Cost—Utility Analysis of an Integrated Genetic/Epigenetic Test for Assessing Risk for Coronary Heart Disease

References

• Califf RM . Biomarker definitions and their applications. Exp. Bio. Med.243(3), 213–221 (2018).
   PubMed Web of Science ®Google Scholar
• Abouezzeddine OF , MckiePM , ScottCGet al. Biomarker-based risk prediction in the community. Eur. J. Heart Fail.18(11), 1342–1350 (2016).
   PubMed Web of Science ®Google Scholar
• Van Holten TC , WaandersLF , DeGroot PGet al. Circulating biomarkers for predicting cardiovascular disease risk: a systematic review and comprehensive overview of meta-analyses. PLoS ONE8(4), e62080 (2013).
   PubMed Web of Science ®Google Scholar
• Knowles JW , AshleyEA. Cardiovascular disease: the rise of the genetic risk score. PLoS Med.15(3), e1002546 (2018).
   PubMed Web of Science ®Google Scholar
• Mosley JD , GuptaDK , TanJet al. Predictive accuracy of a polygenic risk score compared with a clinical risk score for incident coronary heart disease. JAMA323(7), 627–635 (2020).
   PubMed Web of Science ®Google Scholar
• Khan SS , CooperR , GreenlandP. Do polygenic risk scores improve patient selection for prevention of coronary artery disease?JAMA323(7), 614–615 (2020).
   PubMed Web of Science ®Google Scholar
• FDA approves first non-invasive colorectal cancer screening test. Oncology Times36(10), 27–29 (2014).
   Google Scholar
• Suthrum P . Cologuard® plans to capture 40% market share. 21 takeaways from Exact Sciences Q3 2019 Earnings Call. (2019). www.nextservices.com/cologuard-plans-to-capture-40-market-share-21-takeaways-from-exact-sciences-q3-earnings-call/
   Google Scholar
• Taryma-LeÅ›niak O , SokolowskaKE , WojdaczTK. Current status of development of methylation biomarkers for in vitro diagnostic IVD applications. Clin. Epigenet.12(1), 1–16 (2020).
   Web of Science ®Google Scholar
• Heron MP . Deaths: leading causes for 2017. Natl Vital Stat. Rep.68(6), 1–77 (2019).
   PubMedGoogle Scholar
• Mihaylova B , EmbersonJ , BlackwellLet al. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet380(9841), 581–590 (2012).
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention . Vital signs: avoidable deaths from heart disease, stroke, and hypertensive disease – United States, 2001–2010. MMWR Morb. Mortal. Wkly Rep.62(35), 721 (2013).
   PubMed Web of Science ®Google Scholar
• Flather M . Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170 000 participants in 26 randomised trials. Lancet376(9753), 1670–1681 (2010).
   PubMed Web of Science ®Google Scholar
• Nawrocki JW , WeissSR , DavidsonMHet al. Reduction of LDL cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA reductase inhibitor. Arterioscler. Thromb. Vasc. Bio.15(5), 678–682 (1995).
   PubMed Web of Science ®Google Scholar
• Goff DC , Lloyd-JonesDM , BennettGet al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk. Circulation129(2 Suppl. 25), S49–S73 (2014).
   PubMed Web of Science ®Google Scholar
• Ridker PM , CookNR. Statins: new American guidelines for prevention of cardiovascular disease. Lancet382(9907), 1762–1765 (2013).
   PubMed Web of Science ®Google Scholar
• Raghavan S , HoY-L , VassyJLet al. Optimizing atherosclerotic cardiovascular disease risk estimation for veterans with diabetes mellitus. Circ. Cardiovasc. Qual. Outcomes13(9), e006528 (2020).
   PubMed Web of Science ®Google Scholar
• Ridker PM , CookNR , LeeI-Met al. A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. N. Engl. J. Med.352(13), 1293–1304 (2005).
   PubMed Web of Science ®Google Scholar
• Steering Committee of the Physicians’ Health Study Research Group . Final report on the aspirin component of the ongoing Physicians’ Health study. N. Engl. J. Med.321(3), 129–135 (1989).
   PubMed Web of Science ®Google Scholar
• Langer RD , WhiteE , LewisCE , KotchenJM , HendrixSL , TrevisanM. The Women’s Health Initiative Observational Study: baseline characteristics of participants and reliability of baseline measures. Annals Epidemiol.13(9), S107–S121 (2003).
   PubMed Web of Science ®Google Scholar
• Monick MM , BeachSR , PlumeJet al. Coordinated changes in AHRR methylation in lymphoblasts and pulmonary macrophages from smokers. Am. J. Med. Genet. B. Neuropsychiatr. Genet.159B(2), 141–151 (2012).
   PubMed Web of Science ®Google Scholar
• Soriano-Tárraga C , Jiménez-CondeJ , Giralt-SteinhauerEet al. Epigenome-wide association study identifies TXNIP gene associated with type 2 diabetes mellitus and sustained hyperglycemia. Hum. Mol. Genet.25(3), 609–619 (2015).
   PubMed Web of Science ®Google Scholar
• Dekkers KF , Van ItersonM , SliekerRCet al. Blood lipids influence DNA methylation in circulating cells. Genome Biol.17(1), 138 (2016).
   PubMedGoogle Scholar
• Dogan M , BeachS , SimonsR , LendasseA , PenalunaB , PhilibertR. Blood-based biomarkers for predicting the risk for five-year incident coronary heart disease in the Framingham Heart Study via machine learning. Genes9(12), 641 (2018).
   PubMed Web of Science ®Google Scholar
• Dogan MV , KnightS , DoganT , KnowltonK , PhilibertR. External validation of integrated genetic-epigenetic biomarkers for predicting incident coronary heart disease. ( In Press).
   Google Scholar
• Pearson SD . The ICER Value Framework: integrating cost effectiveness and affordability in the assessment of health care value. Value Health21(3), 258–265 (2018).
   PubMed Web of Science ®Google Scholar
• Tsao CW , VasanRS. Cohort Profile: The Framingham Heart Study (FHS): overview of milestones in cardiovascular epidemiology. Int. J. Epidemiol.44(6), 1800–1813 (2015).
   PubMed Web of Science ®Google Scholar
• Allan GM , LindbladAJ , ComeauAet al. Simplified lipid guidelines: prevention and management of cardiovascular disease in primary care. Can. Fam. Physician61(10), 857–867 (2015).
   PubMed Web of Science ®Google Scholar
• Lloyd-Jones DM , WilsonPWF , LarsonMGet al. Framingham risk score and prediction of lifetime risk for coronary heart disease. Am. J. Cardiol.94(1), 20–24 (2004).
   PubMed Web of Science ®Google Scholar
• Filipovic-Pierucci A , ZarcaK , Durand-ZaleskiI. Markov models for health economic evaluation modelling in r with the heemod package. Value Health19(7), A369 (2016).
   Web of Science ®Google Scholar
• World Health Organization . World health statistics 2015.World Health Organization (2015).
   Google Scholar
• Friede A , ReidJA , OryHW. CDC WONDER: a comprehensive on-line public health information system of the Centers for Disease Control and Prevention. Am. J. Public Health83(9), 1289–1294 (1993).
   PubMed Web of Science ®Google Scholar
• National Center for Health Statistics . National Health and Nutrition Examination Survey (NHANES) public use data files.
   Google Scholar
• Agency for Healthcare Research and Quality (US) . DehmerSP , MaciosekMV , FlottemeschTJ. Aspirin use to prevent cardiovascular disease and colorectal cancer: a decision analysis: technical report (Report No.: 15-05229-EF-1). US Preventive Services Task Force Evidence Syntheses (2015).
   Google Scholar
• Pletcher MJ , PignoneM , EarnshawSet al. Using the coronary artery calcium score to guide statin therapy: a cost–effectiveness analysis. Circ. Cardiovasc. Qual. Outcomes7(2), 276–284 (2014).
   PubMed Web of Science ®Google Scholar
• Briffa TG , HobbsMS , TonkinAet al. Population trends of recurrent coronary heart disease event rates remain high. Circ. Cardiovasc. Qual. Outcomes4(1), 107–113 (2011).
   PubMed Web of Science ®Google Scholar
• Van Kempen BJ , FerketBS , SteyerbergEW , MaxW , HuninkMM , FleischmannKE. Comparing the cost–effectiveness of four novel risk markers for screening asymptomatic individuals to prevent cardiovascular disease (CVD) in the US population. Int. J. Cardiol.203, 422–431 (2016).
   PubMed Web of Science ®Google Scholar
• Long D . Global generic and biosimilars trends and insights. Association for Accesible Medicines (2018).
   Google Scholar
• Jackevicius CA , ChouMM , RossJS , ShahND , KrumholzHM. Generic atorvastatin and health care costs. N. Engl. J. Med.366(3), 201 (2012).
   PubMed Web of Science ®Google Scholar
• US Bureau of Labor Statistics . Highlights of women’s earnings in 2019. (2020).
   Google Scholar
• Nyman JA , BarleenNA , DowdBE , RussellDW , CoonsSJ , SullivanPW. Quality-of-life weights for the US population: self-reported health status and priority health conditions, by demographic characteristics. Med. Care45(7), 618–628 (2007).
   PubMed Web of Science ®Google Scholar
• Kohli-Lynch CN , BellowsBK , ThanassoulisGet al. Cost-effectiveness of low-density lipoprotein cholesterol level–guided statin treatment in patients With borderline cardiovascular risk. JAMA Cardiol.4(10), 969–977 (2019).
   PubMed Web of Science ®Google Scholar
• Weinstein MC , RussellLB , GoldMR , SiegelJE. Cost-effectiveness in Health and Medicine.Oxford University Press, Oxford, UK ( 1996).
   Google Scholar
• Patrono C , GarcíaRodríguez LA , LandolfiR , BaigentC. Low-dose aspirin for the prevention of atherothrombosis. N. Engl. J. Med.353(22), 2373–2383 (2005).
   PubMed Web of Science ®Google Scholar
• Pandya A , SyS , ChoS , WeinsteinMC , GazianoTA. Cost-effectiveness of 10-year risk thresholds for initiation of statin therapy for primary prevention of cardiovascular disease. JAMA314(2), 142–150 (2015).
   PubMed Web of Science ®Google Scholar
• Lemstra M , BlackburnD , CrawleyA , FungR. Proportion and risk indicators of nonadherence to statin therapy: a meta-analysis. Can. J. Cardiol.28(5), 574–580 (2012).
   PubMed Web of Science ®Google Scholar
• Min JK , GilmoreA , JonesECet al. Cost-effectiveness of diagnostic evaluation strategies for individuals with stable chest pain syndrome and suspected coronary artery disease. Clin. Imaging43, 97–105 (2017).
   PubMed Web of Science ®Google Scholar
• Hutchins R , VieraAJ , SheridanSL , PignoneMP. Quantifying the utility of taking pills for cardiovascular prevention. Circ. Cardiovasc. Qual. Outcomes8(2), 155–163 (2015).
   PubMed Web of Science ®Google Scholar
• Institute for Clinical Economic Review . Overview of the ICER value assessment framework and update for 2017–2019. (2018).
   Google Scholar
• Mitchell MD , HongJA , LeeBY , UmscheidCA , BartschSM , DonCW. Systematic review and cost–benefit analysis of radial artery access for coronary angiography and intervention. Circ. Cardiovasc. Qual. Outcomes5(4), 454–462 (2012).
   PubMed Web of Science ®Google Scholar
• Morrow D , DeLemos J. Stable ischemic heart disease. In: Braunwald’s Heart Disease: a Textbook of Cardiovascular Medicine (11th Edition). Elsevier, Philadelphia, PA (2019).
   Google Scholar
• Lindbohm JV , SipiläPN , MarsNJet al. 5-year versus risk-category-specific screening intervals for cardiovascular disease prevention: a cohort study. Lancet Public Health4(4), e189–e199 (2019).
   PubMed Web of Science ®Google Scholar
• Silverio A , CavalloP , DeRosa R , GalassoG. Big health data and cardiovascular diseases: a challenge for research, an opportunity for clinical care. Front. Med.6, 36 (2019).
   PubMed Web of Science ®Google Scholar
• Imperiale TF , RansohoffDF , ItzkowitzSHet al. Multitarget stool DNA Testing for colorectal-cancer screening. N. Engl. J. Med.370(14), 1287–1297 (2014).
   PubMed Web of Science ®Google Scholar
• Ambatipudi S , CueninC , Hernandez-VargasHet al. Tobacco smoking-associated genome-wide DNA methylation changes in the EPIC study. Epigenomics8(5), 599–618 (2016).
   PubMed Web of Science ®Google Scholar
• Dogan MV , BeachSRH , PhilibertRA. Genetically contextual effects of smoking on genome wide DNA methylation. Am. J. Med. Genet. B Neuropsychiatr. Genet.174(6), 595–607 (2017).
   PubMed Web of Science ®Google Scholar
• Philibert R , DoganM , BeachSRH , MillsJA , LongJD. AHRR methylation predicts smoking status and smoking intensity in both saliva and blood DNA. Am. J. Genet.183(1), 51–60 (2019).
   Web of Science ®Google Scholar
• Andersen AM , DoganMV , BeachSRH , PhilibertRA. Current and future prospects for epigenetic biomarkers of substance use disorders. Genes6(4), 991–1022 (2015).
   PubMed Web of Science ®Google Scholar
• Mckinnon RA , WardMB , SorichMJ. A critical analysis of barriers to the clinical implementation of pharmacogenomics. Ther. Clin. Risk Manag.3(5), 751– 759 (2007).
   PubMedGoogle Scholar
• Khoury MJ , GaleaS. Will precision medicine improve population health?JAMA316(13), 1357–1358 (2016).
   PubMed Web of Science ®Google Scholar
• Stergiopoulos K , BrownDL. Initial coronary stent implantation with medical therapy vs medical therapy alone for stable coronary artery disease: meta-analysis of randomized controlled trials. Arch. Intern. Med.172(4), 312–319 (2012).
   PubMedGoogle Scholar
• Redberg RF . Informed strategies for treating coronary disease: comment on ‘Initial coronary stent implantation with medical therapy vs medical therapy alone for stable coronary artery disease’. Arch. Intern. Med.172(4), 321–321 (2012).
   PubMedGoogle Scholar
• Liu TYA , BresslerNM. Controversies in artificial intelligence. Curr. Opin. Ophthalmol.31(5), 324–328 (2020).
   PubMed Web of Science ®Google Scholar
• Yu K-H , BeamAL , KohaneIS. Artificial intelligence in healthcare. Nat. Biomed. Eng.2(10), 719–731 (2018).
   PubMed Web of Science ®Google Scholar