This week the FDA approved a new oral PCSK9 inhibitor, the first in that class available as a once-daily pill rather than an injection, for adults with hypercholesterolemia. It joins a growing set of tools for managing LDL cholesterol, including statins, ezetimibe, injectable PCSK9 inhibitors, and other lipid-lowering therapies. GAfPA does not weigh in on which therapy is right for which patient. That determination belongs to patients and their clinicians. What an approval like this does offer is a chance to ask a broader policy question. Are health systems set up to make the most of an expanding treatment landscape, or are patients still going undiagnosed and unmanaged no matter what is available?
Cholesterol Management Is a Cardio-Kidney-Metabolic Issue
Elevated LDL cholesterol rarely exists on its own. It compounds risk in patients who also live with chronic kidney disease, diabetes, obesity, or hypertension, the same overlapping conditions described under the cardio-kidney-metabolic (CKM) framework. Yet in many health systems, lipid management still sits at the periphery of CKM strategy. That is the gap the Cardio-Kidney-Metabolic Policy Forum was convened to close, pressing for care models that treat CKM conditions as interconnected, with cholesterol management holding a seat at that table.
“Early Is Better” Applies to Atherosclerosis, Too
GAfPA has long championed an “early is better” approach across the conditions it advocates for, and atherosclerotic cardiovascular disease, the cardiovascular component of the CKM framework, is a clear case for it. Elevated LDL cholesterol is a primary driver of atherosclerosis, the buildup of plaque in the artery walls that, left unaddressed, raises the risk of a heart attack or stroke. Too often, that risk is addressed only after one of those events has occurred, once care has already shifted to secondary prevention instead of avoiding the event in the first place. That reactive pattern is costly for patients and health systems alike, and it can be changed.
Getting ahead of atherosclerosis means prioritizing three things.
- Routine access to screening, including cholesterol screening as a standard part of primary care rather than an afterthought.
- Earlier diagnosis, so at-risk patients are identified well before a cardiovascular event forces the issue.
- Reliable access to the range of treatment options appropriate to each patient’s risk and preferences once that patient has been identified. A growing menu of therapies only delivers value if patients are found and treated early enough to use it.
Building on GAfPA’s Track Record
This is the same argument behind GAfPA’s Cholesterol Management Awareness campaigns, in South Africa, Australia, and most recently Italy, and behind roundtables such as the one GAfPA convened in Canada, where participants named low patient awareness, limited screening access, and a reactive rather than preventive system as the real barriers to better outcomes. A new therapy approval is a moment to renew that case. Cholesterol management deserves the same early, proactive health system prioritization within CKM strategy that GAfPA champions.