Healthcare decision makers search for cervical cancer (CxCa) 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 modelling study compares clinical outcomes and costs of replacing; 1) cytology with pooled HPV triage (current practice), with 2) cobas® HPV with cytology and CINtec PLUS Cytology® triage (comparator) in the national CxCa screening programme in Denmark.
Sensitivity limitations and subjective interpretation of cytology may lead to missed diagnosis. The combination of primary HPV screening with cytology and CINtec PLUS cytology triage address this shortcoming. CINtec PLUS cytology confirms a transforming HPV infection by detecting cervical cells where HPV has disrupted cellular control (p16/Ki67+) and predicts which women most likely have precancerous cervical lesions and therefore benefit from an immediate colposcopy.
The model compares screening performance, clinical outcomes and costs. Screening of a hypothetical cohort of 796,000 Danish 30-59-year-old women and natural progression/regression of the disease are modelled for two screening cycles. In the current practice; women with normal cytology return to routine screening (30-49-year-old in 3 years and 50-59-year-old in 5 years), ASCUS and LSIL results have a reflex HPV triage, and HSILs undergo a colposcopy. In the comparator; HPV-negative women return to routine screening in 5 years. HPV+ are first triaged with cytology. Women with ASCUS or LSIL results have a reflex CINtec PLUS triage. Negative CINtec results and normal cytologies are followed up with an HPV retest and a reflex CINtec PLUS triage in two years. CINtec positives and HSIL cytologies undergo a colposcopy. Test sensitivity and specificity data are from ATHENA trial. Other inputs include the local prevalence of HPV, HPV genotypes 16/18, CIN1-3 and CxCa. All costs are calculated from healthcare provider’s perspective.
The comparator strategy increases the sensitivity CIN2+ from the current 52.1% to 71.1% and maintains the specificity CIN2+ (current 99.1%, comparator 99.3%). The better screening performance reduces annual incidence of CxCa in the screened population from the current 23.0 to 18.9 per 100,000, and annual CxCa mortality from 5.1 to 4.1 per 100,000. The annual cost increase by 6%, from 79.2 to 83.8 million DKK, which is mainly caused by increasing treatment costs.
The results suggest that replacing the current practice, with primary HPV screening with cytology and CINtec PLUS triage produces better clinical outcomes and increases costs slightly.