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Access to PCSK9 inhibitors challenging, but resources may help
ORLANDO, Fla. — Prescriptions for PCSK9 inhibitors are often denied by payers, but having access to the appropriate resources may help increase approvals, according to a town hall held by the American Society for Preventive Cardiology at the American College of Cardiology Scientific Session.
About 15% of adults in the United States have either diabetes or atherosclerotic CVD and only 55% of these patients are treated with lipid-lowering therapies, according to the town hall.
“Atherosclerotic CVD is not going away,” Seth J. Baum, MD, FASPC, chief medical officer of Excel Medical Clinical Trials, clinical affiliate professor of biomedical science at Florida Atlantic University in Boca Raton and president of the ASPC, said during the town hall. “In fact, in some ways, we may be taking steps backwards.”
Although the rate of stroke has remained unchanged, the rate of acute MI has declined over the past few decades, but is starting to become level.
According to data from the INTERHEART study, lowering lipid levels can have the greatest impact on reducing the risk for MI.
“If we’re going to go after one target and we seem to have this limited box of therapeutics that we’re allowed to play within and we can’t expand outward … What should we go after? We should attack elevated lipids; we could lower lipids to the floor and significantly reduce heart attacks in this country,” Baum said.
Various studies have consistently shown that lower LDL levels are better, especially when they remain low over a long period of time. In patients who are treated with high-intensity statins, 80% of them do not achieve LDL levels below 70 mg/dL.
“We have much work to do, and we need other therapies,” Baum said. “Specifically, we need access to the PCSK9 inhibitors for our patients in whom the FDA has stipulated that these drugs are appropriate.”
Familial hypercholesterolemia is more common than was originally thought, according to the town hall. One in 200 to 500 people have this condition worldwide, and it is seen in one in 250 Americans. Nearly all patients with FH, which is associated with more severe CVD, will need cholesterol-lowering medications.
“It is a very important disorder for us to recognize for us to treat effectively,” Baum said. “FH is a disorder that is not getting enough attention when it comes to the PCSK9 inhibitors.”
Although PCSK9 inhibitors have been approved by the FDA for patients with atherosclerotic CVD and FH, 83% of claims are rejected on the first attempt. More patients with Medicare are approved for the therapy compared with those that are commercially insured, according to the town hall.
“Never had I experienced anything like this,” Baum said. “This was truly unprecedented. It was heartbreaking actually and very troublesome.”
The FH Foundation found that of 110,577 patients who were diagnosed with FH, only 1,188 had a prescription for a PCSK9 inhibitor prescribed.
“Not only are these drugs being denied at unprecedented rates, but they’re also not being used appropriately, so clinicians have a lot to work when it comes to FH in particular,” Baum said. “We need to prescribe those drugs, especially to those at highest risk, and FH patients are extremely high risk.”
Although the lipid guidelines are not harmonized, societies often intervene and become an intermediary between the clinician and the FDA to further clarify how and when PCSK9 inhibitors should be used, but this can backfire when prescribing these treatments to patients.
“It’s not a great idea because what happens with this is … the payers will often take one sentence out of context from one of these statements and use it against the patient,” Baum said. “The purpose of these statements is to help the patient. It’s having the antithetical effect. It’s hurting the patient.”
With all these issues in accessing PCSK9 inhibitors, one of the main factors is process, according to the town hall. The ASPC and other organizations have identified these issues through a variety of town hall sessions over the past 3 years and written papers on the topic.
All of this work has come together this year in a mobile app to improve the payer’s process, which can be done through a 10-step process. The app features other tools, information on denials, the best and worst insurance plans, specialty pharmacies, a list of insurance commissioners, and a link to helpful resources and partner associations.
Other members of the contributing faculty at the town hall discussed their experiences with improved approval rates.
“As a group, we decided that perhaps one way to get better results was to come up with a cohesive strategy to standardize documentation within our electronic medical record,” Michael D. Shapiro, DO, FACC, FASPC, associate professor of medicine and radiology and director of the atherosclerosis imaging program of Knight Cardiovascular Institute at Oregon Health and Science University in Portland, said at the town hall. “To deal with the high rate of denials, we set up a ‘PSCK9 inhibitor clinic.’ Our physician assistant is the director of our PCSK9 inhibitor clinic, and she engineered standardized documentation to accompany the prior authorization, very similar to what you have in your paper, that the payers need to see in order to potentially approve the therapy.”
The physician assistant also provides education on PCSK9 inhibitors and injection teaching. Even with all this effort to develop standardized documentation, denials were still occurring. The approval rate dramatically increased once their physician assistant responded to each of the denials, usually with other standardized documentation.
“We fortunately had the resources to be able to do that,” Shapiro said. “We understand that’s not necessarily relevant to all practices, but having the strategy to use the documentation, being ready to react to denials have become very important elements.”
Martha Gulati, MD, MS, FACC, FAHA, FASPC, cardiologist and chief of the division of cardiology at the University of Arizona in Phoenix, described her experience while at The Ohio State University, where there is a school of pharmacy that aided in their patients’ access to PCSK9 inhibitors.
“We didn’t expect the denial rate either, but as they started happening, we used our specialty pharmacy clinic to get the approvals and work on the denials,” Gulati said.
Not every private practice has access to these resources, but an app like the one that the ASPC developed can provide that help, according to the town hall.
“This app is going to create resources that are easily accessible,” Gulati said. “There are so many things that everyone has to do with caring for their patients, and now having [resources] at one place is certainly going to make it a lot easier because not everybody has a PharmD, a specialty clinic or a PA to take over the work of trying to get these drugs.” – by Darlene Dobkowski
Reference:
Baum SJ, et al. Gaining Access to PCSK9 Inhibitors: Unveiling of a New Mobile App. Presented at: American College of Cardiology Scientific Session; March 10-12, 2018; Orlando, Fla.
Disclosures: The town hall was sponsored by Amgen and Sanofi/Regeneron. Gulati reports that she has no relevant financial disclosures and did not receive payment from any company for speaking at this session.