Colorectal Cancer Screening

3/11/2018

COLORECTAL CANCER SCREEING

QUICK STATS

• In 2017, there was estimated 95,520 new cases of colon cancer and 39,910 cases of rectal cancer diagnosed in the US.

• An estimated 27,150 men and 23,110 women will die from CRC in 2017. • Approximately 4.6% of men (1 in 22) and 4.2% of women (1 in 24) will be diagnosed with CRC in

their lifetime. • The risk of CRC increases with age; the median age at diagnosis for colon cancer is 68 in men

and 72 in women; for rectal cancer it is 63 years of age in both men and women • CRC incidence rates are approximately 30% higher in men than in women, while mortality rates

are approximately 40% higher • CRC incidence and mortality rates are highest in nonHispanic blacks (NHBs) and lowest in

Asians/Pacific Islanders (APIs)

FECAL IMMUNOASSAY TEST ($20) for screening (references at end of protocols)

• Acceptable for HEDIS screening colorectal cancer yearly or every other year • USE ICD-10 Z12.11 CPT 82770 HCPCS G0328 • Qualitative vs Quantitative – Odds ratio of detection (suspicious cancer vs normal) was 3 x higher with

Qualitative • Double FIT testing (one week apart) was cost-effective and should be used for anyone using this method as

their first screening method • FIT testing ($20) vs SEPT9 blood test ($200-300) was about equal in detection rates • Sensitivity FOBT was 50% vs FIT 75% Specificity FOBT was 78% vs FIT of 90% • Sensitivity Cologuard ($509) 92% vs FIT ($20) Specificity Cologuard -87% vs FIT 95% Cologuard results

in higher utilization of negative colonoscopies and testing interval is currently undetermined • In study of 10,000 Cost for screening and treating using FIT including colon for positive testing over 4 years

was $1.4 million and $5.1 million for using stand colonoscopy screening protocol • Same study using FIT scheme as a control, the incremental Cost-Effectiveness Ratio of screening

colonoscopy was US$3,489, US$27,962, US$922,762 and US$23,981 to detect one adenoma, advanced neoplasia, CRC, and a composite endpoint of advanced neoplasia or stage I CRC respectively. This means it cost an additional $3489 to detect one more person with adenoma using colonoscopy versus FIT.

• Same study the cost to detect one more case of colon cancer vs using the FIT was financially significant demonstrating that FIT test may be more cost effective for that endpoint

Attached are the evidenced-based protocols. As always TMGIPA defers to your clinical judgement in arranging appropriate testing. Incorporating FIT into your screening protocol has been shown to be cost-effective in screening for colon cancer.

T screening into your

Medicare HEDIS Colorectal Cancer Screening

(not screening algorithm for general population)

Patient Age 50-75

Fecal Occult Blood (FOBT)

($4)

During Measurement

Year

Flexible Sigmoidoscopy

($295)

During Measurement Year

or prior 4 years

Colonoscopy ($650 office, $820

Amb Surgical Center $1100 outpt hospital)

During Measurement Year

or prior 9 years

CT Colongraphy ($273)

(Need CMS approval for coverage)

During Measurement Year or prior 4 years

Fecal Immunochemical Test (FIT) ($20)

During Measurement Year

Fecal DNA Cologuard

($509)

During Measurement Year

or prior 2 years

Age > 50 years and

No personal history of adenomatous polyps

No personal history of colorectal cancer

No personal history of inflammatory bowel disease

No family history of colorectal cancer in first degree relative

One or more first-degree relatives (parent ,sibling ,child) with colorectal cancer

Family history of adenomatous polyps

Personal history of colorectal adenomatous polyps

Personal history of colorectal cancer

Personal history of endometrial or ovarian cancer prior to age of 60

Personal history of inflammatory bowel disease

Strong family history of colorectal cancer with multiple individuals affected but no genetic syndrome identified

Family history of hereditary non-polyposis colorectal cancer (Lynch Syndrome)

Family history of familial adenomatous polyposis (Gardner's Syndrome)

Personal history of inflammatory bowel disease with pancolitis or left-sided colitis or colitis > 10 years

Average Risk Increased Risk High Risk

If Yes to any of these tests then reevaluate next measurement year

If No to all of these tests then determine Risk

Yes

No Patient

Age >=85

See Screening Protocol Age

<50

Patient Age <50

Patient Age76-84

Routine Screen not

recommended

Consider Screening

Offer FIT Test

FIT Received by lab

Sample OK?

Test and Result FIT

FIT Positive?

Patient Appropriate for colonoscopy?

Complete Colonoscopy

FIT completed

Colonoscopy when appropriate or

Consider double contrast barium enema or CT Colonography or flex sig

Yes

Yes

Yes

Yes

Place in que for yearly recall

History of any negative colon

cancer screening < 10 years

Consider repeating

FIT test

No

No

Yes

No

Yes

No

Recall patient for FIT TEST

No

Protocol For Fecal Immunoassay Testing (FIT) CPT GO328 ICD-10 Z12.11

No

Average Risk Colorectal Cancer Patient Age >50

Prevention and Early Detection

Early Detection

Only

Colonoscopy

CT Colonography

Double Contrast Barium Enema

Normal Repeat in 10 years

If polyps found refer to Increased Risk Screening Protocol for next testing

Normal Repeat in 5 years

Abnormal refer for colonoscopy

Normal Repeat in 5 years

Polyp(s) >= 6mm

Refer for colonoscopy

Polyp(s) < 6mm

Individualize Recommendations for patient

Flexible Sigmoidoscopy

Normal Repeat in 5 years consider yearly FIT testing

Abnormal refer for colonoscopy

Fecal Immunoassay Test (FIT)

Multifocal stool DNA Test Cologuard

Normal Repeat Yearly

Abnormal refer for colonoscopy

High Sensitivity Fecal Occult Blood test can be used but

FIT is more specific/sensitive Normal Screening interval has not been

defined

Abnormal refer for colonoscopy

Increased Risk Colorectal Cancer Patient Age >50 without

personal history of colon cancer

History of Adenomatous Polyps on previous

screening exam

Patient with 1 or 2 tubular adenomas with low grade dysplasia and size < 1cm

Patient with 3-10 adenomas or 1 adenoma > 1 cm or any adenoma with villous

features or high grade dysplasia

Patient with > 10 adenomas on single examination

Patient with sessile adenomas that are removed in pieces

Colonoscopy 5 years after most recent polypectomy or normal exam

Colonoscopy 3 years after most recent polypectomy

Colonoscopy < 3 years after most recent polypectomy

Colonoscopy every 2-6 months to verify removal

Subsequent Follow-up determined by

number and size of polyps at time of

colonoscopy as well as degree of

dysplasia

Follow-up exams are individualized by on

specialist’s judgement

Family History of Colorectal Cancer or Adenomatous Polyps

Colorectal Cancer or adenomatous polyps in first-degree relative before age 60

Colorectal cancer or adenomatous polyps in 2 or more first-degree relatives at any age

Colonoscopy every 5 years

Screening should have started age 40 or 10 years before youngest case in

family

Colorectal Cancer or adenomatous polyps in first-degree relative after age 60

Colorectal cancer in 2 or more second-degree relatives

Screening options as per average risk patients

Screening should have started age 40

High Risk Patients or Patients Age < 50 without personal history of colon cancer or

adenomatous polyps

Patient Age Less than 50 with average risk SCREEING NOT INDICATED

Patients any age with suspected/ family history or documented

genetic syndromes (FAP) (HNPCC)

Familial Adenomatous Polyposis

Hereditary Non-Polyposis Colorectal Cancer

Genetic Diagnosis of FAP or suspected FAP

without genetic evidence

Early Intense Screening Age 10-12

Annual FSIG to determine if patient expressing genetic

abnormality

Consider Genetic Testing and counseling

Genetic Testing

not done

Colectomy Should be Considered

Genetic Testing Positive

Genetic Diagnosis of HNPCC or individual at

increased risk for HNPCC

Screening Age 20-25

or 10 years before the youngest case in family

Colonoscopy every 1-2 years

Consider Genetic Testing and counseling

Genetic Testing

not done

Inflammatory Bowels Disease Higher Risk for

Colorectal cancer

Ulcerative Pancolitis Risk higher 8 years after onset

Left-sided colitis 12-15 years after onset

Ulcerative Colitis for more than 10 years

Screening 8-10 years after onset of disease and colonoscopy with biopsies for dysplasia every

1-2 years

REFERENCES

Comparison of Fecal Occult Blood Test to FIT

FOBT FIT Sensitivity 50% 75% Specificity 77.87% 90.12% Positive likelihood ratio 2.26 7.59 Negative likelihood ratio 0.64 0.28 Positive Predictive Value 3.45% 10.71%

Negative Predictive Value 98.99% 99.56%

Elsafi SH, Alqahtani NI, Zakary NY, Al Zahrani EM. The sensitivity, specificity, predictive values, and likelihood ratios of fecal occult blood test for the detection of colorectal cancer in hospital settings. Clinical and Experimental Gastroenterology. 2015;8:279-284. doi:10.2147/CEG.S86419.

FIT vs Cologuard

Pathological Categories Colored FIT Sensitivity Colorectal Cancer 92% 79%

Imperiale TF, Ransohoff DF, et al Advanced precancerous lesions 42% 24% Multitarget stool DNA testing for

colorectal-cancer screening. Polyps with high-grade dysplasia 69% 46% N Engl J Med. 2014;370:1287–

1297. Serrated Sessile Polyps 42% 5%

Specificity Non-advanced or negative findings 87% 95% Source as above Negative results on colonoscopy 90% 96%

Song L-L, Li Y-M. Current noninvasive tests for colorectal cancer screening: An overview of colorectal cancer screening tests. World Journal of Gastrointestinal Oncology. 2016;8(11):793-800. doi:10.4251/wjgo.v8.i11.793.

Qualitative vs Quantitative FIT TESTING

Scand J Gastroenterol. 2012 Apr;47(4):461-6. doi: 10.3109/00365521.2012.668930

The positivity rate of the qualitative FIT was around three times higher than that of the quantitative FIT. However, the odds ratio for detection of "suspicious cancer and cancer" versus "normal" of the quantitative FIT was about three times higher than that of the qualitative FIT. These findings suggest that quality control may be important, particularly for the qualitative FIT.

Double FIT testing Cai S-R, Zhu H-H, Huang Y-Q, et al. Cost-Effectiveness between Double and Single Fecal Immunochemical Test(s) in a Mass Colorectal Cancer Screening. BioMed Research International. 2016;2016:6830713. doi:10.1155/2016/6830713.

Double FITs are more cost-effective than single FIT in our mass CRC screening based on the evidence of having significantly higher positive and detection rates with an acceptable higher cost by double FITs than single FIT. Double FITs should be encouraged for the first screening in a mass CRC screening

Combination of Blood tests and FIT

The plasma SEPT9 gene methylation test Epi proColon (Epigenomics AG, Berlin, Germany) is currently the only commercially available blood-test for CRC early detection and screening, and was approved recently by the United States FDA as a CRC screening test for average-risk population over 50 years old. Many clinical studies have proved the test to be a method with acceptable sensitivity and specificity for CRC detection. Positive detection rate of SEPT9, fecal immunochemical test and carcino-embryonic antigen tests and various combined tests.

SEPT9 alone FIT alone CEA alone SEPT9 + FIT SEPT9 + CEA FIT + CEA SEPT9 + FIT + CEA

77.00% 74.6% (NS) 41.3%e 94.4%c 86.4%c 84.5% (NS) 97.2%

World J Gastrointest Oncol. 2016 Nov 15; 8(11): 793–800.

Item Cost US $ Item Cost US $

One kit of FIT $25 Treatment for the stage I or II of CRC

18,542

Fecal DNA $650 Colorectal surgery 7,503Sept9 blood test 185 Consultation fees (9

days)2,705

CEA blood test $38 Hospital charges (9 days)

4,706

Colonoscopy 987 Treatment for the stage III of CRC

39,987

Consultation fee 99 Chemotherapy: FOLFOX for 6 months

11,908

Bleeding 3,501 Treatment for the stage IV of CRC

74,513

Polypectomy 206 PET scan 1,987Perforation 11,205 CT scan 575

Test Medicare Cost Avg Risk Test Freq (Months)High Risk Test Freq (Months)

Patient cost screening

only

Barium Enema $ 200 48 24 20%Colonoscopy Office $ 650 120 24 $0 Screen

Colon Ambulatory Surgical $ 830 120 24 20% DiagColonoscopy Outpatient $ 1,100 120 24

FOBT $ 5 12 $0 FIT $ 20 12 $0

Cologuard $ 508 36 $0 Flex Sig $ 275 48 $0

CT Colongraphy $273 Task Force Recommended Under Review not covered

currently

CEA $24 Non SpecificSEPT9 (Epiprocolon) $250-300 Considered Experimental

AVG COSTS (NOT CMS) in STUDY

AVG CMS COSTS

FIT vs Colonoscopy Cost Effectiveness

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4559662/

Colonoscopy is considered cost-effective for screening adenoma, advanced neoplasia, and a composite endpoint of advanced neoplasia or stage I CRC, but not CRC alone.

Wong MC, Ching JY, Chan VC, Sung JJ. The comparative cost-effectiveness of colorectal cancer screening using fecal immunochemical test vs. colonoscopy. Scientific Reports. 2015;5:13568. doi:10.1038/srep13568.

Annual FIT

ScreeningEnrolled 5893 4869Colonoscopy FindingsAdenoma 1.60% 23.60%Advanced Neoplasia 1.00% 3.90%Colorectal Cancer 0.20% 0.30%Cost for FIT testing for 4 years $775,200 0Total Cost colonoscopy plus consult plus polypectomy $540,154 $ 4,916,415 p g cancer stages 1-3 (no stage 4 in colon group) $244,494 $254,826 Total Cost of screening and treatment $1,469,863 $ 5,171,241 Sci Rep. 2015; 5: 13568.

Annual FIT

Screening ICERFindings

p Finding

p Finding Cost Effectivness

Screening Costs $ 1,225,369 $ 4,433,875

Adenoma $ 13,176 $ 4,271 3,489$

Advanced Neoplasia $ 21,882 $ 26,151 27,962$ Colorectal Cancer $ 122,537 $ 357,172 922,762$ Advanced Neoplasia and Stage 1 Colorectal Cancer $ 21,521 $ 23,294 23,981$ Moderate Risk patients 4,940 3,805 3,805 Adenoma $ 14,664 $ 4,520 3,597$ Advanced Neoplasia $ 22,314 $ 32,692 39,513$ Colorectal Cancer $ 128,306 $ 541,761 >1,000,000Advanced Neoplasia and Stage 1 Colorectal Cancer $ 21,925 $ 28,514 32,297$ High Risk Patients 923 1,064 1,064 Adenoma $ 9,959 $ 3,590 3,153$ Advanced Neoplasia $ 19,918 $ 15,555 14,852$ Colorectal Cancer $ 99,592 $ 159,999 184,162$ Advanced Neoplasia and Stage 1 Colorectal Cancer $ 19,708 $ 14,720 13,919$

Colonoscopy finding Colon Vs. FIT

Cost to detect one colorectal neoplasia