[kitt]

I have had a similar situation. First, when they say to take it with protein they really mean 30 or 40 grams of protein each time. I did make a dent in my side effects on the GI side when I increased the protein, but I had a bad hep panel, unrelated to the protein; it is a known side effect. Because I was traveling we cut back to one dose a day, but I continued the high amount of protein 3 times a day. Frankly, my side effects have almost disappeared, maybe small problems 2-3 times a month. I also take a daily probiotic and one Imodium. I traveled 90 days, spread out and did not have to cancel a single tour or excursion. It was a great success .

Now that I am home for two months I am trying the 100 mg dose twice a day and so far no side effect problems. After a month we will redo the HEP panel to make sure the liver can handle this dose.

By the way, my doctor says the side effect profile for the new drug, trade name Fibroneer, appears to be at least a 40% reduction of side effects.

[kitt]

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.

[kitt]

If you go to United Therapuetics website and read the press release they refer to improvement in DLCO. Bear in mind, they need the results from one more clinical trial before they file with the FDA. They do not expect to come to market with this drug for IPF until 2027. Right now it is only approved for PAH.