AIFA approves the reimbursement of drugs for HIV-1 pre-exposure prophylaxis (PrEP)

With BoD Resolution no. 15 of 26 April 2023, the Italian Medicines Agency admits the indication for reimbursement of the combination Emtricitabine/Tenofovir Disoproxil for "Pre-exposure prophylaxis (PrEP) and in order to reduce the risk of sexually transmitted HIV-1 infection in adults and adolescents at high risk". It is an additional prevention tool for HIV-negative people who have high-risk sexual behavior and it is a measure with a significant impact on public health.  

The Agency therefore accepted the proposal made by the Section for the fight against AIDS of the Health Technical Committee of the Ministry of Health, sharing its general approach, the patient selection criteria and the global management strategy. 

The infectious disease specialist can prescribe the therapy, subjecting it to the compilation of a prescription form which contains the treatment inclusion and exclusion criteria and the main characteristics of the management and monitoring programme. The distribution of the treatment takes place only by the hospital pharmacies. 

The provision will enter into force on the day following its publication in the Official Gazette. 

AIFA approves the reimbursement of drugs for HIV-1 pre-exposure prophylaxis (PrEP)