Clinical evaluation and budget impact analysis of cervical cancer screening using cobas 4800 HPV screening technology in the public sector of South Africa

English version

Autoři: Greta Dreyer ^aff001; Christopher Maske ^aff005; Marthinus Stander ^aff006
Působiště autorů: Faculty of Health Sciences, University of Pretoria, Gauteng, South Africa ^aff001; Department Obstetrics & Gynaecology, University of Pretoria, Gauteng, South Africa ^aff002; South African Society of Obstetrics and Gynaecological Oncology, Gauteng, South Africa ^aff003; South African Society of Gynaecologic Oncology, Gauteng, South Africa ^aff004; QLAB Incorporated, Parkhurst, Gauteng, South Africa ^aff005; TCD Outcomes Research (Pty) Ltd, Gauteng, South Africa ^aff006
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pone.0221495

Souhrn

Cytology remains the mainstay of cervical cancer screening in South Africa (SA), however false negative rates are 25–50%. In contrast, human papillomavirus (HPV) screening techniques have higher sensitivity for cervical cancer precursors. The cobas® 4800 HPV test detects pooled high-risk HPV types and individual genotypes HPV 16 and 18. Using a mathematical budget impact model, the study objective was to evaluate the clinical and budget impact of replacing primary liquid-based cytology (LBC) with primary HPV-based screening strategies. In SA, current LBC screening practice recommends one test every ten years, followed by large loop excision of the transformation zone (LLETZ) if indicated. HPV testing can be performed from an LBC sample, where no additional consultations nor samples are required. In the budget impact model, LBC screening for 2 cycles (one test every ten years) was compared to cobas® 4800 HPV test for 2 cycles (one test every 5 years). The model inputs were gathered from literature and primary data sources. Indicative prices for LBC and cobas® 4800 HPV test were R189 and R457, respectively. Model results indicate that best outcomes for detection of disease were seen using cobas® 4800 HPV test. Forty-eight percent of cervical cancer cases were detected compared to 28% using LBC, and 50% of cervical intraepithelial neoplasia (CIN) 2 and CIN3 cases, compared to 25% with LBC. The budget impact analysis predicted that the cost per detected case of CIN2 or higher would be R 56,835 and R46,980 for the cobas® 4800 HPV and LBC scenarios, respectively. This equates to an incremental cost per detected case of CIN2 or higher of R9 855. From this model we conclude that a primary HPV screening strategy will have a significant clinical impact on disease burden in South Africa.

Klíčová slova:

Biology and life sciences – Cell biology – Organisms – Medicine and health sciences – Microbiology – Medical microbiology – Microbial pathogens – Pathology and laboratory medicine – Pathogens – Health care – Diagnostic medicine – Infectious diseases – Viral pathogens – Viruses – Public and occupational health – Urology – Oncology – Cancers and neoplasms – DNA viruses – Viral diseases – Papillomaviruses – Human papillomavirus – Cytology – Cancer detection and diagnosis – Cancer screening – Gynecological tumors – Cervical cancer – Genitourinary infections – Human papillomavirus infection – Sexually transmitted diseases – Health care policy – Screening guidelines – Health screening

Zdroje

1. South African National Cancer Registry. Cancer in South Africa: 2012. [Internet], (2014) Johannesburg [Accessed 1 June 2019] Available from: http://www. nicd.ac.za/index.php/centres/national-cancer-registry/

2. Adamson P, Huchko M, Moss A, Kinkel H, Medina-Marino A. Acceptability and Accuracy of Cervical Cancer Screening Using a Self-Collected Tampon for HPV Messenger-RNA Testing among HIV-Infected Women in South Africa. PLOS ONE. 2015;10(9):e0137299. doi: 10.1371/journal.pone.0137299 26332236

3. Firnhaber C, Van Le H, Pettifor A, Schulze D, Michelow P, Sanne I et al. Association between cervical dysplasia and human papillomavirus in HIV seropositive women from Johannesburg South Africa. Cancer Causes & Control. 2009;21(3):433–443.

4. Dreyer G. (2017). General population screening study & VACCS2 GP. Unpublished raw data

5. McDonald A, Tergas A, Kuhn L, Denny L, Wright T. Distribution of Human Papillomavirus Genotypes among HIV-Positive and HIV-Negative Women in Cape Town, South Africa. Frontiers in Oncology. 2014;4

6. Vesco KK, Whitlock EP, Eder M, Burda BU, Senger CA, Lutz K. Risk factors and other epidemiologic considerations for cervical cancer screening: a narrative review for the US preventive services task force. Ann Intern Med, 2011; 155: 698–705. doi: 10.7326/0003-4819-155-10-201111150-00377 22006929

7. Guideline Document Cervical Cancer Screening in South Africa. The South African Society of Obstetricians and Gynaecologists. (2015). Available at: http://www.sasog.co.za/images/SASOG_screening_for_cervical_cancer_November_final.pdf

8. Arbyn M, Anttila A, Jordan J, Ronco G, Schenk U, Segnan N et al. European guidelines for quality assurance in cervical cancer screening. 2nd ed. Luxembourg; 2008

9. Mayrand MH, Duarte-Franco E, Rodrigues I, Walter SD, Hanley J, Ferenczy A, et al. Human papillomavirus DNA versus Papanicolaou screening tests for cervical cancer. N Eng J Med. 2007; 357: 1579–1588

10. South African HPV Advisory Board, Cervical cancer and human papillomavirus: South African guidelines for screening and testing. South Afr J Gynaecol Oncol 2010; 2 (1):23–26

11. Cobas® HPV. Accessed on: 6 July 2019. Accessed from: https://diagnostics.roche.com/global/en/products/params/cobas-hpv.html

12. Cancer Screening—Medical Services Advisory Committee recommendations [Internet]. Cancerscreening.gov.au. 2013 [cited 10 November 2016]. Available from: http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/MSAC-recommendations.

13. Statistics South Africa. Mid-year population estimates 2018. P0302. July 2018

14. Wright T, Huang J; Baker E, Garfield S, Hertz D, Cox JT. The Budget Impact of Cervical Cancer Screening Using HPV Primary Screening. Am J Manag Care. 2016;22(3):e95–e105. 26978241

15. Council for Medical Schemes Annual Report 2015/2016.

16. Statistics South Africa. Mid-year population estimates 2016. P0302. August 2016.

17. Chetty-Makkan CM, Fielding K, Feldblum PJ, Price MA, Kruger P, Makkan H, et al. (2014) Pregnancy Incidence and Correlates in a Clinical Trial Preparedness Study, North West Province South Africa. PLoS ONE 9(5): e95708. doi: 10.1371/journal.pone.0095708 24802651

18. Bruni L, Barrionuevo-Rosas L, Albero G, Serrano B, Mena M, Gómez D, Muñoz J, Bosch FX, de Sanjosé S. ICO Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in South Africa. Summary Report 15 December 2016.

19. Goldhaber-Fiebert JD, Denny LA, De Souza M, Kuhn L, Goldie SJ (2009) Program Spending to Increase Adherence: South African Cervical Cancer Screening. PLoS ONE 4(5): e5691. doi: 10.1371/journal.pone.0005691 19492097

20. Richter K., Becker P, Horton A, & Dreyer G. 2013 Mar 1. A. Age-specific prevalence of cervical human papillomavirus infection and cytological abnormalities in women in Gauteng Province, South Africa Afr Med J 2013;103(5):313–317.

21. Census 2011: Census in brief (PDF). Pretoria: Statistics South Africa. 2012. p. 18. ISBN 9780621413885. Archived (PDF) from the original on 13 May 2015.

22. HIV and AIDS in South Africa. AVERT global information and education on HIV and AIDS. Accessed on 17 March 2017. Available from: https://www.avert.org/professionals/hiv-around-world/sub-saharan-africa/south-africa

23. Castle PE, Stoler MH, Wright TC Jr, Sharma A, Wright TL, Behrens CM. Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study. Lancet Oncol 2011; 12: 880–90. August 23, 2011. doi: 10.1016/S1470-2045(11)70188-7 21865084

24. Cox JT, Castle PE, Behrens CM, Sharma A, Wright TC Jr, Cuzick J, et al. Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing, and genotyping for HPV 16/18: results from the ATHENA HPV study. Am J Obstet Gynecol 2012.

25. Mbulawa ZZA, Coetzee D, Williamson A. Human papillomavirus prevalence in South African women and men according to age and human immunodeficiency virus status. BMC Infectious Diseases (2015) 15:459 doi: 10.1186/s12879-015-1181-8 26502723

26. South Africa Human Papillomavirus and Related Cancers, Fact Sheet 2016 (2016-12-15). ICO Information Centre on HPV and Cancer. Accessed on: 14 March 2017. Available from: http://www.hpvcentre.net/statistics/reports/ZAF_FS.pdf.

27. Li X, Stander MP, Van Kriekinge G, Demarteau N. Cost-effectiveness analysis of human papillomavirus vaccination in South Africa accounting for human immunodeficiency virus prevalence. BMC Infectious Diseases (2015) 15:566 doi: 10.1186/s12879-015-1295-z 26652918

28. Khan MJ, Castle PE, Lorincz AT, Wacholder S, Sherman M, Scott DR, et al. The Elevated 10-Year Risk of Cervical Precancer and Cancer in Women With Human Papillomavirus (HPV) Type 16 or 18 and the Possible Utility of Type-Specific HPV Testing in Clinical Practice, JNCI: Journal of the National Cancer Institute, Volume 97, Issue 14, 20 July 2005, Pages 1072–1079, https://doi.org/10.1093/jnci/dji187

29. Myers ER, McCrory DC, Nanda K, Bastian L, Matchar DB. Mathematical model for the natural history of human papillomavirus infection and cervical carcinogenesis. Am J Epidemiol. 2000 Jun 15;151(12):1158–71 10905528

30. Kataja V., Syrjänen K., Mäntyjärvi R. Väyrynen, M, Syrjänen, S, Saarikoski, S et al. Prospective follow-up of cervical HPV infections: Life table analysis of histopathological, cytological and colposcopic data. Eur J Epidemiol (1989) 5: 1. https://doi.org/10.1007/BF00145037 2540024

31. Holowaty P, Miller AB, Rohan T, To T. Natural History of Dysplasia of the Uterine Cervix, JNCI: Journal of the National Cancer Institute, Volume 91, Issue 3, 3 February 1999, Pages 252–258, https://doi.org/10.1093/jnci/91.3.252 10037103

32. Firnhaber C, Goeieman B, Faesen M, Levin S, Williams S, Rameotshela S, et al. (2016) Prospective One Year Follow Up of HIV Infected Women Screened for Cervical Cancer Using Visual Inspection with Acetic Acid, Cytology and Human Papillomavirus Testing in Johannesburg South Africa. PLoS ONE 11(1): e0144905. doi: 10.1371/journal.pone.0144905 26730710

33. Mbulawa ZZA, Marais DJ, Johnson LF, Coetzee D, Williamson A-L. Impact of human immunodeficiency virus on the natural history of human papillomavirus genital infection in South African men and women, J Infect Dis, 2012, vol. 206 (pg. 15–27).

34. Sanders GD, Taira AV. Cost-effectiveness of a potential vaccine for human papillomavirus. Emerg Infect Dis 2003;9(1):37–48. doi: 10.3201/eid0901.020168 12533280

35. Denny L, Boa R, Williamson AL, Allan B, Hardie D, Stan R, et al. Human papillomavirus infection and cervical disease in human immunodeficiency virus-1-infected women. Obstet Gynecol. 2008 Jun;111(6):1380–7. doi: 10.1097/AOG.0b013e3181743327 18515522

36. Firdousi K, Van Gelderen C, McIntyre J, Michelow P, Turton D, Adam Y. Cervical intra-epithelial neoplasia in HIV-positive women after excision of transformation zone–does the grade change?. South African Medical Journal, [S.l.], v. 102, n. 9, p. 757–760, Aug. 2012. ISSN 2078-5135. Available at: <http://www.samj.org.za/index.php/samj/article/view/5050/4423>. Date accessed: 23 Mar. 2017. doi: 10.7196/SAMJ.5050 22958700

Clinical evaluation and budget impact analysis of cervical cancer screening using cobas 4800 HPV screening technology in the public sector of South Africa

Souhrn

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