Brinsupri (aka Brensocatib)

I just did an online chat with an Aetna agent, she told me that my provider can submit the request now, then it will be authorized or determined. It seems the drug is already available if we want to try it.
Ling

Not available on my end. I am surprised the agent said it was available as Insmed said they have not finished negotiations with Medicare and other insurers yet.

The cost for someone without part D might be very high.

I wonder which part D plans will cover it?

Thank you scoop! Great information, Linda

I have one of those really low cost part D plans with a high deductible because when I signed up last year I had nothing wrong with me LOL. I don't think I need the medication yet but I am going to be sure to look for a better part D when the window opens up for next year just in case.

If you would like to hear about the new drug BRINSUPRI (BRIN-SU-PREE) you can listen in on the investor call by dialing (800) 770-2030 (domestic) or (609) 800-9909 (international) and referencing conference ID number 6364918.

And be sure to take a look at the slide deck with Northeast support group co-leader, Donna Marie proudly on the cover!

(https://c212.net/c/link/?t=0&l=en&o=4479882-1&h=3211626615&u=https%3A%2F%2Finsmed.com%2F&a=www.insmed.com).

Here is a partial transcript (with possible errors by me) from Dr. Martina Flammer, Chief Medical Officer at Insmed:

Consistent with our expectations, the US package insert does not contain a requirement on number of pulmonary exacerbations.

However, we continue to expect payers to cover treatment for patients that resemble the population studied in the phase three Aspen trial, which required patients to have a minimum of two pulmonary exacerbations in a prior 12 month period.

For the 25 milligram dose, we were pleased to see that the label includes the statistically significant benefits shown on FEV1, a key measure of lung function.

On safety, we’re satisfied that the label is reflective of the safety profile we observed throughout the clinical development program. The label includes warning for known effects such as skin and periodontal issues, all of which were consistent with our expectations.

Finally, we were also pleased that Brinsupri was granted a 24 month shelf life, which allows us to make use of the significant stock of inventory that we have on hand for both doses.”

So I’m thinking we might have this drug sooner rather than later since there are already significant bottles on the shelf!

Regarding side effects, it’s important to remember that all medications have them—whether they’re for high blood pressure, osteoporosis, or the antibiotics many of us need from time to time. Yes, brensocatib may cause gum issues or thickening of the skin (most often on the hands and feet, I believe), but in this study the safety profile was strong enough that the FDA did not require an additional committee review—generally considered a very good sign. I’m no regulatory expert, but that sounds reassuring to me!

If you have serious gum disease, this may not be the right medication for you—that’s a conversation to have with your doctor. Or perhaps you’re doing well right now and can wait a couple of years for more data. But many in our community are suffering, and the hope is that this drug will become available for them and help improve their quality of life.

One thing to remember is that medication decisions are rarely one-size-fits-all. Your overall health, other medications you take, your current symptom control, and even your personal comfort level with “new” treatments all matter. Also, making a decision based on a story we’ve heard—whether positive or negative—is not the best approach. Evidence from well-designed studies is what truly guides good care.

And call me a groupie, but when a paper co-authored by Dr. Charles Daley and Dr. James Chalmers makes it into the prestigious and highly selective New England Journal of Medicine, that speaks volumes. It means the data, the methods, and the findings have passed a level of scrutiny that few studies ever achieve.

Warm regards,
Linda Esposito

I would never be a candidate for this. The gingival side effects would do my very sensitive gums and teeth in and create big problems for my BE and my MAC. I read the testimonial of a man in the trial who lost most of his teeth during the trial. On the other hand, I met a young man at the March NTMir conference that it helped tremendously with chronic, significant hemoptysis. Double-edged sword for some.

Good luck to all those who decide to go for it!

could there be something one could do to prevent the gum side effects??

Ask your dentist. I have to go 4x/yr for cleanings/treatments (including fluoride because our water has none) due to what my inhalers do to my gums. Since I started them I am always close to gum disease. There are also special toothpastes that counter the bad effects. In all not a big deal if you stay on top of it and your dentist knows about this stuff.