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Showing content from https://pubmed.ncbi.nlm.nih.gov/39230793/ below:

The impact of Germany's human papillomavirus immunization program on HPV-related anogenital diseases: a retrospective analysis of claims data from statutory health insurances

Affiliations

• ¹ Center for Observational and Real-World Evidence, Merck & Co., Inc., Rahway, NJ, 07065, USA. elizabeth.goodman@merck.com.
• ² Global Medical and Scientific Affairs, MSD Sharp & Dohme GmbH, Levelingstr. 4a, 81673, Munich, Germany.
• ³ EU Real World Evidence, Xcenda GmbH, Lange Laube 31, 30159, Hanover, Germany.
• ⁴ Department of Market Access, MSD Sharp & Dohme GmbH, Levelingstr. 4a, 81673, Munich, Germany.
• ⁵ Department of Health Economics and Health Care Management, Bielefeld School of Public Health, Bielefeld University, Universitätsstraße 25, 33615, Bielefeld, Germany.
• ⁶ Department of Gynecology and Obstetrics, University Hospital of Düsseldorf, Moorenstrasse 5, 40225, Düsseldorf, Germany.

• PMID: 39230793
• PMCID: PMC11485141
• DOI: 10.1007/s00404-024-07692-y

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Elizabeth Goodman et al. Arch Gynecol Obstet. 2024 Nov.

• ¹ Center for Observational and Real-World Evidence, Merck & Co., Inc., Rahway, NJ, 07065, USA. elizabeth.goodman@merck.com.
• ² Global Medical and Scientific Affairs, MSD Sharp & Dohme GmbH, Levelingstr. 4a, 81673, Munich, Germany.
• ³ EU Real World Evidence, Xcenda GmbH, Lange Laube 31, 30159, Hanover, Germany.
• ⁴ Department of Market Access, MSD Sharp & Dohme GmbH, Levelingstr. 4a, 81673, Munich, Germany.
• ⁵ Department of Health Economics and Health Care Management, Bielefeld School of Public Health, Bielefeld University, Universitätsstraße 25, 33615, Bielefeld, Germany.
• ⁶ Department of Gynecology and Obstetrics, University Hospital of Düsseldorf, Moorenstrasse 5, 40225, Düsseldorf, Germany.

• PMID: 39230793
• PMCID: PMC11485141
• DOI: 10.1007/s00404-024-07692-y

Item in Clipboard

Purpose: Human papillomavirus (HPV) is the most common sexually transmitted infection, responsible for multiple HPV-related diseases, including almost all cervical cancers. The highly effective HPV vaccination has been recommended under the German HPV national immunization program (NIP) since 2007 and is reimbursed by health insurances. Vaccination uptake rates, however, remain suboptimal and data on the real-world impact of HPV vaccination in Germany are lacking. This study aims to demonstrate the population-level impact of Germany's NIP on HPV-related anogenital diseases among young women.

Methods: Retrospective claims data analysis using a classic impact study design comparing disease prevalence among 28- to 33-year-old women before and after introduction of the HPV-immunization program in Germany. Claims data representing approximately two thirds of German health insurances were used. HPV-related disease outcomes included cervical cancer and high grade precancers (cervical intraepithelial neoplasia (CIN) 2+), anogenital warts, as well as vulvar, vaginal, and anal precancer/cancer.

Results: Significant declines were seen for CIN2+, anogenital warts, and vaginal precancer/cancer. Prevalence of CIN2+ declined 51.1% from 0.92% (95% CI = 0.78%, 1.08%) to 0.45% (95% CI = 0.38%, 0.53%). There was a 38.6% decline in anogenital warts prevalence from 0.44% (95% CI = 0.36%, 0.54%) to 0.27% (95% CI = 0.22%, 0.32%) and 75.0% decline in vaginal precancer/cancer prevalence from 0.04% (95% CI = 0.02%, 0.07%) to 0.01% (95% CI = 0.00%, 0.02%).

Conclusion: The German HPV-immunization program has led to significant declines in female anogenital disease among young women in Germany, highlighting the importance of the vaccination. Moreover, the data suggest that increasing vaccination coverage in Germany could further strengthen the public-health impact of its HPV-immunization program.

Keywords: Cervical intraepithelial neoplasia (CIN); Claims data analysis; Genital warts; Germany; HPV vaccination; Human papillomavirus (HPV).

© 2024. Merck & Co., Inc., Rahway, NJ, USA and its affiliates & Monika Hampl 2024.

PubMed Disclaimer

EG is employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. MR and AL are full-time employees of MSD Sharp & Dohme GmbH. TV and CJ are full-time employees of Xcenda GmbH, acting as contractors of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA for the execution of this study and the writing of the manuscript. WG received personal fees from Xcenda GmbH during the conduct of the study. MH received honoraria as speaker and member of medical advisory boards from MSD Sharp & Dohme GmbH.

Study design with observation periods…

Study design with observation periods and vaccination program related timelines. Pre-VR cohort is…

Study design with observation periods and vaccination program related timelines. Pre-VR cohort is shown in green and post-VR cohort in blue. The peri-VR cohort used for sensitivity analyses, is shown in pink, ages for vaccination per the STIKO recommendation (12–17 years) are shown in a solid darker bar. Ages for catch-up vaccination (18–26 years) are show in lighter bars. Periods for which cohorts are available in the Ingef database and 28–30 years old are shown in yellow. Periods for which cohorts are available in the InGef database and 32–33 years old are shown in orange

Annualized prevalence of CIN2 +,…

Annualized prevalence of CIN2 +, anogenital warts, vaginal precancer/cancer, and vulvar precancer/cancer: Prevalence…

Annualized prevalence of CIN2 +, anogenital warts, vaginal precancer/cancer, and vulvar precancer/cancer: Prevalence estimates, associated 95% CIs and p-values for relevant group comparisons are presented for the different anogenital diseases

• Population-level impact and herd effects following the introduction of human papillomavirus vaccination programmes: updated systematic review and meta-analysis.

  Drolet M, Bénard É, Pérez N, Brisson M; HPV Vaccination Impact Study Group. Drolet M, et al. Lancet. 2019 Aug 10;394(10197):497-509. doi: 10.1016/S0140-6736(19)30298-3. Epub 2019 Jun 26. Lancet. 2019. PMID: 31255301 Free PMC article.

• Burden of HPV related anogenital diseases in young women in Germany - an analysis of German statutory health insurance claims data from 2012 to 2017.

  Reuschenbach M, Mihm S, Wölle R, Schneider KM, Jacob C, Braun S, Greiner W, Hampl M. Reuschenbach M, et al. BMC Infect Dis. 2020 Apr 22;20(1):297. doi: 10.1186/s12879-020-05002-w. BMC Infect Dis. 2020. PMID: 32321435 Free PMC article.

• Estimates of the timing of reductions in genital warts and high grade cervical intraepithelial neoplasia after onset of human papillomavirus (HPV) vaccination in the United States.

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