Medical Crossfire®: Optimal Lipid Management for Primary Care Practitioners: An Update on PCSK9 Inhibitors

 


Release Date: August 1, 2018
Expiration Date: August 1, 2019
Media: Internet - based

Activity Overview

“Optimal Lipid Management for Primary Care Practitioners: An Update on PCSK9 Inhibitors: A Medical Crossfire® Activity” is designed to update primary care providers and other health care professionals on the evolving landscape of lipid-lowering therapy. During this Medical Crossfire®, expert faculty, including a lipidologist, cardiologist, primary care physician, and allied health care professional, will engage in a multidisciplinary roundtable discussion to discuss how to best optimize and individualize hypercholesterolemia management with newer therapies.

Acknowledgement of Commercial Support

This activity is supported by an educational grant from Amgen.

Instructions for This Activity and Receiving Credit

  • You will need to login to participate in the activity.
  • Each presentation may contain an interactive question(s). You may move forward through the presentation; however, you may not go back to change answers or review videos/content until you finish the presentation.
  • At the end of the activity, “educational content/video files” will be available for your reference.
  • In order to receive a CME/CE certificate, participants must complete the activity.
  • Complete the posttest and pass with a score of 70% or higher, complete the evaluation and then click on request for credit. Participants may immediately download a CME/CE certificate upon completion of these steps.


Target Audience

This CME activity is primarily intended for community clinicians, primary care clinicians, and cardiologists, as well as other professionals who treat patients with hyperlipidemia.  These HCPs are in positions to educate patients and guide treatment decisions.

Learning Objectives

Upon completion of this CME activity, you should be better prepared to:

  1. Describe the latest guidelines and recommendations on cholesterol management from major clinical organizations.

  2. Discuss potential cholesterol-lowering therapies beyond statins and explain when these nonstatin therapies should be considered.

  3. Summarize in detail the indications for proprotein convertase subtilisin kexin type 9 inhibitor (PCSK9i) therapy.
     

Faculty Presenters

Louis Kuritzky, MD
Clinical Assistant Professor Emeritus
University of Florida
Gainesville, Florida

Disclosure: has no financial information to disclose.

Seth S. Martin, MD, MHS 
Director, Lipid Clinic
Division of Cardiology
Department of Medicine
Johns Hopkins Hospital
Baltimore, Maryland

Disclosure: Consultant: Scientific advisory boards for Amgen and Sanofi/Regeneron

Spouse employment role: Pharmacist at Walgreens

Alan Brown, MD, FACC, FAHA, FNLA, FASPC
Director, Division of Cardiology
Advocate Lutheran General Hospital
Park Ridge, Illinois
Co-Director, Cardiology Service Line
Advocate Medical Group
Park Ridge, Illinois
Clinical Associate Professor
Loyola Stritch School of Medicine
Maywood, Illinois

Disclosure: Consultant: Amarin, Amgen, Kastle, Kowa, Pfizer, Regeneron; Speaker’s Bureau: Amgen Regeneron, Sanofi

Kathleen H. Byrne, MSN, CRNP, FPCNA
Cardiovascular Nurse Practitioner
Johns Hopkins University
Advanced Lipid Disorders Clinic
Pediatric Cardiology
Baltimore, Maryland 

Disclosure: has no financial information to disclose.

The staff of PER® have no relevant financial relationships with commercial interests to disclose.

Disclosure Policy and Resolution of Conflicts of Interest (COI)

As a sponsor accredited by the ACCME, it is the policy of PER® to ensure fair balance, independence, objectivity, and scientific rigor in all of its CME/CE activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME/CE activity to disclose all relevant financial relationships with commercial interests. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that creates a COI.

Additionally, PER® is required by ACCME to resolve all COI. PER® has identified and resolved all COI prior to the start of this activity by using a multistep process.
 

Accreditation/Credit Designation

Physicians' Education Resource®, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians, and is a provider approved by the California Board of Registered Nursing (CBRN).
 
Physicians' Education Resource®, LLC designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™ and for 1.5 contact hours for nurses. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
 
All other health care professionals completing this course will be issued a statement of participation.

Off-Label Disclosure/Disclaimer

This activity may or may not discuss investigational, unapproved, or off-label uses of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CME activity is for continuing medical education purposes only and is not meant to substitute for the independent medical judgment of a physician relative to the diagnostic, treatment, and management options for a specific patient’s medical condition.
 
The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of Physicians’ Education Resource®, LLC, or any of the companies that provided commercial support for this activity.

PER Pulse Recap™

1 of 3
PER Pulse Recap

Optimal Lipid Management for Primary Care Practitioners: An Update on PCSK9 Inhibitors

The online continuing medical education activity Optimal Lipid Management for Primary Care Practitioners: An Update on PCSK9 Inhibitors provides primary care physicians, physician assistants, nurse practitioners, nurses, and other clinicians who treat patients with hyperlipidemia, direction on how to optimize lipid management of those patients with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and other non-statins.

A multidisciplinary panel answered key questions, supported by the presentation of clinical science, about lipid management. This first of 3 PER Pulse Recaps focuses on current lipid guidelines and recommendations.

With the decline of smoking, dyslipidemia has become the No. 1 modifiable risk factor for cardiovascular diseases. More than 100 million adults in the United States have total cholesterol levels greater than 200 mg/dL, and almost 31 million adults have levels that are greater than 240 mg/dL.

For the management of dyslipidemia, the current guidelines primarily recommend a change in lifestyle, then the use of statins followed by non-statin therapies. There are, however, slight differences among them in terms of defining risk.

  • American Heart Association/American College of Cardiology (AHA/ACC) (2013)
    • Focused on cardiovascular risk reduction for the first time rather than a specific low-density lipoprotein cholesterol (LDL-C) goal
      • This poses clinical challenges for patients who were goal oriented.
    • Highlights 4 groups who would benefit from statins:
      • Those with clinical atherosclerotic cardiovascular disease
      • Those with a LDL-C level of 190 mg/dL or higher
      • Those with diabetes
      • Those with a cardiovascular risk factor of 7.5% or greater
    • Nearly half of all adults are eligible for statin therapy based on the 2013 AHA guidelines.
  • AHA/ACC Consensus Update (2016)
    • Recommends non-statin therapies (ezetimibe or PCSK9 inhibitors) for patients who have not obtained at least a 50% reduction on statin therapy or met a threshold of less than 70 mg/dL LDL or a level of 100 mg/non–high-density lipoprotein (HDL)
  • American Academy of Clinical Endocrinologists (2017) (endorsed by National Lipid Association)
    • Contains an extreme risk category: Patients with progressive cardiovascular disease should have an LDL level of less than 55 mg/dL.
    • Recommends non-statins (ezetimibe or PCSK9 inhibitors) in patients whose cholesterol remains uncontrolled on maximal tolerated statins or who cannot tolerate statins
  • National Lipid Association (2017)
    • Considers PCSK9 inhibitors in patients with:
      • Stable or progressive cardiovascular disease whose LDL-C level remains >70 mg/dL or non-HDL >100 mg/dL despite maximal statin therapy
      • Familial hypercholesterolemia phenotype/LDL-C level ≥190 mg/dL
      • Very high-risk patients with statin intolerance
  • The European Society of Cardiology and European Atherosclerosis Society (2017)
    • Similar to the other guidelines, although it uses the European “score system” to determine the 10-year risk of cardiovascular disease, with therapy intensity based on the risk category:
      • Very high risk = more than a 10% 10-year risk
      • High risk = those with a 5% to 10% 10-year risk
      • Intermediate risk = less than 5% risk
  • The panel discussed the benefits of adding ezetimibe to a statin in patients who are uncontrolled just on a statin, noting they can often get a 50% reduction in LDL-C with both.

2 of 3
PER Pulse Recap

Optimal Lipid Management for Primary Care Practitioners: An Update on PCSK9 Inhibitors

The online continuing medical education activity Optimal Lipid Management for Primary Care Practitioners: An Update on PCSK9 Inhibitors provides primary care physicians, physician assistants, nurse practitioners, nurses, and other clinicians who treat patients with hyperlipidemia, direction on how to optimize lipid management of those patients with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and other non-statins.

A multidisciplinary panel answered key questions, supported by the presentation of clinical science, about lipid management. This second of 3 PER Pulse Recaps focuses on PCSK9 inhibitors.

  • The PCSK9 inhibitors are monoclonal antibodies to PCSK9, a protein that attaches to the low-density lipoprotein (LDL) receptor and targets it for destruction. Inhibiting PCSK9 with these compounds reduces LDL receptor destruction and, thus, circulating LDL cholesterol (LDL-C) levels.
  • Their development, said panelist Seth Martin, MD, “is a really inspiring story,” with the compounds moving from the bench to the bedside in a decade. “This was a fantastic triumph and the story of science filling a true gap in care for patients who haven’t been able to get their lipids controlled with existing therapies,” he said.

The panelists described the pivotal clinical trials of the 2 PCSK9 inhibitors, evolocumab and alirocumab:

  • Evolocumab
    • FOURIER clinical trial
      • International study that randomized 27,000 participants with stable cardiovascular disease and an LDL-C level of 70 mg/dL or higher to 140 mg evolocumab subcutaneously every 2 weeks or placebo. Patients remained on background statin therapy.
      • Participant LDL-C levels fell from an average of 90 mg/dL to 30 mg/dL, which translated to a 15% relative risk reduction in the combined cardiovascular endpoint over 2 years.
      • There were no significant adverse effects, including neurocognitive issues such as dizziness, in participants who reached a very low LDL-C level.
  • Alirocumab
    • ODYSSEY outcomes trial
      • Included 18,924 patients at 1315 sites in 57 countries who had an acute coronary event within the previous 12 months and a residual LDL-C level of 70 mg/dL or greater, a non–high-density lipoprotein cholesterol level of 100 mg/dL or greater, or an apoliprotein B level of 80 mg/dL or greater after 2 to 16 weeks of intensive or maximally tolerated statin therapy
      • Patients continued statin therapy and were randomized to either subcutaneous injections of alirocumab 75 mg every 2 weeks or placebo. Alirocumab could be uptitrated to 150 mg every 2 weeks in patients with an LDL-C level of 50 mg/dL or higher, while those with LCL-C levels consistently below 15 mg/dL were switched to placebo.
      • After a median follow-up of 2.8 years, there was a 15% relative risk reduction and a 1.6% absolute risk reduction in cardiovascular events.
      • One interesting finding, said Dr Martin, was that the study suggested that patients with a baseline LDL level less than 100 mg/dL did not receive a benefit from alirocumab.
  • The panelists discussed the fact that African Americans were underrepresented in both trials and what that meant for their African American patients. They agreed that there was no indication that the drugs would work differently in this population.
  • They also noted that the lipid-lowering effect is nearly immediate and that there are no significant adverse effects with either drug.
  • Panelists also discussed the equivalence of the 2 drugs and the fact that the choice of which one to use will likely be driven by “practical matters” like insurance coverage.

3 of 3
PER Pulse Recap

Optimal Lipid Management for Primary Care Practitioners: An Update on PCSK9 Inhibitors

The online continuing medical education activity Optimal Lipid Management for Primary Care Practitioners: An Update on PCSK9 Inhibitors provides primary care physicians, physician assistants, nurse practitioners, nurses, and other clinicians who treat patients with hyperlipidemia, direction on how to optimize lipid management of those patients with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and other non-statins.

A multidisciplinary panel answered key questions, supported by the presentation of clinical science, about hyperlipidemia. This third of 3 PER Pulse Recaps focuses on overcoming barriers to payer approval.

The panelists state, “We know the high cost is often the limiting factor in whether or not our patients can actually take the drug. So how has the high cost affected what you see with your patients?”

  • The published price for the drugs is about $14,000 a year; however, this does not reflect discounts and rebates. Experts suggested the actual cost is likely between $5000 and $9000 a year.
  • Patients are facing co-pays up to $1000 a month or more. This is mitigated with co-payment coupons from the manufacturers for those with commercial insurance, but they are not available for patients covered by Medicare or other federal insurance programs. The manufacturers also offer patient assistance programs based on income.
  • As Dr. Alan Brown said, “I think some people are just going to have to decide, ‘Is it within my economic grasp to obtain this lifesaving agent?’”
  • Access varies depending on the patient and insurer. It may take hours or months for approval, with about 80% of requests denied. With multiple appeals, however, the panelists said they are usually successful in gaining approval.
  • Panelists stressed the need to be honest with patients about access and cost issues but that they should try to get access first before dealing with the cost issue.
  • Most analyses using the list price for the drugs do not find them cost-effective. However, at least 1 analysis found they could be cost-effective over time when discounted.
  • The major medical organizations, including the American College of Cardiology, are developing their own cost analyses. “I’m hopeful that at some point we will get to a real number where we can analyze the benefits and look at the total cost to society,” said Dr. Louis Kuritzky.
  • The panel agreed that it is best for the primary care physician to refer patients to specialists because they have the resources and systems in place to improve the likelihood of approval. They also noted that some patients referred for PCSK9 inhibitors have not had their statin therapies maximized.
  • Primary care clinicians can locate a lipid specialist by zip code at www.lipid.org.

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