Introduction/Background About 30% of women eligible for cervical cancer (CC) screening remain un/under screened in Germany. In Germany, the organised CC screening includes annual Papanicolaou (Pap) cytology for women age 20–34 years and 3-yearly co-testing with human papillomavirus (HPV) and Pap for women age 35 years or older. We systematically evaluated benefits, risks, and cost-effectiveness of offering additionally HPV self-sampling (HPV-SS) to non-attendees.

Methodology A validated Markov model for the German context was used to evaluate additional HPV-SS for non-attendees age 25–65, 30–65 or 35–65 years, every five years with regular invitation, either Opt-in (invitation with link to order test), or Send-to-all (test sent with invitation) compared to standard CC screening alone. German clinical, epidemiological, economic data (indexed 2022/23), along with test accuracy and HPV-SS-attendance data from international meta-analyses and trials were incorporated. Outcomes included undiscounted life-years gained (LYG) per 1000 women compared to standard screening without HPV-SS in non-attendees, and the incremental cost-effectiveness ratio (ICER; in EUR/LYG). Comprehensive sensitivity analyses were conducted to check the robustness of findings.

Results Incremental undiscounted effectiveness per 1000 women (compared to standard screening without HPV-SS) and discounted ICERs (compared to next effective) for non-dominated HPV-SS screening strategies were 0.90 LYG (22,700 EUR/LYG) for offering with five-yearly screening invitation an HPV-SS (Opt-in) to non-attendees age 35–65, 1.659 LYG (25,900 EUR/LYG) for HPV-SS (send-to-all) age 35–65, 1.668 (726,000 EUR/LYG) for HPV-SS (send-to-all) age 30–65, and 1.672 LYG (1,78 mio. EUR/LYG for HPV-SS (send-to-all) age 25–65 years. Other Opt-in strategies were dominated. Results were robust over a wide range of parameter variations.

Conclusion Offering HPV-SS (Send-to-all) to non-attendees every five years as of age 35 as an additional strategy within the organised CC screening program is effective and cost- effective. Findings can be used to inform decision-makers and clinical guideline developers in Germany.

Disclosures This work was performed within the HaSCo Study (Hannoversche Self-Collection-Studie zur Prävention von Gebärmutterhalskrebs Studie) which was funded by the German Cancer Aid (Deutsche Krebshilfe).