The Cost of Guideline Adherence: A Multicenter Analysis of the Financial Implications of Adopting the US Multi-Society Task Force Polypectomy Guidelines.

GOAL: The goal of this study was to determine the financial impact of adopting the US Multi-Society Task Force (USMSTF) polypectomy guidelines on physician reimbursement and disposable equipment costs for gastroenterologists in the academic medical center and community practice settings. BACKGROUND: In 2020, USMSTF guidelines on polypectomy were introduced with a strong recommendation for cold snare rather than cold forceps technique for removing diminutive and small polyps. Polypectomy with snare technique reimburses physicians at a higher rate compared with cold forceps and also requires different disposable equipment. The financial implications of adopting these guidelines is unknown. MATERIALS AND METHODS: Patients that underwent screening colonoscopy where polypectomy was performed at an academic medical center (Loma Linda University Medical Center) and community practice medical center (Ascension Providence Hospital) between July 2018 and July 2019 were identified. The polypectomy technique performed during each procedure was determined (forceps alone, snare alone, forceps plus snare) along with the number and size of polyps as well as disposable equipment. Actual and projected provider reimbursement and disposable equipment costs were determined based on applying the new polypectomy guidelines. RESULTS: A total of 1167 patients underwent colonoscopy with polypectomy. Adhering to new guidelines would increase estimated physician reimbursement by 5.6% and 12.5% at academic and community practice sites, respectively. The mean increase in physician reimbursement per procedure was significantly higher at community practice compared with the academic setting ($29.50 vs. $14.13, P <0.00001). The mean increase in disposable equipment cost per procedure was significantly higher at the community practice setting ($6.11 vs. $1.97, P <0.00001). CONCLUSION: Adopting new polypectomy guidelines will increase physician reimbursement and equipment costs when colonoscopy with polypectomy is performed.

Endoscopic resection is cost-effective compared with laparoscopic resection in the management of complex colon polyps: an economic analysis.

BACKGROUND AND AIMS: Endoscopic resection (ER) is an efficacious treatment for complex colon polyps (CCPs). Many patients are referred for surgical resection because of concerns over procedural safety, incomplete polyp resection, and adenoma recurrence after ER. Efficacy data for both resection strategies are widely available, but a paucity of data exist on the cost-effectiveness of each modality. The aim of this study was to perform an economic analysis comparing ER and laparoscopic resection (LR) strategies in patients with CCP. METHODS: A decision analysis tree was constructed using decision analysis software. The 2 strategies (ER vs LR) were evaluated in a hypothetical cohort of patients with CCPs. A hybrid Markov model with a 10-year time horizon was used. Patients entered the model after colonoscopic diagnosis at age 50. Under Strategy I, patients underwent ER followed by surveillance colonoscopy at 3 to 6 months and 12 months. Patients with failed ER and residual adenoma at 12 months were referred for LR. Under Strategy II, patients underwent LR as primary treatment. Patients with invasive cancer were excluded. Estimates regarding ER performance characteristics were obtained from a systematic review of published literature. The Centers for Medicare & Medicaid Services (2012-2013) and the 2012 Healthcare Cost and Utilization Project databases were used to determine the costs and loss of utility. We assumed that all procedures were performed with anesthesia support, and patients with adverse events in both strategies required inpatient hospitalization. Baseline estimates and costs were varied by using a sensitivity analysis through the ranges. RESULTS: LR was found to be more costly and yielded fewer quality-adjusted life-years (QALYs) compared with ER. The cost of ER of a CCP was $5570 per patient and yielded 9.640 QALYs. LR of a CCP cost $18,717 per patient and yielded fewer QALYs (9.577). For LR to be more cost-effective, the thresholds of 1-way sensitivity analyses were (1) technical success of ER for complete resection in <75.8% of cases, (2) adverse event rates for ER > 12%, and (3) LR cost of <$14,000. CONCLUSIONS: Our data suggest that ER is a cost-effective strategy for removal of CCPs. The effectiveness is driven by high technical success and low adverse event rates associated with ER, in addition to the increased cost of LR.

Race and Prevalence of Large Bowel Polyps Among the Low-Income and Uninsured in South Carolina.

BACKGROUND: Compared to whites, blacks have higher colorectal cancer incidence and mortality rates and are at greater risk for early-onset disease. The reasons for this racial disparity are poorly understood, but one contributing factor could be differences in access to high-quality screening and medical care. AIMS: The present study was carried out to assess whether a racial difference in prevalence of large bowel polyps persists within a poor and uninsured population (n = 233, 124 blacks, 91 whites, 18 other) undergoing screening colonoscopy. METHODS: Eligible patients were uninsured, asymptomatic, had no personal history of colorectal neoplasia, and were between the ages 45-64 years (blacks) or 50-64 years (whites, other). We examined the prevalence of any adenoma (conventional, serrated) and then difference in adenoma/polyp type by race and age categories. RESULTS: Prevalence for ≥1 adenoma was 37 % (95 % CI 31-43 %) for all races combined and 36 % in blacks <50 years, 38 % in blacks ≥50 years, and 35 % in whites. When stratified by race, blacks had a higher prevalence of large conventional proximal neoplasia (8 %) compared to whites (2 %) (p value = 0.06) but a lower prevalence of any serrated-like (blacks 18 %, whites 32 %; p value = 0.02) and sessile serrated adenomas/polyps (blacks 2 %, whites 8 % Chi-square p value; p = 0.05). CONCLUSIONS: Within this uninsured population, the overall prevalence of adenomas was high and nearly equal by race, but the racial differences observed between serrated and conventional polyp types emphasize the importance of taking polyp type into account in future research on this topic.

Colon Capsule Endoscopy for the Detection of Colorectal Polyps: An Economic Analysis.

BACKGROUND: Colorectal cancer is a leading cause of mortality and morbidity in Ontario. Most cases of colorectal cancer are preventable through early diagnosis and the removal of precancerous polyps. Colon capsule endoscopy is a non-invasive test for detecting colorectal polyps. OBJECTIVES: The objectives of this analysis were to evaluate the cost-effectiveness and the impact on the Ontario health budget of implementing colon capsule endoscopy for detecting advanced colorectal polyps among adult patients who have been referred for computed tomographic (CT) colonography. METHODS: We performed an original cost-effectiveness analysis to assess the additional cost of CT colonography and colon capsule endoscopy resulting from misdiagnoses. We generated diagnostic accuracy data from a clinical evidence-based analysis (reported separately), and we developed a deterministic Markov model to estimate the additional long-term costs and life-years lost due to false-negative results. We then also performed a budget impact analysis using data from Ontario administrative sources. One-year costs were estimated for CT colonography and colon capsule endoscopy (replacing all CT colonography procedures, and replacing only those CT colonography procedures in patients with an incomplete colonoscopy within the previous year). We conducted this analysis from the payer perspective. RESULTS: Using the point estimates of diagnostic accuracy from the head-to-head study between colon capsule endoscopy and CT colonography, we found the additional cost of false-positive results for colon capsule endoscopy to be $0.41 per patient, while additional false-negatives for the CT colonography arm generated an added cost of $116 per patient, with 0.0096 life-years lost per patient due to cancer. This results in an additional cost of $26,750 per life-year gained for colon capsule endoscopy compared with CT colonography. The total 1-year cost to replace all CT colonography procedures with colon capsule endoscopy in Ontario is about $2.72 million; replacing only those CT colonography procedures in patients with an incomplete colonoscopy in the previous year would cost about $740,600 in the first year. LIMITATIONS: The difference in accuracy between colon capsule endoscopy and CT colonography was not statistically significant for the detection of advanced adenomas (≥ 10 mm in diameter), according to the head-to-head clinical study from which the diagnostic accuracy was taken. This leads to uncertainty in the economic analysis, with results highly sensitive to changes in diagnostic accuracy. CONCLUSIONS: The cost-effectiveness of colon capsule endoscopy for use in patients referred for CT colonography is $26,750 per life-year, assuming an increased sensitivity of colon capsule endoscopy. Replacement of CT colonography with colon capsule endoscopy is associated with moderate costs to the health care system.

Use of colonoscopy for polyp surveillance in Medicare beneficiaries.

BACKGROUND: Professional society guidelines recommend follow-up colonoscopy for patients with resected colonic adenomas. However, adherence to guideline recommendations in routine clinical practice has not been well characterized. METHODS: The authors used a population-based sample of Medicare beneficiaries to identify all patients aged ≥70 years who had a claim for colonoscopy with polypectomy or hot biopsy during the period from 2001 to 2004. Medicare claims through 2009 identified colonoscopy within the following 5 years as well as fecal occult blood testing, sigmoidoscopy, and barium enema. RESULTS: In total, 12,771 patients were included. At 5 years, 45.7% of patients underwent another colonoscopy, and 32.3% of procedures included a polypectomy. The rates of fecal occult blood testing, flexible sigmoidoscopy, and barium enema at 5 years were 54%, 3.8%, and 2.9%, respectively. There was a marked decrease in repeat colonoscopy at 1 year, 3 years, and 5 years with more recent years of index procedures. Other predictors of undergoing repeat colonoscopy were younger age, African American race, and a colonoscopy before the index examination. There was no association with physician specialty. The decreasing use of colonoscopy with time was maintained in a multivariable analysis. CONCLUSIONS: In a sample of elderly Medicare beneficiaries, there was under use of follow-up colonoscopy at 5 years after polypectomy, and <50% of patients received a repeat examination. In particular, the use of this procedure decreased over the 4-year study period. Coupled with other data indicating the overuse of follow-up colonoscopy in patients without polyps, there appeared to be significant discordance between guidelines and actual practice.

Peculiarities of diagnosis and treatment in the polyp-cancer sequence.

Colorectal cancer, a public health problem with major social implications, has attracted major economic resources and specialized centers focused in the direction of obtaining an early diagnosis from effective screening means in the last decades. It is obvious that the therapeutic results and the social costs are primarily dependent on the precocity of diagnosis. The present paper aims to bring to attention a number of orientations, which may open a new perspective in approaching the genetic and molecular level of these lesions. Out of these, the value of the molecular screening based on the detection of the APC gene located on the short arm of chromosome 5, a method that allows the selection of the subjects to be subjected to further endoscopic screening is underlined. The optimization of the costs as well as the increased compliance of the subjects to such a method is thus accomplished.

Safety and cost-effectiveness of outpatient colonoscopic polypectomy.

BACKGROUND/AIMS: Factors that increase the complications arising from colonoscopic polypectomy have been well studied; however, data regarding complications from outpatient polypectomy is limited. The aim of this study was to identify the safety and costeffectiveness of outpatient colonoscopic polypectomy. METHODOLOGY: Consecutive series of 804 patients who underwent colonoscopic polypectomy for 1,446 polyps were analyzed. Clinical outcomes, complications and medical costs were compared between outpatient (n=731) and planned inpatient groups (n=73) to assess the safety and cost-effectiveness of the colonoscopic polypectomy. The risk factors for polypectomy- related complications were assessed by a multivariate logistic regression analysis. RESULTS: There was no difference in the complication rates between the outpatient polypectomy group (1.1%) and the planned inpatient group (2.7%), and outpatient service was not a significant risk factor of complications in the colonoscopic polypectomy by multivariate analysis. The outcomes of complications were not worsened by outpatient procedures. However, total cost for an outpatient polypectomy for a single polyp without any complication was 37.4% lower than that for a planned inpatient polypectomy, which was a significant reduction (p=0.000). CONCLUSIONS: Colonoscopic polypectomy can be safely and cost-effectively performed in the outpatient setting with minimal controllable complications.

Flexible spectral imaging color enhancement and indigo carmine in neoplasia diagnosis during colonoscopy: a large prospective UK series.

OBJECTIVES: At present, all colonic polyps are removed and sent for histopathological evaluation, resulting in laboratory and reporting costs. Recent American Society for Gastrointestinal Endoscopy (ASGE) guidelines have set standards for in-vivo diagnosis in place of conventional histopathology, and all future technologies will have to be tested against these standards. Data on flexible spectral imaging color enhancement (FICE) were very limited. This study aims to evaluate the accuracy of FICE and indigo carmine (IC) for in-vivo histology prediction for polyps of less than 10 mm in size and to assess the economic impact of this strategy. METHODS: In a screening population, polyps of less than 10 mm were assessed using white light (WLI) by FICE, by IC, and the predicted diagnosis was recorded. Polyps were then removed and sent for histological analysis. Accuracy of the predicted rescope interval was calculated using British Society of Gastroenterology and ASGE guidelines. Two models for using in-vivo diagnosis were proposed and savings in terms of histopathology costs calculated. RESULTS: A total of 232 polyps of less than 10 mm were examined. FICE improved the accuracy of in-vivo diagnosis of adenoma to 88% compared with 75% with WLI (P<0.0001). IC after FICE improved this further to 94%. Rescope interval could be set correctly using FICE or IC in 97% of cases by British Society of Gastroenterology guidelines or 97% with FICE and 99% with IC using ASGE guidelines. A saving of £678,253 (€762767) per annum could be made within the UK national screening population. CONCLUSION: FICE and IC significantly improves the in-vivo diagnosis of colonic polyps over WLI and can lead to significant cost savings.

A quantitative assessment of the risks and cost savings of forgoing histologic examination of diminutive polyps.

BACKGROUND AND AIMS: Endoscopic prediction of polyp histology is rapidly improving to the point where it may not be necessary to submit all polyps for formal histologic assessment. This study aimed to quantify the expected costs and outcomes of removing diminutive polyps without subsequent pathologic assessment. METHODS: Cross-sectional analysis of a colonoscopy database for polyp histology; decision models that quantify effects on guideline-recommended surveillance and subsequent costs and consequences. The database was composed of consecutive colonoscopies from 1999 to 2004 at a single-institution tertiary care center. Patients were those found to have at least one diminutive polyp removed during colonoscopy, irrespective of indication. The main outcome measurements include up-front cost savings resulting from forgoing pathologic assessment; frequency and cost of incorrect surveillance intervals based on errors in histologic assessment; number needed to harm (NNH) for perforation and/or interval cancer. RESULTS: Incorrect surveillance intervals were recommended in 1.9% of cases when tissue was submitted for pathologic assessment and 11.8% of cases when it was not. Based on the annual volume of colonoscopy in the US, the annual up-front cost savings of forgoing the pathologic assessment would exceed a billion dollars. An upper estimate on the downstream costs and consequences of forgoing pathology suggests that less than 10% of the up-front savings would be offset and the NNH exceeds 11000. CONCLUSION: Endoscopic diagnosis of polyp histology during colonoscopy and forgoing pathologic examination would result in substantial up-front cost savings. Downstream consequences of the resulting incorrect surveillance intervals appear to be negligible.

[Screening for colorectal cancer: a cost benefit analysis on a health prevention programme at the Boehringer Ingelheim Company]. / Darmkrebsscreening im betrieblichen Umfeld: Kosten-Nutzen-Analyse einer Maßnahme zur Gesundheitsförderung bei Boehringer Ingelheim.

BACKGROUND AND OBJECTIVE: In Germany, approximately 70.000 people are diagnosed with colorectal cancer every year. With early diagnosis the recovery rates are over 90 % and early intervention can significantly reduce the costs of medical treatment as well as the economic losses from worker productivity. We here present the organisational procedure for bowel cancer screening and have weighed the costs against benefits to employees, the company and the healthcare system. The screening costs are compared with economic benefits. METHODS: The target group for the study consisted of all 11.536 employees at the company's site in Germany. Volunteers were given a standardized questionnaire about the risk factors for colorectal cancers and an immunological fecal occult blood test (IFOBT). If risk factors for development of colorectal cancer were present or if the test result was positive, a colonoscopy was recommended in accordance with DGVS guidelines (German Society of Digestive and Metabolic diseases). RESULTS: A total of 4.287 employees (37.2 %) indicated an interest in undergoing screening; at the end of the period 3.958 complete datasets (2.296 men and 1.662 women, mean age 51.2 years) were available for evaluation. A colonoscopy was performed on 114 persons. Six cases of overt cancer were detected with three in the 36 - 50 age group and three in the 51 - 65 age group. Five of the six cases were stage T1 or T2. Adenomatous polyps were found and removed in 29 persons. The calculated cost benefit ratio was 1:2 for the company and 1:35 for the public health system. CONCLUSION: Using the example of colorectal screening, this study represents a cost benefit analysis of this preventative health measure in a company environment. The results show that even while taking into account the financial and personal commitment required, the cost benefit ratio is positive both for the company and for the healthcare system.

Some diminutive colorectal polyps can be removed and discarded without pathological examination.

BACKGROUND AND STUDY AIMS: Pathological examination of colorectal polyps is useful if clinical management is affected (i. e. when invasive carcinoma is detected or postpolypectomy surveillance interval is guided). Our aim was to assess whether the pathological examination of some diminutive (measuring ≤ 5 mm) polyps can be omitted. PATIENTS AND METHODS: Consecutive patients undergoing a colonoscopy at Pasteur Hospital (Colmar, France) between January and August 2008 were included in this prospective study. Six senior gastroenterologists predicted the future surveillance interval without referring to the result of pathological examination. RESULTS: In all, 350 polyps from 175 patients were removed and analyzed. The endoscopist was able to predict the correct surveillance interval without referring to the result of pathological examination in 118 patients (67.4 %; 95 % confidence interval [CI] 60.5 - 74.4). The pathological examination of 18.4 % (95 % CI 13.7 - 23.1) of diminutive polyps either associated with a cancer or a polyp measuring ≥ 10 mm or removed in very old or frail patients could be omitted without any consequence for the patient. If diminutive polyps one or two in number were discarded without pathological examination in patients with a personal history of colorectal neoplasm, three patients out of 43 would have a 5-year instead of a 3-year surveillance interval. As a whole, if 44.1 % (95 % CI 38.0 - 50.1) of diminutive polyps were discarded, the surveillance interval would remain identical in 98.3 % (95 % CI 96.4 - 100) of patients. CONCLUSIONS: The pathological examination of up to 44 % of diminutive polyps (i. e. 33 % of all polyps), can be safely omitted. The pathological examination would be required only for those with suspicious gross appearance, those three or more in number, and those isolated one or two in number that are removed from people without personal history of colorectal neoplasm.

Value-of-information analysis to guide future research in the management of the colorectal malignant polyp.

PURPOSE: The efficacy of surgery in the postendoscopic management of low-risk malignant polyps is unclear. Although interobserver variability in the histological diagnosis was shown, its importance is unknown. The purpose of this study was to guide future research on the optimal strategy for low-risk polyps with the use of value-of-information analysis. METHODS: A decision-analysis model was constructed comparing the strategies of referring or not referring (waiting) to surgery patients with low-risk polyps. Probabilistic sensitivity analysis was performed to explore the effect of uncertainty about the input parameters. Value-of-information analysis was used to estimate the expected benefit of future research that would eliminate the decision uncertainty. RESULTS: The number of postendoscopic surgeries to prevent 1 cancer-related death was 208. The incremental cost-effectiveness ratio of surgery vs waiting strategy was $215,291/life-year gained, surgery being a suboptimal choice in the reference case analysis. Probabilistic sensitivity analysis demonstrated that surgery was the optimal choice in 61% of the simulated scenarios. Most of the decision uncertainty was related with the combination of histological inaccuracy, prevalence of residual disease, and surgical mortality. The expected societal monetary benefit of further research from the perspective of the United States was estimated to be $1 billion. CONCLUSIONS: The small benefit and the relatively high costs associated with surgery argue against surgical referral for low-risk malignant polyps; however, when a suboptimal histopathological accuracy was simulated, surgery appeared to be the most cost-effective option, prompting the need for further research.

Biopsies of colorectal clinical polyps--emergence of diagnostic information on deeper levels.

Although the occasional appearance of a normal histology of biopsies from endoscopic colorectal (CR) polyps is generally held knowledge, its prevalence has rarely been focused on, and the yield of additional sections in such cases has been previously addressed in merely four communications. Hitherto, this issue has not been discussed in the context of the clinical setting. The prime aim of this study was to evaluate the yield of step sectioning CR biopsies, considered non-diagnostic (non-diagnostic biopsies (NDB)) on routine sections. The results are correlated with the indications for endoscopy. Additionally, an appropriate, cost-effective approach for handling NDB was sought. Biopsies from 480 clinical polyps were prospectively evaluated by one of three gastrointestinal pathologists and classified as (a) diagnostic biopsies (DB), comprising neoplastic polyps, hyperplastic polyps (HP), sessile-serrated polyp, other diverse causes of polyp formation and (b) NDB comprising normal histology (group 1), suspicious of either adenoma (group 2) or HP (group 3). Material grouped 1-3 was subsequently step-sectioned (three sections prepared from each of nine additional levels). The biopsy specimens were obtained from 245 endoscopies and stratified in the following categories according to the clinical indications: relevant symptoms (symptomatic, n=127), previously documented sporadic large bowel neoplasia (follow-up, n=99), and documented or presumed hereditary condition that confer an increased risk of CRC (hereditary, n=19, including 15 hereditary non-polyposis colorectal cancer (HNPCC) cases). Sixty-five (13.5%) of the 480 samples were classified as NDB (normal morphology n=49, suspicious of adenoma n=5, suspicious of HP n=11), constituting roughly 10% of all biopsies from the symptomatic and the follow-up categories, 32.1% of samples from the hereditary cases, the difference between the hereditary and the non-hereditary cases being statistically significant (p<0.0001). Upon leveling the 65 NDB, a DB emerged in 24 (36.9%) cases, with no significant difference in the yield in relation to the delineated indication categories. Thereby, diagnostic information was obtained with three additional levels in 15 cases, the remaining 9 cases requiring additional sections, ranging from 4 to 8 levels. The present step sectioning approach implied an extra expense of about 112 US$ for each NDB converted to a DB. The higher prevalence of NDB in relation to genetic disorders probably reflects sampling of particularly diminutive lesions. Given the high yield of step sectioning NDB coupled with an acceptable price, our strategy delineated here is recommended in routine practice with the modification of an initial preparation of sections from merely three levels, and if still non-diagnostic, supplementation with additional five levels.

Cost-effectiveness analysis on screening for colorectal neoplasm and management of colorectal cancer in Asia.

BACKGROUND: Faecal occult blood testing (FOBT), flexible sigmoidoscopy (FS) and colonoscopy are recommended for subjects above 50 years of age for screening for colorectal cancer (CRC). AIM: To evaluate the cost-effectiveness of FOBT, FS and colonoscopy on the basis of disease prevalence, compliance rate and cost of screening procedures in Asian countries. METHODS: A hypothetical population of 100 000 persons aged 50 undergoes either FOBT annually, FS every 5 years or colonoscopy every 10 years until the age of 80 years. Patients with positive FOBT or polyp in FS are offered colonoscopy. Surveillance colonoscopy is repeated every 3 years. The treatment cost of CRC, including surgery and chemotherapy, was evaluated. A Markov model was used to compare the cost-effectiveness of different screening strategies. RESULTS: Assuming a compliance rate of 90%, colonoscopy, FS and FOBT can reduce CRC incidence by 54.1%, 37.1% and 29.3% respectively. The incremental cost-effectiveness ratio (ICER) for FOBT (US$6222 per life-year saved) is lower than FS (US$8044 per life-year saved) and colonoscopy (US$7211 per life-year saved). When the compliance rate drops to 50% and 30%, FOBT still has the lowest ICER. CONCLUSION: FOBT is cost-effective compared to FS or colonoscopy for CRC screening in average-risk individuals aged from 50 to 80 years.

[Cost-effectiveness evaluation of predictive molecular diagnostics using the example of hereditary non-polyposis colorectal cancer (HNPCC)]. / Kosteneffektivitätsbewertung Prädiktiver Molekulardiagnostik am Beispiel des Hereditären Nichtpolypösen Kolorektalkarzinoms (HNPCC).

STUDY OBJECTIVE: Four different diagnostic strategies, with and without various molecular diagnostic tests, are compared and contrasted not only by years gained and the cost of therapy and diagnosis, but also by the cost-effectiveness of the diagnostic strategies. METHODOLOGY: A fictitious cohort of 100,000 people, whose genetic pre-disposition leading to the development of colorectal cancer corresponds to a representative average amongst the current population, will be studied from their 1st to their 85th year. This data will be then put through Markov models specifically developed for the study. At the end of the Markov process, it will then be possible to compile a cost-effectiveness report in regard to the various diagnostic and treatment strategies. RESULTS: A tiered diagnosis (with family case history, micro-satellite instability, molecular diagnostic diagnosis of an index person and subsequent genetic analysis of all people at risk) represents the most cost-effective method at a rate of euro 3,867 per year gained. The cost-effectiveness of a purely clinical diagnosis has a rate of euro 4,397 per year gained and is followed by the cost of direct gene testing of people at risk from families at risk at a rate of euro 6,208. The worst level of cost-effectiveness, with a rate of euro 15,705, was shown by nationwide gene screening. The incremental cost-effectiveness of Strategy IV and Strategy II is euro 124,168 per gained year. CONCLUSIONS: With the scenarios put forward we can show that a 65% reduction in gene test costs is necessary in order for a cost-effective nationwide gene screening for HNPCC to take place. The break-even level, however, depends only on a few cost-effectiveness drivers such as screening and therapy costs, proportion of HNPCC of all colorectal cancer and discounting rate. Should these changes (e.g., through a restructured medical environment), then we would see such a change in the break-even cost of a gene test and that a cost-effective nationwide gene screening could be made plausible. In a final evaluation of the use of predictive molecular diagnostics, other dimensions (such as possible psychological problems and discriminatory risks) apart from cost-effectiveness should also be included.