What do you think of this new form of Radicava?

[Owen]

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.

[MaryConnolly]

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!

[Mary Jo Peterson]

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.

[Sandra Isaacsoln]

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?

[Lisa]

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!

 

[Carolyn Barry]

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.

[Dagmar]

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!

[Debbie Zolnierowicz]

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.

[Dagmar]

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.

[Bill]

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.

[John]

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.

Cheers All!

 

[Azizullah Khattak]

Does anyone knows where to get the oral Edaravone from.

[MaryConnolly]

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/

[Richard L Wheeler]

Thanks for the post. The study says 33 percent chance of actually helping. So only a 1 in 3 chance. Since my ALS appears to moving very slowly (Thank GOD) I will wait for a better treatment with better odds. I may change my mind if the rate increases though. Static since 2021.

[Kathleen B (Katie)]

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)

[Stephen O'Neill]

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?

Regards,

Stephen

[michellemck]

Today I started oral Radicava.  I have been on i.v. since December 2022.  Before my ALS diagnosis in October 2022, I always was told that I had great veins.  After 9 months of needles, my nurses started having trouble finding veins, so today’s oral dose was MUCH more convenient.

I’m in Canada.  Did it get to Australia yet?

Does anyone else get an onion flavour?

Cheers!

[John]

Hello All! I’ve been on oral Radicava since January 2022 as part of a study which is now being suspended. The Radicava I take must be refrigerated. The study I was a part of was to find any efficacy for a two dose daily regimen. The study found no benefit to the two dose regimen as compared to the single dose regimen. Not sure which I was on given the study was a double blind study but I know I was getting at least a single dose.

Like some have said, who knows if it works but I’ll continue taking it. Can’t hurt.

I am also doing the 3 R’s. Been on Riluzole since May 2021, oral Radicava since January 2022, & Relyvrio since March 2023. The only one I’ve had any side effects is with the Relyvrio beyond the taste.

[Peter]

Hello dear All

I think it is great that the active ingredient is now available in a form that is easier to apply. What I am still missing is, that the description of the efficacy is limited to a small patient group and otherwise the agent is not supposed to have any effect in a large ALS patient group. Since I already received my ALS diagnosis in 2019 (= over 2 years) and suffer from a flail-leg version of ALS that puts me at “0” points (Question with climbing stairs), the agent is not effective in my case, according to the 2017 study. Since 2022 I have the information, that I am carring a ATXN2 gen repeat expension. A review in 2023 reported; the evidence suggests that free radicals play a crucial role in the progression of ALS. Free radicals can harm the central nervous system (CNS) by limited ability to scavenge
free radicals and weak capability for regeneration. Furthermore, reactive oxygen species (ROS) cause genetic mutations by changing the actions of some enzymes, such as superoxide dismutase and glutamate synthetase. The literature supports the oxidative stress hypothesis by concluding that the CNS tissue of ALS patients contained a higher level of 3-nitrotyrosine (3-NT), a biomarker for oxidative stress.
In this context I miss in the evaluation of Edavarone to what extent gene disposition plays a role, patients with SOD1 and SQSTM1 mutations are more at risk for oxidative stress (https://www.nature.com/articles/s41573-022-00612-2/figures/1). Does anyone know if relevant research projects are ongoing on this topic? I myself take a lot of supplements which are supposed to reduce oxidative stress and bind free radicals. Thanks for any links or infos on this subject.

I would like to avoid taking a drug that does not harm me but does not bring me any benefits. With very high therapy costs, which I cannot comprehend, the manufacturer would ultimately profit the most.

Thanks and best regards from Switzerland, Peter

[Peter]

Ferrer published the results of Edavarone trial. Ferrer reports that Phase III ADORE (EudraCT 2020-003376-40 / NCT05178810) clinical trial of oral Edaravone formulation (FAB122) in amyotrophic lateral sclerosis (ALS) patients did not meet primary or key secondary endpoints.

https://www.ferrer.com/en/results-study-ADORE-ALS

As we speak about Edavarone, I would like to know what is the difference about Radicave and ADORE as it is as well Edavarone. Radicava holds 105mg / ADORE used 100mg. I have just seen a statement from the producer of Radicava (https://www.mt-pharma-america.com/media/news/press-releases/2024/01/17/mitsubishi-tanabe-pharma-america-inc-mtpa-statement-on-ferrers-phase-3-adore-clinical-trial-of-fnp122-fab122).

I think the patients should get more details about it. What is your opinion?

ferrer.com

Ferrer reports top-line results from Phase III ADORE study in ALS | Ferrer

Ferrer reports that Phase III ADORE (EudraCT 2020-003376-40 / NCT05178810) clinical trial of oral edaravone formulation (FAB122) in amyotrophic lateral sclerosis (ALS) patients did not meet primary or key secondary endpoints.  

[Yannik]

I take Radicava orally and it goes very well. It takes me 2 minutes. Here in Canada it’s paid by the Government.

[Sheri]

I am a caregiver. My partner has had ALS since 2016. Started Radicava infusions as soon as they were available. The infusions lasted 4 years until ORS was available. She was lucky to have little to no side effects. The freedom that it affords both of us is immeasurable. It is true Medicare Part B paid for the infusions and the ORS is not covered under Part D. However we found Healthwell afforded grants for up to $15,000 per year ( renewable) for those that applied. That amount covers all of her ALS medications. Neudexta, Riluzole, and ORS.

Please remember that everyone has different experiences with this disease. Don’t give up! Live your life to the fullest.

[PCB]

Sherry, I saw your post. In my case with ORS, I went through JourneyMate first, then CVS specialty drug called and said my copay under part D would be over $3000. I got a grant from Healthwell for the 15k but that is still too expensive. How did you get all 3 drugs covered??

[Tara]

I began oral Radicava shortly after my diagnosis in May 2023. I received a $15K grant from HealthWell Foundation with JourneyMate doing the eligibility side. I hoped to renew the grant in May 2024. When I contacted Journeymate a month ago, I was informed that since I have Medicare Part D coverage, I will no longer quality for a renewal of the HWF grant. Apparently a change in eligibility criteria. . . has anyone else experience this??

[Peter]

Hi Dagmar, Ferrer published the results of Edavarone trial. Ferrer reports that Phase III ADORE (EudraCT 2020-003376-40 / NCT05178810) clinical trial of oral Edaravone formulation (FAB122) in amyotrophic lateral sclerosis (ALS) patients did not meet primary or key secondary endpoints.

https://www.ferrer.com/en/results-study-ADORE-ALS

As we speak about Edavarone, I would like to know what is the difference about Radicave and ADORE as it is as well Edavarone. Radicava holds 105mg / ADORE used 100mg. I have just seen a statement from the producer of Radicava (https://www.mt-pharma-america.com/media/news/press-releases/2024/01/17/mitsubishi-tanabe-pharma-america-inc-mtpa-statement-on-ferrers-phase-3-adore-clinical-trial-of-fnp122-fab122).

I think the patients should get more details about it. What is your opinion?