Old 08-09-2017, 12:52 PM #1 (permalink)
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Default Radicava / Edavarone - DENIED!! Help?

Hi!

I was newly diagnosed in March 2017, but problems started around Aug or Sept 2016. So I'm less than 1 year in and doing ok for now, but yes, I'm declining.

Anyway, I was hopeful to go to my 2nd ALS clinic visit because I thought I could get Radicava. My clinic date was 8/4. My doctor said I don't qualify because my FVC decreased to 66%. Back in March I was 81%. He says you have to be at 80% or higher to get the drug.

So very disappointing! Has anyone else experienced this???

I tried to look for the requirements on the drug and did not see that listed in the prescribing information. It does mention that the clinical trial participants were required to be 80% or better, but I don't see anything in writing to state that is now a stipulation to receive the treatment.

I'm going to have someone call Searchlight support to ask about this.

My doctor is absolutely NOT helpful. I've been to ALS clinic twice. He has no bedside manner. All doom & gloom. We don't need that! I'm requesting my medical records so I can try someone else. I don't want them to say I'm going to be fine - I understand what's happening here, but at least have a heart.
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Old 08-09-2017, 01:01 PM #2 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

Definitely check in with searchlight. I do know the insurance companies are setting different criteria. I saw United health had requirements that were similar to the group that was in the second Japanese trial where 80 respiratorywas their cutoff for eligibility I forget if there was a specific respiratory number for united health but they were certainly guidelines that excluded a lot of PALS. Other companies are likely doing similar

Last edited by Nikki J : 08-09-2017 at 02:58 PM
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Old 08-09-2017, 02:55 PM #3 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

I suggest getting a 2nd opinion ASAP to find out if there are good reasons for needing 80% or higher to get benefits from the drug.
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Old 08-09-2017, 04:07 PM #4 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

The doc may be reading from the trial info on the label without having verified reimbursement. Did he actually submit it? That's the first question.

The Radicava Searchlight enrollment form is available here and he can still complete and submit it to get you help with access.
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Old 08-09-2017, 05:00 PM #5 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

According to SearchLight Support - the only requirement is to have a diagnosis of ALS. There are no other restrictions given by the FDA or the manufacturer.

That makes me so MAD!

He even made a point to walk out to the lobby, in front of everyone, to tell me I don't qualify for it. And repeated it multiple times.

I saw other people in the lobby crying before I went back there. The resp therapist said my PFT was best in the group, so basically, they denied EVERYONE that day.

I have since messaged him through the health portal. I wasn't ugly to him, though I want to be and I feel he deserves it, but I want to give him a chance to right his wrong. We'll see!
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Old 08-09-2017, 05:08 PM #6 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

I am confused did he disqualify you ( meaning a blanket rule noone in the clinic under 80 will get it ordered by him)? Or did your insurance after it was submitted? If your insurance covers and he is denying you a try that is awful! It is awful if it is your insurance too, but seems less personal. I am so sorry.

I have no idea what insurance he has but Pete Frates' mom was on tv yesterday saying he is going to try it and he is on a vent. He goes to Mass General as I do and they said back in May they would let any PALS who wanted to, try it. Of course insurance may turn people down and they can't control that.
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Old 08-09-2017, 05:11 PM #7 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

He sounds like he has issues way beyond drug labeling. I'd be doc/clinic-shopping at this point.

Reminders to all: you don't need an ALS clinic for much, if anything, if other options work better. Most of the world doesn't have them, and the longevity benefits ascribed to using them in some studies relate to modern technology more than special insight. In the Internet age, tech and science are disseminated a bit faster than in the past, and you are as close as your browser to knowing what to check out.

If you do want to try all the clinics in your area to see who clicks, you're within your rights (though some may be out of network with your plan). The clinic that diagnosed you has no special claim to you.
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Old 08-09-2017, 05:28 PM #8 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

Thanks everyone! My sincere hope is that no one else has the same experience I've had, although I know for a fact that my doctor is doing this to others as well.

He [my doctor] said I don't qualify for the treatment because my FVC was less than 80%. No one ever checked my insurance or anything else.

I've only been to his clinic twice and never had a good feeling from him. My mom didn't like him and my partner didn't either. The only person there that I liked was the MDA rep. I thought this may be normal, since we're all just kinda stuck with what's happening to us, but this is plain mean, I'm hoping he's just been misinformed...
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Old 08-09-2017, 06:58 PM #9 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

This sickens me. I think I'd find a pulmonologist and shave a couple of inches off your height so your number might hit 80. The cough assist and inspiratory training helped my FVC. Different places even use different %. Mayo, University of FL, and Johns Hopkins all had different "expected rates." Florida Hospital didn't even measure me, they just asked me how tall I was and what I weighed. Same with Johns Hopkins.
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Old 08-09-2017, 07:36 PM #10 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

It sounds like you are doing what you need to sort this out.

I hope those crying people in the waiting room find out they are not excluded too.

I agree 100% with Laurie, an ALS clinic is far from essential. They ARE the people I trust for diagnosis, but beyond that not essential.
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Old 08-10-2017, 08:53 AM #11 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

It is looking like most if not all of the insurance companies are using the trial entry criteria for the second trial. I think this is going to knock out most PALS unfortunately. They include the 80 percent, less than 2 years from onset, and definite or probable ALS by El Escorial. they also are looking at FRS numbers

Given that plus the treatment burden being enough that some eligible PALS will opt out I am thinking not that many will end up getting it.
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Old 08-10-2017, 11:03 AM #12 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

What Nikki said is what I have heard talking to my doctor as well. That insurance companies will likely deny those who don't fit the group from the second trial. I just started the process for insurance approval for Radicava- neuro had me fill out some forms. I have a Clinic visit tomorrow and the only thing I'm worried about is if my breathing numbers might go down since that would affect my eligibility in terms of insurance coverage. My FVC was 85% four months ago. It hasn't been checked since.

But I did read somewhere that the drug company will help with financial assistance for those who can't get it through insurance or something like that. I also think a good doctor will advocate and fight for you with the insurance company. Don't give up mariposa! I would definitely look for a new doctor. Someone who will be on your side through all this!
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Old 08-10-2017, 04:05 PM #13 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

Had an enlightening conversation with our Doctor. Brian still meets criteria even if that's what Medicare decides IS the criteria, but on balance he is not at all sure if he cares, and I do have blame him.

This drug was tested on a very limited number of Japanese participants mostly who showed limited benefits. Doctors and patients are being asked to continue reporting results in a manner not unlike with a study drug because basically it still is a study to use it, just no longer double blind. It's also been shown to be pretty safe, up to the safety standards of an approved drug.

The drug does not restore function, it may well not slow progression, it costs a fortune and there are all those lovely infusions. Talking to the Dr a second time, it sounds more like a super annoying version of Rilutek. Yes, it may extend life by 30%. That's a lot, and I imagine a shot at that is worth a lot.
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Old 08-10-2017, 05:44 PM #14 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

Here is a link to the UHC policy effective 9/1, which includes >/= 80%. So "after exhausting appeals," the patient access protocol would kick in as noted on the enrollment form I linked earlier.

As noted in the UHC document, in traditional Medicare, if furnished incident to a physician service, an infusion should be reimbursable under Part B, since no Medicare determination about the drug itself as been made as yet.
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Old 08-11-2017, 01:49 AM #15 (permalink)
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Default Re: Radicava / Edavarone - DENIED!! Help?

Well my ALS clinic gave me a conditional prescription and registered me with Searchlight. They were to let me know what criteria my insurance company is going to require. I have United HealthCare and a FVC 0f 48. So, I'm out. Such a disappointment. Everything with this disease is so unfair.

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