Dr Katie Elliott CRUK strategic GP Macmillan GP with NE &C Learning disability Network Assistant Clinical Lead Northern Cancer Alliance

Transcription

1 FIT for symptomatic patients Dr Katie Elliott CRUK strategic GP Macmillan GP with NE &C Learning disability Network Assistant Clinical Lead Northern Cancer Alliance

2 AIMS Review National advice Consider some of the uncertainty Working Consider some of the modelling What should happen in the NCA?

3 Current situation NICE NG12 (1) includes occult blood in faeces as a 2ww referral criteria. There is no age limit attached to this. NICE DG30 ( July2017) (2) advises to use FIT test lower risk symptomatic people for occult blood in faeces. National commissioning advice for bowel cancer includes the use of qfit for low risk patients Working Currently this group are likely to be watchful wait in primary care or non-urgent referral to colorectal clinic or being squeezed into 2ww criteria. Already increased demand regionally and nationally on colorectal services and 62 day target No increase in incidence of colorectal cancer

4 Routes to diagnosis Relative survival estimates by presentation route and survival time, Colorectal, from Routes to Diagnosis workbook National Cancer Intelligence website

5 Additional information Routes to diagnosis for colorectal cancer % not 2ww Using FIT test could identify people from routine groups who should be on a 2ww pathway It may identify people in primary care who are not currently being investigated Working Screening Threshold not set Assay agreed but not announced yet Delayed implementation? October 2018 Impact on demand for colonoscopy unknown will increase demand but? How much

6 NICE DG30 - Quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care Use q FIT to guide referral for suspected colorectal cancer in people without rectal bleeding who have unexplained symptoms but do not meet the criteria for 2ww referral. Results should be reported using Threshold >10mcg/g faeces DG30 identifies the group originally described in NICE NG12 for testing for occult blood in faeces with PPV 0.1 3% - offer FIT >50y unexplained abdominal pain/ weight loss (note overlap with Upper GI) <60y with altered bowel habit or iron Working deficiency anaemia (IDA) > 60y with anaemia without IDA Potential increase demand for colonoscopy may be offset by detection of other treatable bowel pathology Advises to refer anyway if symptoms persist

7 Assays 3 possible assays OC Sensor - HM-JACKarc most sensitive most expensive FOB GOLD least evidence but likely to be similar to the others All apparently cost effective in finding colorectal cancer but no assessment against current practice (watchful wait or OPD). (3) More sensitive in men, more specific in women May be affected by medications which increase the chance of bleeding in the gut Working Increased cost effectiveness with increased incidence Decreased cost effectiveness in lower risk population Access to FIT test Gateshead lab only so far have the assay equipment in place

8 Hb threshold Sensitivity Specificity PPV NPV Reference >0 µg Hb/g 100% 43.4% 5.2% 100% Rodriguez- >10 µg Hb/g 96.7% 79.8% 12.8% 99.9% Alonso Dig Liv Dis 2015 >15 µg Hb/g 96.7% 83.1% 15.0% 99.9% >20 µg Hb/g 93.3% 86.1% 17.2% 99.8% 40 µg Hb/g 100% 86.3% 56.6% 100% Kaul Intl J Surgery µg Hb/g 100%? values only given for significant colorectal disease µg Hb/g Any detectable (above 0) Estimated 88% Estimated 74%? values only given for significant colorectal disease 100% Godber Clin Chem Lab Med % 99.7% Hogberg Scan J PHC % 43.4% 6.4% 100% Mowat Gut µg Hb/g 89.3% 79.1% 14.2% 99.5% Mowat Gut 2015

9 What about 2WW? There has been specific guidance about this from the National Clinical Director for Cancer Prof. Chris Harrison. (4) FIT is currently not supported in this higher risk group pending Working the outcomes of the pilot study based in London at UCLH.

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11 Potential cost savings Estimated savings/costs by CCG following the introduction of FIT testing for symptomatic Lower GI patients Region Population Low Impact ( 's) Medium Impact ( 's) High Impact ( 's) NHS North Cumbria 318,229 42, , ,780 NHS Darlington 105,646 14,034-72, ,537 NHS Durham Dales, Easington and Sedgefield 274,594 36, , ,452 NHS Hartlepool and Stockton-on-Tees 288,498 38, , ,818 NHS North Durham 247,549 32, , ,003 NHS North Tyneside 203,307 27, , ,655 NHS Northumberland 316,002 41, , ,038 NHS South Tees 275,802 36, , ,482 NHS South Tyneside 149,418 19, , ,095 NHS Sunderland 277,962 36, , ,112 NHS Newcastle Gateshead 498,070 66, , ,001 NHS Hambleton, Richmondshire and Whitby 153,165 20, , ,392 NCA 3,108, ,910-2,134,051-5,223,367

12 Proposed offer in NCA Offer FIT test in primary care to: <60y with altered bowel habit or iron deficiency anaemia (IDA) >50y unexplained abdominal pain/ weight loss (note overlap with Upper GI) > 60y with anaemia without IDA Use threshold of >10mcg/g faeces for POSITIVE result A positive test will trigger 2ww referral to colorectal team. Negative test will be managed with appropriate safety netting in primary care. People with persistent symptoms may be offered a routine referral ( definition of persistent is required). Working People seen in routine colorectal clinics may be offered the test as part of the clinical decision about offering colonoscopy. Information will be developed to be provided to professionals and patients to clarify the difference between the symptomatic and the screening FIT test. Commissioning groups will audit the outcomes and resource use.

13 What next? Discuss at regional colorectal meeting for consensus. Take the proposal to the leadership and commissioning forum Commissioning arrangements required Develop a standard referral form for FIT test on ICE What should the time scale be to complete the test? For the lab? For the patient? What is the contingency? What if the test is not available or the patient is unable / unwilling to complete the test Safety netting in primary care / routine referral. Working Which assay should be used? Same for all providers? What else do we need to know? Pilot proposed for Northumbria - due to start 1 st June 2018 using Gateshead lab Potential to build this into a decision support tool for GPs.

14 What can we do today? Positive qfit is a criteria for 2WW colorectal referral. Inclusion as a test in the colorectal pathway to inform decision to Working refer and decision to offer whole bowel testing. Agreement to plan regional implementation

15 Resources and References 1. NICE NG NICE DG NICE resource impact report (Enclosure 1) 4. Letter from Prof Chris Harrison (Enclosure 2) 5. Adoption support resource from NICE ( Enclosure 3) 6. Proposed pathway - Mark Welfare (Enclosure 4) NCRAS National Cancer Registration and Analysis Service (CHANGING SOON ) NICE website

16 Thank you Working