Application of PCSK9 Inhibitors in Practice

Kaufman, Tina M.; Duell, P. Barton; Purnell, Jonathan Q.; Wójcik, Cezary; Fazio, Sergio; Shapiro, Michael D.

doi:10.1161/circresaha.117.311532

Cited by 31 publications

(25 citation statements)

References 8 publications

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“…7 Here we shift the focus to the patient perspective, and in doing so highlight the value of our now established model for management of PCSK9i treatment. Overall, the implementation of a dedicated PCSK9i clinic has resulted in a 97% rate of drug approval, far higher than the national average approval rate of 40–50% reported in the literature.…”

Section: Discussionmentioning

confidence: 94%

“…7 Briefly, patients were referred from within OHSU or by outside providers for consultation regarding appropriateness for referral to the PCSK9i clinic. During the initial PCSK9i visit, a clinical pharmacist and a physician assistant performed a medical history and physical exam that included detailed documentation of current medications, past lipid-lowering therapies (allopathic and naturopathic), reported intolerances or side effects, diagnoses of lipid disorders using insurance-guided documentation requirements, instruction on injection technique, and a prescription for the PCSK9i medication in appropriately selected patients.…”

Section: Methodsmentioning

confidence: 99%

“…Prior reports of PCSK9i treatment have provided details from either the clinical trial perspective, 4–6 the provider perspective, 7–12 or the payer and societal perspectives. 13–18 However, few reports have reflected the patient experience with PCSK9i in clinical use.…”

Section: Introductionmentioning

confidence: 99%

“…This is part two of a report that initially described the design and implementation of a dedicated PCSK9i clinic as a means to increase efficiency of referral and access to PCSK9i treatment for patients who meet standard of care indications for this therapy. 7 The goal of this second report is to outline, from the patient’s perspective, a real world experience with PCSK9i therapy in relation to accessibility of the drug, out-of-pocket expense, side effects, and lipid-lowering efficacy using a rigorously structured cohort.…”

Section: Introductionmentioning

confidence: 99%

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Application of PCSK9 Inhibitors in Practice

Kaufman

Warden

Minnier

et al. 2019

Circulation Research

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Protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors (PCSK9i) are set to revolutionize the treatment of hypercholesterolemia in the management of atherosclerotic risk, but numerous reports have detailed unprecedented barriers to access for these drugs. To overcome these challenges, our group created a model to facilitate provision of this new therapy for patients who qualify according to FDA criteria. This report details the real-world follow-up experience of PCSK9i use in a large patient cohort structured to ensure rigor in data collection, analysis, and interpretation. The 271 patients approved and actively followed in our PCSK9i clinic between July 2015 and August 2018 represent a 97% approval rate from insurance, with 28% of prescriptions requiring at least one appeal. Over 50% of patients were statin intolerant. On average, there was a median lapse of 15 days between initial visit and insurance approval. PCSK9i therapy was affordable for most patients, with an average monthly out-of-pocket expense of $58.05 (median $0). Only 2.3% of patients were unable to initiate or continue therapy due to cost. Reductions from baseline in LDL cholesterol and Lp(a) were comparable to published reports with median reductions of 60% and 23% at one year, respectively. PCSK9i therapy was well tolerated overall, though 9% of patients reported adverse events, and 5% of patients discontinued due mostly to musculoskeletal and flu-like symptoms. Our practice model demonstrates that PCSK9i therapy can be accessed easily and affordably for the majority of eligible patients, resulting in dramatic improvement in lipid profile results. Moreover, our registry data suggest that results from the prospective clinical trials of PCSK9i on LDL and Lp(a) reduction and on tolerability are applicable to a real-world cohort.

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Section: Discussionmentioning

confidence: 94%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Application of PCSK9 Inhibitors in Practice

Kaufman

Warden

Minnier

et al. 2019

Circulation Research

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“…Given the current low rate of insurance approvals for PCSK9 agents in the U.S., the situation overall has not drastically changed for FH patients in the nearly three years since the approval of this new class of agents. 27 Other noteworthy, country-specific observations from these registries include the following:…”

Section: International Fh Registriesmentioning

confidence: 99%

Familial Hypercholesterolemia: Use of Registries, Biobanks, and Cohort Studies To Improve its Diagnosis and Management in Non-Western Populations

Shapiro¹,

Fazio²

2018

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Low‐density lipoprotein cholesterol lowering in real‐world patients treated with evolocumab

Desai

Wade

Xiang

et al. 2021

Clinical Cardiology

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Background Low‐density lipoprotein cholesterol (LDL‐C) is a risk factor for atherosclerotic cardiovascular disease (ASCVD). There are limited real‐world data on LDL‐C lowering with evolocumab in United States clinical practice. Hypothesis We assessed LDL‐C lowering during 1 year of evolocumab therapy. Methods This retrospective cohort study used linked laboratory (Prognos) and medical claims (IQVIA Dx/LRx and PharMetrics Plus®) data. Patients with a first fill for evolocumab between 7/1/2015 and 10/31/2019 (index event) and LDL‐C ≥ 70 mg/dL were included (overall cohort; N = 5897). Additionally, a patient subgroup with a recent myocardial infarction (MI) within 12 months (median 130 days) before the first evolocumab fill was identified (N = 152). Reduction from baseline LDL‐C was calculated based on the lowest LDL‐C value recorded during a 12‐month follow‐up period. Results The mean (SD) age was 65 (10) years; 61.9% of patients had ASCVD diagnoses and 70.7% of patients were in receipt of lipid‐lowering therapy. Following evolocumab treatment, changes in LDL‐C from baseline were −60% in the overall cohort (median [interquartile range (IQR)] 146 [115–180] mg/dL to 58 [36–84] mg/dL) and −65% in the recent MI subgroup (median [IQR] 137 [109–165] mg/dL to 48 [30–78] mg/dL). In the overall cohort and recent MI subgroup, 62.1% and 69.7% of patients achieved LDL‐C < 70 mg/dL, respectively. Conclusions In this real‐world analysis, evolocumab was associated with significant reductions in LDL‐C comparable to that seen in the FOURIER clinical trial, which were durable over 1 year of treatment.

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Application of PCSK9 Inhibitors in Practice

Cited by 31 publications

References 8 publications

Application of PCSK9 Inhibitors in Practice

Application of PCSK9 Inhibitors in Practice

Familial Hypercholesterolemia: Use of Registries, Biobanks, and Cohort Studies To Improve its Diagnosis and Management in Non-Western Populations

Low‐density lipoprotein cholesterol lowering in real‐world patients treated with evolocumab

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