OBJECTIVES: The aim of this analysis was to quantify the advantages and the cost-utility of fentanyl sublingual formulation in terms of pain intensity reduction for each episode of breakthrough cancer pain (BTCP) compared to morphine therapy in Italy.

METHODS: A probabilistic model already proposed by Vissers et al. (2011) was developed for the Italian context considering the NHS perspective. The model compared costs and efficacy of fentanyl sublingual formulation versus immediate-release morphine. Pain Intensity (PI) measured on a numerical scale from 1 to 10 was used as a measure of effectiveness. A reduction in PI in BTCP episodes was translated into cost savings and quality-adjusted life-year gains (QALYs). The costs considered in the model concerned the cost of therapy and other costs related to the use of resources (medical visits and hospitalizations).

RESULTS: The model estimated an overall cost for morphine treatment equal to €1,026.83 with an average of 0.51 QALYs. The use of fentanyl sublingual formulation as an effective treatment of pain prevention, is able to obtain 0.12 incremental QALYs with € 1,441.78 more costs. Combining cost and effectiveness, our analysis estimated an ICER equal to € 11,778.85.

CONCLUSIONS: Considering a willingness to pay threshold as reported by the AIES Guidelines (€ 25,000 - € 40,000), fentanyl sublingual formulation is cost-effective compared to oral morphine.