Original Title: Análisis de la efectividad clínica y coste-efectividad de la ampliación a 74 ańos del cribado del cáncer colorrectal en la población general

Authors' objectives: To assess the effectiveness, safety and cost-effectiveness, ethical, patient, social, legal, organizational and environmental considerations, as well as to describe the research needs of expanding population-based CRC screening up to 74 years of age.

Authors' results and conclusions: RESULTS: EFFECTIVENESS AND SAFETY: There is high-quality evidence, based on several population-based randomized trials with variable completion age, that the use of guaiac reduction-based FOBT screening (gFOBT) reduces CRC mortality (RR = 0.88, 95% CI: 0.82-0.93; k = 8; n = 598,933), but not its incidence or mortality from any cause. One trial showed that biennial gFOBT does not reduce mortality in patients between 70-80 years old, and in those aged 60-69 years it only did so in men (RR = 0.42, 95% CI: 0.27-0.66). There is low-quality evidence that screening with the immunological detection test for FOBT (iFOBT) up to age 69 reduces CRC mortality (RR = 0.90, 95% CI: 0.84, 0.95; an observational study). There is good quality evidence that iFOBT shows a sensitivity greater than 70% in the detection of CRC, but low (<25%) in the detection of advanced neoplasia or adenoma. There is no evidence of differences in effectiveness according to age. In terms of diagnostic performance, one study observed a worse sensitivity and specificity of the program in the range of 70-75 years, compared to 50-59 and 60-69. Given the non-invasive nature of faecal tests, the adverse effects of the screening program refer to the possible complications of colonoscopy. There is evidence of a good safety profile of colonoscopy after a positive result of FOBT, with bleeding rates of 17.5 (95% CI: 7.6, 27.5) per 10,000 procedures, and perforation rates of 5.7 (95% CI: 2.8, 8.7) per 10,000 procedures. COST-EFFECTIVENESS AND BUDGET IMPACT ANALYSIS: Four systematic reviews of economic evaluations and 11 cost-effectiveness references (corresponding to 10 studies) were included. No SRs were identified that exactly addressed the research question of this report. The included SRs concluded that all or almost all CRC screening strategies are cost-effective compared to no screening. All cost-effectiveness studies, regardless of the test used for the FOBT analysis, concluded that biennial screening in the age group 50 to 74 (or 75) is cost-effective compared to no screening. All ICERs, after being transformed into 2023 Spanish euros, were less than €20,000/QALY or €/LY. The results of the de novo economic evaluation model carried out show that the extension of CRC screening up to 74 years of age is a dominant alternative (less expensive and more effective) compared to current screening up to 69 years of age. The results of the sensitivity analysis indicate that these results are robust. The budget impact analysis indicates that the expansion of CRC population screening could mean an expense for the NHS that could reach €10,918,777 in the fifth year of its expansion throughout the national territory, assuming 100% coverage and a participation rate of 36.26%. ETHICAL, LEGAL, ORGANIZATIONAL, PATIENT, SOCIAL AND ENVIRONMENTAL ASPECTS: A manual scoping search was carried out in May 2023 and was expanded in November 2023. In this search of electronic databases and websites, 21 potentially relevant articles and a conference abstract were identified to be analysed in detail in full text. All of them were excluded due to the objective of this section. Only one ethical aspect was identified related to territorial inequality due to the different degrees of implementation and age coverage of the CRC screening program. This territorial inequality could decrease with the extension of the age to 74 years. CONCLUSIONS: • Based on the evidence synthesized in the identified SRs and the primary studies included in them, as well as in the economic evaluations included in this report, it is not possible to answer the research question about the convenience of extending CRC screening from 69 to 74 years. • There is high-quality evidence that gFOBT reduces CRC mortality in screening with variable completion age. Regarding differences by age, a population trial initiated in the 1980s in the United States did not obtain a significant effect from biennial screening in people between 70 and 80 years of age. • In the case of iFOBT, the direct evidence is low quality, indicating a significant reduction in CRC mortality in patients up to 69 years of age with a mean follow-up of three years. There is no evidence of differential effectiveness according to age, and only one study reported differences in diagnostic performance, with worse sensitivity and specificity in the range of 70-75 years. • The de novo cost-effectiveness analysis carried out in this report with data from Spain concludes that the extension of CRC population screening to 74 years of age is a dominant alternative from the NHS perspective (that is, less expensive and more effective alternative). • The budget impact analysis estimates that the extension of CRC population screening up to 74 years of age could mean an additional expense of between €10,208,165 and €10,918,777 in the first and fifth year of its extension respectively. This analysis assumed 100% coverage and a participation rate of 36.26%.

Authors' methods: SYSTEMATIC REVIEW OF EFFECTIVENESS, SAFETY AND COST-EFFECTIVENESS: A systematic review (SR) was carried out of: 1) SR that evaluated the effectiveness/safety and/or diagnostic performance of population screening for CRC using FOBT tests (guaiac and immunological) as the first screening test followed by colonoscopy, as well as possible differences according to age groups and 2) economic evaluations that evaluated the cost-effectiveness of this screening strategy for the groups of interest. A search strategy was developed around the terms colorectal neoplasms, mass screening, and faecal occult blood in the electronic databases: MEDLINE, EMBASE, CINAHL, in several databases of Ibero-American publications (IBECS, BRISA, LILACS, WPRIM, ARGMSAL, BINACIS, LIPECS), and in The Cost-Effectiveness Analysis (CEA) Registry in April 2023. The assessment of the methodological quality of the effectiveness and safety SRs was evaluated by two independent reviewers with the AMSTAR-2 scale and the economic evaluations were evaluated following the criteria of Drummond et al. The data extracted were those related to the identification of the study (authors, publication date, country where the study was carried out, funding, etc.), the design and methodology and the results of the study (CRC incidence, mortality, sensitivity and specificity, costs, effectiveness results and incremental cost-effectiveness ratio (ICER)). These data were collected in electronic sheets in Excel format (Microsoft) designed ad hoc. Only numerical results were extracted from the comparisons of interest: screening in the population aged 50-75 versus not screening and screening in the population aged 50-70 versus 50-75. ECONOMIC ANALYSIS AND BUDGET IMPACT ANALYSIS: A complete de novo economic evaluation was conducted out in which the costs and health outcomes of extending population-based CRC screening to age 74 were assessed from the perspective of the NHS. The analysis was based on a decision model that synthesizes the information obtained in the literature on the incidence of the disease, the effectiveness of screening, as well as the consequences of CRC (in terms of both costs and QALYs). In order to do this, a mathematical model was built that combines a decision tree and a Markov model with annual cycles. The time horizon was patient lifetime and a discount of a 3% was applied to both costs and effects. In addition, probabilistic and deterministic sensitivity analysis were carried out. Finally, a 5-year budget impact analysis (from 2023 to 2027) was performed to inform about the cost of extending current population screening for CRC in Spain to age 74. ETHICAL, LEGAL, ORGANIZATIONAL, PATIENT, SOCIAL AND ENVIRONMENTAL ASPECTS: A scoping review was carried out through a series of manual searches in Google, Google Scholar and Pubmed using different combinations of keywords and their derivations using the search terms specific to the aspects evaluated in that section: ethics, acceptability, patient issues, organization, barriers, facilitators, implementation, equity, ageism, qualitative, interview. In addition, a patient association was contacted to find out their perspective.

Project Status: Completed

Year Published: 2023

URL for published report: https://sescs.es/informe-cribado-cancer-colorrectal/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es