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Nerandomilast approved by the FDA
The FDA approved Nerandomilast for IPF on Tuesday. Approval for PPF is expected in the coming months. This is the approval of the first new medication for IPF in more than 10 years. Many here in the Pulmonary Fibrosis Forums have anticipated the approval for a long time. The trials are over, and it is now approved.
https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-idiopathic-pulmonary-fibrosis
Will you talk to your care team about whether this drug is right for you?
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17 Replies
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Unfortunately, it could be 6 months before it appears on the Medicare formulary.
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Was wondering about that. New to Medicare, not new to IPF. Thanks.
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Now, I believe, is the time to make changes to your Medicare Part D drug coverage supplement. Does anyone know, first if those companies are required to put newly approved drugs on their formulary? If not, is there a way to pick a plan, that approve it? If it takes a while, I fear that the opportunity to change to a different Part D provider may close for the year.
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I believe that this drug may appear on the formulary more quickly than most because it is a real improvement, although not a cure. For example the FDA got through its process in only 5 months instead of a year plus because it has both breakthrough and orphan drug designations. The significant difference in side effects means that it should be available to those of us dealing with meaningful side effects may see it sooner.
Someone asked about the cost. Putting aside the Open Door program where BI provides significant support the list price for OFEV is 13,300 or so per month. The new drug is priced at 16,600 and change per month. There is a very complicated formula that calculates the value of a drug for Medicare pricing that I know nothing about, detail wise, but I did see an analyst who thought this price was in the right range for approval.
However, it may not be approved right away for everyone. While I have only been diagnosed since 2023, I understand that OFEV was originally approved for people with FVC under a certain level (which I think may still be the case in England and Canada). So, for example, I am considered “subclinical” because my FVC is still in a normal range. But I have a friend who works in big pharma in the field of these approvals, and she tells me that because of the different side effect profile I may be eligible because my HEP panel cannot handle a full dose, and even on the lower dose it is still iffy. In fact I might be eligible for approval even before it is on the formulary because of the risk of liver damage (I also have other side effect issues).
So the long and short of this is that everyone could have a different situation and it is possible that some insurance companies could say that OFEV is good enough depending on FVC levels, particularly since it goes off patent soon and there may be competition. This is a complicated situation that everyone needs to discuss with their doctor and where we probably won’t have a formulary answer before the Medicare deadline. I think this is where people should also consider contacting a Medicare broker, which is free, and ask for guidance on picking a Medicare Advantage plan.
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I most definitely will be speaking with my doctor about this new drug.
Can’t say whether or not it’ll be in any of the formularies this year, or if it’ll be as expensive as the Ofev I’m currently on, but if this is the case, I hope the makers or one of the other Open Door organizations will offer help with costs.
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The attached screenshot describes Medicare drug coverage. If you would like to see the entire document, it can be found at https://www.medicare.gov/publications/11109-your-guide-to-medicare-prescription-drug-coverage.pdf
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Ofev took anywhere from six months to a year (the shortest was 5-1/2 months) to appear on anyone’s Medicare Part D formulary. Unfortunately, I don’t expect nerandomilast to be any faster given the trial results. I expect the cost to be roughly the same as Ofev, which would make it impossible for most to afford without Part D. Nonetheless, I’m telling my doctor to be on the lookout for it.
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Thanks Sam!
I’ll be selecting my drug plan tomorrow or staying with my current one, depending on how it plays out this year.
I don’t expect to see this new drug on it since the news release came at this particular time, but I’m hopeful all of us will still be around this time next year to be able to take advantage of it. Until then I’m going to remain active and pray for no exacerbations!
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My pumonologist told me that the drug would be best for those who cannot tolerate either Esbriet or OFEV…the results are the same with the new drug. I tolerate Edbriet well, I am relatively stable after 5 years, I will not be trying this new drug.
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I’ve talked with my care team and they are checking if my insurance will cover it.
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I have end stage IPF diagnosed in 2014 and on Ofev since 2016. A year ago dropped down to 100 mg Ofev twice a day. Wondering if Nerandomilast at 18 mg twice daily may help me.
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Ray,
Will you come back and share your care team’s thoughts on your use of Nerandomilast.
Sam…
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I talked to the Walgreens Specialty Drug pharmacy today and they indicated it was in stock and all I needed was a script from my Pulmonologist and they would be able to get the drug added to my WellCare formulary of drugs. At least that is what they told me. I will let you know if it all comes together. I just need a response from my pulmonologist, but it appears they don’t to operate with any urgency.
His office said he would look into it a week ago.
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I also have WellCare and after comparing plans in my zip code, I’m staying with them for 2026. I’d love to know if your team follows through and discovers the answer of this drug being covered.
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I was part of the clinical trial for Nerandomilast over the past 3 years. I was diagnosed with Familial Pulmonary Fibrosis (FPF) over 6yrs ago. I lost my mother and both my brothers to this disease. Unfortunately Ofev and Esbriet were not available at that time. I myself tried both of those drugs but I could not tolerate them. They made a mess of my stomach. I found out recently that during the double blind-study, I was on Nerandomilast from the very beginning. I was very lucky. I tolerated the drug extremely well. I had minor issues for the first two weeks but after that..nothing at all. I believe this drug is a game changer. I wish it was available for my family. I remain quite active, gym, hiking, biking, etc.. I definitely feel a difference in my breathing. When I’m working out it has slowed me down but I have yet to use oxygen. I know Nerandomilast is not a cure but it will for sure slow it down to a crawl. I feel blessed that this drug has come along and remain hopeful for the future. I wish everyone on their journey all the best.
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That sounds very promising! I’m hopeful it’s available and covered even though we’re not likely to know which formulary it may be on before the Dec 7 end date.
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All – In my column, https://pulmonaryfibrosisnews.com/columns/when-can-we-start-taking-new-ipf-treatment-jascayd/ , I am collecting questions you have about jascayd. I will be at the Pulmonary Fibrosis Foundation Summit 2025 in Chicago in mid-November. I am going to be looking for the answers to your questions. Feel free to look at the questions others have left and leave your own.
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