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Managing Cholesterol With PCSK9 Inhibitors and Overcoming Operational Challenges in Practice
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Managing Cholesterol With PCSK9 Inhibitors and Overcoming Operational Challenges in Practice

Laura Joszt
Panelists discuss what PCSK9 inhibitors are, the evidence to support them, and challenges with operationalizing them in practice.
Recent trials have cemented evidence that PCSK9 inhibitors reduce cardiovascular events and fewer prescriptions are being rejected by health plans, according to panelists at a session hosted by The American Journal of Managed Care® and Pharmacy Times Continuing Education at the Academy of Managed Care Pharmacy (AMCP)’s Managed Care and Specialty Pharmacy Annual Meeting.

Ty J. Gluckman, MD, FACC, FAHA, medical director, Center for Cardiovascular Analytics, Research, and Data Science, Providence Heart Institute, led a discussion on what PCSK9 inhibitors are, the evidence to support them, and challenges with operationalizing them in practice with panelists Seth S. Martin, MD, MHS, FACC, FAHA, FASPC, associate professor of medicine, Johns Hopkins University School of Medicine; Joseph J. Saseen, PharmD, professor and vice chair, University of Colorado Anschutz Medical Campus; and Sheila L. Stadler, PharmD, BCPS-AQ Cardiology, CLS, clinical pharmacy specialist, Kaiser Permanente Colorado, and clinical assistant professor, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences.

In 2013, when the first blood cholesterol guidelines came out, the message was that evidence supported statin-based therapy, explained Saseen. However, by 2018 there had been 4 major landmark trials that built off prior knowledge and only 1 of those trials was about statins, the other 3 were about non–statin-based therapies, which gave evidence about where to place non-statin drugs, like PCSK9 inhibitors and ezetimibe in the treatment of patients with cardiovascular risk.

The new guidelines still have the 4 statin benefit groups that are target populations for interventions and they’re now bucketed into primary prevention and secondary prevention. In primary prevention, the overall theory is that lower is better of low-density lipoprotein (LDL) cholesterol. Three of the statin benefit groups fall under primary prevention:
  • Patients with very high cholesterol values of 190 mg/dL and greater. High-intensity statin therapy is recommended.
  • Patients with diabetes.
  • Patients without diabetes who have higher cardiovascular risk.
Patients in this primary prevention group are eligible for not only statin therapy, but also ezetimibe after they have maximized statin therapy.

The high-risk populations with known atherosclerotic cardiovascular disease (ASCVD) are in the secondary prevention group. With this group, patients start with high-intensity statin therapy and if they don’t meet the goal, then that is the indication to go beyond statin therapy. When a patient goes beyond statins, the first option is ezetimibe and there is also clinical information that PCSK9 inhibitors can be used in 2 of the groups: patients with cholesterol of at least 190 mg/dL and those with clinical ASCVD.

Another high-risk condition for cardiovascular events is familial hypercholesterolemia (FH), which is an inherited disorder of very high levels of cholesterol. These patients have elevated levels even at a young age. There are 3 key genes: APOB, LDLR, and PCSK9. There are also 2 types of FH: heterozygous, where the gene is inherited from 1 parent, and homozygous, where genes are inherited from both parents. Homozygous is the more severe type with levels of cholesterol that can get as high as 900 mg/dL or 1000 mg/dL, said Stadler.

Heterzygous FH is pretty common and affects 1 in 250 patients. Once clinicians identify a patient meeting the criteria, it is important to make the patient aware of their FH not only so they know their own risk but also to inform their family members.

“…If we can identify and treat people [with FH] can it reduce overall, not just the morbidity for them, but also costs for the health system, too,” Stadler said.



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