Taking multiple ALS medications

[Dagmar]

I think the biggest question is, how do you know which treatment is working?

[Sherry Campbell]

My husband takes  the 3 r’s. Our neurologist thinks there may a cumulative effect based on the different mechanism for each medication. There is no way to measure the effectiveness, except to say that my husband still walks with a rollator, can talk, eat, and hasn’t loss his mental acuity six years after symptom onset.

[Henry Feinberg]

Dagmar,

I’m curious as to how so many individuals can even afford to purchase the 3 R’s?
From what I can determine,  a months supply of Relyvrio and Radicava can cost a combined $20k a month or more.

Am I missing something ?

Thanks,

Henry

[Sherry Campbell]

The VA provides all of my husband’s meds. I know that some insurances cover a fair amount of the cost, plus the manufacturers often subsidize part of the cost. There are some other programs that assist with cost-sharing. The annual retail cost for the 3 R’s exceeds $300k/year.

[Sandy]

Henry, it depends on your insurance and if you qualify for a subsidy.  My husband has Medicare D prescription insurance.  He also qualified for the Healthwell grant of $15,000 to cover the co-pays ($600-$1000 per month) for Radicava and Relyvrio.  Rilutek is a $4 co-pay.

[Dagmar]

Henry, that is a good question. I hope our members will share how they are funding their multiple medications.

[Sandy]

Regarding which treatment is working, as far as I can tell there is no way to know because each persons progression is different.  That’s why every person who is taking any or all should be tracked.

[Chris Godfrey]

I was taking Radicava, Relyvrio, Riluzole together and stopped Radicava after three months as it made me very unstable and wobbly. I continue to take Relyvrio and Riluzole. I do believe Relyvrio has slowed down the progression, although the taste is awful.

[John E. Mosman]

Hi, I am 14 months from diagnosis amd I am taking the 3R’s along with other meds due to other issues – or -just getting older (75). I must have an iron stomach since along with vitimins take in lots of pills/liquid meds everyday. I have had the first signs of walking issues, bottom of my feet feel asleep so need to think about walking rather than just walking. Being so tired is my main complaint right now – more to come. Progress is slow but unfortuantly still progression.

Take care, John

[Louis Savarese]

Hi,

Sympton onset Dec 2019, diagnosed in Sept 2020 pesudo bulbar palsy. Can’t speak, use a MicKey feeding tube, lost quite a bit of muscle to atrophy, I can still walk a bit, but hand and arm strenght is pronounced.

I can’t say if I’m getting any benefit as my progression continues. Up until last Thanksgiving I was progressing slowly.  We had major stress in our family at that point that was unrelated to my condition and continues today. My progession had picked up speed and made up for the early slow going.

my current ALS meds are:

Riluzole 50mg 2x a day

Scopolamine transdermal patch 1.5mg

Nuedexta 20-10 mg 2x a day

RELYVRIO 2 PACKETS A DAY

ONE BOTTLE A DAY 30MG CNM-Au8 in 60ml oral suspension EXPANDED ACCESS PROGRAM INVESTAGATIONAL DRUG

hope this helps and please try and avoid stress

 

 

<u>Supplement suggested by Dr. Bedlack</u>

AS OF 3/19/2023 ACETYL L-CARNITINE 1,000 MG 3X A DAY

Melatonin 10 mg at bedtime

 

 

prescribed meds are:

 

[Sandy]

My husband had his first symptom, leg weakness, in July 2022.  He was diagnosed March 3, 2023.  By then he was unable to walk and using a wheelchair.  He started Riluzole in April 2023, added Radicava about 2 weeks later and then Relyvrio.  He had no side effects from any of the meds.  At the end of May, genetic testing showed that he had SOD1, even though, to our knowledge, he is the first in the family to have ALS.  Because of the “hype” about QALsody, he decided to go off Relyvrio as (like everyone else)  he was unable to determine if it was helping.  Onward to QALsody.  Insurance approved it and we are waiting for the Neurology Dept to set up the procedure.  He is not well enough to travel to another location as he has lost the use of right arm, left is weaker everyday it seems.  He can talk and swallow, breathing is difficult.  I feel like everyone who has this disease should have the disease process and medications tracked.  I don’t know how else they will figure out if any medication really helps.

[John Ceriotti]

Sandy

i was diagnosed June 2020 and was in the original Tofersen/Qualsody closed study and have had access to the drug since May 2021 or roughly 29 doses… LP every four weeks

There is no hype. It works at least for me as I have actually improved in many areas with some good hard physical therapy twice a week.

Even after abdominal surgery in July, I have recovered well, and hopefully within the next three or four weeks will be back to the heart Physical Therapy

I also take Riluzole two times per day

The Toferson works…That is my belief here at Washington University in St. Louis… Which has the clinic up and running for a few months ever since the accelerated approval!

Good luck!

 

[Sandy]

My husband heard from the doctor today, she wanted to know if he still wants to try QAlsody. She was not very encouraging, saying there is no actual evidence that it is a benefit and that more studies are needed. My husband said yes, he still wants to try it. She is talking about starting the loading doses on Sept 21. She will let us know on Friday after some other things on her schedule come together.

[John Ceriotti]

Why wasn’t she encouraging? I would say that she does not know the drug Tofersen and its benefits. She sounds like a Debbie Downer.

How did the loading doses work out for your husband?

I hope well!

I believe in the drug and with my other daily supplements I truly believe my life has improved and been extended!

Good luck Sandy…please keep posting updates!!

Stay positive…do not let others get you down!!!

[John Walker]

I’ve been taking Rilutek and Relyvrio for 6 weeks now.  I can’t tell if it’s helping or not.  I tolerate it well.  I take loads of supplements that hopefully help slow down ALS.  I’ve was diagnosed 3 years ago.  It took 2 years to diagnose.  Bulbar sent me to the Neurologist.  Looking back, I think I’ve had ALS for about 10 years, when I would occasionally bite my tongue while eating. The latest windmill I’m tilting my lance towards is Mercury poisoning from amalgam comprising my dental fillings.  It’s hard to believe metal in my mouth that’s supposed be 50% Mercury isn’t toxic to the human body.  I worked at a coal fired power plant as a senior engineer and I led most testing that was done to comply with the EPA.  Most critical constituents were measured in parts per Million, PPM.  Mercury detection was done in parts per Billion, PPB. A University brought in a Lab trailer with strict protocols for testing. Filtered air and cleanliness were necessary and test personnel wore face masks because they said the Mercury in the fillings would skew the results.  I recently watched videos through HealingALS.org and became aware of the Mercury angle. The videos with PALS reversing ALS were inspiring.

Note from the Forum Moderator: There is no evidence that ALS is linked to dental fillings. Also, please note that the site HealingALS.org presents many unfounded, untested, and unproven treatments and theories regarding ALS to its followers. 

[Michael]

I was recently diagnosed mid July 2023. My doctor prescribed the 3 R’s, as well as Ultra High Dose B12. Obviously for me it’s too early to tell if the meds are working. In the absence of any other options, I plan on staying the course in the hopes that it’s working. So far no adverse symptoms.

[John Miklosh]

I was taking the 3 R’s for a while but the side effects of Relyvrio made me decide to stop that medication (plus it tastes horrible, lol). I do wish there was some way to quantify the effectiveness of one or any of those medications. At the end of the day it is up to each individual to decide if the risk is worth the reward! I guess you just have to hope and trust that it is doing something for you.

[Mark Andrew Atwater]

I am taking the 3 R’s and there really isn’t a way to determine if they are helping or not.   The Relyvrio is awful but I tolerate it .  I was diagnosed in December of this past year and my feelings are if there is any chance that the drugs can help, I am all for it.

[Steve]

I have been taking Riluzole since late 2019 and Radicava ORS since June 2022. I began first showing symptoms in 2017 and was diagnosed in 2019.

I also feel week and wobbly the first few days while taking Radicava ORS.
The Riluzole really messes with my GI track causing a lot of indigestion and I have learned to live with that.

I am not sure either medication is helping slow the disease progression and believe the disease affects everyone differently. I also believe these medications (except Riluzole)
are nothing more than experimental drugs. Another words, nobody knows if they work or not.

Also I believe these experimental drugs are ridiculously priced for the benefit received. I believe this is why Medicare doesn’t cover them.

It is time the researchers and drug companies focus on a semi cure like with cancer medications and not slowing it down by some unknown percentage.

I wish us all luck,

Steve

[Tara]

Steve, wondering why Medicare isn’t covering your ALS meds- it is covering (the lion’s share) of mine.

[Edward Joseph Mytych]

When a pharmaceutical company develops an antibiotic for a clear-cut bacterial infection, and after patients receive the treatment, the infection is eradicated, there is typically a direct and observable cause-and-effect relationship where the drug visibly eliminates the bacteria. Patients experience noticeable improvements, both subjectively and objectively. They feel better as a result.

In contrast, when it comes to FDA-approved ALS medications, some of which are available at extremely high costs, we have managed to convince ourselves that we might be extending our lives by several months or even years. However, the real dilemma lies in determining how much, if any, we have actually stretched the metaphorical rubber-band-of-time by using these ALS drugs, compared to what our natural lifespan might have been without them. This drug-induced extension is extremely hard to measure and thus, take credit for.

Currently, Relyvrio has been introduced as an ALS treatment (full disclosure: I am taking it). However, there is an ongoing Phase 3 clinical trial that could influence its future. If this trial fails to demonstrate a substantial extension of life using conventional statistical methods, the FDA may request that Amylyx cease distributing Relyvrio in 2024.

In the most recent article, I’ve come across (source: https://www.fiercepharma.com/pharma/amylyxs-als-drug-relyvrio-gets-ground-company-eyes-new-brain-disorder), it’s evident that the European Medicines Agency (EMA) has not yet reached a consensus with Amylyx regarding Relyvrio’s approval, and a decision is also anticipated in 2024. Interestingly, from an investor’s perspective, publicly-traded Amylyx is reporting significant profits, keeping all shareholders satisfied, and rewarding their CEO with over $7,000,000 in compensation in 2022. (source: https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-amlx/amylyx-pharmaceuticals/management)

However, in Europe, a forthcoming rejection is suggested in the following article (source: https://www.amylyx.com/news/amylyx-pharmaceuticals-receives-chmp-negative-opinion-on-its-conditional-marketing-authorisation-application-for-amx0035-for-the-treatment-of-als-in-the-european-union). “On June 23, 2023, Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the application for conditional marketing authorization of AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine, also known as taurursodiol), under the trade name ALBRIOZA®, for the treatment of adults with amyotrophic lateral sclerosis (ALS) in the European Union (EU). This follows the Company’s May 2023 announcement that the CHMP was trending toward a negative opinion.”

If the American Phase 3 trial fails, it’s possible that Relyvrio’s availability may be eliminated in 2024 (source: https://www.biopharmadive.com/news/amylyx-fda-approval-als-drug-relyvrio/632592/). “Remarkably, some experts have called on Amylyx to commit to withdrawing Relyvrio from the market should follow-up testing fail to confirm its benefits. This pledge has been endorsed by at least one panelist who initially voted differently.”

As a community of individuals grappling with this life-threatening disease, we continue to grasp any potential treatment that might offer even a glimmer of hope. We hope that treatments like Relyvrio perform successfully from a statistical standpoint and do not turn out to be ineffective or “snake oil” remedies. Nevertheless, until our researchers and doctors can thoroughly comprehend the true causes of ALS and develop treatments that can be objectively measured through observation and testing, doubts will persist about how our disease might have progressed had we not taken these drugs.

Well, I write this just before dinner, and I go to mix up another $200, 8 oz. glass of possible life extension. Bottoms Up!

[Edward Joseph Mytych]

The latest financial analysis for Relyvrio: https://seekingalpha.com/article/4634289-amylyx-pharmaceuticals-high-risk-high-reward-stock

[Rita Johnson]

Hi,

I was diagnosed in August, 2022 with onset bulbar ALS. I can’t speak, I use my feeding tube for hydration and nutrition. I can still walk, drive, take care of myself (I live alone), but I recently have noticed strength in my left arm and neck getting weaker.

I currently take only 2 R’s: Riluzole and Radicava IV infusions and Nudexta. Like others, the price of these medications was way out of my budget, even with insurance. I don’t qualify for any funding because I am blessed to still be working. After months of frustration and almost deciding to not take anything! I found a online pharmacy (DiRx) that administers ‘generic’ only medications. So, instead of paying $1500/month I now get my Rilutek (generic for Riluzole) for $135 for 3 months’ supply (not using insurance).

Radicava ORS was going to cost me $3,000 / month but found out that Medicare pays for the IV infusions. So, between Medicare & my supplement, I pay nothing for my Radicava infusions. Yes, it’s time consuming instead of just taking a pill, but worth the price.

I don’t have any side effects from either of these medications. I don’t know if either of the medications are working, but I will continue to keep up the fight as long as it’s feasible.

Blessings to everyone,

Rita

[Mark]

I take the 3R’s and my Medicare advantage plan covers the lion share of the exorbitant cost.  As others have said, I’m hopeful that they’re doing some good.  Their’s no way to know of course since I don’t know what my progression would be without taking them.  I haven’t had any unpleasant side effects, although as everybody has mentioned the taste of Relyvrio is terrible (I’ve discovered it’s not quite so bad if you let the powder dissolve in the water glass for 5 minutes or more.  Try it!)

[Clint Williams]

I’m taking the 3Rs plus Neudexta and a handful of supplements to try and slow progression.  I can’t believe how familiar all these stories sound. I too became symptomatic 2 weeks after second Moderna covid Vax. Coincidence, or not, I’m doing all I can to survive longer for my family. My Rs cost me about $0. My Cigna PPO pays for everything except minor copays and Relyvrio. For that, I was contacted by the Amylyx Care Team who granted the medicine to me. Try them. I also have copay assistance from Radicava. My key move was enrolling with Synapticure, who advocates for me every month. I pay out of pocket to see their Neurologist, but the care nurse, genetic counselor and drug advocacy are free!

As to whether I’m slowing anything, who knows. Bulbar symptoms are worsening and now me neck and upper body are weakening. Call me bobblehead!

Regarding HealingALS, Dagmar, they fully qualify their information and encourage you to do what resonates with you. Access is free. They have set up a database for tracking treatments and declines (or progress) with hopes of piecing together a regimen that is helpful. At least they provide hope and actionable items, which allopathic doctors generally do not. They promote some quackery also, but we’re all trying to learn how to live a better life. Tish, Scott, Heather, Rita, Dr. Cowden and the rest at HealingALS should be commended.

[Tim Federwitz]

I only take Riluzole for now. However, I have an interesting anecdote around knowing if it is doing anything!

When I started taking it, I couldn’t tell if it was doing anything for me. However, I am used to my prescriptions auto-filling for me, so I ran out after the first month. It was through some specialty pharmacy that I had never used and I could not figure out how to contact them. Also, since I couldn’t tell if it was doing anything, it wasn’t pressing on me to track it down.

This meant I was off it for a little more than a month. About two weeks after stopping, I noticed finger and muscle twitching/spasms happening more often (I have a strong spastic component as part of ALS). Because it came on slowly, I figured it was just my symptoms progressing again. It did continue to worsen the longer I was off Riluzole. Also, hindsight reveals to me that this twitching was pretty bad before starting Riluzole, but it’s funny how easily we forget things.

I finally figured out how to get a refill for the Riluzole and started taking it again. Three days in, the twitching was still just as bad, so I chalked it up to progression. However, I set a reminder to analyze this again in 2 weeks. Lo and behold, 2 weeks later the twitching and spasms had subsided again!! I liken it to pain meds… when it is working, you likely don’t realize it (especially because it isn’t instantaneous relief). But when the pain meds wear off, you realize they were working!! LOL

Every person with ALS I have ever met is unique with varying symptoms, so it’s hard to say how anything will react for an individual. However, this mistaken test made me feel pretty good knowing that it was helping me to some degree. I am almost a year in on Riluzole now and some of the twitching is creeping back in (mainly when I am super tired or don’t get good sleep), so it isn’t a miracle drug.

I am about to submit for Radicava, and I’ll likely have no idea if that does anything. LOL. My Insurance denied Relyvrio, and even though I might be able to get help from Amelyx, the potential side-effect of diarrhea is putting me off even trying it. Plus, I saw that there are questions of whether or not it truly does anything and they could be asked to stop selling it (just from what I’ve seen on the inter webs… don’t take this as any type of fact).

[John E. Mosman]

I too am taking the 3R’s and able to tolerate without a problem. My VA doc also thinks the cumulative effect 0f all three is helpful.

John

[Timothy R Marshall]

I read your various experiences with great interest. Diagnosed Aug23 with C9orf72 mutation ALS, I am so far on Riluezone (2x50mg), and at an upcoming meeting with my provider will discuss when/if/what other therapies to add.

Your insights on side effects, insurance coverage and apparent efficacy will help my informed medication direction.

[David Rothschild]

I tried Radicava in addition to my riluzole and noticed that I was more fatigued. I took it for three months and developed double vision, which I have a feeling might’ve been caused by the Radicava although it is not a listed side effect. There are multiple ICE side effects from Radicava looking at the data it’s hard to believe that Radicava or the newest medicine make a difference and it’s certainly hard to know what is working when you are in the midst of ALS does exercise help? Do vitamins, and antioxidants help? Who knows. Those people that are blessed with many years of ALS, I just different is my belief. Each of us has a disease that Ron sits on course. I read that the moderator has had a ALS for 13 years. What does she think her success is due to?