The Alliance for Patient Access / IfPA’s Patient Access Policy Blog / New Data, Same Access Challenges for Heart Patients

New Data, Same Access Challenges for Heart Patients

The risk of death may be lower for certain patients taking cholesterol-lowering PCSK9 inhibitors, new research shows.  But how many patients will actually be able to realize the drugs’ benefits?

Research Results

The latest research found that patients had a significantly lower risk of major cardiovascular events when taking PCSK9 inhibitors.  Announced at this weekend’s American College of Cardiology meeting, the Odyssey Trial outcomes also show that a PCSK9 inhibitor decreased patients’ risk of death by 15 percent.

These results are just the latest in a series of studies demonstrating the effectiveness of PSCK9 inhibitors, especially for patients who don’t sufficiently respond to traditional statin therapy.  In 2017, data showed the medicine could reduce cardiovascular events like heart attack and stroke by 27 and 21 percent, respectively.

The drugs work by preventing the PCSK9 protein from destroying a receptor on the liver that clears bad cholesterol. The receptor “lives” longer, clearing more LDL cholesterol.

Yet patients have struggled to access the therapies since the first PCSK9 inhibitor received FDA approval in 2015.

Access Struggles

A new report card series from the Institute for Patient Access demonstrates how health plans use prior authorization to block at least one in every four patients whose doctor prescribes a PCSK9 inhibitor.

High rejection rates and lengthy appeal processes delay treatment for patients.  And working through the process is time consuming and cumbersome for doctors. Despite health care providers’ time and effort, health plans may repeatedly deny authorization requests.

“We found that the burden of the requirements for PCSK9 inhibitors were so high that they raise real concerns about access barriers,” researchers from a January 2018 study noted.

This situation is not unique to PCSK9 inhibitors. Patients with a range of conditions, from psoriasis to hepatitis C, may face a similar fate.

Taken together, these studies signify the need for sensible policy change so patients can access the medication their doctors prescribe.  For patients at risk for heart attack and stroke, that change can’t come soon enough.

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The Alliance for Patient Access is a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care.
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