Estimation of Eligibility for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors and Associated Costs Based on the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk)
2017; Lippincott Williams & Wilkins; Volume: 135; Issue: 25 Linguagem: Inglês
10.1161/circulationaha.117.028503
ISSN1524-4539
AutoresSalim S. Virani, Julia M. Akeroyd, Vijay Nambi, Paul A. Heidenreich, Pamela B. Morris, Khurram Nasir, Erin D. Michos, Vera Bittner, Laura A. Petersen, Christie M. Ballantyne,
Tópico(s)Pharmaceutical Economics and Policy
ResumoHomeCirculationVol. 135, No. 25Estimation of Eligibility for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors and Associated Costs Based on the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBEstimation of Eligibility for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors and Associated Costs Based on the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk)Insights From the Department of Veterans Affairs Salim S. Virani, MD, PhD, Julia M. Akeroyd, MPH, Vijay Nambi, MD, PhD, Paul A. Heidenreich, MD, MS, Pamela B. Morris, MD, Khurram Nasir, MD, Erin D. Michos, MD, MHS, Vera A. Bittner, MD, MSPH, Laura A. Petersen, MD, MPH and Christie M. Ballantyne, MD Salim S. ViraniSalim S. Virani From Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research and Development Center for Innovations, Houston, TX (S.S.V., J.M.A., L.A.P.); Sections of Health Services Research (S.S.V., J.M.A., L.A.P.) and Cardiovascular Research (S.S.V., V.N., C.M.B.), Department of Medicine, Baylor College of Medicine, Houston, TX; Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (S.S.V., V.N.); Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (S.S.V., V.N., C.M.B.); Veterans Affairs Health System, Palo Alto, CA (P.A.H.); Division of Cardiovascular Medicine and Cardiovascular Institute, Stanford University, CA (P.A.H.); Medical University of South Carolina, Charleston (P.B.M.); Center for Healthcare Advancement & Outcomes at Baptist Health South Florida, Miami (K.N.); Ciccarone Center for Prevention of Heart Disease, Johns Hopkins University, Baltimore, MD (E.D.M.); and Division of Cardiovascular Disease, University of Alabama, Birmingham (V.A.B.). , Julia M. AkeroydJulia M. Akeroyd From Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research and Development Center for Innovations, Houston, TX (S.S.V., J.M.A., L.A.P.); Sections of Health Services Research (S.S.V., J.M.A., L.A.P.) and Cardiovascular Research (S.S.V., V.N., C.M.B.), Department of Medicine, Baylor College of Medicine, Houston, TX; Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (S.S.V., V.N.); Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (S.S.V., V.N., C.M.B.); Veterans Affairs Health System, Palo Alto, CA (P.A.H.); Division of Cardiovascular Medicine and Cardiovascular Institute, Stanford University, CA (P.A.H.); Medical University of South Carolina, Charleston (P.B.M.); Center for Healthcare Advancement & Outcomes at Baptist Health South Florida, Miami (K.N.); Ciccarone Center for Prevention of Heart Disease, Johns Hopkins University, Baltimore, MD (E.D.M.); and Division of Cardiovascular Disease, University of Alabama, Birmingham (V.A.B.). , Vijay NambiVijay Nambi From Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research and Development Center for Innovations, Houston, TX (S.S.V., J.M.A., L.A.P.); Sections of Health Services Research (S.S.V., J.M.A., L.A.P.) and Cardiovascular Research (S.S.V., V.N., C.M.B.), Department of Medicine, Baylor College of Medicine, Houston, TX; Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (S.S.V., V.N.); Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (S.S.V., V.N., C.M.B.); Veterans Affairs Health System, Palo Alto, CA (P.A.H.); Division of Cardiovascular Medicine and Cardiovascular Institute, Stanford University, CA (P.A.H.); Medical University of South Carolina, Charleston (P.B.M.); Center for Healthcare Advancement & Outcomes at Baptist Health South Florida, Miami (K.N.); Ciccarone Center for Prevention of Heart Disease, Johns Hopkins University, Baltimore, MD (E.D.M.); and Division of Cardiovascular Disease, University of Alabama, Birmingham (V.A.B.). , Paul A. HeidenreichPaul A. Heidenreich From Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research and Development Center for Innovations, Houston, TX (S.S.V., J.M.A., L.A.P.); Sections of Health Services Research (S.S.V., J.M.A., L.A.P.) and Cardiovascular Research (S.S.V., V.N., C.M.B.), Department of Medicine, Baylor College of Medicine, Houston, TX; Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (S.S.V., V.N.); Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (S.S.V., V.N., C.M.B.); Veterans Affairs Health System, Palo Alto, CA (P.A.H.); Division of Cardiovascular Medicine and Cardiovascular Institute, Stanford University, CA (P.A.H.); Medical University of South Carolina, Charleston (P.B.M.); Center for Healthcare Advancement & Outcomes at Baptist Health South Florida, Miami (K.N.); Ciccarone Center for Prevention of Heart Disease, Johns Hopkins University, Baltimore, MD (E.D.M.); and Division of Cardiovascular Disease, University of Alabama, Birmingham (V.A.B.). , Pamela B. MorrisPamela B. Morris From Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research and Development Center for Innovations, Houston, TX (S.S.V., J.M.A., L.A.P.); Sections of Health Services Research (S.S.V., J.M.A., L.A.P.) and Cardiovascular Research (S.S.V., V.N., C.M.B.), Department of Medicine, Baylor College of Medicine, Houston, TX; Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (S.S.V., V.N.); Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (S.S.V., V.N., C.M.B.); Veterans Affairs Health System, Palo Alto, CA (P.A.H.); Division of Cardiovascular Medicine and Cardiovascular Institute, Stanford University, CA (P.A.H.); Medical University of South Carolina, Charleston (P.B.M.); Center for Healthcare Advancement & Outcomes at Baptist Health South Florida, Miami (K.N.); Ciccarone Center for Prevention of Heart Disease, Johns Hopkins University, Baltimore, MD (E.D.M.); and Division of Cardiovascular Disease, University of Alabama, Birmingham (V.A.B.). , Khurram NasirKhurram Nasir From Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research and Development Center for Innovations, Houston, TX (S.S.V., J.M.A., L.A.P.); Sections of Health Services Research (S.S.V., J.M.A., L.A.P.) and Cardiovascular Research (S.S.V., V.N., C.M.B.), Department of Medicine, Baylor College of Medicine, Houston, TX; Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (S.S.V., V.N.); Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (S.S.V., V.N., C.M.B.); Veterans Affairs Health System, Palo Alto, CA (P.A.H.); Division of Cardiovascular Medicine and Cardiovascular Institute, Stanford University, CA (P.A.H.); Medical University of South Carolina, Charleston (P.B.M.); Center for Healthcare Advancement & Outcomes at Baptist Health South Florida, Miami (K.N.); Ciccarone Center for Prevention of Heart Disease, Johns Hopkins University, Baltimore, MD (E.D.M.); and Division of Cardiovascular Disease, University of Alabama, Birmingham (V.A.B.). , Erin D. MichosErin D. Michos From Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research and Development Center for Innovations, Houston, TX (S.S.V., J.M.A., L.A.P.); Sections of Health Services Research (S.S.V., J.M.A., L.A.P.) and Cardiovascular Research (S.S.V., V.N., C.M.B.), Department of Medicine, Baylor College of Medicine, Houston, TX; Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (S.S.V., V.N.); Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (S.S.V., V.N., C.M.B.); Veterans Affairs Health System, Palo Alto, CA (P.A.H.); Division of Cardiovascular Medicine and Cardiovascular Institute, Stanford University, CA (P.A.H.); Medical University of South Carolina, Charleston (P.B.M.); Center for Healthcare Advancement & Outcomes at Baptist Health South Florida, Miami (K.N.); Ciccarone Center for Prevention of Heart Disease, Johns Hopkins University, Baltimore, MD (E.D.M.); and Division of Cardiovascular Disease, University of Alabama, Birmingham (V.A.B.). , Vera A. BittnerVera A. Bittner From Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research and Development Center for Innovations, Houston, TX (S.S.V., J.M.A., L.A.P.); Sections of Health Services Research (S.S.V., J.M.A., L.A.P.) and Cardiovascular Research (S.S.V., V.N., C.M.B.), Department of Medicine, Baylor College of Medicine, Houston, TX; Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (S.S.V., V.N.); Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (S.S.V., V.N., C.M.B.); Veterans Affairs Health System, Palo Alto, CA (P.A.H.); Division of Cardiovascular Medicine and Cardiovascular Institute, Stanford University, CA (P.A.H.); Medical University of South Carolina, Charleston (P.B.M.); Center for Healthcare Advancement & Outcomes at Baptist Health South Florida, Miami (K.N.); Ciccarone Center for Prevention of Heart Disease, Johns Hopkins University, Baltimore, MD (E.D.M.); and Division of Cardiovascular Disease, University of Alabama, Birmingham (V.A.B.). , Laura A. PetersenLaura A. Petersen From Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research and Development Center for Innovations, Houston, TX (S.S.V., J.M.A., L.A.P.); Sections of Health Services Research (S.S.V., J.M.A., L.A.P.) and Cardiovascular Research (S.S.V., V.N., C.M.B.), Department of Medicine, Baylor College of Medicine, Houston, TX; Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (S.S.V., V.N.); Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (S.S.V., V.N., C.M.B.); Veterans Affairs Health System, Palo Alto, CA (P.A.H.); Division of Cardiovascular Medicine and Cardiovascular Institute, Stanford University, CA (P.A.H.); Medical University of South Carolina, Charleston (P.B.M.); Center for Healthcare Advancement & Outcomes at Baptist Health South Florida, Miami (K.N.); Ciccarone Center for Prevention of Heart Disease, Johns Hopkins University, Baltimore, MD (E.D.M.); and Division of Cardiovascular Disease, University of Alabama, Birmingham (V.A.B.). and Christie M. BallantyneChristie M. Ballantyne From Health Policy, Quality & Informatics Program, Michael E. DeBakey Veterans Affairs Medical Center Health Services Research and Development Center for Innovations, Houston, TX (S.S.V., J.M.A., L.A.P.); Sections of Health Services Research (S.S.V., J.M.A., L.A.P.) and Cardiovascular Research (S.S.V., V.N., C.M.B.), Department of Medicine, Baylor College of Medicine, Houston, TX; Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (S.S.V., V.N.); Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (S.S.V., V.N., C.M.B.); Veterans Affairs Health System, Palo Alto, CA (P.A.H.); Division of Cardiovascular Medicine and Cardiovascular Institute, Stanford University, CA (P.A.H.); Medical University of South Carolina, Charleston (P.B.M.); Center for Healthcare Advancement & Outcomes at Baptist Health South Florida, Miami (K.N.); Ciccarone Center for Prevention of Heart Disease, Johns Hopkins University, Baltimore, MD (E.D.M.); and Division of Cardiovascular Disease, University of Alabama, Birmingham (V.A.B.). Originally published2 May 2017https://doi.org/10.1161/CIRCULATIONAHA.117.028503Circulation. 2017;135:2572–2574Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2017: Previous Version 1 In the FOURIER trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk),1 treatment with evolocumab resulted in a 15% relative (1.5% absolute) risk reduction of major cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD) at a median follow-up of 2.2 years. This trial included patients with low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL or non–high-density lipoprotein cholesterol ≥100 mg/dL on at least moderate-intensity statins. It is not known what proportion of patients with ASCVD would qualify for evolocumab on the basis of FOURIER entry criteria and how eligibility would change if maximal doses of evidence-based lipid-lowering therapies were required. We assessed the number and proportion of US veterans with ASCVD who would qualify for evolocumab on the basis of FOURIER trial entry criteria and how these figures would change if high-intensity statins, ezetimibe, or the combination of both agents were used.Using a cohort of veterans with ASCVD (myocardial infarction, ischemic stroke, or peripheral arterial disease) receiving care in the Veterans Affairs (VA) system between October 2013 and September 2014, we identified all patients with ASCVD 40 to 85 years of age (n=631 855) using previously described algorithms with a positive predictive value of 88% in correctly identifying patients with ASCVD.2 We identified patients meeting 1 major or 2 minor FOURIER protocol criteria and excluded patients with LDL-C <70 mg/dL or non–high-density lipoprotein cholesterol 400 mg/dL, and those meeting other FOURIER exclusions.1Among patients meeting FOURIER inclusion and exclusion criteria, we determined proportions receiving moderate-intensity statins (30%–<50% LDL-C reduction), high-intensity statins (≥50% LDL-C reduction),3 or a combination of moderate- or high-intensity statin and ezetimibe using VA pharmacy records. We then used 3 clinical scenarios to model how eligibility for evolocumab would change (on the basis of an LDL-C reduction to <70 mg/dL) if all patients were titrated to a high-intensity statin (assuming 6% LDL-C reduction with each statin dose doubling), ezetimibe use (assuming a 20% LDL-C reduction),4 or a combination of high-intensity statin plus ezetimibe. Associated costs were estimated assuming a $0.07/d increment for titration to high-intensity statin, $2/d for the addition of generic ezetimibe, and $13 462.28/y for evolocumab.5 The protocol was approved by the Institutional Review boards at Baylor College of Medicine and the Michael E. DeBakey VA Medical Center.Among 631 855 patients with ASCVD who were 40 to 85 years of age, 154 823 (24.5%) would be evolocumab eligible with the use of FOURIER inclusion/exclusion criteria. The largest proportion were excluded because of LDL-C <70 or non–high-density lipoprotein cholesterol <100 mg/dL (38.2%). However, only half (49.9%) of those who qualified were on high-intensity statins, whereas 47.5% were on moderate-intensity statins, and 2.6% were on a statin/ezetimibe combination. Mean proportion of days covered was 0.76 for statins with 40.5% patients having poor statin adherence (proportion of days covered <0.8).Titration to a high-intensity statin would be expected to reduce LDL-C to <70 mg/dL in an additional 28 930 FOURIER-eligible patients (18.7%) with a mean achieved LDL-C of 63 mg/dL. Initiation of ezetimibe would lead to LDL-C <70 mg/dL in an additional 78 507 patients (50.7%) with a mean achieved LDL-C of 60 mg/dL. Finally, a combination of high-intensity statin plus ezetimibe would lead to LDL-C <70 mg/dL in 92 538 patients (59.8%) with a mean achieved LDL-C of 58 mg/dL. Estimated costs associated with treating the 154 823 patients eligible for FOURIER in the VA system with evolocumab would be $2.08 billion/y (Figure). Restricting evolocumab to patients with LDL ≥70 mg/dL, after accounting for cost associated with titration to high-intensity statin plus ezetimibe, would be expected to result in an annual net cost savings of $1.13 billion. Doubling the ezetimibe cost to $4/d would decrease the cost savings by $111 million to $1.02 billion/y.Download figureDownload PowerPointFigure. Cost implications of titrating FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk)-eligible patients to high-intensity statin and ezetimibe. LDL-C indicates low-density lipoprotein cholesterol.In summary, approximately one-fourth of US veterans 40 to 85 years of age with ASCVD would qualify for evolocumab with the use of FOURIER trial criteria. However, approximately half of eligible patients are not receiving high-intensity statins. Uptitration of standard therapy could lead to significant cost savings by decreasing eligibility for evolocumab by ≈20% with high-intensity statins, by 50% with the addition of ezetimibe, or by ≈60% with the combination of high-intensity statins and ezetimibe. Furthermore, these efforts would be augmented by concomitantly targeting improved statin adherence.The reasons for current undertreatment may include patient preference, statin intolerance, or provider clinical inertia. Thus, universal treatment with high-intensity combination therapy may be challenging. It is also possible that our estimates of improvement in LDL-C are optimistic because of medication nonadherence or variability in drug response among those adherent. In addition, the clinical practice guidelines for lipid management in the VA system differ from the 2013 American College of Cardiology/American Heart Association cholesterol guideline.3 Finally, the LDL-C levels achieved with statin and ezetimibe titration strategies are still higher than the median LDL-C of 30 mg/dL achieved with evolocumab in the FOURIER trial. The impact of these LDL-C differences <70 mg/dL requires further study.Our results have implications for the VA and other healthcare systems by providing estimates of patient eligibility and potential costs. Importantly, we show that healthcare systems have considerable opportunity to increase the use of evidence-based high-intensity statins and ezetimibe, which may reduce the need for additional costly therapies such as evolocumab.Salim S. Virani, MD, PhDJulia M. Akeroyd, MPHVijay Nambi, MD, PhDPaul A. Heidenreich, MD, MSPamela B. Morris, MDKhurram Nasir, MDErin D. Michos, MD, MHSVera A. Bittner, MD, MSPHLaura A. Petersen, MD, MPHChristie M. Ballantyne, MDSources of FundingThis work was supported by an American Heart Association Beginning Grant-in-Aid (14BGIA20460366), an American Diabetes Association Clinical Science and Epidemiology award (1-14-CE-44), and a Houston Veteran's Affairs Health Services Research & Development Center for Innovations grant (grant CIN13-413). The opinions expressed reflect those of the authors and not necessarily those of the Department of Veterans Affairs, the US government, or Baylor College of Medicine.DisclosuresDr Nambi reports receiving a research grant from Merck (paid to Baylor College of Medicine), reports serving as a consultant to and on an advisory board for Sanofi-Regeneron, reports receiving an honorarium for event adjudication for a clinical trial by Siemens Healthcare Diagnostics, and reports holding provisional patent 61721475 entitled "Biomarkers to Improve Prediction of Heart Failure Risk" filed by Baylor College of Medicine and Roche. Dr Morris reports serving as a consultant for Amgen, AstraZeneca, and Sanofi Regeneron and having received research funding from Amgen. Dr Nasir reports serving as a consultant for Sanofi Regeneron and serving on the advisory board for Quest Diagnostics. Dr Michos reports receiving an honorarium for event adjudication for a clinical trial by Siemens Healthcare Diagnostics. Dr Bittner reports serving on steering committees (her institution [University of Alabama at Birmingham] was compensated) for the ODYSSEY trial (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; Sanofi-Regeneron) and for the development of the cholesteryl ester transfer protein inhibitor (Eli Lilly), reports being national coordinator of the STRENGTH trial (Outcomes Study to Assess Statin Residual Risk Reduction With Epanova in High CV Risk Patients With Hypertriglyceridemia; AstraZeneca), reports serving on advisory boards for Eli Lilly and Amgen, reports being coinvestigator on a University of Alabama School of Public Health–Amgen contract related to Medicare analyses, and reports holding the position of past local site principal investigator for a Pfizer Inc SPIRE trial (Studies of PCSK9 Inhibition and the Reduction of Vascular Events). Dr Ballantyne reports receiving grant and research support (all paid to Baylor College of Medicine) from Abbott Diagnostic, Amarin, Amgen, Eli Lilly, Esperion, Novartis, Pfizer Inc, Otsuka, Regeneron, Roche Diagnostic, Sanofi-Synthelabo, Takeda, National Institutes of Health, American Heart Association, and American Diabetes Association and reports serving as a consultant to Abbott Diagnostics, Amarin, Amgen, AstraZeneca, Eli Lilly, Esperion, Genzyme, Isis, Matinas BioPharma Inc, Merck, Novartis, Pfizer Inc, Regeneron, Roche, and Sanofi-Synthelabo. Dr Virani reports serving on the steering committee (with no financial remuneration) for the PALM Registry (Patient and Provider Assessment of Lipid Management) at the Duke Clinical Research Institute.FootnotesCirculation is available at http://circ.ahajournals.org.Correspondence to: Salim S. Virani, MD, PhD, Health Services Research and Development (152), Michael E. DeBakey Veterans Affairs Medical Center, 2002 Holcombe Boulevard, Houston, TX 77030. E-mail [email protected]References1. Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease.N Engl J Med. 2017; 376:1713–1722. doi: 10.1056/NEJMoa1615664.CrossrefMedlineGoogle Scholar2. Virani SS, Akeroyd JM, Ramsey DJ, Chan WJ, Frazier L, Nasir K, S Rajan S, Ballantyne CM, Petersen LA. Comparative effectiveness of outpatient cardiovascular disease and diabetes care delivery between advanced practice providers and physician providers in primary care: implications for care under the Affordable Care Act.Am Heart J. 2016; 181:74–82. doi: 10.1016/j.ahj.2016.07.020.CrossrefMedlineGoogle Scholar3. 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