Andrew Briggs, DPhil; Sergio Fazio, MD, PhD; Khurram Nasir, MD, MPH
This activity is jointly provided by Global Education Group and Integritas Communications.
This activity is supported by an educational grant from Sanofi US and Regeneron Pharmaceuticals.
Andrew Briggs, DPhil
Professor, health economics
London School of Hygiene and Tropical Medicine
London, United Kingdom
Visiting Investigator, Center for Health Policy and Outcomes
Memorial Sloan Kettering Cancer Center
New York, New York
Sergio Fazio, MD, PhD
The William and Sonja Connor Chair of Preventative Cardiology
Professor of Medicine and Physiology & Pharmacology
Director, Center for Preventive Cardiology, Knight Cardiovascular Institute
Oregon Health & Science University
Khurram Nasir, MD, MPH
Director, Population Health and Health System Research
Associate Professor of Medicine
Division of Cardiology
Center for Outcome Research and Evaluation
Yale School of Medicine
New Haven, Connecticut
Hypercholesterolemia is a major risk factor for cardiovascular disease, a leading cause of death. Statins and other lipid-lowering therapies are not sufficient for some high-risk patients, making them candidates for the relatively recently approved proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Clinical trial data have demonstrated the efficacy of these treatments for lowering the risk of major adverse cardiovascular events (MACE), particularly in patients with the highest risk. Recent decreases in pricing for PCSK9 inhibitors have made these therapies more cost effective for a select group of patients; understanding pricing and optimal strategies to access PCSK9 inhibitors will greatly improve patient outcomes. This Clinical Research Update will provide an overview of cardiovascular outcomes trials of PCSK9 inhibitors, pharmacoeconomic models and recent cost effectiveness analyses of PCSK9 inhibitors, and strategies to increase patient access to PCSK9 inhibitors.
The educational design of this activity addresses the needs of managed care medical directors, cardiologists, lipidologists, and additional physicians involved in the ongoing management of patients with persistently elevated low-density lipoprotein-cholesterol (LDL-C) levels.
After completing this activity, the participant should be better able to:
- Discuss the study designs and results from large cardiovascular outcomes trials examining PCSK9 inhibitors
- Describe the strengths and weaknesses of the various pharmacoeconomic models
- Discuss recent pharmacoeconomic analyses related to PCSK9 inhibition and cost effectiveness in various high-risk populations
- Participate in managed-care processes to reduce barriers to patient access and facilitate optimization of long-term health outcomes with nonstatin LDL-C lowering medications
Physician Accreditation Statement
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Global Education Group (Global) and Integritas Communications. Global is accredited by the ACCME to provide continuing medical education for physicians.
Physician Credit Designation
Global Education Group designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Pharmacist Accreditation Statement
Global Education Group is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Continuing Pharmacy Education
Global Education Group designates this continuing education activity for 1.0 contact hour (0.10 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number - 0530-9999-19-244-H01-P)
This is a knowledge-based activity.
Term of Offering
This activity was released on October 24, 2019 and is valid for one year. Requests for credit must be made no later than October 24, 2020.
Disclosure of Conflicts of Interest
Global requires instructors, planners, managers, and other individuals and their spouses/life partners who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by Global for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.
The faculty reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity:
Andrew Briggs, DPhil: Consultant/Independent Contractor: Amgen, Sanofi/Regeneron
Sergio Fazio, MD, PhD: Consultant/Independent Contractor: Amgen, Amarin, AstraZeneca, Novartis, Esperion
Khurram Nasir, MD, MPH: Honoraria: Amgen Inc.; The Medicines Company, Sanofi/Regeneron
The planners and managers reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity:
Lindsay Borvansky: Nothing to disclose
Andrea Funk: Nothing to disclose
Liddy Knight: Nothing to disclose
Ashley Cann: Nothing to disclose
Gena Dolson, MS: Nothing to disclose
Jim Kappler, PhD: Nothing to disclose
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration. Global and Integritas Communications do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
Fee Information & Refund/Cancellation Policy
There is no fee for this educational activity.
Instructions to Receive Credit
In order to receive credit, participants must complete the following:
- Read the educational objectives, accreditation information, and faculty disclosures at the beginning of this activity.
- Complete the Preactivity Questions.
- Read or review the activity content.
- Complete the Postactivity Test Questions and Evaluation.
- Achieve a grade of 70% on the Postactivity Test Questions and complete the Evaluation to receive credit.
- Pharmacist learners must check the CPE Monitor for credits within 60 days of the activity.
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credit amount 1.00
credit type CME
Implications for PCSK9 Inhibitors in Clinical Practice