colorectal cancer screening · 2018-03-26 · world j gastrointest oncol. 2016 nov 15; 8(11):...
TRANSCRIPT
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