Abstract
Introduction: The use of oral FTC/TDF for pre-exposure prophylaxis (PrEP) among high-risk people without HIV is emerging as an innovative strategy to decrease HIV epidemic. The study aims at evaluating the implications related to PrEP introduction, from a multidimensional point of view, with particular attention to the sustainability of its implementation. Methods: To achieve this objective a Health Technology Assessment was conducted, within 35 Italian Infectious Disease Departments. Data were collected from literature review and using validated questionnaires and literature evidence. The introduction of PrEP (applied as "add-on" and "substitute" prevention strategy) into the clinical practice was compared with a baseline scenario (use of condoms among men who have sex with men and serodiscordant couples, and the use of Needle Syringe Programme among injection drugs users). Results: Despite the improvement in patients’ quality of life, PrEP would generate a decrease of patient safety, and an increase in staff workflow, with investment in medical supplies and training courses. PrEP would lead to significant economic investments both for the NHS, and for citizens (40% and 2,377% respectively) if used as an add-on strategy, assuming FTC/TDF patent cost. With the off-patent drug, the NHS would benefit from an advantage (37%) and a shrink of the patients' expenditure emerged (+682%). More economic resources are required if PrEP is applied as a substitute strategy, considering both the patent (NHS: 212%; citizens: 3,423%) and the off-patent drug (NHS: 73%; citizens: 1,077%). Conclusions: The most cost-containing strategy would be the use of PrEP, as an add-on strategy, assuming the off-patent drugs, even if safety and organisational aspects would be deeply considered.
