CV Risk Rises When Payers Deny Alirocumab, Evolocumab Coverage

Megan Brooks

July 26, 2019

It has real-world health consequences when patients prescribed PCSK9 inhibitors don't actually get their medication, which often happens because their third-party payer doesn't cover the costly drugs, suggests a retrospective study.

Patients in the analysis who could not take advantage of their prescriptions for alirocumab (Praluent, Sanofi/Regeneron) or evolocumab (Repatha, Amgen), either because they were rejected by payers or never filled, showed a greater risk for cardiovascular (CV) events than patients who filled and received their PCSK9 inhibitor prescriptions.

The study was published online July 23 in Circulation: Cardiovascular Quality and Outcomes, with lead author Kelly Myers, chief technology officer of the FH Foundation.

It included data from patients with recommended indications for the drugs, including atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH).

"Either one of them should have allowed for these patients to receive additional LDL-cholesterol-lowering therapy," Robert Rosenson, MD, Icahn School of Medicine at Mount Sinai, New York City, who wasn't involved in the study, told theheart.org | Medscape Cardiology.

Approved in 2015 largely on the basis of the ODYSSEY Outcomes and FOURIER trials, alirocumab and evolocumab are indicated for the treatment of hypercholesterolemia in people with FH or clinical ASCVD who still have elevated low-density-lipoprotein cholesterol (LDL-C) despite maximally tolerated statins. The drugs dramatically lower LDL-C.

But the PCSK9 inhibitors have been pricey, costing about $14,000 a year at the time the study was conducted. Both Sanofi and Amgen recently cut the price of the injectable medicines to about $5800 a year.

"The elephant in the room has been the cost of these drugs," Parag Joshi, MD, UT Southwestern Medical Center, Dallas, told theheart.org | Medscape Cardiology.

"The high costs led to a prior-authorization approval process through insurance payers, which made it challenging for our patients to get these medications. Commonly our patients are denied the medication through the approval process with their insurance provider. Or even when approved, the out-of-pocket cost remained too high for them to afford the medication," said Joshi, who was not involved in the study.

Researchers for the current analysis reviewed medical records and pharmacy claims data for 139,036 patients prescribed a PCSK9 inhibitor between August 2015 and December 2017.

Only about one-quarter of patients (24%) had their PCSK9 inhibitor medication covered by insurance, defined as getting at least 168 days of paid medication within a 12-month period, they write.

For 15% of patients, prescriptions were covered by payers but patients didn't arrange to have them filled, probably owing to high copays, the group proposes. Payers rejected PCSK9 inhibitor prescriptions in 61% of patients, in line with previous studies.

Even individuals at highest risk of a CV event, those with both FH and ASCVD, showed a PCSK9 inhibitor coverage rejection rate as high as 63.5%.

That rate is "concerning," Myers told theheart.org | Medscape Cardiology. Although more recent data show rejection rates have improved a little, "for a lot of health plans, rejection rates are still above 50%, even for these high-risk groups."

Women, minorities, and those with lower income or education levels had higher rates of rejected or unfilled prescriptions. About 65% of unfilled prescriptions were in people with Medicare prescription coverage.

The outcomes data are even more concerning, said Myers. Altogether, 3.4% of patients prescribed a PCSK9 inhibitor had a CV event in the 11.5 months after the prescription date.

In propensity-matched analyses, compared with patients with paid prescriptions, their peers with rejected prescriptions showed a 10% higher adjusted risk for a composite of MI, unstable angina, coronary revascularization, stroke, and cardiac arrest (hazard ratio [HR], 1.10; 95% CI, 1.02 - 1.18; P = .02).

Those with abandoned prescriptions — that were never filled or obtained from the pharmacy — also showed an increase in the clinical end point (adjusted HR, 1.12; 95% CI, 1.02 - 1.23; P = .03).

In a stricter analysis, where "paid" patients were defined as getting at least 338 days of therapy in a year, patients were 16% more likely to have a CV event if their prescription was rejected than if it was covered and filled (HR, 1.16; 95% CI, 1.02 - 1.30; P = .04).

And they were 21% more likely to have a CV event if the prescription was approved but abandoned (HR, 1.21; 95% CI, 1.04 - 1.38; P = .03).

With this analysis, "we see strong suggestions of what we feared would be true. The patients who were prescribed a PCSK9i but could not or did not get it, had higher rates of cardiovascular events compared with those who were able to obtain the medication," Joshi said.

This study "really brings to the forefront the interference of the insurance companies that are trying to decrease their budget for prescriptions that is resulting in more costs overall for society," Rosenson observed. "They need to evaluate not the cost of the medication alone but the total cost of not providing this therapy."

"Status quo is not an option anymore for parties on both sides of the aisle," says an accompanying editorial, with lead author Khurram Nasir, MD, Yale School of Medicine, New Haven, Connecticut.

"As the market forces have led to significant reduction in PCSK9i prices, we think that the cardiovascular community is right to question these persistent obstacles in providing the right care for the right patient," they write.

Joshi is optimistic for several reasons. "For starters, there is a learning curve with the approval process. And while it was challenging to navigate early on, we have learned a lot about the process and how to provide the necessary information to get approvals," he said.

"Perhaps more significant, there has been a significant reduction in the price over the last year or so by the pharmaceutical companies that make these drugs, which will hopefully get passed on to our patients' out-of-pocket costs," Joshi said.

"Finally, the most recent cholesterol treatment guidelines outline clearly the groups that stand to benefit the most from these drugs and the steps that should be taken to get them," he said.

"I am hopeful that this will all lead to smoother access to these drugs for our patients with residually high cholesterol levels and risk for further cardiovascular events."

The FH Foundation, which funded the study, is a 501c3 public charity research and advocacy organization that receives contributions and sponsorships from individuals, foundations, and diagnostic and pharmaceutical companies, including the manufacturers of PCSK9 inhibitors. Myers and three coauthors are paid consultants for the FH Foundation. Three other authors are employees of the FH Foundation. Joshi has no relevant disclosures. Rosenson has served as a consultant for Amgen, The Medicines Company, and Regeneron, and Mount Sinai receives research funding from all three companies. Nasir has no relevant disclosures.

Circ Cardiovasc Qual Outcomes. Published July 23, 2019. Full text, Editorial

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