Cost-Effectiveness Analysis of 4% Fluorouracil for the Treatment of Actinic Keratosis in the Czech Republic

OBJECTIVES: Clinical evidence suggests that 4 % fluoruracil (4-FU) provides benefit in complete clearance of actinic keratosis (AK). Our aim was to assess cost-effectiveness of 4-FU in the treatment of AK in comparison with cryotherapy in the Czech Republic.

METHODS: We developed a two-year decision tree model. The model comprises six possible states: 1)success, 2)non-success, 3)recurrence, 4)no recurrence, 5)retreatment, and 6)no retreatment allowing to undergo first, second and third line of treatment depending on subsequent health state. Direct evidence of probability of success of cryotherapy vs. 4-FU was not available from published literature. It was calculated combining published probability of complete clearance for 4-FU and odds ratio (OR, cryotherapy versus 5% fluoruracil) in published network meta-analysis (NMA). Clinical evidence suggests non-inferiority efficacy of 4 % and 5 % fluoruracil. Probability of success in 4-FU arm was based on published clinical trial. Probabilities of other health states were derived from published clinical trials or relevant evidence. The model projects quality-adjusted life-years (QALYs) and costs from healthcare payers’ perspective. Costs were based on actual list prices and reimbursement tariffs, and previous pharmacoeconomic analyses as of 2015/2016. Utilities were derived from the published literature. Costs and outcomes were discounted by 3%. Results were evaluated at the Czech willingness-to-pay (WTP) threshold is equal to ≈ €48,600(1.2 mil CZK).

RESULTS: Over a two-year time horizon, 4-FU yields additional 0.0100 QALY (1.9532 vs. 1.9433) at the additional total costs of €42.71 (€158.07 vs. €115.36) compared with cryotherapy, with the incremental cost-effectiveness ratio of €6,100. Probability sensitivity analysis (PSA; 3,000 interactions) showed that 4-FU is cost-effective with probability of 66.4 % at the WTP. One-way and scenario sensitivity analyses were also performed.

CONCLUSIONS: 4-FU is a cost-effective therapy for patient with AK. Sensitivity analyses confirmed the robustness of the base-case results.