In EU countries with a Liquid Based Cytology (LBC) screening program cervical cancers are missed due to the low sensitivity of cytology. Primary HPV screening will hardly miss cancers due to the high sensitivity, but due to the lower specificity will lead to multiple unnecessary procedures (e.g. colposcopies, biopsies, follow-up visits).
To improve the outcome of a LBC screening program (every 3 years) a new algorithm was developed by the combination of primary HPV testing and dual stain cytology (CINtec® PLUS Cytology test (p16 & Ki-67)) (every 5 years). The objective of present study was to simulate the budget impact for both screening concepts and to compare the costs and health outcomes from a payer's and patient’s perspective in Belgium.
A Budget Impact analysis based on a Markov model compared the costs and outcomes over two screening intervals (10 years compared to 6 years) for both screening algorithms. For the base case women aged between 30 and 65 years old were selected. For the Belgian situation it was assumed that all cervical intraepithelial neoplasia (CIN) were tested with dual staining. In the absence of intervention, disease may progress to another stage of disease, therefore patients with CIN 2 or higher were always sent to treatment. In our Markov model the probability of all disease transitions were based on the available literature (ATHENA and PALMS trials). For each screening algorithm, the total annual costs from the payer's perspective for ≥CIN2 and for cervical cancer were calculated.
Compared to LBC primary screening, the use of cobas® HPV primary screening with triage by the dual stain cytology (CINtec® PLUS Cytology test) increases the detection of CIN2, CIN3 and cervical cancer by an average of 56%. The clinical impact of the algorithm showed a reduction in cervical cancer incidence of 30 % and a reduction in cancer death by 30 %. The budget impact analysis of the proposed screening algorithm showed a reduction of the screening budget by 22% (this is an annual cost saving of 5 million euro for the Belgian HealthCare system).
The strategy of primary HPV screening with a dual stain cytology triage reduces significantly the incidence of cervical cancer, cervical cancer death and the screening budget. The proposed screening algorithm is therefore beneficial for all stakeholders.