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

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

Souhrn

Klíčová slova:

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