almirall sales representative for the most current list of in-network pharmacies in your region, or direct patients to almiralladvantage.com.

Medicare and Medicaid Patients: Additional Considerations

Patients on Medicare Part D or Medicaid cannot use the Almirall Advantage manufacturer copay card. For these patients, Klisyri coverage depends entirely on their specific formulary placement. GoodRx coupons can be used (though not simultaneously with Medicare coverage), and may offer savings of approximately $280.79 versus the retail price of ~$1,959. For Medicare patients where cost is prohibitive, documenting clinical necessity and pursuing prior authorization is the primary path. If denied, a therapeutic alternative (5-FU, imiquimod) is often the practical solution.

Clinical Decision-Making: When to Choose Klisyri vs. Alternatives

Current AAD guidelines do not designate a preferred agent among topical AK treatments. Clinical decision-making should consider:

Patient adherence profile: Klisyri's 5-day course (shortest available) favors patients who struggle with 4–12 week regimens

Tolerability concerns: Klisyri has generally comparable local skin reaction profile to other agents, with 91% erythema and 82% flaking/scaling in clinical trials, though reactions are shorter-duration than 5-FU

Insurance coverage: Step therapy requirements make Klisyri harder to get first-line for most commercial plans; commercial copay card helps bridge the gap

Efficacy data: Klisyri demonstrated 44–54% complete clearance at day 57 in Phase 3 trials; comparable to 5-FU and imiquimod

Treatment area: The 2024 FDA expansion to 100 cm² makes Klisyri more suitable for larger areas of field cancerization

How medfinder Can Help Your Patients

When patients are struggling to locate Klisyri locally, medfinder for providers is a resource you can share. medfinder calls local pharmacies on the patient's behalf to identify which ones can fill the prescription. This eliminates the burden on your administrative staff and patients, and reduces prescription abandonment.

Also see our dedicated provider guide: How to help your patients find Klisyri in stock.