Cost-effectiveness of Including p16/Ki-67 Dual Staining in the Detection of Cervical Lesions in Colombia, 2024

Objectives: To assess the cost-effectiveness of incorporating p16/Ki-67 dual-stain cytology into cervical cancer screening protocols compared to the standard diagnostic pathway in Colombia. Material and methods: A decision-tree model was developed from the healthcare provider perspective, using real-world data and scientific evidence. The primary outcome was the number of invasive procedures avoided. Deterministic and probabilistic sensitivity analyses were performed to address uncertainty. Results: Incorporating p16/Ki-67 dual-stain cytology proved to be a dominant strategy, significantly reducing unnecessary colposcopies and biopsies and generating cost savings (–COP $80 million for women aged 25 to 29 and –COP $54 million for women aged 30 to 65). Sensitivity analyses confirmed model robustness. Conclusions: The cost-effectiveness analysis suggests the advisability of incorporating the p16/Ki-67 dualstaining test into cervical cancer screening protocols, as it reduces unnecessary examinations and improves resource allocation. Studies are needed that evaluate the performance of screening tests in the local context and that incorporate morbidity and mortality outcomes to assess hard outcomes over a longer time horizon.