Cost-effectiveness of a Risk-Tailored Pancreatic Cancer Early Detection Strategy among Patients with New-Onset Diabetes

7017 Background: There are no established methods for pancreatic cancer (PC) screening, but the National Cancer Institute and the Pancreatic Cancer Action Network (PanCAN) are investigating risk-based screening strategies in new-onset diabetes (NOD)—a group with elevated PC risk. Preliminary estimates of the cost-effectiveness of these strategies can provide insights about potential value and inform supplemental data collection. Using data from the Enriching New-Onset Diabetes for Pancreatic Cancer (ENDPAC) risk model validation study, we assessed the potential value of CT screening for PC in those determined to be at elevated PC risk, as is being done in a planned PanCAN Early Detection Initiative (EDI) trial. Methods: We created an integrated decision tree and Markov state-transition model to assess the cost-effectiveness of screening those age ≥50 and with NOD for PC using CT imaging vs. no screening. PC prevalence, sensitivity, and specificity were derived from the ENDPAC validation study. PC stage distribution in the no screening strategy and PC survival were derived from SEER. Background mortality for diabetics, screening and cancer care expenditure, and health state utilities were derived from the literature. The base case assumed 40% of screen-detected PC cases were resectable, and a threshold analysis explored the fraction required for screening to be <$100,000 per QALY gained. Life years (LYs), quality-adjusted life years (QALYs), and costs were tracked over a lifetime horizon and discounted at 3% per year. Results are presented in 2019 USD, and we took a U.S. payer perspective. Results: In the base case, screening resulted in 0.0055 more LYs, 0.0045 more QALYs, and $305 in additional expenditure for a cost per QALY gained of $68,059 (Table). Among PC cases, screening resulted in 0.67 more LYs, 0.55 more QALYs, and $22,691 in additional expenditure. In probabilistic analyses, screening resulted in a cost per QALY gained of <$50,000 and <$100,000 in 34% and 99% of simulations, respectively. In the threshold analysis, >25% of screen-detected cases needed to be resectable for the cost per QALY gained with screening to be <$100,000. Conclusions: We found that risk-based pancreatic cancer screening in NOD is likely to be cost-effective in the U.S. if even a modest fraction (>25%) of screen-detected cases are resectable. Future studies should reassess the value of this intervention once PanCAN EDI data become available. [Table: see text]

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Potential Cost-Effectiveness of Risk-Based Pancreatic Cancer Screening in Patients With New-Onset Diabetes

Journal of the National Comprehensive Cancer Network ◽

10.6004/jnccn.2020.7798 ◽

2021 ◽

pp. 1-9

Author(s):

Naomi R.M. Schwartz ◽

Lynn M. Matrisian ◽

Eva E. Shrader ◽

Ziding Feng ◽

Suresh Chari ◽

...

Keyword(s):

Pancreatic Cancer ◽

Cost Effectiveness ◽

Validation Study ◽

The United States ◽

Potential Cost ◽

Lifetime Horizon ◽

Potential Value ◽

Onset Diabetes ◽

The Cost ◽

New Onset

Background: There are no established methods for pancreatic cancer (PAC) screening, but the NCI and the Pancreatic Cancer Action Network (PanCAN) are investigating risk-based screening strategies in patients with new-onset diabetes (NOD), a group with elevated PAC risk. Preliminary estimates of the cost-effectiveness of these strategies can provide insights about potential value and inform supplemental data collection. Using data from the Enriching New-Onset Diabetes for Pancreatic Cancer (END-PAC) risk model validation study, we assessed the potential value of CT screening for PAC in those determined to be at elevated risk, as is being done in a planned PanCAN Early Detection Initiative trial. Methods: We created an integrated decision tree and Markov state-transition model to assess the cost-effectiveness of PAC screening in patients aged ≥50 years with NOD using CT imaging versus no screening. PAC prevalence, sensitivity, and specificity were derived from the END-PAC validation study. PAC stage distribution in the no-screening strategy and PAC survival were derived from the SEER program. Background mortality for patients with diabetes, screening and cancer care expenditure, and health state utilities were derived from the literature. Life-years (LYs), quality-adjusted LYs (QALYs), and costs were tracked over a lifetime horizon and discounted at 3% per year. Results are presented in 2020 US dollars, and we took a limited US healthcare perspective. Results: In the base case, screening resulted in 0.0055 more LYs, 0.0045 more QALYs, and $293 in additional expenditures for a cost per QALY gained of $65,076. In probabilistic analyses, screening resulted in a cost per QALY gained of <$50,000 and <$100,000 in 34% and 99% of simulations, respectively. In the threshold analysis, >25% of screen-detected PAC cases needed to be resectable for the cost per QALY gained with screening to be <$100,000. Conclusions: We found that risk-based PAC screening in patients with NOD is likely to be cost-effective in the United States if even a modest fraction (>25%) of screen-detected patients with PAC are resectable. Future studies should reassess the value of this intervention once clinical trial data become available.

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New Onset of DiabetEs in aSsociation with pancreatic ductal adenocarcinoma (NODES Trial): protocol of a prospective, multicentre observational trial

BMJ Open ◽

10.1136/bmjopen-2020-037267 ◽

2020 ◽

Vol 10 (11) ◽

pp. e037267

Author(s):

Dóra Illés ◽

Emese Ivány ◽

Gábor Holzinger ◽

Klára Kosár ◽

M Gordian Adam ◽

...

Keyword(s):

High Risk ◽

Early Detection ◽

Pancreatic Ductal Adenocarcinoma ◽

Clinical Symptoms ◽

Risk Group ◽

High Risk Group ◽

Ductal Adenocarcinoma ◽

Onset Diabetes ◽

Dismal Prognosis ◽

New Onset

IntroductionPancreatic ductal adenocarcinoma (PDAC) has a dismal prognosis with an overall 5-year survival of approximately 8%. The success in reducing the mortality rate of PDAC is related to the discovery of new therapeutic agents, and to a significant extent to the development of early detection and prevention programmes. Patients with new-onset diabetes mellitus (DM) represent a high-risk group for PDAC as they have an eightfold higher risk of PDAC than the general population. The proposed screening programme may allow the detection of PDAC in the early, operable stage. Diagnosing more patients in the curable stage might decrease the morbidity and mortality rates of PDAC and additionally reduce the burden of the healthcare.Methods and analysisThis is a prospective, multicentre observational cohort study. Patients ≥60 years old diagnosed with new-onset (≤6 months) diabetes will be included. Exclusion criteria are (1) Continuous alcohol abuse; (2) Chronic pancreatitis; (3) Previous pancreas operation/pancreatectomy; (4) Pregnancy; (5) Present malignant disease and (6) Type 1 DM. Follow-up visits are scheduled every 6 months for up to 36 months. Data collection is based on questionnaires. Clinical symptoms, body weight and fasting blood will be collected at each, carbohydrate antigen 19–9 and blood to biobank at every second visit. The blood samples will be processed to plasma and analysed with mass spectrometry (MS)-based metabolomics. The metabolomic data will be used for biomarker validation for early detection of PDAC in the high-risk group patients with new-onset diabetes. Patients with worrisome features will undergo MRI or endoscopic ultrasound investigation, and surgical referral depending on the radiological findings. One of the secondary end points is the incidence of PDAC in patients with newly diagnosed DM.Ethics and disseminationThe study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (41085-6/2019). We plan to disseminate the results to several members of the healthcare system includining medical doctors, dietitians, nurses, patients and so on. We plan to publish the results in a peer-reviewed high-quality journal for professionals. In addition, we also plan to publish it for lay readers in order to maximalise the dissemination and benefits of this trial.Trial registration numberClinicalTrials.gov NCT04164602

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New‐onset Diabetes as a Harbinger of Pancreatic Cancer: is Early Diagnosis Possible?

Clinical Pancreatology for Practising Gastroenterologists and Surgeons ◽

10.1002/9781119570097.ch51 ◽

2021 ◽

pp. 409-417

Author(s):

Dana K. Andersen ◽

Suresh T. Chari ◽

Eithne Costello ◽

Tatjana Crnogorac‐Jurcevic ◽

Phil A. Hart ◽

...

Keyword(s):

Pancreatic Cancer ◽

Early Diagnosis ◽

Onset Diabetes ◽

New Onset

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Reply: Letter to the Editor: Prospective Assessment for Prediabetes and New-Onset Diabetes in High-Risk Individuals Undergoing Pancreatic Cancer Screening

Gastroenterology ◽

10.1053/j.gastro.2022.01.014 ◽

2022 ◽

Author(s):

Ishani Shah ◽

Mandeep S. Sawhney

Keyword(s):

Pancreatic Cancer ◽

Cancer Screening ◽

High Risk ◽

Letter To The Editor ◽

Onset Diabetes ◽

Pancreatic Cancer Screening ◽

Prospective Assessment ◽

New Onset

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The Screening and Early Detection of Pancreatic Cancer: Who, When, and How?

The Korean Journal of Pancreas and Biliary Tract ◽

10.15279/kpba.2020.25.2.65 ◽

2020 ◽

Vol 25 (2) ◽

pp. 65-71

Author(s):

Jae Hyuck Chang

Keyword(s):

Pancreatic Cancer ◽

Chronic Pancreatitis ◽

General Population ◽

Early Detection ◽

Imaging Modality ◽

Ductal Adenocarcinoma ◽

Average Risk ◽

Cystic Lesions ◽

Low Prevalence ◽

New Onset

More than 80% of patients with pancreatic ductal adenocarcinoma (PDA) present with symptomatic, surgically unresectable disease. If a “stage shift” from the current 20% resectable proportion to greater by early detection can be achieved, it will unequivocally lead to improved survival in this otherwise dismal disease. Although the goal of early detection of PDA is laudable, the relatively low prevalence PDA renders general population screening infeasible. To avoid the perils of overdiagnosis and to focus early detection efforts on individuals deemed to be at higher-than-average risk, we need to define those subsets of individuals, such as familial kindred and patients with precursor cystic lesions, chronic pancreatitis, and new-onset diabetes. The next step is to determine when and how often to conduct surveillance in the atrisk individuals and the modalities (biomarkers and imaging) that will be used in the surveillance and diagnostic settings, respectively. Nonetheless, vast challenges still remain in terms of validated blood-based biomarkers, imaging modality, and when and how often the surveillance.

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