Radicava (oral) approval time

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We too are trying to get the oral Radicava.
We just received denial from private insurance company saying

"The use of this medication without normal respiratory function with a forced vital capacity (FVC) greater or equal to 80 percent does not establish medical necessity for this drug..."

Is this true?
Should we appeal?
 
They are using criteria from the trial of IV radicava that was used to get approval. The first failed to show efficacy but a subgroup analysis showed benefit for those with early disease, decent breathing that were fairly fast progressing so they did a trial with this group that met its primary endpoint. That doesn’t necessarily mean it doesn’t help others but if it does it didn’t show a signal in the first trial Japanese trials are only allowed to be 6 months for a placebo arm

ask your neurologist to appeal. FWIW my neurologist said they had to appeal every ors prescription. Whether the appeal is successful will depend on many factors but it doesn’t hurt to try. Is he currently on iv?
 
Definitely appeal. After my neurologist submitted 6 pages including clinical data to the appeals department I was finally approved.
 
no, he is not on the iv
 
Not good update - stupid Cigna called and left a voicemail that it wasn’t approved and our appeal rights. UGHH - they said it was all good to go last week and he would receive the medicine tomorrow.
 
That looks like the form for iv radicava since it talks about who is administering it and where
 
Nikki, it could be - we were just trying to determine if he met the criteria. The denial letter stated no reason to deny him and was signed by a Dr who specializes in “sleep studies.”

If this happens to anyone else - file an immediate complaint with your state insurance commissions office. The office replied to Cigna yesterday and gave them a deadline of 15 business days to reply to us and said that we wanted the medication immediately approved. We got a notification that the medicine has actually shipped from Accredo today with a tracking number. So I really really hope it’s on it’s way.
 
A tracking number is very hopeful. Did you look at the status? i had Accredo in the past for riluzole. They lied repeatedly and delayed. Finally they said they sent it but they did not. I never got it and they never billed it. Maybe they have cleaned up their act but both google and my pcp told me it was standard for them. That was several years ago though. I never had a tracking number
 
Ugh! I really really hope it’s coming.

There is a tracking number and it says it was shipped on 10/4 and will be arriving on 10/6. However, we got the Cigna denial on Monday and filed a claim with the state insurance commissioners office on Monday night. I don’t know if they could have changed their denial that fast but it did seem to be fraudulent denial. (They had no reason to deny the medication for him.). 🤞🏼
 
If it has actually reached the shipper and not just label created you should be good as they would have had to produce a package. keep us posted
 
I hope it's on the way. My pharmacy shipped mine overnight, I received it this morning.
Keeping my fingers crossed 🤞 that yours arrives today.
 
It left CA and was shipped (confirmed by accredo). But the customer service person seemed confused that it was sent out because she said it was held back because he didn’t have a pre authorization. So at this point, we have no idea what’s happening and are just hoping the medicine makes it to us tomorrow. 🤞🏼
 
@Marieb425 we are sure crossing everything we have waiting with you.
So insensitive to think people are treated this way, as if you don't have enough stress dealing with ALS.
 
The medication DID arrive today!!!! We also had his first ALS clinic today. Phew we are tired. I’m not sure why/how Accredo sent the medication out, but I’m glad it’s here. If this does happen to anyone else, do file a complaint with your state insurance commissioner. They replied promptly the next day and gave Cigna a deadline to reply to us with more information on why it was denied. And then the medication was shipped to us (still not sure why but maybe it was the pressure from the insurance commissioner’s office).
 
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