Promoting HPV Vaccination Against Cervical Cancer in Low- and Middle-Income Countries: A Framework for Budget Impact Analysis and Case Study in China

Abstract Background Human Papillomavirus (HPV) vaccination is an effective preventive measure against cervical cancer. Low- and Middle-Income Countries (LMICs) burdened with a high incidence have not implemented National Immunization Programs (NIP) of HPV vaccines. In the context of limited resources, the economic evidence provided by Budget Impact Analysis (BIA) becomes crucial for the inclusion of vaccines in the NIP. Unfortunately, the main issue contributing to insufficient evidence in LMICs may be that LMICs do not have a complete, referenced, and standardized BIA framework for HPV vaccines to conduct their analyses. This study establishes a BIA framework to promote the immunization of HPV vaccine in LMICs and provides a case study in China. Methods BIA framework for introducing vaccines into immunization programs was developed following the principles of the International Society for Pharmacoeconomics and Outcomes Research. The case study of China estimated the impact of HPV vaccination on BMIS fund in 2019–2110. It postulated differing reimbursement rates and market substitution rates for imported and domestically produced bivalent HPV vaccines. Parameters were derived from public sources, published literature, and a database of field surveys on treatment costs for patients of cervical cancer in China. Outcome indicators encompassed the incidence of cervical cancer, treatment costs of cervical cancer, vaccination costs, and etc. Results The framework consisted of three parts: target population, BIA, and uncertainty analysis, with three scenarios based on vaccine prices and reimbursement rates. In the case of China, without immunization program, the average yearly spent on cervical cancer treatment throughout the country amounts to 6, 736, 507. 32. Upon the execution of the immunization program, this expenditure reduced to 6, 645, 564. 95 each year. Under Scenario 1–3, the BMIS vaccine reimbursement costs were 93, 769, 903. 10, 67, 390, 961. 06, and 88, 374, 244. 91, respectively. During the NIP implementation period, annual vaccination costs range between 0. 06 to 0. 46 parts per million of current fund expenditure and 0. 40 and 2. 25 parts per million of current fund balance. Conclusions This study has developed a BIA framework for HPV vaccination, aiming to provide a reference for policy formulation in other LMICs with a high burden of cervical cancer that have not yet included the vaccine in their NIPs.