Tagged: ALS research, ALS treatments, Radicava
- This topic has 14 replies, 13 voices, and was last updated 9 months ago by Stephen O’Neill.
May 24, 2022 at 1:00 am #21986
Radicava is an ALS treatment (used to help slow ALS symptom progression) that has been available in the US since 2017. But it was always only available as an into-the-vein therapy with an intense, rigid schedule that many patients found inconvenient and difficult to follow. Recent news is that Radicava is now in a liquid suspension formulation – – and can now be taken orally or via a feeding tube.
The medication comes in a portable bottle, includes a 5 mL oral syringe for accurate dosing, and does not need refrigeration or reconstitution before administration. It still requires the same dosing regimen as the infusion Radicava: (an initial treatment cycle of daily dosing for 14 days, followed by a 14-day treatment-free period, and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day treatment-free periods.)
You can read the full article here: Radicava Oral Suspension Earns FDA Approval
How does this new option change your opinion of Radicava? Do you currently have the infusions and will you switch? Will you be more interested in starting Radicava? Has Radicava (in any format) been of help for your ALS?
May 24, 2022 at 2:10 pm #22000OwenParticipant
For me, Radicava falls into the same category as Riluzole- marginally beneficial. My wife has taken Riluzole basically since diagnosis, but decided against Radicava because the cons (needing a port, needing to have someone come to the house to do infusions daily for weeks) outweighed the pros (slowed progression by ~3 months). With a liquid form that can be administered easily by any caregiver, that changes the calculation significantly. Unless it’s prohibitively expensive, or not covered by insurance, it would make sense to add it to the regimen.
May 24, 2022 at 3:59 pm #22003MaryConnollyParticipant
We’re excited to have a non-infusion option! My husband has been on Radicava for ~2.5 years and I was trained to administer the drug by infusion when he started treatment early in 2020. A nurse comes to the house to activate the port at the beginning of a cycle and then mid-cycle to change the needle. I’ve been trained to deactivate the port and was learning how to activate the port until the announcement about oral Radicava. Over the years, we’ve developed an infusion routine that also includes shaving the port site and surrounding area, covering the port site (when activated with the needle) with a 7″ x 7″ water shield, and timing infusions so that on needle change day he is ‘needle free’ for at least 24-30 hours. It’s been a labor of love.
That said, he’s already reached out to his neurologist and is in the process of applying to get it as soon as it becomes available. It would be good to have clinical data about the efficacy of oral/feeding tube delivery compared to IV delivery. I’ve been looking for the study and I believe that more info will be released soon.
As Owen pointed out, oral Radicava changes the calculation significantly—easy to administer, same regimen as IV Radicava, no port and associated port issues or maintenance (although a port is handy for blood draws), etc. It’s a game changer. I sure hope insurance will cover it—it’s got to be less expensive than the hands-on human time (pALS, caregiver and a nurse ) and plethora of materials (saline, heparin, IV lines, needles, dressing change trays, alcohol pads, gloves) to deliver the therapy.
I’m all in!
May 24, 2022 at 4:20 pm #22004Mary Jo PetersonParticipant
What Mary C said. I’ve been infusing for almost 4 years. The oral option will be great! I, too am concerned about Medicare/Insurance coverage.
May 24, 2022 at 4:30 pm #22005Sandra IsaacsolnParticipant
It sounds great. I was diagnosed in October 2020. I decided not to pursue Radicava because of the IV dosing schedule. Does anyone know who the manufacturer will be of the new oral form, and will it be available in pharmacies like CVS?
May 24, 2022 at 4:59 pm #22009LisaParticipant
I have been doing the infusion at home for about 18 months, I can’t wait for the oral form!! I have no idea if the medication is doing anything for me but I don’t seem to have any side effects and most of the cost is covered by my insurance so I figure why not do it. I currently administer the infusion to myself but have a nurse visit just to access my port twice during the cycle. I am able to de-access myself. The infusion is not covered under a prescription plan but under the medical side of someone’s insurance and the oral form will fall under one’s prescription drug plan, whether or not it will be covered is another story. I am thinking it will not be a “formulary” drug which means it will at least be at a higher cost to us and I would think that it will be as available as Riluzole is from pharmacies.
A few of the benefits that I can see:
– the convenience of not having a nurse come twice a month will be great, although anyone with a port will still need accessed once/month to have their port flushed.
-not having a needle in my chest for 30% of my life is also great
-not being tethered to an IV pole for over an hour with each infusion
I am sure there are more reasons to switch!
May 25, 2022 at 6:44 am #22012Carolyn BarryParticipant
I too have been on Radacava infusions for about 18 months. I have had no side effects whatsoever, and had a port placed back in September. I was very happy that the oral formulation of Radacava was approved by the FDA, though my anticipation of actually being able to switch to this was short lived. I am very fortunate that my infusions are covered 100% by Medicare and my Supplemental insurance, which then falls under my medical coverage. I quickly found out that the oral Radacava would be covered under my Medicare Part D insurance, which is my Rx coverage, as opposed to the medical coverage. I knew that it would be filled by a Specialty Pharmacy, and I then filled out the necessary 5 page form for JourneyMate. They are the company that investigates a person’s insurance coverage, in order to determine if it will be covered, and if so, what the out of pocket cost will be. My neurologist had to fill out their portion and submit the form. A decision was to be made in a few days, and it came back pretty quickly. I was told that this is not a Formulary Drug and it would not be covered at all. Again, this falls under Part D, which is completely different than being under the medical coverage. The fact that it must cost significantly less is not at all a factor, as it is two different policies that determine coverage. I was quite disappointed, but I’m actually not surprised. My neurologist said she would reach out to the drug manufacturer to see if there are any other options. I’ll stay with my infusions, which are incredibly time consuming and exhausting, since they aren’t done at home, due to insurance only covering the cost if it’s done at a clinic. The staff there are very kind and compassionate, so I am most grateful for their care.
May 25, 2022 at 5:09 pm #22017
Carolyn, you have hit the nail on the head as to what’s wrong with our Medicare-health insurance-other payors-etc. system. What you describe is the catch-22 many of us face when trying to obtain an ALS medication. grrr!
May 31, 2022 at 8:40 am #22053Debbie ZolnierowiczParticipant
I have worked in home infusion and home medical equipment for most of my adult life. There are a lot of confusing rules, some of which are different between Medicare and private insurance.
This is one of the reasons I support a single-payer system! We spend too much administratively on differentiating coverage, in prior approvals, appeals, claims processing, etc. It would be great if all of those resources went to expanded coverage with one single system, including affordable options.
Back to infusion though…Medicare Part B doesn’t cover oral drugs. However when the drug must be administered via IV, voila. Covered. As a matter of fact, it’s somewhat concerning that there IS an oral option now, because Medicare could stop covering IV option. Part D drug supplement is where coverage would be seen, when they get around to adding it to the formulary. Notifying your local US Rep about this concern is a good place to start.
There is a loophole in some of this Medicare coverage, and that’s with the Medicare Advantage plans. They MAY opt to cover it. Open enrollment is a ways away (fall) but it gives you time to research if such a switch works for you. You’d want to research coverage of the other drugs in your regimen, as well as other therapies and treatments. And of course, whether or not your physicians would be in network.
And hence my reason for saying that we spend too many resources in differentiating coverages.
May 31, 2022 at 11:24 am #22054
Debbie, thank you for sharing your knowledge of these issues with us. Your past experiences working in these areas is so helpful to those of us who find health insurance and coverage so confusing.
May 26, 2022 at 2:47 pm #22022BillParticipant
Does anyone know yet of medicare position on Oral Radicava? I’ve never done the infusion so don’t even know what that would cost me with my Medicare advantage drug plan.
May 26, 2022 at 5:37 pm #22029JohnParticipant
I don’t know if I am fortunate or unfortunate when it comes to radicava treatment. I was diagnosed this past May with ALS.
I say unfortunate because my insurance company would not approve me for the in-vane radicava treatment requiring additional information regarding my diagnosis thereby delaying treatment for seven months. So, I was not treating my ALS with anything more than Riluzole, TUDCA, and a few vitamin supplements for seven months following diagnosis.
Fortunately, by the time insurance was ready to approve the treatment (approximately seven months later) I was able to enroll in an Oral Radicava study which I have been participating since January this year. The downside was I had to give up the TUDCA to participate in the study. I actually felt the TUDCA was working. Could simply be my imagination though.
The study I am participating is a double blind study with one group receiving a dose of radicava and a placebo and the other group receives a double dose. The study is focused on what if any benefit twice the typical dose will have on functionality and slowing progression. What I can say is the oral suppression is taken once daily, typically in the morning, and mine does have to be refrigerated. The medication requires at least 8 hours fasting prior to and up to 2 hours following with no food but an 8oz glass of water is okay. Lol! What I can’t tell you all is whether or not it works or doesn’t work. I have no idea if I am in the group with a single dose and placebo or in the group with a double dose. But, I have not experienced any side-effects and it doesn’t taste that bad.
May 26, 2022 at 10:45 pm #22035Azizullah KhattakParticipant
Does anyone knows where to get the oral Edaravone from.
May 27, 2022 at 8:24 am #22036MaryConnollyParticipant
Please carefully read this very long press release about Radicava ORS. There are links to resources including the JourneyMate program which may help you understand and provide information and support for obtaining Radicava ORS. https://www.mt-pharma-america.com/2022/05/12/mitsubishi-tanabe-pharma-america-announces-fda-approval-for-the-treatment-of-als/
May 31, 2022 at 3:11 pm #22057Kathleen B (Katie)Participant
Input from someone who had ‘fall down fatigue’ experience with Riluzole …and the ALS Clinic neuro was willing to work with me on making all kinds of adjustments for 2 months following diagnosis & starting the Riluzole pill, because I really wanted it to help. Unfortunately, he finally talked with me about the fact that for whatever reason, my system would not accept this med use…and it would not help to try Radicava infusions, as it was the same ‘bottom line’ drug. (At diagnosis, i quickly turned down the infusion option, as it seemed very difficult to manage AND think about quality of life, etc., while at the same time hearing what ALS was/is). So, the oral form of Radicava will not be an option either for me. I do TOTALLY appreciate the information and insight about Medicare and insurance — that has been a confusing nightmare for me — as a I moved into Medicare coverage just 3 months before being diagnosed! (Katie)
June 17, 2022 at 5:58 pm #22168Stephen O’NeillParticipant
Hi Everyone, hope you are all well.
I am keen to try the Radicava Ors, but i live in Australia, and it is not approved here yet.
I have a script from my doctors and can import the drug myself under the personal importation scheme or the SAS scheme, but i’m struggling to find anywhere to buy it online, can anyone help at all please?
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