Barriers to Care Access for Patients with HoFH

EP: 1.Overview of Homozygous and Heterozygous Familial Hypercholesterolemia (HoFH)

EP: 2.Patient Outcomes Impacted by HoFH

EP: 3.Presentation of Homozygous FH

EP: 4.Importance of Early Identification and Diagnosis of HoFH

EP: 5.Childhood Diagnosis of HoFH

EP: 6.Guideline-Directed Treatment for Patients with HoFH

EP: 7.Drivers of Health Care Utilization in Patients with HoFH

EP: 8.HoFH Treatment Landscape

EP: 9.Role of LDL-C Apheresis in Treatment of HoFH

EP: 10.Treatment of HoFH involving Lomitapide and Evinacumab (Part 1)

EP: 11.Lomitapide and Evinacumab for Treatment of HoFH: Part 2

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EP: 12.Barriers to Care Access for Patients with HoFH

EP: 13.Navigating Required Documentation for Treatment in HoFH

EP: 14.How Payers can Improve Access to Care for Patients

EP: 15.Unmet Needs in Treatment of HoFH

EP: 16.HoFH Treatments on the Horizon

Seth Baum, MD: Barriers to access is an issue that comes up throughout cardiology over the past, I would say, 6 years or 7 years. Ever since PCSK9 [proprotein convertase subtilisin/kexin type 9] inhibitors came to the market. We had never experienced that before, now it’s a daily, an hourly burden, I would say. Barriers to access is a problem. Now in the setting of HoFH [[homozygous familial hypercholesterolemia], it’s even more of a problem because these patients are in such desperate need for appropriate therapeutics. Remember, they have LDLs [low-density lipoproteins] in the 500, 600, and 700 range. They have events in their teens, heart attacks, strokes, interventions, and aortic valve replacements for supravalvular stenosis. So it’s a disease that requires urgent and extreme care. When a barrier to access presents itself, it’s even more egregious and more problematic. I’ll tell you that across all therapeutics, there are barriers to access even in apheresis. So we do apheresis and I will tell you that not a month goes by where we don’t have to justify the management of our patients to insurance companies, our patients who are on apheresis and have been on apheresis for even decades, as ridiculous as that sounds. So to go back and say, “Yes. This patient requires apheresis.” He or she, remember, at the age of 15, for example, hypothetically, had an aortic valve replacement for supravalvular stenosis. Have had multiple infarcts, multiple bypasses, multiple carotid endarterectomies, and multiple percutaneous coronary interventions. Yes, still needs the apheresis. It’s absurd, but that barrier, in the absence of a good system in an office, that barrier really prevents entrance to apheresis by a number of centers around the country. There are many, many more people who would be performing apheresis if they didn’t have these barriers. It’s impossible sometimes to run a center because of these barriers unless you had the infrastructure to manage the barriers. So that is a huge problem.

Erin Michos, MD, MHS: Across the board, both in HoFH and also HeFH [heterozygous familial hypercholesterolemia], some of the challenges are these preauthorizations with insurance companies. I have more of a challenge often with HeFH, and this is where genetic testing confirming their diagnosis can be really helpful. In order to get these therapies approved, whether it be lipid apheresis or evinacumab, it’s important that you make sure that you have an established diagnosis and that you have the appropriate coding. So since 2016, we do have a diagnosis code for FH. It’s E78.01. We have the same code, E78, whether its homozygous vs heterozygous FH, but at least we have an FH diagnosis code, which distinguished it before when we only just had an elevated cholesterol hyperlipidemia code. And it’s important that we discern FH, even HeFH, because individuals who have a genetic mutation are at much greater risk of cardiovascular disease compared to those without a gene who just have hyperlipidemia. For HoFH, you need to have the diagnosis code, and then there are codes you have to learn for billing and administrative codes. So this is given, as mentioned, either in an injection center or in some kind of hospital center or some kind of clinic that can give IV infusions, so you would want to bill for giving the IV infusion. And then there are these things called HCPCS [Healthcare Common Procedure Coding System] J-codes, so what that is infused drugs that patients can’t administer themselves. Like evinacumab, they can’t give it to themselves at home. So these are often billed under a patient’s medical benefit plan, not their pharmacy plan, from their health insurance. These are often referred to as healthcare benefits as J-code drugs, and so this is how the drugs are billed. We want a code for the infusion and then you give a J-code for the specific drug, so J1305 is for evinacumab. And this can be quite challenging for centers to figure out how to bill for these to patients’ insurance, and fortunately, there are some helpful phone numbers that one can call from the company, Regeneron, and other services if you’re struggling with how to bill and code for administration of this agent.

Transcript edited for clarity.