Category: PCSK9

PCSK9 Inhibitors: 1 Year After Approval

One year after FDA approval, are PCSK9 inhibitors living up to expectations?

It’s been about 1 year since the two currently available PCSK9 inhibitors, evolocumab and alirocumab, received US FDA approval. (Bococizumab is still completing phase 3 studies.) Uptake, as most in the healthcare community know, has been slow, largely due to the cost associated with the two therapies.

The US FDA recently approved a monthly single-dose administration option for evolocumab. The system consists of a hands-free device which is designed to provide 420 mg of evolocumab in a single dose and allows patients the freedom of being able to continue with moderate physical activity such as walking, reaching, and bending. The cost is expected to remain similar to twice weekly dosing, and given how new it is, it remains to be seen what kind of impact on clinical practice it will have. Read more

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ACC Releases Guidance on Role of Nonstatin Therapies for LDL-C Lowering

The American College of Cardiology (ACC) has released guidance on the role of nonstatin therapies in the lowering of LDL cholesterol, as additional data on their use have become available since the ACC and American Heart Association (AHA) last updated the cholesterol guidelines in 2013. According to Donald M. Lloyd-Jones, MD, Northwestern University Clinical and Translational Sciences Institute, and Chair of the document’s writing committee, the goal of this latest guidance is to assist clinicians in interpreting the newest data for use in clinical practice and help guide their patients in making treatment decisions.

Seven different algorithms were produced for patients with cardiovascular disease or comorbidities and recommends the consideration of nonstatin drugs for patients at high risk whose LDL has not been reduced by 50% with lifestyle and statin therapy. The algorithms endorse the four evidence-based statin benefit groups already identified in the 2013 ACC/AHA cholesterol guidelines and assume the patient is taking a statin or has attempted statin therapy. Two different algorithms were created for patients with familial hypercholesterolemia (FH) and recommend a lower threshold for the use of PCSK9 inhibitors. Read more

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PCSK9 Inhibitors May Benefit Patients with Acute Coronary Syndrome

Results of a recent study published in the Annals of Internal Medicineshowed that patients with acute coronary syndrome (ACS) who were treated with PCSK9 inhibitors benefited not only from LDL-cholesterol reduction but plaque stabilization as well. Currently, the PCSK9 inhibitors evolocumab and alirocumab are approved for lowering of LDL in patients with familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who are not at goal despite maximally tolerated statin therapy.

According to the study authors, acute coronary events result in a dynamic increase of PCSK9 levels that may have an effect on plaque vulnerability of both culprit and nonculprit coronary vessels, thus leading to a potential role for PCSK9 inhibitors in managing ACS. Further, formal study on the timing of PCSK9 inhibitor administration to patients with ACS and their effects on inflammatory and thrombosis pathways will be necessary. For more perspective on the study, read here.

To learn more on managing high-risk patients in the PCSK9 era, don’t miss the Best of the CMHC Regional Conference Series taking place in Atlanta, GA on May 7 and in Chicago, IL on June 18, as well as the 11th Annual CMHC in Boston, MA October 5- 8, 2016.

Navarese EP et al. Proprotein convertase subtilisin/kexin type 9 monoclonal antibodies for acute coronary syndrome: a narrative review. Ann Intern Med. Published online 22 March 2016 doi:10.7326/M15-2994.

Healio. PCSK9 inhibitors may be appropriate for use in patients with ACS.

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As PCSK9 Inhibitors Come to Market, Concern Over 2013 Guidelines Resurfaces

Now that the first PCSK9 inhibitors have received FDA approval, the ambiguity of the 2013 ACC/AHA cholesterol-treatment guidelines are again being called into question. Because the new class of LDL-lowering agents are expensive specialty medications, with alirocumab priced at about $14,600 per year, payers are expressing concern that the removal of specific LDL-C targets from the 2013 guidelines will complicate treatment choices and inhibit utilization management tools, such as step therapy and prior authorization, to manage costs. Consequently, they are asking the American College of Cardiology and American Heart Association to return specific LDL targets to the guidelines.

In a recent publication in the European Heart Journal, however, Drs. Jennifer G. Robinson and Neil J. Stone explain the concept of net benefit, which was introduced in the 2013 ACC/AHA guidelines, and how net benefit can be used to identify patients most likely to benefit from statin therapy and which patients may benefit from the addition of a non-statin agent, such as ezetimibe or another LDL-lowering medication. Read more

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