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- Title
Eligibility for alirocumab or evolocumab treatment in 1090 hypercholesterolemic patients referred to a regional cholesterol treatment center with LDL cholesterol ≥70 mg/dL despite maximal-tolerated LDL-cholesterol-lowering therapy.
- Authors
Jetty, Vybhav; Glueck, Charles J.; Lee, Kevin; Goldenberg, Naila; Prince, Marloe; Kumar, Ashwin; Goldenberg, Michael; Anand, Ishan; Ping Wang; Wang, Ping
- Abstract
<bold>Background: </bold>Proprotein convertase subtilisin/kexin type 9 inhibitors, Praluent (alirocumab [ALI]) and Repatha (evolocumab [EVO]) have been approved as adjuncts to the standard-of-care maximal-tolerated dose (MTD) of low-density lipoprotein cholesterol (LDLC)-lowering therapy (LLT), statin therapy, in heterozygous (HeFH) (ALI or EVO) or homozygous (EVO) familial hypercholesterolemia, or clinical atherosclerotic cardiovascular disease (CVD) where LDLC lowering is insufficient (both). Since LDLC lowering has been revolutionized by ALI and EVO, specialty pharmaceutical pricing models will be applied to a mass market.<bold>Methods: </bold>We applied US Food and Drug Administration (FDA) and insurance eligibility criteria for ALI and EVO to 1090 hypercholesterolemic patients serially referred over 3 years who then received ≥2 months maximal-tolerated dose of standard-of-care LDL cholesterol-lowering therapy (MTDLLT) with follow-up LDLC ≥70 mg/dL. MTDLLT did not include ALI or EVO, which had not been commercially approved before completion of this study.<bold>Results: </bold>Of the 1090 patients, 140 (13%) had HeFH by clinical diagnostic criteria and/or CVD with LDLC >100 mg/dL despite ≥2 months on MTDLLT, meeting FDA insurance criteria for ALI or EVO therapy. Another 51 (5%) patients were statin intolerant, without HeFH or CVD.<bold>Conclusion: </bold>If 13% of patients with HeFH-CVD and LDLC >100 mg/dL despite MTDLLT are eligible for ALI or EVO, then specialty pharmaceutical pricing models (~$14,300/year) might be used in an estimated 10 million HeFH-CVD patients. Whether the health care savings arising from the anticipated reduction of CVD events by ALI or EVO justify their costs in populations with HeFH-CVD and LDLC >100 mg/dL despite MTDLLT remains to be determined.
- Subjects
OHIO; PROPROTEIN convertases; ANTICHOLESTEREMIC agents; SUBTILISIN inhibitors; HYPERLIPIDEMIA; CHOLESTEROL; HYPERCHOLESTEREMIA; CARDIOVASCULAR diseases; CARDIOVASCULAR disease prevention; HYPERCHOLESTEREMIA diagnosis; THERAPEUTIC use of monoclonal antibodies; THERAPEUTIC use of protease inhibitors; MEDICAL referrals; OUTPATIENT services in hospitals; MONOCLONAL antibodies; ANTILIPEMIC agents; COST control; COST effectiveness; DRUG dosage; DRUG toxicity; LOW density lipoproteins; EVALUATION of medical care; MEDICAL care costs; TIME; ELIGIBILITY (Social aspects); TREATMENT effectiveness; STATISTICAL models; ECONOMICS
- Publication
Vascular Health & Risk Management, 2017, Vol 13, p247
- ISSN
1176-6344
- Publication type
journal article
- DOI
10.2147/VHRM.S133690