Estimated burden of cardiovascular disease and value-based price range for evolocumab in a high-risk, secondary-prevention population in the US payer context

Journal of Medical Economics

Volumn 20, Issue 6, 2017, Pages 555-564

  Toth, Peter P ^a,b   Danese, Mark ^c   Villa, Guillermo ^d   Qian, Yi ^d   Beaubrun, Anne ^d   Lira, Armando ^d   Jansen, Jeroen P ^e  

^a CGH MEDICAL CENTER   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c Outcomes Insights Inc   (United States)

^d AMGEN INC   (United States)

^e PRECISION HEALTH ECONOMICS   (United States)

Author keywords

burden of disease; cardiovascular disease (CVD); cost effectiveness; Evolocumab; low density lipoprotein cholesterol (LDL C); PCSK9 inhibition; value based pricing

Indexed keywords

EVOLOCUMAB; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; HYPOCHOLESTEROLEMIC AGENT; MONOCLONAL ANTIBODY;

ACUTE CORONARY SYNDROME; AGED; ARTICLE; ATHEROSCLEROSIS; ATRIAL FIBRILLATION; BRAIN ISCHEMIA; CARDIOVASCULAR DISEASE; CARDIOVASCULAR MORTALITY; CHOLESTEROL BLOOD LEVEL; COHORT ANALYSIS; DIABETES MELLITUS; DRUG COST; ECONOMIC MODEL; FEMALE; FOLLOW UP; HEART FAILURE; HEART MUSCLE REVASCULARIZATION; HIGH RISK PATIENT; HUMAN; MAJOR CLINICAL STUDY; MALE; QUALITY ADJUSTED LIFE YEAR; SENSITIVITY ANALYSIS; CEREBROVASCULAR ACCIDENT; COMORBIDITY; COST BENEFIT ANALYSIS; DRUG EFFECTS; ECONOMICS; RISK FACTOR; SECONDARY PREVENTION; STATISTICAL MODEL; UNITED STATES; VERY ELDERLY;

ACUTE CORONARY SYNDROME; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTICHOLESTEREMIC AGENTS; ATHEROSCLEROSIS; CARDIOVASCULAR DISEASES; CHOLESTEROL, LDL; COMORBIDITY; COST-BENEFIT ANALYSIS; FEMALE; HEART FAILURE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MODELS, ECONOMETRIC; QUALITY-ADJUSTED LIFE YEARS; RISK FACTORS; SECONDARY PREVENTION; STROKE; UNITED STATES;

EID: 85010644707     PISSN: 13696998     EISSN: 1941837X     Source Type: Journal    
DOI: 10.1080/13696998.2017.1284078     Document Type: Article

References (47)

1. Catapano AL, Graham I, De, Backer G, et al. 2016 ESC/EAS guidelines for the management of dyslipidaemias:the task force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) developed with the special contribution of the European Assocciation for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J 2016;37:2999-3058. DOI:10.1093/eurheartj/ehw272
2. Smith SC, Jr, Collins A, Ferrari R, et al. Our time:a call to save preventable death from cardiovascular disease (heart disease and stroke). Eur Heart J 2012;33:2910-16
3. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics—2015 update:a report from the American Heart Association. Circulation 2015;131:e29-e322
4. Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults:a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014;129(25 Suppl 2):S1-S45
5. Bonafede MM, Johnson BH, Richhariya A, et al. Medical costs associated with cardiovascular events among high-risk patients with hyperlipidemia. Clinicoecon Outcomes Res 2015;7:337-45
6. Punekar RS, Fox KM, Richhariya A, et al. Burden of first and recurrent cardiovascular events among patients with hyperlipidemia. Clin Cardiol 2015;38:483-91
7. Wadhera RK, Steen DL, Khan I, et al. A review of low-density lipoprotein cholesterol, treatment strategies, and its impact on cardiovascular disease morbidity and mortality. J Clin Lipidol 2016;10:472-89
8. Cholesterol Treatment Trialists (CTT) Collaboration, Baigent C, Blackwell L, et al. Efficacy and safety of more intensive lowering of LDL cholesterol:a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet 2010;376:1670-81
9. Cholesterol Treatment Trialists (CTT) Collaboration, Fulcher J, O’Connell R, et al. Efficacy and safety of LDL-lowering therapy among men and women:meta-analysis of individual data from 174,000 participants in 27 randomised trials. Lancet 2015;385:1397-405
10. Aggarwal J, Patel J, Yu J, et al. LDL-C goal achievement after adding or switching to ezetimibe in patients with clinical atherosclerotic cardiovascular disease or probable HeFH [abstract]. J Manag Care Spec Pharm 2016;22:S86
11. Gouni-Berthold I, Descamps OS, Fraass U, et al. Systematic review of published phase 3 data on anti-PCSK9 monoclonal antibodies in patients with hypercholesterolaemia. Br J Clin Pharmacol 2016;82:1412-43
12. Sullivan D, Olsson AG, Scott R, et al. Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients:the GAUSS randomized trial. JAMA 2012;308:2497-506
13. Koren MJ, Lundqvist P, Bolognese M, et al. Anti-PCSK9 monotherapy for hypercholesterolemia:the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab. J Am Coll Cardiol 2014;63:2531-40
14. Robinson JG, Nedergaard BS, Rogers WJ, et al. Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia:the LAPLACE-2 randomized clinical trial. JAMA 2014;311:1870-83
15. Raal FJ, Stein EA, Dufour R, et al. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2):a randomised, double-blind, placebo-controlled trial. Lancet 2015;385:331-40
16. Blom DJ, Djedjos CS, Monsalvo ML, et al. Effects of evolocumab on vitamin E and steroid hormone levels:results from the 52-week, phase 3, double-blind, randomized, placebo-controlled DESCARTES study. Circ Res 2015;117:731-41
17. Nissen SE, Stroes E, Dent-Acosta RE, et al. Efficacy and tolerability of evolocumab vs ezetimibe in patients with muscle-related statin intolerance:the GAUSS-3 randomized clinical trial. JAMA 2016;315:1580-90
18. Hirayama A, Honarpour N, Yoshida M, et al. Effects of evolocumab (AMG 145), a monoclonal antibody to PCSK9, in hypercholesterolemic, statin-treated Japanese patients at high cardiovascular risk–primary results from the phase 2 YUKAWA study. Circ J 2014;78:1073-82
19. Sabatine MS, Giugliano RP, Keech A, et al. Rationale and design of the Further cardiovascular OUtcomes Research with PCSK9 Inhibition in subjects with Elevated Risk trial. Am Heart J 2016;173:94-101
20. Tyler LS, Cole SW, May JR, et al. ASHP guidelines on the pharmacy and therapeutics committee and the formulary system. Am J Health Syst Pharm 2008;65:1272-83
21. Alberti KG, Eckel RH, Grundy SM, et al. Harmonizing the metabolic syndrome:a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention. National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation 2009;120:1640-5
22. Mearns BM., Dyslipidaemia:1-year results from OSLER trial of anti-PCSK9 monoclonal antibody evolocumab. Nat Rev Cardiol 2014;11:63
23. Gandra SR, Villa G, Fonarow GC, et al. Cost-effectiveness of LDL-C lowering with evolocumab in patients with high cardiovascular risk in the United States. Clin Cardiol 2016;39:313-20
24. Cholesterol Treatment Trialists (CTT) Collaborators, Mihaylova B, Emberson J, et 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. Lancet 2012;380:581-90
25. Fox KM, Wang L, Gandra SR, et al. Long-term economic burden associated with cardiovascular events among high-risk patients with hyperlipidemia. Value Health 2015;18:A139-40
26. Lipinski MJ, Cauthen CA, Biondi-Zoccai GG, et al. Meta-analysis of randomized controlled trials of statins versus placebo in patients with heart failure. Am J Cardiol 2009;104:1708-16
27. Sanders GD, Neumann PJ, Basu A, et al. Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses:Second panel on cost-effectiveness in health and medicine. JAMA 2016;316:1093-103
28. Anderson JL, Heidenreich PA, Barnett PG, et al. ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures:a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines. Circulation 2014;129:2329-45
29. Neumann PJ, Cohen JT, Weinstein MC., Updating cost-effectiveness—the curious resilience of the $50,000-per-QALY threshold. N Engl J Med 2014;371:796-7
30. CVS/caremark. Repatha (evolocumab) FEP Clinical Criteria [Internet]. Lee's Summit, MO:CVS/caremark. http://www.caremark.com/portal/asset/FEP_Criteria_Repatha.pdf. Accessed November 14, 2016
31. Prime Therapeutics LLC. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors prior authorization with quantity limit criteria program. Summary [Internet]. St. Paul, MN:Blue Cross and Blue Shield of Minnesota; updated May 2015. https://www.bluecrossmn.com/healthy/public/portalcomponents/PublicContentServlet?contentId=P11GA_13569744. Accessed November 14, 2016
32. TM (evolocumab) [Internet]. Minnetonka, MN:UnitedHealth Group, Incorporated; updated Aug 2016. https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Pharmacy%20Resources/Clinical%20Programs/PA_Med_Nec_Repatha.pdf. Accessed November 14, 2016
33. Briggs A, Sculpher M, Claxton K., Decision modelling for health economic evaluation. Oxford, UK:Oxford University Press; 2006
34. National Institute for Health and Care Excellence (NICE). Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia. Technology appraisal guidance [TA394] [Internet]. London, UK:NICE; updated June 2016. https://www.nice.org.uk/guidance/TA394/. Accessed October 17, 2016
35. Credit Suisse. Equity research, major pharmaceuticals:Global pharma [Internet]. Zürich, Switzerland:Credit Suisse Group AG; updated May 2015. https://doc.research-and-analytics.csfb.com/docView?language=ENG&format=PDF&source_id=csplusresearchcp&document_id=1047911451&serialid=hfXhzuK6sK6xRrBsMZzLqZ96QTl7v2YM0kkwWJRGRVU%3D. Accessed October 17, 2016
36. Jena AB, Blumenthal DM, Stevens W, et al. Value of improved lipid control in patients at high risk for adverse cardiac events. Am J Manag Care 2016;22:e199-e207
37. Kazi DS, Moran AE, Coxson PG, et al. Cost-effectiveness of PCSK9 inhibitor therapy in patients with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease. JAMA 2016;316:743-53
38. Henk HJ, Paoli CJ, Gandra SR. A, retrospective study to examine healthcare costs related to cardiovascular events in individuals with hyperlipidemia. Adv Ther 2015;32:1104-16
39. Hallberg S, Gandra SR, Fox KM, et al. Healthcare costs associated with cardiovascular events in patients with hyperlipidemia or prior cardiovascular events:estimates from Swedish population-based register data. Eur J Health Econ 2016;17:591-601
40. Jernberg T, Hasvold P, Henriksson M, et al. Cardiovascular risk in post-myocardial infarction patients:nationwide real world data demonstrate the importance of a long-term perspective. Eur Heart J 2015;36:1163-70
41. Davis KL, Meyers J, Zhao Z, et al. High-risk atherosclerotic cardiovascular disease in a real-world employed Japanese population:Prevalence, cardiovascular event rates, and costs. J Atheroscler Thromb 2015;22:1287-304
42. LaRosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005;352:1425-35
43. Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med 2015;372:2387-97
44. Kolh P, Kurlansky P, Cremer J, et al. Transatlantic Editorial:a comparison between European and North American guidelines on myocardial revascularization. Eur J Cardiothorac Surg 2016;49:1307-17
45. Kaul S, Chang WC, Lincoff AM, et al. Optimizing use of revascularization and clinical outcomes in ST-elevation myocardial infarction:insights from the GUSTO-V trial. Eur Heart J 2006;27:1198-206
46. Gusmano M, Allin S., Health care for older persons in England and the United States:a contrast of systems and values. J Health Polit Policy Law 2011;36:89-118
47. Law MR, Wald NJ, Rudnicka AR., Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke:systematic review and meta-analysis. BMJ 2003;326:1423