OBJECTIVES: Healthcare decision makers search for cervical cancer (CC) screening strategies that produce better clinical outcomes, while controlling the cost. Possibilities for the introduction of primary HPV screening are currently investigated in Denmark. This modeling study compares clinical benefits and costs of the current practice; cytology with HPV triage, with a comparator; Cobas® HPV test with cytology and CINtec PLUS Cytology® (CINtec) triage in the national CC screening program in Denmark.

METHODS: The Markov model compares screening performance, clinical outcomes and costs. A hypothetical cohort of 796,000 Danish 30-59-year-old women is followed for two screening cycles. Screening intervals are; the current practice is 3.9 years (weighted average) and the comparator five years. Test sensitivity and specificity data are from ATHENA trial. Other inputs include the local prevalence of HPV, CIN1-3 and CC. Screening, diagnosis and CC treatment costs are calculated from a healthcare provider’s perspective in 2015. In the current practice; normal cytologies return to routine screening, ASCUS and LSIL results have a reflex HPV triage, and HSIL undergo a colposcopy. Sensitivity limitations of this strategy may lead to missed diagnoses. The comparator addresses this shortcoming. HPV- return to routine screening, HPV+ have a reflex cytology triage. ASCUS and LSIL have a CINtec triage, which identifies women with high-grade pre-cancerous cervical lesions. CINtec+ or HSIL undergo a colposcopy. Normal cytologies or CINtec- have an HPV re-test in two years.

RESULTS: The comparator improves the detection of ≥CIN2 cases from 52.1% to 71.2% and reduces annual CC incidence in the screened population from 183.3 to 150.1. The annual cost increase by 9%, from 105 to 114 million DKK, which is mainly caused by increasing treatment costs.

CONCLUSIONS: The results suggest that replacing the current practice, with HPV primary screening with cytology and CINtec triage produces better clinical outcomes and increases costs by 9%.