Original Title: Impacto de la implantación de un programa de cribado poblacional de cáncer de cérvix, siguiendo las recomendaciones europeas (prueba/intervalo) en relación a la situación actual

Authors' objectives: – To analyse the effectiveness and safety of population-based cervical cancer screening with respect to opportunistic screening. – To analyse the effectiveness and safety of the European screening proposal (cytology every three years in women aged between 25 and 34 years, test for HPV and triage with cytology in women aged more than 35 years). – To analyse the organisational implications of implementing the European recommendations. – To analyse the costs and estimate the budgetary impact of implementing a population-based programme with detection of HPV as the primary test.

Authors' results and conclusions: Concerning the impact of implementing an organised, population-based programme: The implementation of a population-based cervical cancer screening programme may reduce the incidence and mortality of cervical cancer with respect to opportunistic screening to a significant and relevant degree, provided it is carried out in an organised manner and with adequate quality control. Concerning the impact of implementing the strategy with HPV DNAbased testing and triage with cytology: The organised screening alternative with detection of HPY DNA and triage with cytology in women aged 35 to 65 years provides a significantly higher relative detection rate and positive predictive value than cytology for CIN2+ and CIN3+ lesions. However, the relative specificity is not statistically different for these two alternatives. Concerning organisational implications: An adequate organisational basis is a sine qua non requirement to ensure that implementation of a population-based screening programme gives positive results in terms of safety and effectiveness. The transition from an opportunistic to a population-based model should be performed gradually and with prior pilot schemes in one or more regions. The implementation of a screening system based on the detection of HPV as the primary test will have an important effect on the activity of laboratories, therefore it is advisable to conduct prior pilot studies to allow adequate levels of quality at all levels to be verified. Correct interpretation of the information obtained by both women and healthcare professionals is important in order to avoid unnecessary testing (screening in very young women or at very short time intervals) that could lead to overuse of the resources available by up to 90%. Concerning costs: The total cost attributable to one year of the population-based cervical cancer screening programme is €1,461,455 for a population of women aged between 25 and 65 years, with 117,343 being invited and 100,000 screened. The programme analysed comprises the introduction of a liquid-based cytology screening tests every three years for women aged between 25 and 34 years and an HPV DNA test for women aged between 35 and 65 years at five-year intervals for those women who test negative. If the screening test is positive, referral to colposcopy, detection of HPV or cytology will be conducted depending on age and/or diagnosis. In those cases in which the HPV DNA test is positive and cytology negative, the HPV DNA test will be repeated at 12 months. The cost attributable to one year of the opportunistic cervical cancer screening programme is €1,235,000 for 100,000 cervical cancer screening tests performed in women aged between 25 and 65 years. The programme analysed comprises performing conventional cytology (Papanicolau tests) as the initial screening test every three years for those women in that age group with negative results. If the cytology test is positive, and depending on the diagnosis, additional cytology at one year or a diagnostic colposcopy will be performed.

Authors' methods: A search for de novo was carried out and those studies that provide a higher level of evidence selected on the basis of their design (from a higher to lower level of evidence: randomised clinical trials, non-randomised controlled studies, cohort studies, case-control studies, case series) and their correct methodological conduct. For those questions for which it proved possible, a quantitative analysis (meta-analysis) of the evidence available was conducted. In the opposite case, the evidence was analysed and summarised qualitatively. The cost analysis was performed from the financial perspective of the National health System. The direct costs related to a population-based cervical cancer screening programme implemented in accordance with IARC recommendations, and an opportunistic cervical cancer screening programme such as that carried out by the different Autonomous Communities in Spain, were calculated.

Project Status: Completed

Year Published: 2016

URL for published report: https://www.ogasun.ejgv.euskadi.eus/r51-catpub/es/k75aWebPublicacionesWar/k75aObtenerPublicacionDigitalServlet?R01HNoPortal=true&N_LIBR=051788&N_EDIC=0001&C_IDIOM=es&FORMATO=.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government