FIT Programme (Faecal Immunohistochemical Test) Jonathan Miller South West Cancer Programme Lead

Patients groups for FIT Low risk as per NICE Referral Guidance (NG12) Subject of a Bid by the SWAG Cancer Alliance Higher risk – ie those meeting 2 week wait referral guidance Subject to further review in England. NHS England hopes to be able to advice service to use by April 2018 Screening To begin April 2018 Surveillance following screening review paper by Wendy Atkins – protocol nationally agreed Surveillance following a diagnosis For local decision on appropriateness

Evidence from NICE indicates that Triage using qFIT at thresholds around 10 μg Hb/g faeces has the potential to correctly rule out colorectal cancer and avoid colonoscopy in approximately 75% of symptomatic patients and that this estimate does not appear to vary greatly between qFIT assays. Further, the relatively high proportion of qFIT false positives observed when the target condition is colorectal cancer may be mitigated by the detection of other bowel pathologies in these patients; we estimate that between 22.5 and 93% of patients with a positive qFIT test and no colorectal cancer will have other significant bowel pathologies, depending largely upon how many and which diagnoses are included in the target condition. https://www.nice.org.uk/guidance/GID- DG10005/documents/diagnostics-assessment-report

Low Risk Group Per NICE (NG12) : Aged 50 years and over with unexplained abdominal pain or weight loss Aged under 60 years with changes in their bowel habit or iron deficiency anaemia Aged 60 years and over and have anaemia – even in the absence of iron deficiency  

FIT for Low Risk Group No national evidence on demand for this group Local audit in Devon suggest 12 per 1000 population per year Proportion of positive FIT test in this group not explicitly reviewed However, positive rates in 2ww group approx. a third, using 10µg/g as the cut-off Local audit suggest a quarter of patients in this group are referred on a colorectal 2ww already, with up to a half overall having a referral of some kind. NICE does not recommend a referral for the lower risk group, so the alternative to a qFIT test with a high negative predictive risk value is no test. This means that patients with a false negative test are no worse off than if they had no test at all.

Protocol GP gives patient FIT kit in surgery Patient uses and posts to laboratory Process to follow up kits not used Results sent back to GP, who acts accordingly: FIT >10µg/g - 2 week wait referral FIT <10µg/g - manage in primary care with appropriate safety netting, unless a referral to an alternative service is appropriate (now that the risk of colorectal cancer has been identified as low). The GP should consider advice and guidance with Gastroenterology, where available, or routine referral if symptoms are not resolving within 6 weeks.

Proposed 28 Day Standard Clinical Radiological Pathological Defining Diagnosis Yes it is cancer No it isn’t cancer We definitely don’t know if it’s cancer or not (come back in 3 months for another test) Brain lesions are excised before any pathology is available – hence treatment is before pathological diagnosis

Flow Chart

Business Case Parameter Information A Patients meeting NICE criteria being referred as 2ww approx. 26% B cost of 2ww £317 per 2ww referral, from referral to first diagnostic test. (assuming that 90% of patients have a diagnostic test. C Demand for the qFIT in primary care from those meeting NICE criteria 12 per 1000 population per year D Cost of qFIT test Approx. £6 per test E Proportion of qFIT tests positive from those meeting NICE criteria Approx. 25% at thresholds around 10 μg Hb/g faeces F Value of qFIT test that is deemed positive Studies in 2ww population commonly used 10µg/g, or perhaps 7µg/g or even undectable haem. However, given this is a lower risk group could a larger value be considered. 20µg/g is the value OC Sensor have suggested, whilst the value proposed for the use of qFIT in screening is much at higher at 150µg/g. G Cost and location of qFIT Pathology service Indicative price from OC Sensor £19k for 170k test per year

Breakeven Additional costs £6 per patient Savings £317 per referral avoided So need to save one referral for every 50 FIT done Or about 2% or 3% reduction in current colonoscopy activity