Report in English with a Dutch summary (KCE reports 45A)

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158 Screening for Colorectal Cancer: Appendices KCE reports vol.45 surveillance and follow-up of individuals at increased risk disagree on exact risk stratification and cut off ages and most recommendations for population subgroups are mainly empiric. Although all guidelines recommend screening, policy makers in many countries have been reluctant to implement national screening programs for fear of the low sensitivity of the commonly used guaiac FOBT (gFOBT). Effectiveness of mass screening has been investigated in average risk males and females starting from the age of 45 or 50 and up to the age of 75 years. Only for the guaiac FOBT there is high quality evidence that screening reduces CRC mortality. The estimated reduction attributable to screening is around 15% in RCTs in intention to treat analyses and around 33% in per protocol analyses. For other techniques considered for primary screening, such as the immunochemical FOBT (iFOBT), flexible sigmoidoscopy, colonoscopy, virtual colonoscopy or DNA detection methods in stool there is currently no direct evidence of CRC mortality reduction in mass screening circumstances. All studies on mass screening emphasize the crucial importance of a high participation rate to reach the goals for CRC mortality reduction. Although there is high quality evidence that FOBT based screening can reduce CRC mortality, there is no evidence for overall mortality reduction. The strongest economic evaluations are, obviously, based on the clinical evidence available, while other economic evaluations are mainly based on assumptions that are at least speculative: all economic evaluations of colonoscopy as a screening tool were based on overly optimistic and unrealistic assumptions, especially regarding participation. The available economic evaluations show that annual or biennial gFOBT followed by colonoscopy for screen positive participants is a cost effective intervention. Incremental cost effectiveness ratios (ICERs) range from approximately 2000 to 30.000 per life year gained. Those ICERs are mainly sensitive to the frequency of screening (biennial testing has better ICERs than annual testing), to the sensitivity and specificity of the test (the less sensitive unrehydrated test has better ICERs) and, as expected, to the cost of testing (both FOBT and subsequent colonoscopy). Those economic evaluations also show that choosing the optimal target population (age range) has an important influence on the ICER as have the participation rate with the screening program and compliance with colonoscopy after a positive FOBT, at least in those evaluations where program costs were incorporated. From none of the economic evaluations there is evidence for a better ICER for the iFOBT tests, but this depends of course on the performance characteristics and price of iFOBT and this could change in the future. In various countries around the world screening programs are being tested, but currently there are only a few countries with an established national CRC program, such as Finland and Australia. In those countries with national or regional screening programs FOBT (mostly guaiac, always biennial) is the screening method chosen. Although most guidelines emphasise the importance of surveillance for individuals at increased risk for CRC, organised surveillance programs are only fragmentarily available. To evaluate the financial consequences of implementing a biennial gFOBT based screening program in Belgium, we conducted a budget impact analysis. The model used to estimate the budget impact was based on international literature, and whenever possible on Belgian prices. We considered two extreme scenarios. In a first scenario the General Practitioner (GP) is the key person. The invited individual goes to his/her GP for information and counselling and distribution of the test kit, and when results are available returns to this GP for
KCE reports vol.45 Screening for Colorectal Cancer: Appendices 159 follow-up. This scenario is roughly comparable to the French model. In the second scenario, the individual receives the invitation and the test kit by mail, with instructions on whether to participate and how to use the test kit. In this scenario, the participant only visits the GP in case of positive FOBT for information and counselling and referral for colonoscopy. This scenario is roughly comparable to the Finnish and Australian models. Those alternatives should be considered as two extremes that could be modified when implementing an organised program. A call-centre, for example, could be necessary in the mailing system approach, to help patients resolve specific questions about the screening program and their eligibility to participate. Moreover, in the Belgian Healthcare system not every patient has his/her regular GP since patients are allowed to choose freely from the medical care available; this causes potential problems in both scenarios. We included upfront program costs, and used costing assumptions that were either based on existing tariffs and prices or on published data and expert opinion. Because of the important uncertainties about screening performance assumptions and some of the costs we conducted a probabilistic sensitivity analysis and results are shown with 95% confidence intervals (CI) from these analyses. In a baseline analysis with biennial screening for all men and women aged 50-74 years of age, the yearly cost during the first round for the GP based scenario would be around M 35 ( 35.000.000) with uncertainty ranging from M 18 to M 52. The main uncertainty is the participation rate with an important influence on number of tests (FOBT and colonoscopy). Estimated cost per CRC detected would be around 50.000. A similar program with the same effect but based on the direct mailing system would cost M 20 (14 26), and cost per CRC detected would be around 29.000. The results of the budget impact analysis heavily depend on some of the assumptions. The most important of these is the participation rate, especially for the cost of the program but also for the cost per CRC detected. There is important uncertainty about this parameter which is of crucial importance to a CRC screening program. Other important uncertainties are program costs (mailing, campaign, etc). Those costs will clearly depend on the organisation of the program. Other uncertainties are related to compliance with colonoscopy after positive FOBT and CRC detection rates through colonoscopy after positive FOBT. Those issues should be field-tested in Belgium. Regarding capacity, our budget impact analysis shows that in the biennial FOBT scenario with Hemoccult II, around 10.000 colonoscopies per year would be necessary in the first screening round, and slightly less in subsequent years. Compared to the 100.000 colonoscopies performed yearly in Belgium this would represent 10%. 9.2 RECOMMENDATIONS AND RESEARCH AGENDA This HTA report shows that CRC screening using a biennial guaiac FOBT screening followed by colonoscopy in case of a positive FOBT in individuals aged 50 years and older (exact age range to be defined) can be a cost-effective mass screening program when properly organised. Therefore, we recommend introducing such a screening program in Belgium. However, before such a program can be successfully implemented, a series of key issues need to be addressed and resolved. We recommend the implementation of a few pilot screening programs to investigate these issues. A political decision on whether to implement a CRC screening program can be made based on the existing information to date in consultation with the competent authorities on the federal and regional levels and in collaboration
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