gms | German Medical Science

Introduction: In Germany, about 30% of eligible women for cervical cancer (CC) screening do not participate in this organized national early detection program, regularly. Offering self-sampling for human papillomavirus (HPV) screening in addition to the organized CC screening with annual Papanicolaou (Pap) cytology for women in the age of 20-34 years and 3-yearly co-testing with HPV plus Pap for women as of age 35 years may be beneficial and cost effective. We conducted a systematic decision-analytic comparative evaluation of the long-term health impact and cost-effectiveness of introducing HPV self-sampling (HPV-SS) as an additional option for non-participants and compared different HPV-SS variants.

Methods: A validated Markov state-transition model for the German context was used to evaluate eight different screening HPV-SS strategies compared to standard clinician-based screening including HPV-SS for non-participants in the age ranges 25-65, 30-65 or 35-65 years, every five years with regular invitation, either opt-in (invitation with link to order the test) or send-to-all (test sent with invitation). German clinical, epidemiological, economic data (index year 2023), along with test accuracy and HPV-SS-participation data from international meta-analyses and trials were incorporated. Reported outcomes included undiscounted life-years gained (LYG) per 100,000 women compared to standard screening without HPV-SS in non-participants, and the incremental cost-effectiveness ratio (ICER; in EUR/LYG). Comprehensive sensitivity analyses were performed to check the robustness of findings.

Results: Incremental undiscounted effectiveness per 100,000 women (compared to standard screening without HPV-SS) and discounted ICERs (compared to next effective) for non-dominated HPV-SS screening strategies were 89.6 LYG (22,700 EUR/LYG) for offering with five-yearly screening invitation an HPV-SS (opt-in) to non-participants age 35-65, 165.9 LYG (25,900 EUR/LYG) for HPV-SS (send-to-all) age 35-65, 166.8 (726,000 EUR/LYG) for HPV-SS (send-to-all) age 30-65, and 167.2 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.

Discussion: Based on our results, screening offered with HPV-SS every five years for women who do not participate in the established screening can be considered more effective in terms of life-years gained compared to the established organized screening alone performed by medical personnel and may be cost effective in the context of the German screening program. We have assessed a number of HPV-SS variants, however, not all possible strategies for implementing HPV-SS within the established screening program have been considered. Therefore, further research should include additional relevant strategies with different age limits (start and end), intervals or target populations for HPV-SS to assess the impact on health effects and costs. In addition, quality-of-life data may be included in further analyses.

Conclusion: Offering HPV-SS every five years as of age 35 (send-to-all) to women not participating in the organized national screening program as an additional strategy within the organized cervical cancer screening program is effective and cost-effective in the German healthcare context. Findings can be used to inform decision makers and developers of S3 clinical guideline regarding the specific version of HPV self-sampling into established organized cervical cancer screening program in Germany.

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