Living With MS

Discussing all aspects of Multiple Sclerosis, various treatments, including accurate information regarding Tysabri.

Saturday, April 07, 2007

My Tysabri Diary...

Happy Easter Everyone! I pray you all have a blessed holiday tomorrow :)

I just crack up everytime I see the above photo of the two chocolate bunnies, so I thought I'd share a smile before I posted important Tysabri information.

As some of you may or may not know, NICE (National Institute for Health and Clinical Excellence) is an organization in the UK that recommends or does not recommend drugs be paid for by England's and Wales' NHS (National Health System)...and it is much like our FDA Advisory Committees.

Unfortunately, they had rejected Tysabri (Natalizumab) in 2006, and their preliminary analysis in 2007 of new data submitted by the sponsors of Tysabri (Biogen & Elan) still has not been able to convinced them to recommend Tysabri to the NHS.

This is extremely worrisome as the UK has only been reviewing and rejecting Tysabri for highly active relapsing-remitting MS (which usually strikes young adults in their prime). The MS'ers in the UK need our help in convincing NICE to recommend Tysabri to their NHS so their MS patients can receive Tysabri (the best and superior in efficacy of 68%) MS therapy available to date to help them fight their MS, and have it paid for by the NHS. Without same, they will basically be condemend to a lifetime of suffering debilitating and accumulating relapses and resulting disabilities, combined with disease progression.

Apparently, cost-effectiveness (according to NICE) is more important than their MS'ers Quality of Life - I still can't figure out how they can put a price on suffering MS patient's Quality of Life and basically state that they aren't worth it...bottom line, we are ALL worth it!

If you agree with me, please become involved and speak out/be a patient advocate for the UK's MS patients and fight with me in attempting to convince NICE that they need to RECOMMEND TYSABRI TO THEIR NHS BEFORE the cutoff date of APRIL 23, 2007, as their final decision will be published in July, 2007. Should they recommend against Tysabri once again, they won't even consider looking at Tysabri (Natalizumab) again until 2010!

Here is their website to submit your comments (Appraisal Consultation Document):

http://guidance.nice.org.uk/article.aspx?o=418937&ifaction_start=contact&frmobj=418937

(Note: be sure to copy your comments into an email or a document on your computer first, because once you submit them in the one box provided, the website then takes you back to the beginning of their page again, but at that time, it gives you separate boxes to enter your arguments in-and then you can just copy and paste your arguments into the separate boxes where appropriate - typical bureaucrats - ugh)....,

Here are my arguments/comments sent that are shown below in their combined form. I later broke them down by copying and pasting same into the various boxes provided:


"Reconsideration is desperately needed of NICE's decision not to recommend Natalizumab (hereinafter referred to as Tysabri) for Multiple Sclerosis patients. To effectively assess the advantages or disadvantages of Tysabri, or any disease modifying drug treatment, NICE needs to significantly recognize that once disability has set in, treatment is too late and for the person with MS, the clock cannot be turned back.

Over the last decade, research shows emphatically that MS needs to be treated from the start to prevent permanent disability and slow the disease process down (which usually strikes young adults in their prime). Advantages of Natalizumab (Tysabri): Natalizumab is a welcome advance in the treatment of multiple sclerosis in that it 1) reduces disease progression; 2) reduces number & severity of relapses; 3) reduces use of costly & damaging steroids; 4) reduces costly hospital admissions; and 5) improves quality of life & reduces cognitive decline.

Tysabri has been shown to reduce the annual rate of relapses by 68%, and after one year, 77% of patients on treatment were relapse free as compared to 56% in the placebo group. Tysabri has sustained effect on the annual relapse rate in MS patients treated for up to
three years.

The approximate cost per relapse avoided with Tysabri was between $13,000 (USD) & $24,000 (USD) lower than that of the other disease-modifying therapies (the ABCR's). A reduction of the number of relapses will enable the person with MS to stay working, pay taxes, have a more meaningful family & social life.

Tysabri offers an important therapeutic option for many patients living with the debilitating effects of MS. It is impossible to over-estimate the impact of a long-term condition such as MS (which is huge), just as it is impossible to under-estimate the positive impact of early treatment with Tysabri early in the disease course.

Persons with MS have a much higher level of depression and suicide than the general population. Lack of work (due to the increasing disabilities of MS) and lack of effective management of their condition is a major contributor to the suicide risk. The enormous benefits of Tysabri far outweigh it's minimal .1% risk of PML, and MS patients, such as myself, are willing to take such a minimal risk in order to stop/slow our disease progression, and reduce our relapse rate with further accumulating disabilities. Additionally, the risks of Mitoxantrone (Novantrone) carries a 1:200 risk of permanent cardiac damage and a 1:400 risk of promyelocytic leukaemia. This compares with the minimal 1:1000 risk of PML with Tysabri.

When comparing relapse reduction rates (Tysabri-67%; Avonex (Interferon beta-1a IM) 32%; Betaseron(R) (Interferon beta-1b) 34%; Copaxone(R) (glatiramer acetate) 29%; and Rebif(R) (Interferon beta-1a SC) 32%),
it is clear that Tysabri is needed in the UK to treat it's MS patients in a cost-effective manner.

Another advantage to Tysabri is that it is administered via an IV infusion every 28 days and this is another positive for persons with MS. It is not only convenient, it ensures that they will be monitored while having their monthly treatment, and it will further ensure compliance that the patient stay on their MS therapy, while removing any fear of self-injection as required for the current disease modifying drug therapies, and non-compliance with same due to their horrific side effects and injection site reactions. Tysabri is well tolerated, easy to administer, and adherence/compliance will be high among patients if approved by the NHS.

To not have Tysabri available by the NHS would leave persons with MS, who have highly active relapsing disease, only hopelessness and dispair, further debilitating relapses with accumulating disabilities, and a rapid decline in their health and well-being, with increased suffering.

Failure of the NHS to authorize Tysabri will result in untreated highly active relapsing-remitting MS leading to repeated hospital admissions for eventual ineffective steroid treatments and increased costs to be borne by the NHS, and an ultimate showing of a wanton disregard for the complete destruction of a suffering patient's life.

Finally, give the MS patient hope and a fighting chance to live a fulfilling life and substantially contribute to society. Do the right thing, recommend Tysabri (Natalizumab) to the NHS for the treatment of highly active relapsing-remitting forms of Multiple Sclerosis.

Respectfully submitted,
Lauren Roberts
(MS patient for 31 years & current Tysabri patient) "

Thank you for helping our UK MS bretheren, and thank you to each person that has left a comment on my Blog recently.Please enjoy your holiday tomorrow everyone, enjoy your loved ones while they are still around, including your friends....Be Blessed!


(((hugs)))
Love, Lauren
A very proud member of www.MSpatientsforchoice.org

PS: I had my 6 month checkup with my neurologist, and she was surprised and delighted at the strength I have gained while on Tysabri! She wrote orders for another 6 months of Tysabri for me...Wooohooo!

3 Comments:

  • At 10:49 AM, Blogger Cyndee said…

    Hi Lauren! Wow, I thought getting Tysabri here was hard! I am so happy for you, that you are getting stronger and that you will be able to continue taking Tysabri. PARTY!!!!!

     
  • At 8:51 PM, Anonymous Shannon said…

    I just wanted to say thank you. I'm starting on Tysabri as soon as Cigna finishes the approval (probably about 2 weeks) and I'm terrified. I can't say how much it helped to read your posts. I'm 24 and really don't feel like I'm done yet, or that I'm willing to risk more damage. I'm so lucky that I can still go dancing and whatnot, and I'm not willing to lose that without a fight! But it is so, so scary. A Big Thank You for everything you've done to help us gain access to Tysabri and to keep us sane!!!!!

     
  • At 3:47 PM, Blogger CC said…

    Yippee Lauren! I am so happy to hear about your next six months of Tysabri treatments. You are truly a blessing to all of us trying to get access to Tysabri.

     

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