9-valent Human Papillomavirus (HPV) Recombinant Vaccine (Hansenula Polymorpha)(Shanghai Bovax Biotechnology)

The Japanese 2020 cervical screening guidelines recommend conventional cervical cytology screening every 2-years for women aged 20-69 years. The nonavalent human papillomavirus (HPV) vaccine has also recently been approved in Japan. We therefore evaluated the cost-effectiveness of cervical cancer screening strategies alongside universal nonavalent HPV vaccination of girls (12-16 years).

A cost-effectiveness analysis was performed using an age-specific Markov microsimulation model for Japan to evaluate total costs, quality adjusted life-years (QALYs) gained, incremental cost-effectiveness ratios (ICER), colposcopies, biopsies, precancer and cervical cancer treatments for 29 combined vaccination and screening strategies (conventional cytology, liquid-based cytology (LBC), HPV testing, and HPV self-collection). A cohort of 100,000 girls (12-16 years old) over a lifetime offered the nonavalent HPV vaccine was used (current vaccination coverage = 0.08%, current screening coverage = 43.7%). A discount rate of 3% was applied to costs and QALYs. Univariate and probabilistic sensitivity analysis was performed to assess robustness of the findings. Costs were reported in US dollars (2023).

Compared with conventional cytology, evaluated strategies would incur an additional cost of US$839,280-738,182,669 and gain 62,755-247,347 quality-adjusted-life-years. HPV testing distinguishing HPV16/18 with reflex LBC (3-yearly) would be most cost-effective (ICER = US$7511 per QALY gained). At a willingness-to-pay (WTP) of 1-times gross domestic product (GDP) per capita, the probability of it being cost-effective was 70%. At historically high vaccination coverage (70%) ICERs decreased overall but did not affect the ranking of the most cost-effective strategy. While a 5-yearly interval became more cost-effective than a 3-yearly interval. Including HPV self-collection for under-screened women made all strategies more cost-effective.

At current cervical screening participation (43.7%) and low vaccination coverage (<1.0%), HPV testing distinguishing HPV16/18 with reflex LBC (3-yearly) would be the most cost-effective screening strategy compared to conventional cytology (2-yearly).

Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (17H03589) and Grants of the National Cancer Center Japan (Gan Kenkyu Kaihatsuhi 31-A-20 and 2023-A-23).

Human papillomavirus (HPV) vaccines represent an important strategic opportunity to prevent cervical cancer in low‐middle income countries, such as India. The economic evaluation of HPV vaccines is crucial to inform public‐health decisions; however, the scarce economic evaluations from India have focused on the value for money of bivalent vaccines and took a healthcare perspective. The aim of this study is to conduct a cost‐effectiveness analysis of all available HPV vaccines in India.

The Papillomavirus Rapid Interface for Modelling and Economics (PRIME) model was used to evaluate the cost‐effectiveness of HPV vaccination of 12‐year‐old girls in India, from both healthcare and societal perspectives. Cervical cancer cases, deaths averted and the incremental cost per Disability Adjusted Life Years (DALY) averted were reported as primary outcomes. Sensitivity analysis was undertaken to handle any uncertainty or variability in the results.

Compared with no vaccination, the incremental cost per DALY averted was USD 362.78 for nonavalent vaccine, USD 393.16 for quadrivalent vaccine and USD 432.24 for bivalent vaccine from a healthcare perspective. From a societal perspective, the incremental cost per DALY averted was USD 334.28 for nonavalent vaccine, USD 364.67 for quadrivalent vaccine and USD 403.75 for bivalent vaccine. Assuming constant prices per dose for all vaccines, the nonavalent vaccine dominated both quadrivalent and bivalent vaccines, indicating that it is the more cost‐effective strategy.

Vaccinating girls against HPV is a cost‐effective strategy to reduce the incidence of cervical cancer and mortality due to cervical cancer in India.