Groundbreaking Study: FH Optimal Care in the US
the Family Heart Foundation’s FOCUS study shows that there is a significant barrier to access for innovative new PCSK9 inhibitor treatments. We heard from patients and healthcare providers that coverage of these treatments is often denied by insurance carriers. The FOCUS Study looked at insurance claims data, along with lab results and other healthcare encounter and outcomes data available through the Family Heart Foundation’s database, to examine whether what we were hearing anecdotally is affecting the broader FH population. We thought we might see that the highest risk patients were getting approved at a higher rate, but we did not.
After comparing insurance claims data, the Family Heart Foundation found that 63.3% of FH patients were denied approval for PCSK9 inhibitor treatment by their insurance carrier. This was among even the most high risk FH patients who were on 1) high intensity statins, and 2) moderate intensity statins plus ezetimibe, and with LDL cholesterol levels still over 190 mg/dL. This is compared to 9% denied approval for ezetimibe and a 62% rejection rate for all patients prescribed a PCSK9 inhibitor.
Now that clinical trial results are out showing that treatment with a PCSK9 inhibitor can reduce cardiac events like heart attacks, we expect that both healthcare providers and insurance carriers will feel the urgency to ensure that FH patients who need them have meaningful access to these promising treatments, approved by the Food and Drug Administration for their use.
Knowles, J., Howard, W., Karayan, L., Baum, S., Wilemon, K., Ballantyne, C., & Myers, K. (2017). Access to Non-Statin Lipid Lowering Therapies in Patients at High-Risk of Atherosclerotic Cardiovascular Disease. Circulation, CIRCULATIONAHA.117.027705.