Abstract
The presence of both P16INKa and KI-67 in cervical tissue indicates HPV infections, as well as precursor and cancerous lesions, given which they can be used as a complementary test to Papanicolau. Additionally, while in Papanicolau the patient needs negative results for three years, with these biomarkers the patient only needs one negative result. A complete economic evaluation of the immunocytochemistry test for the simultaneous qualitative detection of proteins P16INKa and KI-67 (CINtec PLUS Cytology Kit®) in cervical tissue was carried out from the payer perspective, to evaluate the cost-effectiveness of this test in comparison to the available alternatives in the National Formulary. A decision tree approach was used to determine the flow of women through the screening algorithm; then, a markov model was used to evaluate disease progression of those with a diagnosis of CIN3 or cervical cancer, selected from the first model. The efficacy of the alternatives was obtained from a meta-analysis developed from a systematic review. Cost are expressed in Mexican pesos. The time horizon was 3 years with a discount rate of 5%. Deterministic and probabilistic sensitivity analysis were performed on the variables that could generate uncertainty. CINtec PLUS Cytology Kit® showed higher effectiveness than its comparator (standard monitoring) in detecting lesions CIN2 with a cost-saving of $1,852.00 and an extra effectiveness of 0.03. In cases where cervical cancer was detected, CINtec™ PLUS Cytology Kit also showed a higher effectiveness in the prompt detection (incremental effectiveness of 0.14) and a cost-saving per patient of $1,678.70. Tornado diagram showed that the costs of routine visits are the ones that affect most the results. The immunocytochemistry test CINtec PLUS Cytology Kit® for the simultaneous detection of proteins P16INKa and KI-67 in cervical tissue is a cost-effective option in comparison to available alternatives in public health institutions in Mexico.
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