PCSK9i and the Impact of Cost on Treating Hypercholesterolemia

A recent study into the impact of PCSK9 inhibitors is putting into question the price and accessibility of those agents for patients looking for an effective means to prevent future adverse cardiovascular events. 



To evaluate the impact of pricing and access on patients, investigators performed an analysis that examined whether acute coronary syndrome, coronary interventions, stroke, and cardiac arrest were more prevalent in patients with rejected or abandoned PCSK9i prescriptions than those with paid prescriptions. 



"We have both treatment guidelines and available medications to help reduce cholesterol and associated cardiovascular events in the most vulnerable high-risk patients,” said lead investigator Kelly Myers, BS, chief technology officer for The FH Foundation. “And yet barriers in the healthcare system - such as higher treatment costs, tight restrictions on approvals, Medicare rules against co-payment assistance, and lack of coverage - are delaying treatment."

Using a dataset obtained from Symphony Health in Phoenix, AZ, investigators carried out a retrospective propensity score-matched cohort study using diagnosis, procedure, and prescription claims on 221,138,729 patients. The current analysis was performed on a cohort of patients who were prescribed a PCSK9i between Aug. 2015 to Dec. 2017.

A total of 161,181 patients were prescribed a PCSK9i, but only 139,036 met inclusion criteria allowing for tracking of their cardiovascular events. The primary outcome measure of the study was a composite outcome of any 1 of 7 cardiovascular events. Those events included myocardial infarction (MI), unstable angina (UA), acute ischemic heart disease (AIHD), ischemic stroke (IS), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) surgery, cardiac arrest, and heart failure (HF).

Investigators found the average age of the group of 66 years, 51% of patients were female, and 63% were white. Additionally, 31% were college graduates, 31% were high school graduates or less, and 17% had an associate’s degree or higher. Investigators noted that a fraction of patients did not have education, ethnicity, and income data but that this was the only incomplete data included in the study — an “unknown” categorization was used for analyses.

Of the 139,036 included in the study, 32,886 (24%) were placed within the paid group, 85,370 (61%) for rejected (RJ) group, and 20,780 (15%) for abandoned (AB) group. A group of 88,770 patients had a history of atherosclerotic cardiovascular disease (ASCVD) prior to their final adjudication status (FAS) date and 2889 (2.1%) had a documented diagnosis of familial hypercholesterolemia (FH). Of the FH groups, 1.4% (1944) also had a history of ASCVD prior to their FAS date. Investigators also noted that 35% of the population had no diagnosis of FH or pre-FAS ASCVD. 



A total of 4702 (3.4%) patients were prescribed a PCSK9i and met the definition of a composite cardiovascular outcome. Rejected (1.10; 95% CI, 1.02 to 1.18; p=0.02) and abandoned (1.12; 95% CI, 1.02 to 1.23; p=0.03) status were associated with significantly higher probability of experiencing a cardiovascular event compared with paid status.

In an analyses that adjusted the definition of paid (388 or more days versus 168 days), investigators found rejected (1.16; 95% CI, 1.02 to 1.30; p=0.04) and abandoned (1.21; 95% CI, 1.04 to 1.38; p=0.03) prescriptions continued to be associated with composite cardiovascular events. Additionally, investigators found that women, minorities, and those with lower education or lower income levels were less likely to receive approval for a PCSK9i prescription and were less likely to fill a prescription if approved.

While he was not an investigator of the current study, Donald Lloyd-Jones, MD, member of the writing committee for the American Heart Association, praised the results of the study but noted that multiple steps have been taken to make PCSK9i prescriptions more available and affordable. 



“The (American Heart) Association has taken bold action in working directly with pharmaceutical companies to address the considerable costs that can hinder access to life-saving medications,” said Lloyd-Jones, who is also chair of the department off preventive medicine at Northwestern University. “So, we hope to see this trend turning and for future data to show that people have access to the medications they need and are using them to their greatest benefit."

This study, titled “Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes,” is published in Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal.