Donald M. Lloyd-Jones, M.D., Sc.M., FACC, FAHA, Senior Associate Dean for Clinical and Translational Research and Chair of the Department of Medicine, Northwestern University
People whose cholesterol-lowering drug prescriptions are rejected or abandoned are more likely to have heart events than those whose prescriptions are covered.
That’s the finding of a study published today in the American Heart Association journal Circulation: Cardiovascular Quality and Outcomes.
The study’s investigators include patients affected by familial hypercholesterolemia; the Familial Hypercholesterolemia Foundation; physician researchers; practicing clinicians; and data scientists. Researchers classified the patients as those having prescriptions approved by payers and receiving medication for 168 or more days within 12 months (paid); approved by payers but not collected or refilled (abandoned); or rejected by payers. They then compared outcomes across these groups for a composite of cardiovascular events, including acute coronary syndromes (heart attacks and unstable angina), coronary interventions, stroke and cardiac arrest among more than 139,000 adults prescribed PCSK9 inhibitors from mid-2015 through the end of 2017.
- Compared to patients with paid prescriptions, those with rejected prescriptions had 10% higher risk for cardiovascular events and those with abandoned prescriptions had 12% higher risk; both of these findings were statistically significant.
- Women, minorities and those with lower education or income levels were less likely to get approved for a PCSK9 inhibitor prescription and were less likely to fill an approved prescription.
- Even the highest-risk patients — those with diagnosed familial hypercholesterolemia and atherosclerotic cardiovascular disease — had a prescription rejection rate of 63.5% by their insurance.
Clinical guidelines and improved access
Adding a PCSK9 inhibitor to a statin regimen can reduce LDL cholesterol a further 43% to 64%, and thereby reduce clinical events, according to the American Heart Association’s 2018 guideline on managing blood cholesterol. But average monthly copays exceed $100 for paid prescriptions — an economic barrier that contributes to prescription abandonment.
Recent price reductions for PCSK9 inhibitors may help lower this barrier and can improve the medication’s cost value. Furthermore, the economic value of these medications will be improved by restricting their use to very high-risk patients, as recommended by the AHA.
Besides talking to patients about the net benefits, safety and cost of PCSK9 inhibitors, physicians and other healthcare providers can be compelling advocates for increasing access to these effective medications.
The study clearly shows how disparities in access to PCSK9 inhibitor prescriptions affect cardiovascular outcomes and the need to improve health equity. So as we continue to make inroads to prevent and treat heart disease — the world’s leading killer — we must capitalize on data from this study and others that quantify ways we can make a difference.