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https://www.readbyqxmd.com/read/29326146/prior-authorization-requirements-for-proprotein-convertase-subtilisin-kexin-type-9-inhibitors-across-us-private-and-public-payers
#1
Jalpa A Doshi, Justin T Puckett, Michael S Parmacek, Daniel J Rader
BACKGROUND: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) are an innovative treatment option for patients with familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require further lowering of low-density lipoprotein cholesterol. However, the high costs of these agents have spurred payers to implement utilization management policies to ensure appropriate use. We examined prior authorization (PA) requirements for PCSK9is across private and public US payers...
January 2018: Circulation. Cardiovascular Quality and Outcomes
https://www.readbyqxmd.com/read/29307022/fluorescein-videoangiography-during-extracranial-to-intracranial-bypass-surgery-preliminary-results
#2
Alessandro Narducci, Julia Onken, Marcus Czabanka, Nils Hecht, Peter Vajkoczy
BACKGROUND: Over the last years, intraoperative use of fluorescein is gaining ground in the field of neurosurgery, due to development of a microscope-integrated YELLOW 560 module, with reported experiences in brain malignancies, aneurysms, and arteriovenous malformation surgery. The aim of this study is to determine the feasibility and value of fluorescein videoangiography during bypass procedures. METHODS: The authors enrolled 11 patients who underwent extracranial-to-intracranial bypass for moyamoya disease, atherosclerotic steno-occlusive cerebrovascular disease, and flow replacement during a giant middle cerebral artery (MCA) aneurysm treatment...
January 6, 2018: Acta Neurochirurgica
https://www.readbyqxmd.com/read/29181773/budget-impact-analysis-of-pcsk9-inhibitors-for-the-management-of-adult-patients-with-heterozygous-familial-hypercholesterolemia-or-clinical-atherosclerotic-cardiovascular-disease
#3
Usha G Mallya, Susan H Boklage, Andrew Koren, Thomas E Delea, C Daniel Mullins
OBJECTIVE: The aim of this study was to assess the budget impact of introducing the proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) alirocumab and evolocumab to market for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular (CV) disease requiring additional lowering of low-density lipoprotein cholesterol (LDL-C). METHODS: A 3-year model estimated the costs of lipid-modifying therapy (LMT) and CV events to a hypothetical US health plan of 1 million members, comparing two scenarios-with and without the availability of PCSK9i as add-on therapy to statins...
November 27, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/29171769/alirocumab-for-the-treatment-of-hyperlipidemia-in-high-risk-patients-an-updated-review
#4
Michael Farnier
Alirocumab is a fully human immunoglobulin G1 monoclonal antibody directed against proprotein convertase subtilisin/kexin type 9 (PCSK9) approved for the treatment of hypercholesterolemia in high-risk patients. The objective is to provide an updated review of the recent data published for alirocumab. Areas covered: The efficacy and safety of alirocumab has been initially evaluated in a comprehensive phase 3 program conducted in more than 6 000 patients with primary non-familial and heterozygous familial hypercholesterolemia: alirocumab reduced LDL-cholesterol up to 62% in phase 3 with every 2-week dosing compared with placebo, and up to 36% compared with ezetimibe, with an excellent safety and tolerability profile...
November 24, 2017: Expert Review of Cardiovascular Therapy
https://www.readbyqxmd.com/read/29162357/2017-guidelines-for-the-management-of-arterial-hypertension-in-primary-health-care-in-portuguese-speaking-countries
#5
Gláucia Maria Moraes de Oliveira, Miguel Mendes, Marcus Vinícius Bolívar Malachias, João Morais, Osni Moreira Filho, Armando Serra Coelho, Daniel Pires Capingana, Vanda Azevedo, Irenita Soares, Alda Menete, Beatriz Ferreira, Miryan Bandeira Dos Prazeres Cassandra Soares, Mário Fernandes
The World Health Organization goal's to reduce mortality due to chronic non-communicable diseases by 2% per year demands a huge effort from member countries. This challenge for health professionals requires global political action on implementation of social measures, with cost-effective population interventions to reduce chronic non-communicable diseases and their risk factors. Systemic arterial hypertension is highly prevalent in Portuguese-speaking countries, and is a major risk factor for complications such as stroke, acute myocardial infarction and chronic kidney disease, rivaling dyslipidemia and obesity in importance for the development of atherosclerotic disease...
November 18, 2017: Portuguese Journal of Cardiology: An Official Journal of the Portuguese Society of Cardiology
https://www.readbyqxmd.com/read/29124655/enhanced-bioactivity-of-the-anti-lox-1-scfv-engineered-by-multimerization-strategy
#6
Wei Hu, Qiuhong Xie, Ling Liu, Hongyu Xiang
Single-chain variable fragment (scFv) antibodies as therapeutic agents have the potential to reduce the production cost and immunogenicity relative to monoclonal antibodies, but their monovalency and lack of a fragment crystallizable region can lead to reduced function. Multimerization is one strategy for recovering the function; however, their application is limited by the production of multimeric proteins. In our previous study, an anti-lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) scFv showed potential use in diagnosis and therapy of atherosclerotic diseases, but is limited by its inherent low antigen-binding activity...
November 9, 2017: Applied Biochemistry and Biotechnology
https://www.readbyqxmd.com/read/29099363/the-effects-of-oral-health-on-systemic-health
#7
Shawn F Kane
The oral cavity is the intersection of medicine and dentistry and the window into the general health of a patient. Hundreds of diseases and medications impact the oral cavity, and pathologic conditions in the mouth have a greater systemic impact than many providers appreciate. It is unclear whether there is true causality or just an association between periodontal disease and certain other systemic conditions, including atherosclerotic vascular disease, pulmonary disease, diabetes, pregnancy-related complications, osteoporosis, and kidney disease...
November 2017: General Dentistry
https://www.readbyqxmd.com/read/29079501/beyond-discrimination-a-comparison-of-calibration-methods-and-clinical-usefulness-of-predictive-models-of-readmission-risk
#8
Colin G Walsh, Kavya Sharman, George Hripcsak
BACKGROUND: Prior to implementing predictive models in novel settings, analyses of calibration and clinical usefulness remain as important as discrimination, but they are not frequently discussed. Calibration is a model's reflection of actual outcome prevalence in its predictions. Clinical usefulness refers to the utilities, costs, and harms of using a predictive model in practice. A decision analytic approach to calibrating and selecting an optimal intervention threshold may help maximize the impact of readmission risk and other preventive interventions...
October 24, 2017: Journal of Biomedical Informatics
https://www.readbyqxmd.com/read/29076309/optimization-of-dual-wavelength-intravascular-photoacoustic-imaging-of-atherosclerotic-plaques-using-monte-carlo-optical-modeling
#9
Nicholas Dana, Timothy Sowers, Andrei Karpiouk, Donald Vanderlaan, Stanislav Emelianov
Coronary heart disease (the presence of coronary atherosclerotic plaques) is a significant health problem in the industrialized world. A clinical method to accurately visualize and characterize atherosclerotic plaques is needed. Intravascular photoacoustic (IVPA) imaging is being developed to fill this role, but questions remain regarding optimal imaging wavelengths. We utilized a Monte Carlo optical model to simulate IVPA excitation in coronary tissues, identifying optimal wavelengths for plaque characterization...
October 2017: Journal of Biomedical Optics
https://www.readbyqxmd.com/read/29068582/prevalence-of-cardiovascular-disease-risk-factors-among-pharmacy-students-from-wroclaw-medical-university-poland
#10
Rafał Ilow, Dorota Różańska, Bożena Regulska-Ilow
BACKGROUND: Atherosclerotic processes begin in childhood and their development worsens during adolescence. Early prevention of CVD risk factors may have an important impact on the future health of young people. It can be also helpful in reducing the costs of treating CVD later in life. OBJECTIVES: The aim of this study was to assess the prevalence of selected cardiovascular disease risk factors among pharmacy students. MATERIAL AND METHODS: The study group consisted of 1,168 pharmacy students (892 women and 276 men) from Wroclaw Medical University...
August 2017: Advances in Clinical and Experimental Medicine: Official Organ Wroclaw Medical University
https://www.readbyqxmd.com/read/29045612/fractional-flow-reserve-and-myocardial-perfusion-by-computed-tomography-a-guide-to-clinical-application
#11
Joanne D Schuijf, Brian S Ko, Marcelo F Di Carli, Jacqueline Hislop-Jambrich, Abdul-Rahman Ihdayhid, Sujith K Seneviratne, João A C Lima
The aim of this paper is to provide a guide to the clinical application of the functional computed tomography (CT) techniques fractional flow reserve (CT FFR) and myocardial perfusion (CTP) in patients presenting for the evaluation of coronary artery disease (CAD). Both techniques have recently been introduced to complement coronary CT angiography (CTA) with physiological information. Evidence supporting their diagnostic accuracy accumulates at a fast pace, and both techniques are moving from research tools to clinical applications for specific subgroups of patients...
October 17, 2017: European Heart Journal Cardiovascular Imaging
https://www.readbyqxmd.com/read/29019319/the-asymptomatic-carotid-surgery-trial-2-acst-2-an-ongoing-randomised-controlled-trial-comparing-carotid-endarterectomy-with-carotid-artery-stenting-to-prevent-stroke
#12
Richard Bulbulia, Alison Halliday
BACKGROUND: A successful open surgical operation to remove atheromatous carotid artery narrowing that has not yet caused a stroke (asymptomatic carotid stenosis) carries some procedural risk but, if completed successfully, halves patients' future annual stroke risk for at least 10 years. A newer, less invasive alternative is carotid stenting, which also carries some procedural risk, especially if the carotid lesion has recently given rise to a stroke (symptomatic carotid stenosis). For both surgery and stenting, improvements in technique (and in medication) have reduced risk...
October 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28983441/high-value-care-in-the-evaluation-of-stroke
#13
Prakrity Urja, Eric H Nippoldt, Virginia Barak, Carrie Valenta
Value-based care emphasizes achieving the greatest overall health benefit for every dollar spent. We present an interesting case of stroke, which made us consider how frequently health care providers are utilizing value-based care. A 73-year-old Caucasian, who was initially admitted for a hypertensive emergency, was transferred to our facility for worsening slurring of speech and left-sided weakness. The patient had an extensive chronic cerebrovascular disease, including multiple embolic type strokes, mainly in the distribution of the right temporal-occipital cerebral artery and transient ischemic attacks (TIAs)...
August 1, 2017: Curēus
https://www.readbyqxmd.com/read/28978220/pcsk9-inhibitors-and-managing-cost-in-the-managed-care-setting
#14
Sheila L Stadler, Thomas J Cook
In patients with hypercholesterolemia who have atherosclerotic cardiovascular disease and/or familial hypercholesterolemia, a new class of drugs may be helpful in reducing serum levels of low-density lipoprotein cholesterol (LDL-C) beyond maximally tolerated statin therapy. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors lower LDL-C through a different mechanism of action than standard cholesterol-lowering therapies. Currently approved PCSK9 inhibitors are the monoclonal antibodies alirocumab and evolocumab...
June 2017: American Journal of Managed Care
https://www.readbyqxmd.com/read/28973087/association-of-prior-authorization-and-out-of-pocket-costs-with-patient-access-to-pcsk9-inhibitor-therapy
#15
Ann Marie Navar, Benjamin Taylor, Hillary Mulder, Eugene Fievitz, Keri L Monda, Anna Fievitz, Juan F Maya, J Antonio G López, Eric D Peterson
Importance: Although PCSK9 inhibitors (PCSK9i) were approved in 2015, their high cost has led to strict prior authorization practices and high copays, and use of PSCK9i in clinical practice has been low. Objective: To evaluate patient access to PCSK9i among those prescribed therapy. Design, Setting, and Participants: Using pharmacy transaction data, we evaluated 45 029 patients who were newly prescribed PCSK9i in the United States between August 1, 2015, and July 31, 2016...
November 1, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28888913/the-renaissance-of-lipoprotein-a-brave-new-world-for-preventive-cardiology
#16
REVIEW
Katrina L Ellis, Michael B Boffa, Amirhossein Sahebkar, Marlys L Koschinsky, Gerald F Watts
Lipoprotein(a) [Lp(a)] is a highly heritable cardiovascular risk factor. Although discovered more than 50 years ago, Lp(a) has recently re-emerged as a major focus in the fields of lipidology and preventive cardiology owing to findings from genetic studies and the possibility of lowering elevated plasma concentrations with new antisense therapy. Data from genetic, epidemiological and clinical studies have provided compelling evidence establishing Lp(a) as a causal risk factor for atherosclerotic cardiovascular disease...
October 2017: Progress in Lipid Research
https://www.readbyqxmd.com/read/28866767/the-parthenon-clinical-development-program-the-role-of-ticagrelor-in-patients-with-atherothrombotic-disease
#17
REVIEW
Paul P Dobesh, Manesh Patel
Although the rate of cardiovascular disease (CVD)-related mortality has declined over the last decade, it is still the leading cause of mortality in the USA, accounting for over 1.4 million deaths annually. In addition, total direct (primarily hospital admissions) and indirect costs of CVD in the US is over $316 billion annually and is expected to grow to over $918 billion by 2030. Much of the etiology of CVD is due to atherosclerosis and its thrombotic complications, and central to this is the role of platelets...
August 2017: Cardiovascular Drugs and Therapy
https://www.readbyqxmd.com/read/28832867/cost-effectiveness-of-evolocumab-therapy-for-reducing-cardiovascular-events-in-patients-with-atherosclerotic-cardiovascular-disease
#18
Gregg C Fonarow, Anthony C Keech, Terje R Pedersen, Robert P Giugliano, Peter S Sever, Peter Lindgren, Ben van Hout, Guillermo Villa, Yi Qian, Ransi Somaratne, Marc S Sabatine
Importance: The proprotein convertase subtilisin/kexin type 9 inhibitor evolocumab has been demonstrated to reduce the composite of myocardial infarction, stroke, or cardiovascular death in patients with established atherosclerotic cardiovascular disease. To our knowledge, long-term cost-effectiveness of this therapy has not been evaluated using clinical trial efficacy data. Objective: To evaluate the cost-effectiveness of evolocumab in patients with atherosclerotic cardiovascular disease when added to standard background therapy...
October 1, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28831261/real-world-use-of-pcsk-9-inhibitors-by-early-adopters-cardiovascular-risk-factors-statin-co-treatment-and-short-term-adherence-in-routine-clinical-practice
#19
Kathleen A Fairman, Lindsay E Davis, David A Sclar
BACKGROUND: Inconsistency of real-world medication use with labeled indications may affect cost and clinical value of pharmacotherapy. PCSK-9 inhibitors are labeled in the US for use with statins to reduce low-density lipoprotein cholesterol in patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH). OBJECTIVE: To assess consistency with labeled indications and treatment persistency for early (first 5 post-launch months) adopters of PCSK-9 inhibitor pharmacotherapy...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28814290/predicted-impact-of-lipid-lowering-therapy-on-cardiovascular-and-economic-outcomes-of-swedish-atherosclerotic-cardiovascular-disease-guideline
#20
Gunilla Journath, Kristina Hambraeus, Emil Hagström, Billie Pettersson, Mickael Löthgren
BACKGROUND: The effects on cardiovascular disease (CVD) by treatment recommendations on prevention of atherosclerotic CVD remain to be evaluated. The objectives were to assess treatment gap for low density lipoprotein cholesterol (LDL-C) according to guidelines, potential impact on CVD outcomes, and possible avoided economic costs, in post myocardial infarction (MI) patients, if target LDL-C levels of ≤1.8 mmol/L would be achieved. METHODS: All patients registered in the Swedish Secondary Prevention after Heart Intensive care Admission register, with one-year post-MI follow-up during 2013 were selected...
August 16, 2017: BMC Cardiovascular Disorders
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