Implementation of Faecal Immunochemical Testing as the screening test for Bowel Screening. Programme in Wales

Transcription

1 Immunochemical Testing as the screening test for Bowel Screening. Programme in Wales Information to Public Health Wales Board prior to introduction Author: Dr Sharon Hillier, Acting Director Screening Division Date: 2 January 2018 Version: 1 Sponsoring Executive Director: Dr Quentin Sandifer, Executive Director of Public Health Services and Medical Director Who will present: Dr Quentin Sandifer, Executive Director of Public Health Services and Medical Director Date of Board / Committee meeting: January 2018 Committee/Groups that have received or considered this paper: Trust Executive Team The Board / Committee are asked to: (please select one only) Approve the recommendation(s) proposed in the paper. Discuss and scrutinise the paper and provide feedback and comments. Receive the paper for information only. Link to Public Health Wales commitment and priorities for action: (please tick which commitment(s) is/are relevant) Priorities for action Strategic Objective 6D: Improved early detection of bowel cancer in eligible population Date: 2 January 2018 Version: v1 Page: 1 of 7

2 1. Introduction The UK National Screening Committee has recommended that the bowel screening programme should move from using the current Faecal Occult Blood test (FOB) as the initial screening test to using a Faecal Immunochemical Test (FIT). Welsh Government has considered the recommendation and agreed this should be implemented in the programme in Wales (Appendix). This briefing is to provide background information to the Public Health Wales Board on the introduction of Faecal Immunochemical Testing (FIT) to the Bowel Screening Programme in Wales. 2. Background Bowel Screening Wales was implemented in Wales in 2008 and offers screening to all resident men and women in Wales aged between 60 and 74 years of age using the faecal occult blood test (FOB). The aim of bowel screening is to reduce the risk of dying from bowel cancer by detecting disease early when it likely to be easier to treat and there are better health outcomes. Each year Bowel Screening Wales identifies over 200 participants with cancer and about 1000 participants have polyps detected and removed. The uptake to the programme is about 54% which is lower than the target of 60%. The current method requires participants to take 6 samples from 3 separate bowel movements. On return to the laboratory the test is completed via a manual chemically assisted sight inspection. The introduction of FIT will provide participants with an easier to use sample taking kit which only requires one sample with a quantitative result being undertaken via an automated test. The decision to change to Faecal Immunochemical Testing (FIT) followed recommendations from UK National Screening Committee and Welsh Government and as a result Public Health Wales made a commitment via its Operational Plan for 2017/18 (Strategic Objective 6D) to: - Plan the Introduction of FIT Testing in Bowel Screening Wales - Carry out procurements required for Bowel Screening Wales post FIT primary testing. Date: 2 January 2018 Version: v1 Page: 2 of 7

3 The project to deliver this was commissioned in January 2017 in line with the Welsh Government requirement for FIT to be introduced from January Description 3.1 Faecal Immunochemical Testing and the benefits of introduction The Faecal Immunochemical Test detects hidden blood in the stool, which can be an early sign of cancer. FIT only detects human blood from the lower intestines and medicines and food do not interfere with the test. FIT is a quantitative test and can detect human haemoglobin at lower concentrations than the current FOB test and a cut off level can be set for the test. In Wales the cut off for introduction has been agreed with Welsh Government to be at 150ng/ml. Other UK countries have or are already implementing FIT and the cut off level varies across the UK. The benefits of introducing FIT to the population of Wales are: It needs only one faecal sample instead of 6 samples from 3 bowel motions required by the current test. FIT is more acceptable to the public than the current test and has been showed to have an increased uptake (about 5%) and reduced inequalities in uptake. FIT can detect human haemoglobin (Hb) at lower concentrations and with much less interference from non human blood. It can detect more cancers and advanced adenomas (tumours that may become cancers), and will have fewer false positives. FIT will reduce the number of repeat tests needed as there are no borderline results which require a repeat test. FIT is already being successfully used in other home nations and this will provide people in Wales with access to a better test. 3.2 Procurement As part of the project a procurement team was established and tasked to develop a detailed technical specification to procure the required automated analyser, laboratory consumables and participant kits. The tender document was published via OJEU in November 2017 and is scheduled to complete in January The overall evaluation process will be robust and is based on a scoring ratio of Quality (60%) and Cost (40%). Date: 2 January 2018 Version: v1 Page: 3 of 7

4 The procurement team are currently working to assess and evaluate the tender responses and a final recommendation will be produced in February for consideration by the Executive team and a recommendation to the Board. 3.3 Colonoscopy capacity and timeliness of offer of colonoscopy Access to endoscopy is problematic across Wales, with long waits in many areas for symptomatic and screening colonoscopy. For the screening programme, performance at an All-Wales level against the colonoscopy waiting time standard has not been achieved since October As the symptomatic and surveillance service demands are high there are competing priorities for colonoscopy capacity. The plan is to introduce the initial test cut off of 150ng/ml which is at the lower end of the potential range of sensitivity. However, this will still result in increased demand for colonoscopy as a result of expected increase in uptake and slightly increased sensitivity. We expect to lower the cut off over time in a planned way. Modelling suggests that implementation at this sensitivity will result in an additional 350 screening colonoscopies per year across Wales with an additional 90 cancers (a 43% increased detected). The current service delivery model is not able to cope with the current demand for colonoscopy and therefore work is required to ensure a sustainable model that can cope with future increased demand and enable early diagnosis of bowel cancer to reduce the burden of disease in our population. There is recognition that this is a whole-system problem and only by looking at symptomatic and screening colonoscopy together can this be solved. Following meetings between Public Health Wales and Welsh Government a paper has been prepared setting out strategic approaches to address this challenge. Meanwhile, work is underway with health boards to plan for the implementation of FIT but this is expected to be challenging. 4. Financial Implications A key issue is the funding for the change in approach to this screening programme. The introduction of FIT testing is more expensive than the current method of testing. The bowel screening programme currently costs 2.7m and the estimated cost of the programme using the new test is 3.8m. However, we will not be able to establish the full cost until the tender process is completed. Date: 2 January 2018 Version: v1 Page: 4 of 7

5 To offset the additional costs, detailed work is underway on identifying savings arising out of the transition from cervical cytology to Human Papilloma Virus (HPV) testing. Principally this will come from the release of staff costs associated with the current laboratory services and involves discussions with health boards about possible future deployments. What is known at this stage is that these savings are not expected to start to be released until the financial year and even then are not expected to cover the expected costs of FIT in full. The letter from Welsh Government acknowledges both the service capacity challenge and the financial impacts on Public Health Wales and health boards. Public Health Wales has discussed these matters with Welsh Government and when we have a better understanding of the financial impact we will hold further discussions. 5. Recommendation The Board is asked to: RECEIVE this paper; NOTE that the Board will be asked to agree the outcome of the procurement at its meeting in March 2018; and NOTE that we continue to work actively to produce a financial plan that addresses the challenges of implementing this new test. This plan will embrace the substitution and reduction of costs and the funding options. Date: 2 January 2018 Version: v1 Page: 5 of 7

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