Rituximab in the USA - Dr. Kogelnik

[Roy S]

This is a blog by a patient about her first visit to Dr. Kogelnik.

http://bikechick06.blogspot.com/2012/01/visit-at-dr-kogelniks-office.html

"So far he is getting the same results as the Norwegian study and he is in contact with dr Fluge and Mella once every 2 weeks. he is expecting that clinical trials will happen within a year."

Thanks to XGA for the link.
http://www.facebook.com/pages/XMRV-Global-Action/216740433250

 

[justinreilly]

Great! Though the slow pace of the drug trial process is very frustrating! I hope they do everything they can to speed it up! We need help now!

 

[Camilla]

I read this blog post about the Rituximab patent running out - sounds most worrying!

The shameful story of Rituximab in Multiple Sclerosis
http://neuroimmunology.wordpress.co...ful-story-of-rituximab-in-multiple-sclerosis/

 

[Levi]

Great,

Wait a little bit longer and ME/CFS patients will be able to get a melamine flavored Chinese Rituximab generic at a fraction of the cost . . .

 

[floydguy]

Great,

Wait a little bit longer and ME/CFS patients will be able to get a melamine flavored Chinese Rituximab generic at a fraction of the cost . . .

Yum! That will take care of things quickly! Later on they'll probably come out with lead and cadmium flavoring as well. The sad irony is that would be more humane than the CDC & NHS approach.

 

[Tia]

Great! Though the slow pace of the drug trial process is very frustrating! I hope they do everything they can to speed it up! We need help now!

Exactly what I was thinking..I feel like I have 8 months TOPS, and that's stretching it. Look more (and feel more) dead than alive anyway so if even 8 months, I'm "lucky". Speeeeed please!

 

[Waverunner]

I'd greatly appreciate it, if they would speed things up a little bit.

 

[fusroy]

Anyone Else using Retuximab for ME/CFS in the U.S.?

Does anyone on this thread know if anyone else, besides Dr. Kogelink is using Retuximab for ME/CFS treatment in the U.S.? If so, please let me know who else is using it and where they can be contacted. I also don't understand why Dr. K. has been authorized to use the drug if no one else is. Doesn't the drug need to get a general approval for treating ME/CFS first? Please let me know if you can answer either of these questions.
Thanks, B.F.

 

[Kati]

fusroy Currently Rituximab for ME has been used as clinical trial and is not approved by FDA for use in our population.

I don't know if it's the case for sure, but it is in my opinion that it's not that Dr K is the only dr "authorized" to use it in the US, but he is the only one currently willing to try it and eventually offer formal clinical trials. Using the drug off-label is a risk that they take in order to take care of their patients. As you may know Rituximab is not without risks.

Initiating clinical trials is extremely complex and time consuming, needs ethical review and FDA approval, and of course funding. I hear Dr Enlander and Dr Klimas are considering the drug for clinical trials. thisis the only way that can lead to approval of the drug by FDA for a treatment of ME.

 

[smoothfox99]

I'm finished with infusion 3, I live in CA. He is authorized to use it because he is a top researcher and is in contact with every important ME doctor around the world all looking at our vast amounts of blood.

It is a rough start infusion 1 is hard painful and long
But after that it goes pretty smoothly.

I have been told that we need to stay positive because it looks like infusion 3, 4 are the ones that start to take effect
So I'm confident this is our cure.

Love to all, prayers too.
Rachel

 

[dsdmom]

Rachel thanks for the update. Could you provide your blog address here for those of us not on twitter?

Fusroy, any dr is "authorized" to write a prescription for rituxan, it just depends on whether or not they are comfortable doing so. To date dr k seems to be the only one who is.

 

[usedtobeperkytina]

The key is not just who is willing to give it, but who is going to pay for it. Still rather expensive. However, might be able to get drug company to give it on hardship.

After the CFSAC, there will be a private think tank meeting to discuss what the Rituximab study portends. According to Dr. Friedman, they hope to produce a paper from that think tank meeting to be published. The goal is to get the NIH interested in funding a large-scale study, since the drug company has no interest.

Tina

 

[MCRobbie]

Could anyone comment about how the Drug is being paid for for those who are being treated with it by Dr Kogelnik. Is it an out of pocket expense for everyone or........does anyone know if any patients have found some form of coverage for the medication........or is it being 'covered' as part of a trial..........

Thanks.

 

[Sushi]

Could anyone comment about how the Drug is being paid for for those who are being treated with it by Dr Kogelnik. Is it an out of pocket expense for everyone or........does anyone know if any patients have found some form of coverage for the medication........or is it being 'covered' as part of a trial..........

Thanks.

I believe a trial will be starting soon.

Sushi

 

[Kati]

Dr Kogelnik requests patient assistance from Genentech Foundation- there are a few requirements to meet- the big ones to qualify is you must not make more than 100 000$. I have paid 0$ for the drug. Last time I heard it was 6300$ a dose.

This is not considered a trial. It is a pilot study- which usually precedes formal clinical trials.

 

[MCRobbie]

Well Heck, thats an easy requirement. How many people suffering from CFS are making a 100 Grand! Certainly not me!

Thanks Kati for the information. All kidding aside thats very interesting. I hope you find some improvement!

Thanks too Sushi for the info on possible trial.

 

[dsdmom]

Hi, I'm set to start rituxan in a couple weeks but not with dr k. My doc got it covered by insurance...we shall see how it goes.

 

[Wally]

Well Heck, thats an easy requirement. How many people suffering from CFS are making a 100 Grand! Certainly not me!

Thanks Kati for the information. All kidding aside thats very interesting. I hope you find some improvement!

Thanks too Sushi for the info on possible trial.

Dr Kogelnik requests patient assistance from Genentech Foundation- there are a few requirements to meet- the big ones to qualify is you must not make more than 100 000$. I have paid 0$ for the drug. Last time I heard it was 6300$ a dose.

This is not considered a trial. It is a pilot study- which usually precedes formal clinical trials.

It is my understanding that there may be other avenues that are available to see if the drug will be covered if you do not qualify for Genentech's patient assistance program for ME/CFS. If people are interested in looking into whether or not they may be a candidate for a trial (pilot study) of Rituxan, then contacting the Open Medicine Clinic for more information is probably the way to go.
http://www.openmedicineinstitute.org/Contact_Us.html

Dr. Peterson's recent interview on MECFS Alert Episode 26 discusses his plans to participate in a formal clinical trial, which the Open Medicine Clinic is currently working on setting up.

See Episode 26 with Dr. Peterson at the 4:00 minute mark to the 5:00 minute mark.

See also Episode 22 (this is Part 1) with Dr. Kogelnik at the 4:36 minute mark to the end of the video.

and
Episode 22 Part 2 with Dr. Kogelnik at the 5:28 minute mark to the end of the video.

Wally

 

[Fred1234567]

In Australia on the PBS website it states that the cost of rituximab from the manufacturer is about $2 300 then there is 7.5% wholesaler mark up... which brings the 500 ml vial up to around $2700 per treatment (average person 375 ml per treatment) - the difference between $2700 and what you are charged is the retail pharmacy mark up. Genertech in the USA seems to have a very generous approach to helping people out. Roche is halving the price of Rituximab in South Africa and India...!!!

 

[Kati]

In Australia on the PBS website it states that the cost of rituximab from the manufacturer is about $2 300 then there is 7.5% wholesaler mark up... which brings the 500 ml vial up to around $2700 per treatment (average person 375 ml per treatment) - the difference between $2700 and what you are charged is the retail pharmacy mark up. Genertech in the USA seems to have a very generous approach to helping people out. Roche is halving the price of Rituximab in South Africa and India...!!!

My dosage is 1000 mg and need 2 vials. The cost I mentioned is for 2 vials. Dosage varies per disease (lower dosage for combined regimen as in lymphoma) and usually is quoted per meter square (BSA) (skin surface).