Costs and cost-effectiveness of LEEP versus cryotherapy for treating cervical dysplasia among HIV-positive women in Johannesburg, South Africa

Abstract

BackgroundCervical cancer incidence is significant in countries, such as South Africa, with high burdens of both HIV and human papillomavirus (HPV). Cervical cancer is largely preventable if dysplasia is diagnosed and treated early, but there is debate regarding the best approaches for screening and treatment, especially for low-resource settings. Currently South Africa provides Pap smears followed by colposcopic biopsy and LEEP if needed in its public health facilities. We estimated the costs and cost-effectiveness of two approaches for treating cervical intraepithelial neoplasia grade 2 or higher (CIN2+) among HIV-infected women, most of whom were taking antiretroviral treatment, at a public HIV treatment facility in Johannesburg, South Africa.MethodsMethod effectiveness was derived from an intention-to-treat analysis of data gathered in a clinical trial completed previously at the study facility. In the trial, women who were diagnosed with CIN2+ and eligible for cryotherapy were randomized to cryotherapy or LEEP. If women were CIN2+ at six months as determined via Pap smear and colposcopic biopsy, all women—regardless of their original treatment assignment—received LEEP. “Cure” was then defined as the absence of disease at 12 months based on Pap smear and colposcopic biopsy. Health service costs were estimated using micro-costing between June 2013 and April 2014. Capital costs were annualized using a discount rate of 3%. Two different service volume scenarios were considered, and results from an as-treated analysis were considered in sensitivity analysis.ResultsIn total, 166 women with CIN2+ were enrolled (86 had LEEP; 80 had cryotherapy). At 12 months, cumulative loss to follow-up was 12.8% (11/86) for the LEEP group and 13.8% (11/80) for cryotherapy. Based on the unadjusted intention-to-treat analysis conducted for this economic evaluation, there was no significant difference in efficacy. At 12 months, 83.8% (95% CI 73.8–91.1) of women with CIN2+ at baseline and randomized to cryotherapy were free of CIN2+ disease. In contrast, 76.7% (95% CI 66.4–85.2) of women assigned to LEEP were free from disease. On average, women initially treated with cryotherapy were less costly per patient randomized at US$ 118.00 (113.91–122.10), and per case “cured” at US$ 140.90 (136.01–145.79). Women in the LEEP group cost US$ 162.56 (157.90–167.22) per patient randomized and US$ 205.59 (199.70–211.49) per case cured. In the as-treated analysis, which was based on trial data, LEEP was more efficacious than cryotherapy; however, the difference was not significant. Cryotherapy remained more cost-effective than LEEP in all sensitivity and scenario analyses.ConclusionsFor this cost-effectiveness analysis, using an intention-to-treat approach and taking into consideration uncertainty in the clinical and cost outcomes, a strategy involving cryotherapy plus LEEP if needed at six months was dominant to LEEP plus LEEP again at six months if needed for retreatment. However, compared to other studies comparing LEEP and cryotherapy, the eff...

Efficacy, acceptability and safety of ablative versus excisional procedure in the treatment of histologically confirmed CIN2/3: A systematic review

“…Table S1 shows the characteristics of the four eligible trials included in the current review 13‐18 . The studies included a total of 1165 women with a diagnosis of CIN2/3 on histopathology.…”

“…The South African RCT observed cryotherapy to be more cost‐effective, with an incremental cost effectiveness ratio (ICER) per disease‐free case of $497.85 18 . In an intention‐to‐treat analysis, cryotherapy was less costly than LLETZ.…”

REBACIN® is an optional intervention for persistent high‐risk human papillomavirus infection: A retrospective analysis of 364 patients

“…With regard to the results of the HPV DNA typing test, the rate of efficacy was defined as the rate of clearance of more than one type of HPV, whereas with regard to the results of the HC2 hrHPV DNA test, it was defined as the rate at which more than 25% of the hrHPV load decreased 12–15 …”

The Value of Different Types of Economic and Budget Analysis for Informing Real World Decision Making: the Case of Cervical Cancer Screening in South Africa

“…We obtained provider cost and health care utilization data for these strategies from published cost-effectiveness studies conducted at the same sites and in parallel with the clinical trials mentioned above (21,22). Personnel, consumables, equipment and laboratory costs were included, but building costs were excluded.…”