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Aug 16, 2019

Strict Insurance Policies Reduce Access to Life-Saving Cholesterol Drugs

Most patients never get the PCSK9 inhibitors they’re prescribed, putting them at increased risk for heart events.

Three out of four patients never receive the cholesterol drugs they’re prescribed, based on a recent analysis of prescription data for a new class of drugs called PCSK9 inhibitors. Findings were published in Circulation: Cardiovascular Quality and Outcomes and highlight the consequences of strict insurance policies on patient health.

Using a health care dataset of more than 221 million patients, this study looked at prescription rates for PCSK9 inhibitors and their impact on health outcomes. The goal was to see how many patients prescribed this new type of cholesterol drug end up receiving it and how this affects heart risks.

PCSK9 inhibitors are a new class of drugs that were approved by the FDA in 2015 as an add-on therapy for patients with high cholesterol. Similar to cholesterol-lowering statins, PCSK9 inhibitors have been shown to significantly reduce risk for life-threatening heart events in patients with high cholesterol. They’re recommended in patients who can’t tolerate statins or for those who still have high cholesterol despite high-dose statin use.

However, the steep price tag of PCSK9 inhibitors—initially $14,000 a year—led to strict insurance policies around approval. Nearly all insurance companies require prior authorization for PCSK9 inhibitors, which means doctors need pre-approval from insurance to prescribe the drug. Perhaps worse, even those who are approved can face high out of pocket costs that prevent them from filling the prescription.

Based on study findings, these barriers to access are taking a toll on patients’ health.

The recent analysis included 139,036 patients who were prescribed at least one PCSK9 between 2015 and 2017. Based on insurance data, only 24% of these patients actually received the drug. The remaining 61% of patients were denied coverage and 15% were approved but never filled their prescription.

After comparing outcomes, researchers found that patients who never received the drug had 10-12% greater risk for heart events than those who received at least six months’ worth of medication. When compared to patients who received one years’ worth of medication, the difference was even greater. Analysis showed that patients not receiving PCSK9 inhibitors had 16-21% greater risk for heart events when compared to patients who received a years’ worth of the drug. Researchers also found that patients denied coverage were more likely to be female, minority and lower-income than patients who received approval.

Findings highlight a major flaw in the current health care system, which is preventing patients from getting the treatment they need. Many patients denied coverage have extremely high risk for heart events and could benefit greatly from PCSK9 use. However, insurance coverage and out-of-pocket costs are limiting how many patients have access to the novel drug.

Now that the cost for PCSK9 inhibitors has dropped, experts encourage changes to insurance policies to improve access to the drug. They also explain that doctors are an important part of the solution, as following guidelines and documenting treatment is key to insurance approval. That means always trying statins as a first line of treatment for high cholesterol, increasing the dose as needed, and then turning to PCSK9 inhibitors when these efforts fail.

Questions for You to Consider

  • What are the risks associated with high cholesterol?
  • High cholesterol can cause atherosclerosis, the build-up of plaque on artery walls. This accumulation of deposits can cause serious complications, such as chest painheart attack and stroke. High cholesterol is largely preventable and treatable, so getting screened and making healthy lifestyle choices can go a long way in controlling cholesterol levels.
  • What are statins?
  • Statins are drugs used to lower cholesterol. They help lower low-density lipoprotein (LDL or “bad”) cholesterol and raise high-density lipoprotein (HDL or “good”) cholesterol, which can help prevent heart attack and stroke. Statins prevent your body from making new cholesterol and may help reduce the amount of plaque already built up on artery walls.

Featured Video

LDL – the bad cholesterol. LDL is the cholesterol that gums up your arteries and causes the buildup of blockages. It’s also the cholesterol that is toxic to the lining of your arteries, increasing the risk of a heart attack or stroke.


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