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New HTA Decisions in Scotland
December 2021
Drug name
KLISYRI® (tirbanibulin)
Almirall Ltd
Decision date
Therapeutic area
Skin conditions
Therapeutic sub area
Skin conditions: general and other
Field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.
Decision Detail
Following a full submission, tirbanibulin (Klisyri®) is accepted for use within NHSScotland.
The key evidence supporting the efficacy and safety of tirbanibulin comes from KX01-AK-003 and KX01-AK-004, which were two identical, multicentre, randomised, double-blind, parallel group, phase III studies. A significantly greater proportion of adults with AK lesions within a contiguous area of 25cm sq. on either the face or scalp (containing four to eight clinically typical, visible, and discrete AK lesions) achieved complete clearance when treated with tirbanibulin 1% ointment compared with vehicle. The submitting company presented a cost-utility analysis evaluating tirbanibulin ointment (Klisyri®) for the field treatment of non-hyperkeratotic, non-hypertrophic AK (Olsen grade 1) of the face or scalp in adults. Comparisons were provided versus diclofenac 3% gel, imiquimod 3.75% (Zyclara®) cream, imiquimod 5% cream, 5-fluorouracil 5% (Efudix®) cream, and 5-fluorouracil 0.5% with salicylic acid 10% (Actikerall®) solution. The company excluded cryotherapy and photodynamic therapy from the analysis following feedback from clinical experts that these treatments were not widely used in Scottish clinical practice. A number of limitations of the economic evaluation were identified such as the following: • The vast majority of cost savings predicted from tirbanibulin stem from a reduction in health care resource use due to a greater number of patients initiating treatment in primary rather than secondary care. These assumptions have been entirely based on clinical expert opinion and there does not appear to be any other data to validate these assumptions. SMC clinical experts were asked to provide their opinion on the reasonableness of the company’s assumptions which provided reassurance to the committee when considering a situation in the long-term once clinicians are familiar with this treatment. • The company had originally excluded photodynamic therapy as a comparator from the analysis but this treatment was mentioned by SMC clinical experts as a potential comparator. The company provided a comparison versus photodynamic therapy upon request, which indicated that tirbanibulin was cost saving versus this comparator. • No data were available to inform the relative effectiveness of tirbanibulin versus any comparator given the vehicle control design of the key clinical studies for this treatment. A Bayesian NMA was therefore carried out to estimate relative effectiveness across all comparators. The width of the credible intervals for achieving complete clearance of AK lesions is large for the majority of comparators, indicating uncertainty in their estimation; if comparator treatments are more effective than tirbanibulin then the economic results will not account for this. • The methods used to derive the health state utility values associated with having AK were non-standard and inconsistent with the preferred approach for submissions to SMC; however, a comparison of the estimated utility gain following complete clearance with other available estimates suggests that the values used by the company are reasonable. Furthermore, given the committee preference for a cost-minimisation analysis, this limitation was of lesser importance. Despite the limitations outlined above, the economic case was demonstrated.