Rilutek Discussion: Cost, Effectiveness and Availability

[grp_believes_in_God]

Thanks guys for replying. My father is in India and I am in USA. The doctor over there prescribed Rilutek, but they cannot obtain it in India. I inquired about it in the pharmacies here in USA and they told be it costs $900 for 60 tablets, which is just crazy. I am trying if it can be obtained in India at a cheaper price. Does anyone know any cheap way to get Ruletek? How useful is it anyway ? How much "stock" should we put in it?
Anyway, He is seeing another neuro and I am praying for a miracle somehow that the diagnosis be reversed. Thanks again to those who expressed sympathy.

grp

[Al]

Hi grp. There are online pharmacies in Canada that sell to people in the states. Rilutek is only $ 670.00 here for 60 tablets which is a months supply. The US dollar is worth about 15 cents more than Canadian so you would save another$105 so for about $550 give ot take a few dollars it would be cheaper. Do a google search for Canadian mail orde pharmacies. You still need the prescription though. Hope this helps.
Al.

[ekoozmin]

Hi all--

I read somewhere that if you write to Aventis Pharmaceuticals and explain your situation, that they have a policy of providing it at no cost, but you have to qualify somehow. I tried their website this evening but it was down.

Liz

[ladave]

From the Aventis Rilutek website:

"The Rilutek Patient Assistance Program
The Patient Assistance Program has helped to cover the cost of Rilutek for hundreds of eligible patients. The program is sponsored by Aventis Pharmaceuticals and administered by the National Organization for Rare Disorders (NORD). Eligibility is determined solely by medical and financial criteria. All eligibility decisions are made by NORD."

I'd also suggest you contact your local ALSA and MDA for assistance.

As to how useful the drug is- initial studies showed benefits at 12 months but not 18 months (see Aventis website for details). Several subsequent studies show a modest effect in slowing the disease.

My insurance covers Rilutek with a monthly $20 copay. If I had to pay $900 for a month's supply it would be hard to justify given that the benefits of the drug are modest even if it does work. In my opinion one should never have to choose not to take an indicated medication for financial reasons. However the world does not live by my rules. If it did a lot of things would be different (I guess I should stop there before I get on my political soapbox:-)))

[Al]

Would that be a Republican or a Democrat soap box Dave? Seriously though I am on a pension and while it keeps the wolf away from the door I would not or could not pay $ 900 per month for meds. I also take other drugs for heart condition that cost about a grand a month. Thank God and the union for having a drug plan with a $25 deductible per year.

[marlo]

Thanks guys for replying. My father is in India and I am in USA. The doctor over there prescribed Rilutek, but they cannot obtain it in India. I inquired about it in the pharmacies here in USA and they told be it costs $900 for 60 tablets, which is just crazy. I am trying if it can be obtained in India at a cheaper price. Does anyone know any cheap way to get Ruletek? How useful is it anyway ? How much "stock" should we put in it?
Anyway, He is seeing another neuro and I am praying for a miracle somehow that the diagnosis be reversed. Thanks again to those who expressed sympathy.

grp

Hello GRP,

Very sorry to hear about your father. I know most of the people on here probably would disagree with me on this matter. But in answer to your question about the Ruletek drug. Both of the neurologist that i saw, said it wasn't worth the money for it so they didn't recommend it. They put me on 400 mg of coq - 10. It does seem to help my pain. Hope this info, is helpful. Best of luck with your father.
Love and Prayers
Marlo

[ladave]

Marlo-

I find it interesting that your neuros are making judgements about medication based on cost. To me that's what's wrong with our medical system. In my case I'm lucky, my insurance covers it except for a $20 copay per month, so my doctors and I are able to make a medical judgement unencumbered by cost-benefit issues. But that's not the point.

A treatment should be undertaken based on the benefit it provides as weighed against the side effects. Period. Based on this, some may choose not to take Rilutek, but it would be a medical decision, not an economic decision. (Yes I know I'm dreaming, but I couldn't help commenting.)

[Al]

In the case of people in Ontario that don't have a drug plan from their work there is the Trillium plan. It sets a deductible yearly based on your income. A guy making $100 thousand would have a deductible of around $8 thousand. Less money less deductible. From what I have heard some of the clinics will help get funding from the manufacturer as well. So there are options. I would think MDA or ALSA would be able to offer assistance if needed in the U.S.

[Dee]

I thought I would comment on the Rilutek thing. I am in agreement with Marlo not because of a money situation although as ALS increasing the expense can be enormous but I have read over and over again, that Rilutek only increases life spam of about 3 months. My dad and a friend of our family were diagnosed with ALS two months apart. Our friend had Bulspar(sp?) and went on Rilutek and my dad choose not too. My dad lived over a year longer. I too don't mean to be negative but I haven't read anything that great about the drug so for $600 - $900 a month seems like a lot for most people. My dad went the vitamin and nutrient route.

[Al]

Not wanting to be the bearer of bad news but Bulbar patients last 6 to 18 months only most times. Some are longer but generally 6 to 18 is it. Limb onset patients generally last 2 to 5 years or longer but 80-90% are gone in 2-5 but some last even longer than 10 or 15 years. Who gets the longevity prize?. No one knows. It might not be the one who prays the most but then again it might be. You just have to do what feels right for you. We're all different. I haven't fallen down until tonight but missed a step on the walkway while looking for the door key. Down I went smacking up right knee and hip left hand and scrapes and sore muscles where I didn't think I had muscles anymore. Some of the people I know of have been falling lots. My first. We're different once again. I guess I just have to pay more attention walking and yes Carol and Tbear wine was involved luckily or I might have broken more than my ego. LOL.

[CIARA1]

Al ,I hope it was red wine that was involved with the fall.

[TBear]

... falling due, in part, to red wine consumption is allowed/encouraged! So long as it's good red wine! Just back from Barcelona and could not find a bad bottle of Rioja... and the professor and I looked a lot!

T.

[braveheart]

I have read many comments on what Rilutek does, "extends life by only 3 months" for example. My understanding is that these are months added to each year to 18 mos. of survival, so it is accumulative, I like that and hope I'm one of the 10% that live past 5 years! :)

[ladave]

The rilutek question is more complicated than the "three months" calculations. I'm not even sure where that number comes from. Initial studies showed rilutek to be neuroprotective. The two "double-blind" studies done thereafter, which formed the basis of FDA approval, actually showed a benefit at ,6, 9 and 12 months but not 18 months. These have become controversial results to some PALS who claim that the numbers were "fudged" because aparently in one of the studies, different measures were used to calculate the final results than had originally been proposed.

Since then multiple reviews of the drug have been done. An open label study done with Mexican patients found a statistically significant slowing of disease progression:


Results
One-year treatment ended January 1998 for the 50 patients initially enrolled, of which 31 (62%) completed the study. Of those did not complete treatment protocol, 14 (28%) were because of non-compliance with study visits our voluntary drop-out, mainly in the first two month of treatment with riluzole; 4 patients (8%) died of respiratory failure (none of them presented treatment related side-effects), within a mean of 5 month after riluzole was started; one patient (2%) has to continue drug therapy because of skin rash which disappeared after stopping riluzole.

Thirty-one patients (11 women, 35% and 20 men, 65%), with a men age of 47.67 (SD 10.35) years (49.16 years for women and 44.63 years for men) completed the one-year treatment. Mean clinical evolution of ALS was 25.83 (SD 13.43) months (29.66 months in women and 23.73 months in men). None of the patients had a greater then two-fold increase in aminotransferase . Mean values for alanine aminotransferase and aspartate aminotransferase were 27.78 U/L at study entry, and 27.58 U/L and 26.76 U/L at the end of one-year therapy, respectively. Complete blood counts were not significantly different before and after treatment.

Full Article-> http://www.medicosecuador.com/revecuatneurol/vol8_n3_1999/open_label_study_of_riluzole.htm

The "Cochrane" review of existing studies concluded rilutek conferred a two-month survival extension, but also cautioned these results were skewed by the fact that one study included multiple older, fast-progressing patients:

(broken link removed)

Perhaps most intriguing were reports from three separate patient databases presented at the 2001 International Symposium on ALS describing long range
experience with riluzole. All three reports suggest a trend of increasing survival with riluzole over time. It was concluded that "more studies that are double blind and controlled are needed to confirm these database observations. The trend appears to indicate that longer periods of time than those used in the riluzole clinical trials may be needed to see the long-term survival advantage of the drug."

http://www.als.ca/_news/64.aspx

Interestingly, I find no evidence that any such "studies" were ever done to confirm the database observations. It seems to me, then, that rilutek may be far more effective than the original studies indicated; my own nueurologist told me that current thinking among his colleagues is that the drug is more likely to be beneficial when given to patients in earlier stages of the disease and that it is probably much better than most doctors originally thought. Now, that may be self-delusional puffery to make the docs think they are doing something they really aren't. But it is interesting nonetheless.

[rcharlton]

I think there are quite a few studies showing that rilutek may be a lot more effective than people originally thought. I know that my neurologist formerly advised patients that there was little benefit to taking the drug - but is now recommending patients to take it based on recent studies.

The problem I have with these studies, as with all treatments for ALS, is that no one can really say for certain whether a given treatment is actually making any difference.

From my understanding, for ALS studies, due to ethical reasons, they do not have the usual control group being given a placebo to compare against a group being given the drug; however, even a regular control group would not be much help in ALS studies.

Every ALS case is different. Plus the natural progression of the disease for each PAL will involve ups and downs with occassional improvements. Complicating matters is that we don't know what causes ALS. There are so many factors and variables that could be contributing to motor neuron deterioration - so we can't isolate or remove the factors contributing to cell death or know if they are present to the same extent in each subject. Also - the disease itself may have changed over time - it may be affecting younger and younger people who may be able to survive the ravages of the disease than older people. As a result of all of these factors - trying to determine whether a given treatment is effective is next to impossible.

Really the only way to determine whether a drug is effective for ALS would be to take a group of people - then create a test group by making make true copies of every member in the group - not even cloning would be enough - we would need duplicates that are the result of the same genetic and environmental factors - give the original group the drug and the test group a placebo - subject each group to identical diets and living conditions in all respects - then wait and see if there is a difference in survival rates and progession between the groups. Of course this would be impossible.

Another problem with determining the effectiveness of Rilutek is that it has to be taken on an empty stomach. My understanding is that if your stomach is not empty, the drug will just bind with the undigested food and be wasted.

I don't know about the rest of you, but my regimen involves eating or nibbling on something or taking some kind of supplement almost every moment I'm awake.

I'm on rilutek - and I have to wake up in the middle of the night to take one of the doses - but that's probably not so great because the pill is then probably just sitting in my gullet or throat all night.

So even if there are benefits to rilutek - I may not experience any benefitis personally because of my eating habits.

Sigh - ALS is the ultimate mind%@#.

We gotta just keep on truckin'.

[John1]

RC,

Do know how long before eating one is to take it? I usually gobble them down a few minutes before a meal. I've been doing this for 4+ years!

John

Edit. I've just googled it and found this. Glad you posted, I'll be changing my ingestion times.

DOSAGE AND ADMINISTRATION
The recommended dose for RILUTEK is 50 mg every 12 hours. No increased benefit can be expected from higher daily doses, but adverse events are increased.

RILUTEK tablets should be taken at least an hour before, or two hours after, a meal to avoid a food-related decrease in bioavailability.

[ladave]

RC-

Your post summarized many of my feelings about ALS generally and rilutek in particular. With such a variable disease, it is hard to know whether any given treatment is "working". Consider this hypothetical- person starts taking treatment "x", within two weeks his arm strength improves somewhat. Is it the treatment, or were denervated muscles "reinnervated" through normal disease process?

Rilutek is even harder to judge because even if it works, you don't get "better", you just get worse more slowly.

Myself, I tend to think it must confer some benefit because every study seems to so indicate. What benefit, I cannot know for sure. I'm on it about three weeks now and have noticed no change in my rate of progression- ALSFRS and ALSFRS-R scores constant, fasciculations slightly worse (noticeable in right calf and right cheek). Three weeks, though, is not much of a test, and I too must be more careful to take on an empty stomach.

[Granny]

I find taking Rilutek on and empty stomach is a pain....but I take it at 10 am and 10 pm or as close to those times as I can. Most of my food is tube fed, or puddings, or shakes so I just work around those. I have been taking Rilutek for a year and a half, and does it work? Who knows. I have Bulbar ALS, was diagnosed in April 04. That is two years ago, and if the survival rate of bulbar patients is 12 to 18 months, I have outlived the norm...yahoo. My age also works against me...I am not a spring chicken, so I feel I am blessed to be doing this well. Prayer, and friends and a positive outlook, and humour (which I learned here) and maybe Rilutek, who knows what part the drug plays.

[marlo]

Marlo-

I find it interesting that your neuros are making judgements about medication based on cost. To me that's what's wrong with our medical system. In my case I'm lucky, my insurance covers it except for a $20 copay per month, so my doctors and I are able to make a medical judgement unencumbered by cost-benefit issues. But that's not the point.

A treatment should be undertaken based on the benefit it provides as weighed against the side effects. Period. Based on this, some may choose not to take Rilutek, but it would be a medical decision, not an economic decision. (Yes I know I'm dreaming, but I couldn't help commenting.)


Hello Dave,
I agree with you that the doctors sometimes make decisions for the wrong reasons and we are the ones to pay the price. However,, All i can tell you about my neuros is that they dont' like each other too much and yet they both said the same thing to me at two different appointments so they didnt' know what the other one had said. I got the feeling,, for them it wasn't so much about the cost as it was the fact that it only gives a person an added 3 months or so. They didn't say that was per year or anything,, just 3 months. We all have to do what we have to do ,, but for me,, i can't afford it. I figure when the good Lord is ready to take me home,, i'll go and not a day before,, regretless of what medicine i'm on. If he wants me that bad,, it won't matter if i'm on Rilutek or not,, he'd just crash my car or something. You see,, i believe HE is in charge ,, not me.

Marlo

[ladave]

Marlo-

I understand your circumstances and would always fully support any decision made by any PALS with regard to their treatment. My comment was more to the general principle of money playing a role in medical decisions, which I think stinks. Medical decisions should be made for medical reasons, period.

Now, as to the rest of what you said- each of us has our own beliefs about the sacred (and the profane for that matter). As for myself, I've always put great stock in that old saying, "The Lord helps those who help themselves". I believe God no more wants PALS to die than S/He wants Saddam Hussein to live. More basically, I believe we were created with free will and that our choices are our own to make. That God may already know the outcome changes things not one bit for us down here on Earth. So I will use the intellect God gave me to make the best choices I can and to maximize what time I'm given.

[grp_believes_in_God]

Hi Marlo, Thanks for your kind sympathy. I will pray for you and other PALS while I pray for my dad. My dad saw another neuro yesterday who said rilutek was waste of money and not of much use. THe first neuro did prescribe it so I guess every doc has different opinion.
I appreciate the discussion on this thread. Every opinion has its merits and its good to know different perspectives. Ultimately its an individual decision whether to take rilutek. Certainly financial situation will play a part. Right now I think I can afford RIlutek (it costs about $500/month in India). If it cost $50 we wouldn't be having this discussion. I don't know why it takes that much to make a tiny little pill.
I want my dad to live long enough so I will provide him with all financial assistance I can give. I think I can afford $500/month. It's not going to make any difference in my standard of living. It will however give me some peace of mind.
So unless there is a medical reason (like side effects) I will urge dad to take this pill.
Everytime I read a post that says bulbar pals have shorter life it breaks my heart but when I read a posts that says people lived many years it cheers me up. I am willing to cling to any piece of hope I can see. Certainly rilutek gives me some hope.

[shackney]

GRP,

For the record, I think the common sentiment that Bulbar ALS is "worse" than limb onset or that the prognosis is shorter is based on complications that arise from speaking/swallowing difficulties, not disease progression. I am not a neurologist or even a doctor (I am, ahem, a lawyer), but my internet research leads me to conclude that Bulbar ALS may actually have a slower disease progress than limb onset. This is so because the Bulbar symptoms often remain localized in the Bulbar region of the brain before spreading to the limbs. Once they spread to the limbs, disease progression is consistent with limb onset. Logically that leads me to conclude that there is a longer disease path in Bulbar.

The problem is in the complications -- I think many pALS resist feeding tubes and may encounter depression as a result of losing an "essential" function -- meaning one as deeply personal -- as speech. As a result, the nutritional difficulties and attending depression may put Bulbar pALS behind the eight ball. These problems can be readily addressed, however, with PEG tubes and AAC solutions. Thus, though there is some truth to the notion that Bulbar ALS is "worse" than limb onset -- I do not accept the notion that it is faster when viewed purely in the context of disease progression.

My Dad has Bulbar ALS and this is the reason both for my defensiveness as well as for my attempts to get to the bottom of the "Bulbar is faster" theory. Good luck with your Dad.

[marlo]

Hello Dave and GRP,

Sounds like we are pretty much in agreement about this disease. I do believe that we should do all we can to stay alive. And if you can afford to take a costly drug ,, and it's something you want to do ,, i think you should go for it. However, in my situation,, i can't afford it,, and as GRP , said, " it does appear that the doctors are still in debate over the drug", so who knows if it helps or not. Sometimes we fool ourselves into thinking something makes us feel better even if it doesn't. How else can you explain those tests done on people where half get a sugar pill and the rest get the real drug. In several cases the people given the sugar pill calmed to get better. I think it's simply mind over matter. In anycase ,, we were born as you say with a "free will" so the choice is ours to make. But i think if I was meant to take expensive drugs ,,, God,,, would also be a big enough God to provide the means in which to do so. When he does that then i will have to make another decision. Until then my hands are tied. I am glad some of you are able to have that choice. I'm at peace with it until the situation changes.
As for the Bulbar ALS,, being faster in breaking down the body. I think i would have to agree with Shackney. I have Bulbar myself,, and know of two other people in my town that have just been diagnosed with Limb ALS. So far they are going down hill faster than i am. And i no at least one of them is on the expensive drugs. However, i guess that doesn't really mean anything. Since the verdict is still out on that one. I just think it's more of an individual thing,, and no matter what we do,, it will break down as fast or as slow as our Maker allows.
Hope you all have a good.
Love and Prayers
Marlo

[MtPockets]

Marlo I agree with you completely. I had just started a new thread when I found this one on the search icon. I now am not as upset as I was when I posted this on the other thread.
Thanks for reminding who is really in control.
God Bless
Capt AL

I have been disabled for over 18 years due to nerve damage and chronic low back pain in my lower back. I have always been able to get the medicines I needed for this through my workers compensation coverage out of Alaska, where I was originally injured. I now live in Gulfport Mississippi where I had returned to see my back surgeon after the injury. So for all these years I have not had to pay for any of my back related medicines and treatments.

Last week I needed 5 prescriptions paid for by my workers comp worker and they were all turned down. The reason was the treating physican who has been seeing me for years had put the diagnosis right on each prescription as DX/ALS. After the prescriptions were rejected I talked with the doctors office several times and they said every visit I have had since I was DX with ALS May 11, 2006 has been written up as an ALS visit. Even though 90% of them were not ALS visits. They are apparently totally ignoring 18 years of back pain and nerve damage treatment.

So now workers compensation will not pay for any of the prescriptions. I have tried to get in to see the doctor and explain that 4 out of 5 of the prescriptions were back injury related and not ALS related, but he refused to see me again saying I needed to go to see a second neurologist for a another opinion?

I cannot afford the Rilutek and have no way to pay for it at this time. Does anyone know of a source that can help, such as a drug company or something?

This just about threw me off the edge when they told me this. My back pain has been getting worse all the time due to additional effects of the ALS, losing my legs etc. With the added stress of this it was just too much for me handle at one time.

My pain management doc has me scheduled for some back injections today to try to get some relief from the back pain, and he will bill workers Compensation without any problems. But this other Doctor is my family doctor for years, and he does not want to even discuss the issue and workers compensation will not let me change doctors again. This is sooooo frustrating.

Sorry to be so down, but this is a bummer. Any suggestions?

God Bless
Capt AL

[Meg1]

Just a couple of points:

There was a British study of long-term ALS survivors published a couple of years ago that determined that, contrary to popular belief, bulbar ALS suffers are as likely as limb-onset patients to survive for more than ten years. IIRC, among PALS who have lived with the disease for the longest, aproximately 30% are bulbar-onset patients which is almost exactly the incidence of bulbar onset among all PALS. It seems that there's almost a reverse bell curve tracing years-til-death for bulbar PALS. A greater number of them die early, but fewer die in the average (three-to-five year) period.

As for economics and medications, OF COURSE price does and should be considered in the drug-taking decision-making process (feeling like Jesse Jackson here). Economics have to be part of the cost/benefit equation in the real world because dollars are a scarce commodity, whether they're being shelled out by an individual or an insurance company. Would you pop a Tylenol every time you had a muscle ache if they cost $100 each? Of course not. We always have to weigh the potential benefits from anything (food, clothing, drugs) against their costs which always include the monetary costs. It's only when the benefit approaches life versus death (definitely not the case with Rilutek, IMO) that monetary cost ceases to be an important consideration.

And that's your economics lesson for today.

[MtPockets]

Just a word of caution to some who might consider purchasing drugs overseas or over the internet, there is a very large business in counterfeiting drugs in other countries. Yes, you may find Rilutek or some other drug somewhere very cheap, but are you really getting that drug?

I myself have decided it's not worth the cost to take Rilutek anymore. I have been on it for about 8 months, and have noticed no difference in my progression. Just my personal choice.

God Bless
Capt AL