What You Need to Know About Cholesterol Treatments

Hyperlipidemia is an increased amount of lipids, such as cholesterol and triglycerides, in the blood. Hypercholesterolemia, a high level of low-density lipoprotein cholesterol (LDL-C) in the blood, increases fatty deposits in arteries and, in turn, the risk of blockages, according to the American Heart Association (AHA).

“Cholesterol is one of the primary causal factors in the development of atherosclerotic cardiovascular disease which leads to strokes and heart attacks,” says Luke Laffin, MD, a cardiologist at Cleveland Clinic. “Hyperlipidemia screening occurs in about 70% of U.S. adults and, based on more contemporary American cholesterol guidelines, it has been estimated that, between 2016 and 2025, 12.24 million more Americans will be treated with statins, increasing treatment costs by $3.9 billion.”

Laffin also says that, with the increasing availability of therapies for hyperlipidemia to decrease patients’ cardiovascular risk, managed care systems will have to balance the increased costs and multiple choices for cholesterol and triglyceride reducing medications. He adds that absolute cardiovascular risk reduction in an asymptomatic population may only derive benefits 15 to 20 years down the road.

Newly approved and pipeline treatments

One of the most recently-approved classes of medications for the treatment of high LDL-C is the proprotein convertase subtilsin-kexin type 9 (PCSK9) inhibitors. PCSK9 inhibition increases the number of available LDL receptors on hepatocytes to clear LDL-C, resulting in decreased plasma LDL-C. There are currently two PCSK9 Inhibitors approved by the FDA: Sanofi/Regeneron’s Praluent (alirocumab) and Repatha (avolocumab) from Amgen.

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“The high cost of the PCSK9 Inhibitors presents a huge barrier for patient access, as a number of health insurance companies do not want to cover them,” says Megan Harrington, PharmD, clinical staff pharmacist, Gerald Champion Regional Medical Center in Alamogordo, New Mexico. “Measuring these drugs against treatments like statins will prove to be difficult because these traditional methods are tried and true with years of safety and efficacy data at a very affordable price tag.”

Cholesterol-lowering agents

• Vascepa (icosapent ethyl) from Amarin Corp. recently showed significant cardiovascular risk reduction by lowering serum triglycerides in the REDUCE-IT trial, according to Laffin. A similar study using AstraZeneca’s Epanova (omega-3-carboxylic acids), is slated to be completed by the end of 2019.

• Bempedoic acid from Esperion, a once-daily, oral therapy is a first-in-class, non-statin, targeted therapy designed to inhibit cholesterol biosynthesis. Bempedoic acid reduces LDL by 15% to 20% and is currently in clinical trials to see if this decrease in LDL results in less strokes and heart attacks, according to Laffin.

• Inclisiran from The Medicines Company is an investigational medication designed to inhibit the synthesis of PCSK9 protein in hepatocytes, thereby reducing LDL-receptor turnover and lowering plasma LDL-C. Initial study results show patients with a 52% reduction in cholesterol levels six months after their first injection of inclisiran, according to Harrington. She says that phase 3 trials have a scheduled completion date in the third quarter of 2019. “Time will tell how much this treatment will cost and how the insurance companies plan to help their patients have access to these treatments,” she says.

Future

“The future of these new treatments might be a little brighter than in previous years as the AHA and the American College of Cardiology (ACC) just released new cholesterol managements guidelines in November 2018,” says Harrington. “For now, insurance companies will continue to see statins as first-line medication therapy in control of cholesterol; however, there are evidence-based guidelines from trusted institutions that could change the way insurance companies view these medications.”

Managed care organizations and payers will have to decide how to prioritize drugs and treatments for cardiovascular disease, including hyperlipidemia, while maintaining reasonable costs, Laffin says.

“The hope would be that increased availability of therapies to reduce LDL and triglycerides results in more comparative effectiveness studies and more competitive pricing from drug companies,” says Laffin. “It may also encourage payers and pharmaceutical companies to think outside the box when it comes to paying for novel therapies, including outcomes-based contracts or other strategies to align incentives for the patient and provider, insurer, and payer.”

Erin Johanek, PharmD, RPh, is a staff pharmacist at Southwest General Health Center, Middleburg Heights, Ohio.