The FDA’s approval of lecanemab for Alzheimer disease is very important, but there will remain significant challenges around pricing and access that will need to be addressed to deliver on the promise the therapy actually represents, said Alvaro Pascual-Leone, MD, PhD, of Harvard Medical School.
The FDA’s approval of lecanemab for Alzheimer disease is very important, but there will remain significant challenges around pricing and access that will need to be addressed to deliver on the promise the therapy actually represents, said Alvaro Pascual-Leone, MD, PhD, medical director, Deanna and Sidney Wolk Center for Memory Health; senior scientist, Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife; professor in neurology, Harvard Medical School; and chief medical officer, Linus Health.
What is the importance of the FDA approving lecanemab for Alzheimer disease?
It's the first medication that if translated to clinic harbors the promise of changing the progression of the disease. It’s the first pharmacologic intervention, let me emphasize that, because I think one thing that we keep losing sight of is the fact that lifestyle modification, extremely hard as it is to really do it, has level A evidence, including prospective trials—the FINGER study, for example—showing that it can have a significant impact on the risk of progression from MCI [mild cognitive impairment] to dementia, or the progression of dementia. This is a pharmacologic intervention that I think needs to come be combined with these kind of lifestyle modifications. But that said, this would be the first pharmacologic intervention to show that and that's super exciting.
But, approval by the FDA is necessary, but it's not sufficient to make it available to patients. It's a necessary regulatory step, but then questions of pricing and approval and coverage by CMS have to be sorted out even in the US—similarly in other health care systems. But in addition to that, I think the health care system that we have in the US but also elsewhere, is really ill prepared to cope with making lecanemab available to patients. I think we are going to have to sort out significant challenges to make sure that we can deliver on the hope and the promise that having lecanemab available would actually represent.
What are the next steps after approval? Does there need to be a confirmatory trial?
No, I don't know that that's necessarily the case. It depends on the terms of the approval. I think that the approval may require additional trials for specific subpopulations [such as] women or people on anticoagulation. So you could have black box warnings or specific demands of a narrowing of the indication. And/or there could be a requirement for a phase 4 trial, a sort of real-world rollout where you're in the clinical setting, but you're required to continue to gather data so that we can keep learning. That I think is almost for sure going to be a requirement, but it's a very standard sort of requirement and it’s important for all of us.
But I think that the immediate next step would be the question of: given FDA approval, whether CMS is going to approve coverage of that as a benefit for Medicare patients, which is the bulk of the patients that would be eligible here. Because otherwise what we're going to be faced with is the challenge of who can afford it? Which private insurances will cover it? And how do we cope with a potential discrimination that would come from that?