Skip to main content

Healthcare Cost Implications of Utilizing a Dietary Intervention to Lower LDL Cholesterol: Proof of Concept Actuarial Analysis and Recommendations

Current Cardiology Reports volume 22, Article number: 138 (2020) Cite this article

Abstract

Purpose of Review

To determine if subsidizing the cost of a food-based intervention for managing hyperlipidemia could be cost-effective under commercial insurance and/or Medicare coverage scenarios.

Recent Findings

A large number of patients eligible for pharmaceutical treatment of hyperlipidemia either cannot or will not use lipid lowering drugs, leaving them at increased cardiovascular risk. Lipid levels can be modified by diet, but food has never enjoyed covered benefit status. We evaluated the financial implications of providing insurance coverage for a specifically formulated suite of food products previously documented to yield statistically significant lipid reductions, using multiple product uptake and lipid impact scenarios in both commercially covered and Medicare-covered populations.

Summary

Even after controlling for multiple confounders, we noted positive payback on subsidizing the cost of lipid-lowering foods under all scenarios. Addressing a root cause of hyperlipidemia by directly encouraging dietary modification provides a cost-effective alternative for cholesterol management, especially for statin intolerant or statin unwilling patients.

This is a preview of subscription content, access via your institution.

Access options

Buy single article

Instant access to the full article PDF.

USD 39.95

Price includes VAT (USA)
Tax calculation will be finalised during checkout.

Fig. 1
Fig. 2
Fig. 3

References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, et al. Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation. 2017;135:e1–e458.

    Google Scholar 

  2. National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (adult treatment panel III). Third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (adult treatment panel III) final report. Circulation 2002;106(25):3143–3421.

  3. Soran H, Dent R, Durrington P. Evidence-based goals in LDL-C reduction. Clin Res Cardiol. 2017;106(4):237–48. https://doi.org/10.1007/s00392-016-1069-7.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  4. •• Silverman MG, Ference BA, Im K, et al. Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions: A Systematic Review and Meta-analysis. JAMA. 2016;316(12):1289–97. https://doi.org/10.1001/jama.2016.13985Findings from this study suggest that a direct correlation exists between LDL-C reduction and reduction in cardiovascular risk, irrespective of method of lipid lowering.

    Article  PubMed  CAS  Google Scholar 

  5. Delahoy PJ, Magliano DJ, Webb K, Grobler M, Liew D. The relationship between reduction in low-density lipoprotein cholesterol by statins and reduction in risk of cardiovascular outcomes: an updated meta-analysis. Clin Ther. 2009;31(2):236–44. https://doi.org/10.1016/j.clinthera.2009.02.017.

    Article  PubMed  CAS  Google Scholar 

  6. Fischer S, Schatz U, Julius U. Practical recommendations for the management of hyperlipidemia. Atheroscler Suppl. 2015;18:194–8. https://doi.org/10.1016/j.atherosclerosissup.2015.02.029.

    Article  PubMed  CAS  Google Scholar 

  7. AbuMweis SS, Marinangeli CPF, Frohlich J, Jones PJH. Implementing phytosterols into medical practice as a cholesterol-lowering strategy: overview of efficacy, effectiveness, and safety. Can J Cardiol. 2014;30(10):1225–32. https://doi.org/10.1016/j.cjca.2014.04.022.

    Article  PubMed  Google Scholar 

  8. Hunter PM, Hegele RA. Functional foods and dietary supplements for the management of dyslipidaemia. Nat Rev Endocrinol. 2017;13(5):278–88. https://doi.org/10.1038/nrendo.2016.210.

    Article  PubMed  CAS  Google Scholar 

  9. Thompson PD, Panza G, Zaleski A, Taylor B. Statin-associated side effects. J Am Coll Cardiol. 2016;67(20):2395–410. https://doi.org/10.1016/j.jacc.2016.02.071.

    Article  PubMed  CAS  Google Scholar 

  10. Mendis S, Puska P, Norrving B. WHO | global atlas on cardiovascular disease prevention and control. WHO. 2011:2–13 https://www.who.int/cardiovascular_diseases/publications/atlas_cvd/en/.

  11. Lloyd-Jones DM, Hong Y, Labarthe D, et al. Defining and setting national goals for cardiovascular health promotion and disease reduction: the american heart association’s strategic impact goal through 2020 and beyond. Circulation. 2010;121(4):586–613. https://doi.org/10.1161/CIRCULATIONAHA.109.192703.

    Article  PubMed  Google Scholar 

  12. Anderson TJ, Grégoire J, Pearson GJ, et al. 2016 Canadian cardiovascular society guidelines for the management of dyslipidemia for the prevention of cardiovascular disease in the adult. Can J Cardiol. 2016;32(11):1263–82. https://doi.org/10.1016/j.cjca.2016.07.510.

    Article  PubMed  Google Scholar 

  13. Denke MA. Reviewing your investment strategy: where does diet fit in your personal portfolio. Am J Clin Nutr. 2005;81(2):339–40. https://doi.org/10.1093/ajcn.81.2.339.

    Article  PubMed  CAS  Google Scholar 

  14. de Jesus JM, Kahan S, Eckel RH. Nutrition interventions for cardiovascular disease. Med Clin North Am. 2016;100(6):1251–64. https://doi.org/10.1016/j.mcna.2016.06.007.

    Article  PubMed  Google Scholar 

  15. Wadhera RK, Steen DL, Khan I, Giugliano RP, Foody JM. A review of low-density lipoprotein cholesterol, treatment strategies, and its impact on cardiovascular disease morbidity and mortality. J Clin Lipidol. 2016;10(3):472–89.

    PubMed  Google Scholar 

  16. Jenkins D, Kendall C, Marchie A, Faulkner DA, Wong J, de Souza R, et al. Direct comparison of a dietary portfolio of cholesterol-lowering foods with a statin in hypercholesterolemic participants. Am J Clin Nutr. 2005;81:380–7.

    PubMed  CAS  Google Scholar 

  17. Kendall CW, Jenkins DJ. A dietary portfolio: maximal reduction of low-density lipoprotein cholesterol with diet. Curr Atheroscler Rep. 2004;6(6):492–8.

    PubMed  Google Scholar 

  18. Jenkins DJ, Kendall CW, Faulkner DA, et al. Assessment of the longer-term effects of a dietary portfolio of cholesterol-lowering foods in hypercholesterolemia. Am J Clin Nutr. 2006;83(3):582–91.

    PubMed  CAS  Google Scholar 

  19. Streppel MT, Ocké MC, Boshuizen HC, Kok FJ, Kromhout D. Dietary fiber intake in relation to coronary heart disease and all-cause mortality over 40 y: the Zutphen study. Am J Clin Nutr. 2008 Oct;88(4):1119–25.

    PubMed  CAS  Google Scholar 

  20. Brown L, et al. Cholesterol-lowering effects of dietary fiber: a meta-analysis. Am J Clin Nutr. 1999;69(1):30.42.

    PubMed  Google Scholar 

  21. Bazzano LA. Effects of soluble dietary fiber on low-density lipoprotein cholesterol and coronary heart disease risk. Curr Atheroscler Rep. 2008;10(6):473–7.

    PubMed  CAS  Google Scholar 

  22. Anderson JW, Hanna TJ. Impact of nondigestible carbohydrates on serum lipoproteins and risk for cardiovascular disease. J Nutr. 1999 Jul;129(7 Suppl):1457S–66S.

    PubMed  CAS  Google Scholar 

  23. Kris-Etherton PM, Yu-Poth S, Sabate J, Ratcliffe HE, Zhao G, Etherton TD. Nuts and their bioactive constituents: effects on serum lipids and other factors that affect disease risk. Am J Clin Nutr. 1999;70(3 Suppl):504S–11S.

    PubMed  CAS  Google Scholar 

  24. Kris-Etherton PM, Hu FB, Ros E, Sabate J. The role of tree nuts and peanuts in the prevention of coronary heart disease: multiple potential mechanisms. J Nutr. 2008;138(9):1746S–51S.

    PubMed  CAS  Google Scholar 

  25. Hyson DA, Schneeman BO, Davis PA. Almonds and almond oil have similar effects on plasma lipids and LDL oxidation in healthy men and women. J Nutr. 2002;132(4):703–7.

    PubMed  CAS  Google Scholar 

  26. Jenkins DJ, Kendall CW, Marchie A, et al. Dose response of almonds on coronary heart disease risk factors: blood lipids, oxidized low-density lipoproteins, lipoprotein(a), homocysteine, and pulmonary nitric oxide: a randomized, controlled, crossover trial. Circulation. 2002;106(11):1327–32.

    PubMed  CAS  Google Scholar 

  27. Sabate J, Haddad E, Tanzman JS, Jambazian P, Rajaram S. Serum lipid response to the graduated enrichment of a step I diet with almonds: a randomized feeding trial. Am J Clin Nutr. 2003;77(6):1379–84.

    PubMed  CAS  Google Scholar 

  28. Spiller GA, Jenkins DA, Bosello O, Gates JE, Cragen LN, Bruce B. Nuts and plasma lipids: an almond-based diet lowers LDL-C while preserving HDL-C. J Am Coll Nutr. 1998;17(3):285–90.

    PubMed  CAS  Google Scholar 

  29. Kris-Etherton PM, Pearson TA, Wan Y, et al. High-monounsaturated fatty acid diets lower both plasma cholesterol and triacylglycerol concentrations. Am J Clin Nutr. 1999;70(6):1009–15.

    PubMed  CAS  Google Scholar 

  30. O'Byrne DJ, Knauft DA, Shireman RB. Low fat-monounsaturated rich diets containing high-oleic peanuts improve serum lipoprotein profiles. Lipids. 1997;32(7):687–95.

    PubMed  CAS  Google Scholar 

  31. Morgan WA, Clayshulte BJ. Pecans lower low-density lipoprotein cholesterol in people with normal lipid levels. J Am Diet Assoc. 2000;100(3):312–8.

    PubMed  CAS  Google Scholar 

  32. Abbey M, Noakes M, Belling GB, Nestel PJ. Partial replacement of saturated fatty acids with almonds or walnuts lowers total plasma cholesterol and low-density-lipoprotein cholesterol. Am J Clin Nutr. 1994;59(5):995–9.

    PubMed  CAS  Google Scholar 

  33. Almario RU, Vonghavaravat V, Wong R, Kasim-Karakas SE. Effects of walnut consumption on plasma fatty acids and lipoproteins in combined hyperlipidemia. Am J Clin Nutr. 2001;74(1):72–9.

    PubMed  CAS  Google Scholar 

  34. Chisholm A, Mann J, Skeaff M, et al. A diet rich in walnuts favourably influences plasma fatty acid profile in moderately hyperlipidaemic subjects. Eur J Clin Nutr. 1998;52(1):12–6.

    PubMed  CAS  Google Scholar 

  35. Morgan JM, Horton K, Reese D, Carey C, Walker K, Capuzzi DM. Effects of walnut consumption as part of a low-fat, low-cholesterol diet on serum cardiovascular risk factors. Int J Vitam Nutr Res. 2002;72(5):341–7.

    PubMed  CAS  Google Scholar 

  36. Sabate J, Fraser GE, Burke K, Knutsen SF, Bennett H, Lindsted KD. Effects of walnuts on serum lipid levels and blood pressure in normal men. N Engl J Med. 1993;328(9):603–7.

    PubMed  CAS  Google Scholar 

  37. Zambon D, Sabate J, Munoz S, et al. Substituting walnuts for monounsaturated fat improves the serum lipid profile of hypercholesterolemic men and women. A randomized crossover trial. Ann Intern Med. 2000;132(7):538–46.

    PubMed  CAS  Google Scholar 

  38. Djoussé L, Arnett DK, Carr JJ, Eckfeldt JH, Hopkins PN, Province MA, et al. Investigators of the NHLBI FHS. Dietary linolenic acid is inversely associated with calcified atherosclerotic plaque in the coronary arteries: the National Heart, Lung, and Blood Institute family heart study. Circulation. 2005;111(22):2921–6 Epub 2005 May 31.

    PubMed  Google Scholar 

  39. Harper CR, Jacobson TA. The fats of life; The role of Omega-3 fatty acids in the prevention of coronary heart disease. Arch Intern Med. 2001;161:2185–92.

    PubMed  CAS  Google Scholar 

  40. Zhao G, Etherton TD, Martin KR, et al. Dietary -Linolenic Acid Reduces Inflammatory and Lipid Cardiovascular Risk Factors in Hypercholesterolemic Men and Women. J Nutr. 2004;134:2991–7.

    PubMed  CAS  Google Scholar 

  41. Mattson F, Grundy SM. Comparison of effects of dietary saturated, monounsaturated and polyunsaturated fatty acids on plasma lipids and lipoproteins in man. J Lipid Res. 1985;26:194–202.

    PubMed  CAS  Google Scholar 

  42. Prasad K. Flaxseed and cardiovascular health. J Cardiovasc Pharmacol. 2009;54(5):369–77.

    PubMed  CAS  Google Scholar 

  43. Bassett CM, Rodriguez-Leyva D, Pierce GN. Experimental and clinical research findings on the cardiovascular benefits of consuming flaxseed. Appl Physiol Nutr Metab. 2009;34(5):965–74.

    PubMed  CAS  Google Scholar 

  44. Pan A, Yu D, Demark-Wahnefried W, Franco OH, Lin X. Meta-analysis of the effects of flaxseed interventions on blood lipids. Am J Clin Nutr. 2009;90(2):288–97 Epub 2009 Jun 10.

    PubMed  PubMed Central  CAS  Google Scholar 

  45. Mandaşescu S, Mocanu V, Dăscaliţa AM, Haliga R, Nestian I, Stitt PA, et al. Flaxseed supplementation in hyperlipidemic patients. Rev Med Chir Soc Med Nat Iasi. 2005;109(3):502–6.

    PubMed  Google Scholar 

  46. West SG, Krick AL, Klein LC, Zhao G, Wojtowicz TF, McGuiness M, et al. Effects of diets high in walnuts and flax oil on hemodynamic responses to stress and vascular endothelial function. J Am Coll Nutr. 2010;29(6):595–603.

    PubMed  PubMed Central  CAS  Google Scholar 

  47. Fukumitsu S, Aida K, Shimizu H, Toyoda K. Flaxseed lignan lowers blood cholesterol and decreases liver disease risk factors in moderately hypercholesterolemic men. Nutr Res. 2010;30(7):441–6.

    PubMed  CAS  Google Scholar 

  48. Prasad K. Flax lignan complex slows down the progression of atherosclerosis in hyperlipidemic rabbits. J Cardiovasc Pharmacol Ther. 2009;14(1):38–48.

    PubMed  CAS  Google Scholar 

  49. Bloedon LT, Balikai S, Chittams J, Cunnane SC, Berlin JA, Rader DJ, et al. Flaxseed and cardiovascular risk factors: results from a double blind, randomized, controlled clinical trial. J Am Coll Nutr. 2008;27(1):65–74.

    PubMed  CAS  Google Scholar 

  50. Patade A, Devareddy L, Lucas EA, Korlagunta K, Daggy BP, Arjmandi BH. Flaxseed reduces total and LDL cholesterol concentrations in native American postmenopausal women. J Women's Health (Larchmt). 2008;17(3):355–66.

    Google Scholar 

  51. Zhang W, Wang X, Liu Y, Tian H, Flickinger B, Empie MW, et al. Dietary flaxseed lignan extract lowers plasma cholesterol and glucose concentrations in hypercholesterolaemic subjects. Br J Nutr. 2008;99(6):1301–9 Epub 2007 Dec 6.

    PubMed  CAS  Google Scholar 

  52. Prasad K. Hypocholesterolemic and antiatherosclerotic effect of flax lignan complex isolated from flaxseed. Atherosclerosis. 2005 Apr;179(2):269–75 Epub 2005 Jan 26.

  53. Chicco AG, D'Alessandro ME, Hein GJ, Oliva ME, Lombardo YB. Dietary chia seed (Salvia hispanica L.) rich in alpha-linolenic acid improves adiposity and normalises hypertriacylglycerolaemia and insulin resistance in dyslipaemic rats. Br J Nutr. 2009;101(1):41–50 Epub 2008 May 20.

    PubMed  CAS  Google Scholar 

  54. Ayerza R Jr, Coates W. Effect of dietary alpha-linolenic fatty acid derived from chia when fed as ground seed, whole seed and oil on lipid content and fatty acid composition of rat plasma. Ann Nutr Metab. 2007;51(1):27–34 Epub 2007 Mar 14.

    PubMed  CAS  Google Scholar 

  55. Zibadi S, Rohdewald PJ, Park D, Watson RR. Reduction of cardiovascular risk factors in subjects with type 2 diabetes by Pycnogenol supplementation. Nutr Res. 2008;28(5):315–20.

    PubMed  CAS  Google Scholar 

  56. Devaraj S, Vega-López S, Kaul N, Schönlau F, Rohdewald P, Jialal I. Supplementation with a pine bark extract rich in polyphenols increases plasma antioxidant capacity and alters the plasma lipoprotein profile. Lipids. 2002;37(10):931–4.10.

    PubMed  CAS  Google Scholar 

  57. Diaz MN, Frei B, Vita JA, Keaney JF Jr. Antioxidants and atherosclerotic heart disease. N Engl J Med. 1997;337(6):408–16.

    PubMed  CAS  Google Scholar 

  58. Kalt W, Foote FSAE, Lyon M, Van Lunen TA, McRae KB. Effect of blueberry feeding on plasma lipids in pigs. Br J Nutr. 2008;100(1):70–8.

    PubMed  CAS  Google Scholar 

  59. Basu A, Du M, Leyva MJ, Sanchez K, Betts NM, Wu M, et al. Blueberries decrease cardiovascular risk factors in obese men and women with metabolic syndrome. J Nutr. 2010;140(9):1582–7.

    PubMed  PubMed Central  CAS  Google Scholar 

  60. Basu A, Rhone M, Lyons TJ. Berries: emerging impact on cardiovascular health. Nutr Rev. 2010;68(3):168–77.

    PubMed  PubMed Central  Google Scholar 

  61. Puglisi MJ, Mutungi G, Brun PJ, McGrane MM, Labonte C, Volek JS, et al. Raisins and walking alter appetite hormones and plasma lipids by modifications in lipoprotein metabolism and up-regulation of the low-density lipoprotein receptor. Metabolism. 2009;58(1):120–8.

    PubMed  CAS  Google Scholar 

  62. Krauss RM, Eckel RH, Howard B, Appel LJ, Daniels SR, Deckelbaum RJ, et al. AHA dietary guidelines revision 2000: a statement for healthcare professionals from the nutrition committee of the American heart association. Circulation. 2000;102:2284–99.

    PubMed  CAS  Google Scholar 

  63. • Chiavaroli L, Nishi SK, Khan TA, et al. Portfolio dietary pattern and cardiovascular disease: a systematic review and meta-analysis of controlled trials. Prog Cardiovasc Dis. 2018;61(1):43–53. https://doi.org/10.1016/j.pcad.2018.05.004Findings from this study suggest that diet-based interventions can yield rapid, medication-level cholesterol reductions.

    Article  PubMed  Google Scholar 

  64. Connor WE. Importance of n-3 fatty acids in health and disease. Am J Clin Nutr. 2000;71(1 Suppl):171S–5S. https://doi.org/10.1093/ajcn/71.1.171S.

    Article  PubMed  CAS  Google Scholar 

  65. Sokoła-Wysoczańska E, Wysoczański T, Wagner J, et al. Polyunsaturated fatty acids and their potential therapeutic role in cardiovascular system disorders: a review. Nutrients. 2018;10(10). https://doi.org/10.3390/nu10101561.

  66. Davis BC, Kris-Etherton PM. Achieving optimal essential fatty acid status in vegetarians: current knowledge and practical implications. Am J Clin Nutr. 2003;78(3):640S–6S. https://doi.org/10.1093/ajcn/78.3.640S.

    Article  PubMed  CAS  Google Scholar 

  67. Valenzuela A, Sanhueza J, Nieto S. Cholesterol oxidation: health hazard and the role of antioxidants in prevention. Biol Res. 2003;36(3–4):291–302. https://doi.org/10.4067/S0716-97602003000300002.

    Article  PubMed  CAS  Google Scholar 

  68. Seal CJ. Whole grains and CVD risk. Proc Nutr Soc. 2006;65(1):24–34. https://doi.org/10.1079/PNS2005482.

    Article  PubMed  CAS  Google Scholar 

  69. Siti HN, Kamisah Y, Kamsiah J. The role of oxidative stress, antioxidants and vascular inflammation in cardiovascular disease: a review. Vasc Pharmacol. 2015;71:40–56. https://doi.org/10.1016/j.vph.2015.03.005.

    Article  CAS  Google Scholar 

  70. Kopecky S, Alias S, Klodas E, Jones PJH. Effects of a novel food intervention for lipid management in individuals unable or unwilling to use statin therapy: a randomized clinical trial. Submitted for publication.

  71. Alldredge W. Step one foods. Personal communication.

  72. Bonafede MM, Johnson BH, Richhariya A, Gandra SR. Medical costs associated with cardiovascular events among high-risk patients with hyperlipidemia. Clinicoecon Outcomes Res. 2015;7:337–45 Published 2015 Jun 9. https://doi.org/10.2147/CEOR.S76972.

  73. Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the Management of Blood Cholesterol. J Am Coll Cardiol. 2019;73(24):e285–350.

    PubMed  Google Scholar 

  74. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics--2015 update: a report from the American Heart Association [published correction appears in Circulation. 2015 Jun 16;131(24):e535] [published correction appears in Circulation. 2016 Feb 23;133(8):e417]. Circulation. 2015;131(4):e29-e322. https://doi.org/10.1161/CIR.0000000000000152

  75. https://www.biopharmadive.com/news/amgen-not-done-in-quest-to-prove-repatha/550622/

Download references

Funding

This analysis was funded by Step One Foods.

Author information

Authors and Affiliations

  1. Wakely Consulting Group, New York, NY, USA

    Ivy Dong

  2. Step One Foods, Minneapolis, MN, USA

    Elizabeth Klodas

Authors
  1. Ivy Dong
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Elizabeth Klodas
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Elizabeth Klodas.

Ethics declarations

Conflict of Interest

Elizabeth Klodas is founder and Chief Medical Officer of Step One Foods. Ivy Dong reports grants from Step One Foods. However, Wakely Consulting is organizationally and financially independent to Step One Foods.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

This article is part of the Topical Collection on Public Health Policy

Appendices

APPENDIX 1

SELECTED DIAGNOSES UTILIZED FOR ANALYSIS

I21.01 ST elevation (STEMI) myocardial infarction involving left main coronary artery.

I21.02 ST elevation (STEMI) myocardial infarction involving left anterior descending coronary artery.

I21.09 ST elevation (STEMI) myocardial infarction involving other coronary artery of anterior wall.

I21.11 ST elevation (STEMI) myocardial infarction involving right coronary artery.

I21.19 ST elevation (STEMI) myocardial infarction involving other coronary artery of inferior wall I21.21.

ST elevation (STEMI) myocardial infarction involving left circumflex coronary artery.

I21.29 ST elevation (STEMI) myocardial infarction involving other sites.

I21.3 ST elevation (STEMI) myocardial infarction of unspecified site.

I21.4 Non-ST elevation (NSTEMI) myocardial infarction.

I22.0 Subsequent ST elevation (STEMI) myocardial infarction of anterior wall.

I22.1 Subsequent ST elevation (STEMI) myocardial infarction of inferior wall.

I22.2 Subsequent non-ST elevation (NSTEMI) myocardial infarction.

I22.8 Subsequent ST elevation (STEMI) myocardial infarction of other sites.

I22.9 Subsequent ST elevation (STEMI) myocardial infarction of unspecified site.

I23.7 Postinfarction angina.

I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris.

I25.110 Atherosclerotic heart disease of native coronary artery with unstable angina pectoris.

I25.111 Atherosclerotic heart disease of native coronary artery with angina pectoris with documented spasm.

I25.118 Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris.

I25.119* Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris.

I25.2 Old myocardial infarction.

I25.5 Ischemic cardiomyopathy.

I25.6 Silent myocardial ischemia.

I25.700* Atherosclerosis of coronary artery bypass graft(s), unspecified, with unstable angina pectoris.

I25.701* Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris with documented spasm.

I25.708* Atherosclerosis of coronary artery bypass graft(s), unspecified, with other forms of angina pectoris.

I25.709* Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina pectoris.

I25.710 Atherosclerosis of autologous vein coronary artery bypass graft(s) with unstable angina pectoris.

I25.711 Atherosclerosis of autologous vein coronary artery bypass graft(s) with angina pectoris with documented spasm.

I25.718 Atherosclerosis of autologous vein coronary artery bypass graft(s) with other forms of angina pectoris.

I25.719* Atherosclerosis of autologous vein coronary artery bypass graft(s) with unspecified angina pectoris.

I25.720 Atherosclerosis of autologous artery coronary artery bypass graft(s) with unstable angina pectoris.

I25.721 Atherosclerosis of autologous artery coronary artery bypass graft(s) with angina pectoris with documented spasm.

I25.728 Atherosclerosis of autologous artery coronary artery bypass graft(s) with other forms of angina pectoris.

I25.729* Atherosclerosis of autologous artery coronary artery bypass graft(s) with unspecified angina pectoris.

I25.730 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unstable angina pectoris.

I25.731 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with angina pectoris with documented spasm.

I25.738 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with other forms of angina pectoris.

I25.739* Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unspecified angina pectoris.

I25.750 Atherosclerosis of native coronary artery of transplanted heart with unstable angina.

I25.751 Atherosclerosis of native coronary artery of transplanted heart with angina pectoris with documented spasm.

I25.758 Atherosclerosis of native coronary artery of transplanted heart with other forms of angina pectoris.

I25.759* Atherosclerosis of native coronary artery of transplanted heart with unspecified angina pectoris.

I25.760 Atherosclerosis of bypass graft of coronary artery of transplanted heart with unstable angina.

I25.761 Atherosclerosis of bypass graft of coronary artery of transplanted heart with angina pectoris with documented spasm.

I25.768 Atherosclerosis of bypass graft of coronary artery of transplanted heart with other forms of angina pectoris.

I25.769* Atherosclerosis of bypass graft of coronary artery of transplanted heart with unspecified angina pectoris.

I25.790 Atherosclerosis of other coronary artery bypass graft(s) with unstable angina pectoris.

I25.791 Atherosclerosis of other coronary artery bypass graft(s) with angina pectoris with documented spasm.

I25.798 Atherosclerosis of other coronary artery bypass graft(s) with other forms of angina pectoris.

I25.799* Atherosclerosis of other coronary artery bypass graft(s) with unspecified angina pectoris.

I25.810 Atherosclerosis of coronary artery bypass graft(s) without angina pectoris.

I25.811 Atherosclerosis of native coronary artery of transplanted heart without angina pectoris.

I25.812 Atherosclerosis of bypass graft of coronary artery of transplanted heart without angina pectoris.

I25.82 Chronic total occlusion of coronary artery.

I25.83 Coronary atherosclerosis due to lipid rich plaque.

I25.84 Coronary atherosclerosis due to calcified coronary lesion.

I25.89 Other forms of chronic ischemic heart disease.

I25.9* Chronic ischemic heart disease, unspecified.

E78.0 Pure hypercholesterolemia.

E78.2 Mixed hyperlipidemia.

E78.4 Other hyperlipidemia.

E78.5 Hyperlipidemia, unspecified.

E78.9 Disorder of lipoprotein metabolism, unspecified.

E88.81 Metabolic syndrome.

I50.1 Left ventricular failure.

I50.20* Unspecified systolic (congestive) heart failure.

I50.21 Acute systolic (congestive) heart failure.

I50.22 Chronic systolic (congestive) heart failure.

I50.23 Acute on chronic systolic (congestive) heart failure.

I50.30* Unspecified diastolic (congestive) heart failure.

I50.31 Acute diastolic (congestive) heart failure.

I50.32 Chronic diastolic (congestive) heart failure.

I50.33 Acute on chronic diastolic (congestive) heart failure.

I50.40* Unspecified combined systolic (congestive) and diastolic (congestive) heart failure.

I50.41 Acute combined systolic (congestive) and diastolic (congestive) heart failure.

I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure.

I50.43 Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure.

I50.9* Heart failure, unspecified.

I10 Essential (primary) hypertension.

R73.09 Prediabetes.

E278.00 & 278.01 Obesity.

Medication Utilization

We used the Medi-span to find NDC codes that matched to a list of names of common brand and generic Statins and PCSK9s. The list of names that we used was as follows:

Alirocumab Fluvastatin Sodium ER Pravachol
Altocor Lescol Pravastatin
Amlodipine-Atorvastatin Lescol XL Pravastatin Sodium
Atorvastatin Lipitor Repatha
Atorvastatin Calcium Livalo Repatha Pushtronex System
Crestor Lovastatin Repatha Sureclick
Equapax/Atorvastatin/COQ10 Lovastatin Rosuvastatin
Evolocumab Mevacor Rosuvastatin Calcium
Ezetimibe-Simvastatin Pitavastatin Simvastatin
Fluvastatin Praluent Zocor
Fluvastatin Sodium   

APPENDIX 2

DISCLOSURES AND LIMITATIONS

Wakely was commissioned by Step One Foods to perform analyses relevant to the value proposition of offering Step One products to individuals with cholesterol issues. Wakely was primarily responsible for the steps of the analysis that used the MarketScan and LDS data and for the estimates of the prevalence rates, medical costs, drug utilization and risk scores of the target and non-target populations. Wakely was also responsible for the comparisons and case studies derived from the estimates, as well as the assumptions used for the savings estimate in the case studies.

Ivy Dong is the actuary at Wakely responsible for the analysis and report. Ivy is a member of the American Academy of Actuaries and Fellow of the Society of Actuaries. She meets the Qualification Standards of the American Academy of Actuaries to issue this analysis. Ivy Dong is financially independent and free from conflict concerning all matters related to performing the services underlying this analysis. In addition, Wakely is organizationally and financially independent from Step One Foods, the sponsor of this report.

Dr. Klodas was responsible for providing clinical guidance for the analysis. Dr. Klodas provided the diagnosis codes used for identifying the target and non-target populations, as well as the criteria for identifying conditions including atherosclerosis, heart failure, hyperlipidemia, hypertension, ischemia, infarction, obesity and prediabetes for the analysis. Dr. Klodas was also responsible for providing the LDL-C Lowering Therapies included in Analysis. In addition, Step One Foods provided the cost of a typical order used in the case study.

Wakely’s analysis represents a technical evaluation and summarization of available benchmark data resources and does not represent support for any particular product, intervention, or strategy. Wakely does not intend for this report and described analyses to create a reliance by any third party on Wakely.

Wakely is not responsible for any use of the report or consequences of such use outside the specific purpose for which it was intended. Users of the report results should be qualified to use it and understand the results, limitations, and the inherent uncertainty. The report should be considered in its entirety.

Wakely has relied on others for data and assumptions used in the assignment, including the IBM MarketScan® claims and eligibility data sets, and Step One Foods for cholesterol issues identification logic. Wakely has reviewed portions of the data for reasonableness, but has not performed any independent audit or otherwise verified the accuracy of the data/information. If the underlying information is incomplete or inaccurate, the estimates may be impacted, potentially significantly.

Note that the observations and data summaries presented herein do not reflect conclusions of causative relationships between the offering/use of cholesterol interventions and lower medical costs. Rather, the observations and data summaries reflect associative correlation between cholesterol issues and claims cost levels, as well as hypothetical modeling of potential economic outcome of providing cholesterol lowering interventions. A more robust study of clinical practice patterns and beneficiary care compliance patterns, considering other confounding variables, would be needed to expound a causal relationship between cholesterol lowering interventions and lower medical cost.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Dong, I., Klodas, E. Healthcare Cost Implications of Utilizing a Dietary Intervention to Lower LDL Cholesterol: Proof of Concept Actuarial Analysis and Recommendations. Curr Cardiol Rep 22, 138 (2020). https://doi.org/10.1007/s11886-020-01397-9

Download citation

  • Published:

  • DOI: https://doi.org/10.1007/s11886-020-01397-9

Keywords

  • Hyperlipidemia
  • Low density lipoprotein (LDL)
  • Food
  • Healthcare costs
  • Cost analysis
  • Statin intolerance