Dr Jay Edelberg on Safety, Efficacy of Praluent and Remaining Payment Challenges

New results on alirocumab (Praluent) show that it is safe and effective for patients with familial hypercholesterolemia (FH), and yet these patients are faced with an unprecedented situation where some payers refuse to pay for the therapy, said Jay Edelberg, MD, PhD, vice president and head of Cardiovascular Development and Cardiovascular Affairs at Sanofi.

What do the results of ODYSSEY ESCAPE tell us about the safety of Praluent for patients with familial hypercholesterolemia?
These results of ODYSSEY ESCAPE really build on our continued knowledge of the safety and efficacy of Praluent for our patients who continue to live with FH. Now, ESCAPE specifically focused on those patients who required apheresis to help remove the cholesterol from their blood. And we’ve seen great results with Praluent being able to actually be both safe and effective for patients with FH, and, in fact, many patients actually probably don’t need as much apheresis when they’re taking Praluent.

Results presented at AHA show that of the patients who stopped taking Praluent, 30% did so because their payer would not pay or stopped paying for the therapy. Is there any precedent for this?
There’s no precedent for what we’re seeing in terms of the difficulty of our patients to be able to get Praluent when they’re prescribed. The appropriate patients for Praluent are those with FH or atherosclerotic cardiovascular disease who need additional [low-density lipoprotein] lowering on top of maximally tolerated statins. Those patients are having a really hard time about getting this when they’re prescribed. That’s really unprecedented.
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