An Italian cost-utility analysis of 20-valent pneumococcal conjugate vaccine for routine vaccination in infants.

Background: Streptococcus pneumoniae represents a significant global public health threat, causing approximately 45 million lower respiratory tract infections and 350,000 deaths annually among children under 5 years of age. Conjugate pneumococcal vaccines (PCVs), such as PCV15 and PCV20, have been developed to mitigate this burden by providing protection against serotypes responsible for the disease. The present analysis aims to evaluate the cost-utility of PCV20 compared to PCV15 as a vaccination strategy for preventing pneumococcal diseases in children in Italy.

Methods and materials: A cost-utility analysis (CUA) was conducted using a static Markov model adapted to the Italian context to simulate the economic and clinical effects of vaccination over a 10-year time horizon. The study adopted the perspective of the Italian National Health Service (NHS), considering only direct healthcare costs. Deterministic and probabilistic sensitivity analyses were performed to explore parameter uncertainty.

Results: The model showed that PCV20 is a dominant strategy compared to PCV15, generating cost savings of €6.45 million and a gain of 101,708 QALYs (quality-adjusted life years). These benefits are attributed to PCV20's broader serotype coverage, which significantly reduces the incidence of invasive and non-invasive pneumococcal diseases. Vaccination with PCV20 offers substantial clinical and economic advantages over PCV15.

Conclusions: The introduction of PCV20 as a vaccination strategy for children in Italy represents a cost-effective and clinically advantageous option. Its implementation can reduce the burden of pneumococcal disease and associated healthcare costs, improving public health outcomes and the economic efficiency of the healthcare system.