A pharmacoeconomic evaluation of seven-valent pneumococcal conjugate vaccine in Spain

Background: Streptococcus pneumoniae is a leading cause of illness in children. Seven-valent pneumococcal conjugate vaccine (PCV-7), recently approved in the United States, is the first vaccine to provide protective immunity against pneumococcal disease in children under the age of 2. PCV-7 is nearly 100% effective in preventing invasive pneumococcal infections and has been shown to significantly decrease the incidence of pneumonia and otitis media. Objective: The objective of this study was to evaluate the health outcomes, costs, and cost-effectiveness of vaccination with PCV-7, compared with no vaccination for children in Spain. Methods: A health state model was used to determine the health and economic outcomes in vaccinated and unvaccinated groups among children less than 5 years old. This analysis was conducted for a 10-year time horizon, beginning with initial vaccinations. Information on the burden of pneumococcal disease, in terms of data on the incidence and seroprevalence of disease, was collected from published and unpublished records, supplemented, and verified by Spanish pediatric and infectious disease experts. The efficacy of PCV-7 was based on updated findings of the Kaiser Permanente Efficacy Study. A cost-of-illness estimate for each pneumococcal disease was determined using decision tree analysis that considered direct and indirect costs. A birth cohort analysis compared the expected cost of vaccinated populations to age-matched unvaccinated populations. Results: Implementing a PCV-7 vaccine program in Spain in a birth cohort of 360,000 is expected to save approximately 16 lives and 132,000 cases of pneumococcal disease over 10 years, resulting in total savings estimated at 81 million (ESP13.5 billion), of which 43.5 million (ESP7.1 billion) are direct medical savings. At a vaccine cost up to 56.87 per dose (ESP9,462, the total cost of vaccinating a birth cohort of 360,000 will be offset by the total savings owing to reduced morbidity. Conclusions: Implementing a universal PCV-7 vaccination program in Spain will significantly decrease the mortality and morbidity associated with pneumococcal infections in young children. At an assumed cost of 48.56 (ESP8,080) per dose, PCV-7 vaccination of Spanish children under the age of 5, followed over a 10-year period, is cost saving from the societal perspective and cost-effective from the payer perspective at 22,500 per LYG (ESP3,734,713), comparing favorably with other preventive programs in Spain.