Edaravone APPROVED in US!!!

[AKNate]

Ash, this is his 3rd month of Mon - Sat 1hr infusions a day. We haven't noticed an improvement however the clinical data from the trial showed people on placebo lost 7 points during the trial vs 5 points on the medicine. My husband has lost about 5 points in 5 years... so it's very hard to tell at this stage

 

[Manhattanite]

Biggest hurdle for my PALS will be the IV administration. He is extremely phobic of needles. The NYT article mentions something about an IV line being left in place "indefinitely" - maybe he will learn to tolerate it as he tolerated the PEG.

The point he has reached though: unable to speak, eat, home bound, unable to lift his head... would he want a drug that would extend this way of "living"? That is for him to answer.

 

[Nikki J]

When considering whether this is for you please read this and pay special attention to the fact, explained in the first section, that the first study showed no benefit until they analyzed subgroups. Only one group showed benefit ( less than 2 years of symptoms, definite or probable ALS, relatively good function equivalent to at least a 2 on every aspect of functional rating scale, and FVC at least 80 percent)

A 24-Week, Phase III, Double-Blind, Parallel-Group Study of Edaravone (MCI-186) for Treatment of Amyotrophic Lateral Sclerosis (ALS) (P3.189)

This study which showed benfit only looked at that group.

This is definitely something to discuss with your neurologist given the difficult treatment schedule even if insurance covers.

 

[psychmusic]

For those who are currently on Medicare, keep in mind that this is an infusion drug that will likely need to be administered by a healthcare professional. As a result, it may fall under Medicare Part A or B rather than Part D. Hopefully that would make the process for approval somewhat easier because you wouldn't have to deal with drug lists, etc. For a summary, see here - https://www.cms.gov/outreach-and-education/outreach/partnerships/downloads/11315-p.pdf

 

[preacherman]

Wonder if this is the kind of thing the VA would provide?

Or did I miss that answer.....

 

[Lkaibel]

Important points Nikki and I did see those specs on the group that benefited. As of today, it describes Brian perfectly. That is why we would even ask the Dr. About it. I bet by June he will have done very clear ideas aboout which patients to recommend/prescribe this new drug for.

PIC lines are not really a big deal at all. I had one many years ago after an accident ( long story). I use to forget it was there.

 

[adrivtham]

We administered edaravone to my husband,and at the beginning was very encouraging... then we stopped for about 2 months because there was a clinical trial the np001 and he couldn't be taking any medicine except rilutec. Sadly his progression during this time was fast and they rejected him for the trial.
This medicine is good for early stages but for later doesn't help. You can get this medicine in India for affordable price.

 

[frankb]

re.VA and Edaravone. Folks at Radicava (trademark for edaravone) says that nothing has been worked out with the VA. However, this is a response from Radicava's "call center" and not all call centers have the latest info.

 

[GregK]

Wonder if this is the kind of thing the VA would provide?

Or did I miss that answer.....

I notified my VA PCP, she's checking.

 

[maggie1]

Hi adrivtham, I have sent you a wall message but would love to have information on how to get treatment from India, many thanks

 

[Luesco24]

It comes with a price $145,000 a year. 30% slow down the disease like Rilutek. It will be nice for new diagnosed if they can afford it.

 

[GregK]

It comes with a price $145,000 a year. 30% slow down the disease like Rilutek. It will be nice for new diagnosed if they can afford it.

It's way too soon to be making decisions based on cost - read the comments above: the company has indicated that there wll be some form of assistance/relief.

 

[AKNate]

You can buy it from a Netherlands company & adminiser it at home with a nurse now that it's approved in the US. It'll cost way less than what is in the news articles.

I highly doubt it'll cost so much - does anyone know a medicine that does? But then again, I don't know much about US health systems...

Rilutek slows down by 10%... not 33%

 

[Nikki J]

It is illegal to import drugs to the US except under certain circumstances. Ironically it would be legal to import edaravone while it is unavailable/ unapproved because an exception is made for serious illnesses if there is not treatment available. If a drug is available you are not allowed to import something because it is cheaper.

People do this of course with pills a lot from online Canadian pharmacies. I think edaravone comes powdered and is reconstituted? Suspect Customs looks hard at strange powders entering the country

There are definitely other meds that cost this much. I have a friend who survived cancer but needs ongoing chemo ( a pill) to sustain her remission. The list price is more than this.

Private insurances will negotiate with the company I am sure. The company has programs for copay assistance and also for the uninsured. We don't know how it is all going to work but I doubt there are many ( any?) who are going to be writing checks for 145k plus administration fees!

 

[Lkaibel]

The cost of the drug to you cannot be determined by the retail cost. For example, the 12 pill cure for Hepatitis C retails for $130,000.00 . Medicare, assuming you carry both parts and a supplemental covers the entire cost minus your normal deductible, whatever that is for you.

Next, it is a misnomer to say it is for the newly diagnosed. It apparently has been shown to be effective in people who can still perform many/ most activities of daily living. That is a broad interpretation and includes many slow progressors like my husband as well as some but not all of the newly diagnosed.

Let's remember this is new, and few have discussed it with their Doctors yet. I am about the farthest thing from a chirpy optimist on the nightmare horror show that is ALS but I don't want to discount this drug right out of the gate either. Personally I feel a lot more inspired by the idea of new meds than opportunities to participate in clinical trials, essential as those are to finding the cure/ effective treatment.