OBJECTIVES:

Specific immunotherapy (SIT), either subcutaneous (SCIT) or sublingual (SLIT), is an allergen-oriented immunomodulation. It consists in administrating increasing doses of the sensitizing allergen, to induce tolerance or “desensitization”. Nonetheless, the usefulness of SLIT in paediatric asthma is still matter of debate due to sporadic studies, a non-rigorous methodology, the lack of a real assessment of costs associated. The aim of our study was to evaluate the efficacy of SLIT vs Placebo in term of QoL and the related costs in children with allergic asthma measured under the usual circumstances of health care practice.

METHODS:

A 24-month, multicentre, prospective, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability, and cost-effectiveness of SLIT in combination with asthma SoC in children and adolescents in 8 Italian Centres.The NHS, the patient and the society perspectives have been considered. QoL has been assessed considering activity limitation; emotional problems and the global PACQLQ score. QALY has not been assessed since results from mapping disease specific and generic questionnaires’ were still not available. Simulation considered: a 1,000 patient cohort, assessed unit costs and a time discrete Markov model with a discount rate of 3.5%.Transition probabilities come from transition rates by assessing the exponential matrix of a Kolmogorov model of patient condition evolution.

RESULTS:

Total costs from the NHS, patient, and society perspectives of 1,000 patients are €1,201,534.12, €1,030.42, €1,880,004.15 respectively for the control group, and €1,316,556.09; €0.00; €1,399,226.49 for the study group. QoL shows a higher mean in the study than in the control group. Differences of emotional problem and PACQL scores assessed before and after randomization are not statistically different in the two groups.

CONCLUSIONS:

With comparable QoL, SLIT induces an increasing of direct costs but a reduction of societal costs because of a reduction in out-of-pocket expenses and indirect costs.