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Welcome to Connecting ALS. Today we discuss the push for insurers to make treatments more widely available.
Connecting ALS is a weekly podcast produced by The ALS Association in partnership with CitizenRacecar. We aim to discuss research and technology developments, highlight advocacy efforts, and share the personal stories woven through the community.
This transcript was exported on Dec 20, 2022 - view latest version here.
Melanie Lendnal:
This is something that we are committed to seeing through. We will continue to advocate for everyone living with ALS so that anyone who wants to access this drug has the ability to do so.
Jeremy Holden:
Hello everyone and welcome to Connecting ALS. I'm your host, Jeremy Holden. The ALS community is closing out 2022 with a big win. The U.S. Department of Veterans Affairs has made AMX 35 now marketed in the United States as Relyvrio, available for the treatment of ALS for veterans who are living with the disease and who receive care at VA clinics or through ALS specialists. While the VA is one of the first healthcare payers or insurers to provide access to the drug, they're not alone. Several private health insurers have also included the treatment in their formularies.
The process of making sure insurance companies and other health payers like the VA or Medicare and Medicaid, cover-approved treatments is complicated. We spoke earlier this year with Dave Zuck, a public policy advisor to the ALS Association about the ways insurance companies make drug coverage decisions. And as we look ahead to the many emerging treatments currently in the drug development pipeline, I would encourage listeners to revisit that conversation. That is because there is a role for advocates to play in making sure that approved treatments are made available without unnecessary burdens, without any strings attached. Recently, for example, the ALS Association sent more than 40 letters to the payer community, including the VA and Medicare, urging them to provide coverage for Relyvrio without exclusion. In those letters, the association encouraged insurers not to restrict access to the drug based on considerations that are not consistent with the FDA-approved label, which established that Relyvrio has been approved for the treatment of ALS for all adults living with the disease.
The association further urged payers to avoid putting any unnecessary delays to accessing Relyvrio caused by things like prior authorization, step therapy, or other barriers to access. We can share links in the show notes for more information on that ensuing fight for access. In the coming months, we'll be talking about more ways that advocates can help make sure that the insurance industry makes approved treatments available for people living with ALS. In the meantime, we are pleased to be joined this week by Melanie Lendnal, the ALS Association's Senior Vice President for Policy and Advocacy to give us a deeper dive into the fight for access to approved therapies. Melanie, thanks for being with us this week on Connecting ALS.
Melanie Lendnal:
Thank you for having me, Jeremy.
Jeremy Holden:
It's an exciting time. I mean, I think folks have been abuzz since the FDA's decision to approve AMX 35, now marketed in the United States as Relyvrio for the treatment of ALS. What have we been hearing from folks living with the disease who have been trying to get access to Relyvrio as we now call it?
Melanie Lendnal:
Well, first I will say you are absolutely correct. It is a big deal that the FDA approved Relyvrio. Everyone in the ALS community rallied to make that happen. Certainly, we do know that this drug is safe and effective which is why we advocated so strongly for expeditious approval of this drug. But one of the things that we are hearing unfortunately, is that people are having difficulty accessing Relyvrio. This is something we expected and something we planned for. We do know that part of our commitment to the community is not just to ensure that drugs that are safe and effective get to market as quickly as possible, but that people actually can access them, and that access piece we have been hearing has become a challenge.
As a result, we have been in contact with over 40 different health insurance companies throughout the country. That includes Medicare, it includes the VA. We do understand that when Relyvrio was first available to patients particularly through the VA, that there were some difficulties. We worked very closely with the VA and we're happy to say that we have now rectified that situation, but there remains a challenge for people across the country. This is something that we are committed to seeing through. We will continue to advocate for everyone living with ALS so that anyone who wants to access this drug has the ability to do so.
Jeremy Holden:
Melanie, you mentioned the VA and obviously a big win with the decision announced recently to add Relyvrio to its formulary. How important is that for the ALS community?
Melanie Lendnal:
It's really important. By having a drug added to the formulary, it ensures that the VA, at least in this case, will cover Relyvrio for people living with ALS. Originally, the VA put out guidance and communications that seem to indicate that they would only cover it for a small percentage of people living with ALS. As a result, we engaged heavily with the VA and advocated very strongly for coverage for everyone living with ALS, not just a small subset of people. And we are happy to say that the advocacy efforts that we were engaged in with the VA have paid off and they have agreed to put it on the formulary and cover it for all people living with ALS.
Jeremy Holden:
That's an important point, the issue of all people living with ALS. Talk to me a little bit about the labeling process. So the FDA approves a drug and they go through this process of writing a label, of coming up with a label, of determining who it's approved for. That doesn't necessarily mean that my insurance company, that Medicare, that the VA is going to use the same standard. Am I getting this right?
Melanie Lendnal:
That's correct. So all insurance companies, including the VA, including Medicare, Medicaid, have some authority to be able to determine what they are going to approve, specifically in terms of who will be able to access the drug regardless of what the label says. We were very happy to see that the label that was approved by the FDA is broad and does indicate that this is something that is approved for all adults living with ALS. Initially, the VA approved it much more narrowly, so we fought hard to change that. So this is a big deal. We do know that a lot of people living with ALS had VA coverage and we wanted to ensure that this was changed as quickly as possible if for no other reason to ensure that people who have VA coverage are able to access Relyvrio. But we certainly didn't want other insurance companies looking at what the VA did and copy that as well.
Jeremy Holden:
You talk about insurance companies copying what the VA does. How important is CMS, the bureaucratic organization that kind of governs Medicare, Medicaid? What role do they play in terms of setting standards for private healthcare companies?
Melanie Lendnal:
Private healthcare companies tend to look to CMS, but they don't necessarily do exactly what CMS does all the time. It really varies on a case-by-case basis, but since we do know that a huge population of people living with ALS choose Medicare as their primary coverage, getting Medicare coverage right, getting VA coverage right, was critical.
Jeremy Holden:
So 40 letters to private insurers, to CMS, to the VA. It strikes me and I think back to my childhood, and yeah, I know I'm dating myself here, but I think of that old how a bill becomes a law cartoon and if I'm remembering it correctly, that ends with signing the bill into law, right? But advocacy extends beyond that. So what role can folks living with ALS, caregivers, can people play, in terms of encouraging health insurers to provide coverage for new treatments as they emerge?
Melanie Lendnal:
You just hit on a couple of incredibly important points, the first of which is, just because a bill is signed into law doesn't mean that anything is automatically going to change. A new law is only as good as its implementation and enforcement. So that's one very critical piece of this. Advocacy is incredibly important here because by advocating, by continuously communicating with public policy officials about the importance of the law, whatever it was that was passed, continues that drumbeat to ensure that policymakers are focused on implementation and enforcement, and this is where people can really engage. It's not just engagement to pass a law. It's also the engagement subsequent to the passage of a law that can really make the difference between real change versus just words on a paper.
Jeremy Holden:
It strikes me, we haven't had this conversation in the ALS community for over five years since edaravone was approved. Now we're talking about Relyvrio, AMX 35, but we're also now at a place where in just four months, we're going to be having another FDA decision around Tofersen and Dr. Kuldip Dave has been on the show frequently and talks about how robust the drug development pipeline is. So it just strikes me that these conversations around not just approval, but access and availability are only going to become more frequent and more prominent going forward.
Melanie Lendnal:
I think you're a hundred percent correct, Jeremy. I think this really is a tipping point for the ALS community. We saw the Ice Bucket Challenge occur. We saw all of the funding that was raised as a result of that. It was all put into research and now we are seeing a lot of those results come to fruition. My hope is that we will have frequent advisory committee meetings being held to consider approval for all of the treatments that we believe are going to be coming down the pipeline within the next few years. So while it certainly creates a lot of work for everyone across the board, the results I think will have a huge impact on quantity and quality of life for people living with ALS, and hopefully we will find a cure in the not too distant future.
Jeremy Holden:
Well, from what I've seen, it's a very tenacious community, so health insurance and the payers' community is on notice. We're going to be having these conversations a lot in the coming years and I'm looking forward to it. Melanie, thanks so much for being with us today.
Melanie Lendnal:
Thank you, Jeremy.
Jeremy Holden:
I want to thank our guest this week, Melanie Lendnal. If you like this episode, share it with a friend, and while you're at it, rate and review Connecting ALS wherever you listen to podcasts. It's a great way for us to attract new listeners. We are going to be off next week celebrating the holiday, but we will be bringing you a look back into that big win the community had this week in getting AMX 35 over the finish line and approved for the treatment of ALS. Our production partner for the series is CitizenRacecar, post-production by Alex Brower, production management by Gabriela Montakeen, supervised by David Hoffman. That is going to do it for this week. Thanks for tuning in. We'll connect with you again soon.
ConnectingALS_122222_Ready1 (Completed 12/20/22)
Transcript by Rev.com
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