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

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.

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Funding

This analysis was funded by Step One Foods.

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Correspondence to Elizabeth Klodas.

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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.

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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.

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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

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

Keywords

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