Patients Denied Access to PCSK9 Inhibitors Have Worse Cardiovascular Outcomes

Adverse cardiovascular outcomes were more prevalent among patients with rejected or abandoned PCSK9 inhibitor prescriptions, new research suggests.

The researchers looked specifically at the hypothesis that outcomes such as acute coronary syndromes, coronary interventions, stroke, and cardiac arrest would be more prevalent among patients without the PCSK9 inhibitor coverage. The study, published in Circulation: Cardiovascular Quality and Outcomes, identified 139,036 individuals who were prescribed a PCSK9 inhibitor between August 2015 and December 2017, who had claims history, and who had established dates of exposure for paid, rejected, or abandoned status. The team used propensity score matching to minimize confounding due to baseline characteristics in both patient groups. The authors defined “paid” as having paid PCSK9 inhibitor coverage for 168 or more days during a 12-month period.

According to the results, the hazard ratios were 1.10 (95% CI, 1.01 to 1.19; P=0.02) in the “rejected” group (compared to paid) and 1.12 (95% CI, 1.01 to 1.24; P=0.03) in the “abandoned” group (compared to paid). A stricter analysis (defining “paid” as 338 or more days of therapy in a 12-month period showed hazard ratios of 1.16 (95% CI, 1.02 to 1.30; P=0.04) for rejected versus paid, and 1.21 (95% CI, 1.04 to 1.38; P=0.03) for abandoned versus paid.

“Individuals in the rejected and abandoned cohorts had significantly increased risk of cardiovascular events compared with those in the paid cohort,” the authors wrote. “Rejection, abandonment, and disparities related to PCSK9 inhibitor prescriptions are related to higher cardiovascular outcome rates.”

Due to their high cost, access to PCSK9 inhibitors can be uneven, and disparities were more likely to affect minority populations, those in lower income groups, and women.

“We demonstrate[d] that individuals with primary prevention familial hypercholesterolemia and secondary prevention atherosclerotic cardiovascular disease statistically have no difference in risk of future cardiovascular events, and both high-risk cohorts were denied access to PCSK9 inhibitors is at the same rate as the general population.”

@CircOutcomes >80,000 people had ⬆️Mi’s or strokes when their #PCSK9i prescription was unfilled or rejected
🔺pts w FH 3x ⬆️ CVD events
🔺pts w FH who did not have cvd have the same high risk as pts with CVD
🔺pts w FH + CVD 5x ⬆️risk CVD events
https://t.co/NwtxWlctrz#KnowFH pic.twitter.com/Tx4yTYMf8y

— Ritu Thamman MD (@iamritu) July 23, 2019

https://twitter.com/cpcannon/status/1153638571225571328

Is pre-authorization by insurers another way that disparities in healthcare arise? This paper shows that: "Higher PCSK9i rejection rates were observed with women, racial minorities, and lower-income groups.” Why should this be? #disparities @CircOutcomes https://t.co/U61B3i1IMS pic.twitter.com/hpn9n6vn9u

— Harlan Krumholz (@hmkyale) July 23, 2019

Sad story: What happens to high risk patients (FH or ASCVD) who get their PCSK9i scripts rejected by 3rd party payers or if they do not comply (often because of co-pay) – Women had higher rejection and abandonment rates than men. https://t.co/1I9IbUxaUj @TheFHFoundation

— Thomas Dayspring (@Drlipid) July 23, 2019