Your Health Insurance may Not Cover New Cholesterol Drugs

Your health insurance may not cover PCSK9 inhibitors, the new cholesterol drugs prescribed to people with high bad cholesterol levels.

Evolocumab and Alirocumab, the new prescription drugs for cholesterol have lesser than half coverage ratings from the insurance companies found a new study published in Circulation, Journal of the American Heart Association.

PCSK9 inhibitors, //like Repatha (evolocumab) and Praluent (alirocumab), work by increasing the removal of low-density lipoprotein (LDL) or "bad" cholesterol from the blood.

PCSK9 Inhibitors Do Not Increase Short-term Risk of Type 2 Diabetes
PCSK9 inhibitors are novel drugs used to control the levels of LDL cholesterol. A new study found that PCSK9 does not increase the risk of type 2 diabetes.

‘The most significant factor associated with approval rates were the type of insurances, it was found that the private insurances had the greater rejection rates when compared to Medicare’

They have been shown to reduce LDL by 60 percent and decrease major cardiac events but cost much more than other cholesterol-lowering drugs with an average cost of $14,300 per year. Prescriptions require prior authorization by health insurance companies.

In a nationwide review of the pharmacy claims combined with Electronic Medical Records (EMRs) lab test results of 9,357 patients prescribed the drug between July 2015 and August 2016, 4,397 (47 percent) were approved for PCSK9 inhibitor therapy, and 4,960 (53 percent) were rejected.

Sixty percent of those patients had a history of the Atherosclerotic cardiovascular disease (plaque-build-up of the arteries) while 40 percent did not.

Updated Analysis Finds Newer Type of LDL-C Reducing Drugs Still Not Cost-effective
A cost-effectiveness analysis of PCSK9 inhibitors indicated that their 2015 price would need to be reduced by more than two-thirds to meet generally accepted cost-effectiveness thresholds.

"With the controversy surrounding whether or not these drugs were cost effective, we were anticipating that there might be some reluctance by insurance companies to cover these medications," said senior author Robert Yeh, M.D., director of the Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center in Boston.

"However, we were surprised by the very high rate of rejection, even when prescribed to patients with a known Atherosclerotic cardiovascular disease, very high LDL levels and those who were intolerant of statins, for example," he said.

Alcohol Use Affects Levels of Cholesterol Regulator
PCSK9 gene explains the differences in how cholesterol is processed in people who drink alcohol or may affect those taking new class of PCSK9 cholesterol-lowering drugs.

Researchers also found that the most significant factor associated with approval rates was insurance type, with the lowest approval rates for private insurance and the highest approval for Medicare.

"Whether or not we can agree on the cost-effectiveness of these drugs, I believe most would agree that one’s access to medications should be driven primarily by the strength of the indications for the prescription as opposed to what drug plan you happen to carry," said Yeh, who is also an Associate Professor of Medicine at Harvard Medical School.

Low Levels of Bad Cholesterol tolerated in Heart Disease Patients
Some patients need to reduce their LDL cholesterol than what they are able to achieve with a maximally tolerated statin or other lipid-lowering therapies.

"Approximately 1 out of 3 patients who had their prescription approved did not purchase or receive the medication. Those patients who didn’t purchase their medication had an out-of-pocket cost that was twice as high as those who did purchase it," said Dr. Gregory Hess, first study author and senior fellow of Health Economics at the University of Pennsylvania and chief medical officer at Symphony Health.

The findings are based on Symphony Health’s HIPPA-compliant patient-level data from all fifty states and all payer types.

"Better education for providers prescribing these medications and more uniform guidelines by insurers about what will and will not be covered are necessary to reduce the amount of administrative waste that is created to reject prescriptions for new medications," Yeh said.

The study was a retrospective analysis and could not determine whether patients suffered any harm from the rejection of these prescriptions.

Source-Eurekalert