PCSK9 Inhibitor Research Paper

Breaking Down the Latest PCSK9 Inhibitor Access Research

New research from the Family Heart Foundation shows access to PCSK9 inhibitors (PCSK9i) has slightly improved, but there are still major barriers to these lifesaving drugs.

What is a PCSK9i?

Cardiovascular disease remains the leading cause of death and illness in American adults. LDL cholesterol is a major risk factor for heart attacks and strokes. High LDL levels remain a huge health concern even though there are many medications available to get to the LDL Safe Zone. These include PCSK9 inhibitors (PCSK9i).

PCSK9i are a class of medications that can lower LDL cholesterol by 50% to 60%. They have also been shown to reduce cardiovascular events.

Access issues from 2015 – 2018

However, the stories we heard at the Family Heart Foundation indicated that many people were not able to get these medicines. From 2015 to 2018, we looked at data from the Family Heart Database and discovered that 46% of PCSK9i prescriptions were rejected.

This number was astounding, so we went to work asking what needed to change so more people would have access to these lifesaving medicines.

From the time we conducted our initial research until 2019 there were four significant events affecting PCSK9i access. These events should have addressed concerns from insurance companies about the value of people living with diseased arteries or at high-risk of cardiovascular disease:

  • Outcomes trials were published showing PCSK9i medications significantly reduce cardiovascular events.
  • Guidelines for doctors now recommend PCSK9i use in high-risk patients.
  • There was a 60% reduction in price for both PCSK9 inhibitors.
  • The FDA expanded the label for both medications to reflect the fact that PCSK9is reduce cardiovascular events.

These events gave hope to many in the Family Heart community that they would be able to access their medicines. In 2019, we looked at real-world data in our Family Heart Database to see how access changed.

Access issues from 2019 – 2021

When we looked at data from 2019 to 2021, we found that nearly a third of PCSK9i prescriptions were still being rejected. While this is better than 46%, it's clear that the people prescribed these medicines are experiencing barriers to timely and appropriate medical care.

Then, we compared this data to other cardiometabolic medicines. The comparative drugs were similarly priced medications and had proven cardiovascular benefits.  Despite these similarities, PCSK9 inhibitors were rejected by insurance companies far more often.

Why does this matter?

When patients don’t receive their PCSK9i treatment, they live at an increased risk of heart attack or stroke. No family should have to experience the sudden loss of a loved one from heart disease just because their insurance company, who they pay monthly, refused to pay for their medicines. Increasing fair and medically appropriate access to these lifesaving medications is one crucial step to saving more families and more hearts.

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