Hello all,
I am new to the Campath forum but some of you may recognize me from the Tovaxin forum. I want to for some feedback from you folks, especially the those who have gone through the Campath treatment. Below the paragraph with my questions is a description of my situation if that helps with your input.
After the Tovaxin study was shut down, the Campath folks finally decided to let us Tovaxin folks into the CARE-MS II Campath study. Unfortunately for me, last Thursday at my baseline visit I was informed that I had been randomized to the Rebif arm. Needless to say, I'm pretty bummed out. I don't have confidence in another interferon and I'm afraid that I can't spare 2 years and an expected 2 major flares (based on my Betaseron experience) to wait for the crossover to Campath.
There is an MS clinic just south of Nashville, TN that prescribes Campath as an "off label" treatment for MS. They do the infusions and a couple of followup visits and then all of the monthly blood work is handled through your regular physician. The cost is about $6000 for the month 0 infusions and $4000 to $5000 for the month 12 infusions.
For the people who have gone through the Campath treatment, would you do it again? Do you suggest to other folks that it is a treatment that they really should consider? With the monetary costs out of the equation, is this an option that I should really consider?
My MS situation:
I have had MS for 5+ years now and my MS is primarily thoracic spinal cord involved. My symptoms are mostly problems with leg mobility and balance leaving my ability to walk certainly compromised. Depending on the day, my EDSS ranges from 4.0 to 5.0. Throw in a fair amount of tingling in my hands and feet as well as spasticity in my legs and you have how MS affects me.
I started out with Betaseron but things did not go well for me on that. I continued to have a fairly severe exacerbation every 9 months. After 18 months I switched to Copaxone and while I did feel better on that I still continued to have a fairly severe exacerbation every 9 months. After 18 months on Copaxone, I then entered the Tovaxin trial and did get the actual Tovaxin treatment for the first year and then went into the Tovaxin extension study. There, I received 4 of the 5 vaccinations before the study was shut down. During the total of 2 years in the Tovaxin study and extension I had only 1 relatively minor flare.
Thanks for your input,
Mike
Campath feedback please
-
CureOrBust
- Family Elder
- Posts: 3374
- Joined: Wed Jul 27, 2005 2:00 pm
- Location: Sydney, Australia
Re: Campath feedback please
hmtucker wrote:that prescribes Campath as an "off label" treatment for MS. ... The cost is about $6000 for the month 0 infusions and $4000 to $5000 for the month 12 infusions.
Mike, could you please make this a little clearer what you mean by this? I have found that it is illegal for Campath to be used off label in Australia for MS, and so am considering options of OS.-
hmtucker
- Family Elder
- Posts: 100
- Joined: Tue Nov 28, 2006 3:00 pm
- Location: Versailles, Kentucky
- Contact:
Re: Campath feedback please
Cure,CureOrBust wrote:Mike, could you please make this a little clearer what you mean by this? I have found that it is illegal for Campath to be used off label in Australia for MS, and so am considering options of OS.
Here in the US, once the FDA (Food and Drug Administration) approves a drug for use in humans it does not attempt to regulate the use of the drug. The company that makes it can only advertise or market the drug for the specific disease that it went through clinical trials and approval for. Since the FDA does not regulate its use, that allows physician to prescribe the drug based on their best judgement. When prescribing it off label the doc needs to make it painfully clear that the drug has not been approved for the disease that they are prescribing it for. In Campath's case, it's been approved for years for use in B-cell lymphoma so that makes it open territory for a doctor to prescribe it for MS as long as the patient understands that it has not been approved for MS therapy.
Clear as mud?
Mike
Last edited by hmtucker on Tue Feb 24, 2009 12:38 pm, edited 1 time in total.
-
hmtucker
- Family Elder
- Posts: 100
- Joined: Tue Nov 28, 2006 3:00 pm
- Location: Versailles, Kentucky
- Contact:
Hey Lars,Lars wrote:Hey Mike,
Fancy meeting you over here. I'm sorry to here about your randomization to Rebif. Sounds like you may be heading to off label???? Thanks for the update and for the information. Stay in touch.
Yep, I got Rebif and off label Campath is definitely the direction that I'm heading.
So have you had your randomization yet? If so, did you get Campath?
Take care,
Mike
-
CureOrBust
- Family Elder
- Posts: 3374
- Joined: Wed Jul 27, 2005 2:00 pm
- Location: Sydney, Australia
Mike,
I'm starting to wonder about my Karma. I got a call today from my coordinator saying she got word that they would NOT accept me. Even though the Tovaxinites were approved, they were approved for Care 2 not Care 1. Obviously there was some confusion on this point. After an awkward goodbye and I'm sorry that was that. An hour later I got a second call saying that the trial Doc was going to bat for me, so, at this point all I know for sure is nothing. There is a huge catch 22 going on, I can't be in Care 2 because I haven't been on therapy and Tovaxin doesn't count and I can't be in Care 1 because I have been on therapy, Tovaxin. If any of that makes sense to you, please let me know because my coordinator and Doc are equally confused.
Lars
I'm starting to wonder about my Karma. I got a call today from my coordinator saying she got word that they would NOT accept me. Even though the Tovaxinites were approved, they were approved for Care 2 not Care 1. Obviously there was some confusion on this point. After an awkward goodbye and I'm sorry that was that. An hour later I got a second call saying that the trial Doc was going to bat for me, so, at this point all I know for sure is nothing. There is a huge catch 22 going on, I can't be in Care 2 because I haven't been on therapy and Tovaxin doesn't count and I can't be in Care 1 because I have been on therapy, Tovaxin. If any of that makes sense to you, please let me know because my coordinator and Doc are equally confused.
Lars
-
CureOrBust
- Family Elder
- Posts: 3374
- Joined: Wed Jul 27, 2005 2:00 pm
- Location: Sydney, Australia
I have a similar issue. I can't go in CARE I because I was on rebif for 4 months, and I can't go into CARE II, because I was not on rebif for 6 months or more.Lars wrote:I can't be in Care 2 because I haven't been on therapy and Tovaxin doesn't count and I can't be in Care 1 because I have been on therapy, Tovaxin.
But I knew it was not helping after only 4 months!Do you know what he charges for it off-label? or have I already asked you this before.freiguy wrote:My doctor has gived the campath off label outside of the trial.
Re: Campath feedback please
.
Last edited by Lyon on Sat Nov 26, 2011 2:19 pm, edited 1 time in total.
Freiguy,
When your doctor prescribes Campath off-label, does he follow the same protocol as the trial, i.e. the monthly blood draws and monitoring of platelets?
When I was looking into the Campath trials, I considered traveling out of state to a clinic to try and get the treatment. The closest site would have been about a 7 hour drive, but even if I had to return for monthly check-ups, that would have been no big deal. My biggest concern was if I developed complications (worst case ITP), I felt it would be best to have the doctor that administered the Campath nearby.
When your doctor prescribes Campath off-label, does he follow the same protocol as the trial, i.e. the monthly blood draws and monitoring of platelets?
When I was looking into the Campath trials, I considered traveling out of state to a clinic to try and get the treatment. The closest site would have been about a 7 hour drive, but even if I had to return for monthly check-ups, that would have been no big deal. My biggest concern was if I developed complications (worst case ITP), I felt it would be best to have the doctor that administered the Campath nearby.
I cannot believe they're charging $12K for 2 treatments! maybe that's their malpractice premiums ;)
I don't know much about Tovaxin but I know what it's like to feel like you've tried all available options and nothing works so you're ready get aggressive!
I think campath has done a good job of slowing down the damage.
If time and money weren't major limiting factors & no other study would take me, i'd check into stem cells. and because i'm in the care ms study i'm probably going to be excluded from future studies. so i'll be in your boat, ready to shell out a ton of $$ for "back alley treatments" i just made that phrase up; no offense intended! (have tremendous respect and appreciation for doctors ok w/ off-label!!!)
best of luck!
kristin
I don't know much about Tovaxin but I know what it's like to feel like you've tried all available options and nothing works so you're ready get aggressive!
I think campath has done a good job of slowing down the damage.
If time and money weren't major limiting factors & no other study would take me, i'd check into stem cells. and because i'm in the care ms study i'm probably going to be excluded from future studies. so i'll be in your boat, ready to shell out a ton of $$ for "back alley treatments" i just made that phrase up; no offense intended! (have tremendous respect and appreciation for doctors ok w/ off-label!!!)
best of luck!
kristin
I'm not sure what the deal is but I have never been treated with anything besides iv steroids and 4 of 5 Tovaxin injections prior to the axe falling. My clinic went to bat for me and I am in the CareMS II study. I was told Tovaxin treatment is considered similar to FDA approved treatments for acceptance into the trial.
Marcia
Marcia
Marcia