Drugmakers, insurers collaborate to boost access to PCSK9 inhibitors

The deal Regeneron and Sanofi cut with Express Scripts to lower the prices of their PCSK9 inhibitor in exchange for simpler preauthorization forms has opened the floodgates for another two dozen such deals for the cholesterol-lowering drug class, the New York Times reported.

Officials estimate access to the costly drugs for patients with commercial insurance has improved by 33 percent, but cardiologist Leslie Cho, MD, told the newspaper the Cleveland Clinic had to hire staff specifically to handle paperwork associated with PCSK9 inhibitors and that it still takes at least four to six weeks for a patient to get access to the drugs because of a burdensome preauthorization process.

According to a 2017 study in Circulation, 63.3 percent of patients with presumptive familial hypercholesterolemia (FH) and LDL cholesterol values above 190 mg/dL despite taking statins had their requests for PCSK9 inhibitors rejected by insurers. Among patients with either FH or atherosclerotic cardiovascular disease who ultimately had their requests approved, 40 percent of prescriptions took more than two months to approve while 34 percent took 30 days or fewer.

The list prices for PCSK9 inhibitors are as high as $14,600 per year, the Times reported. Insurers are reluctant to cover the expensive drugs for patients without assurances that every alternative has been attempted, leading to the lengthy approval process.

“They might want to know every statin you ever tried, or force you to try statins that make no sense, like trying simvastatin when you have already tried three other statins,” Cho said.

The process can be frustrating for clinicians and patients who struggle with high cholesterol despite trying other lipid-lowering agents. These drugs may the best opportunity to get their cholesterol under control—if they can get their hands on them.

Read the full story from the Times below:

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Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.

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