My Tysabri Diary...

WOOOOHOOOO......5 days after my Tysabri infusion Monday.....today being Saturday, 10/21...get this: I lifted my right foot about an inch off the ground by just thinking it to move, and I moved my left foot forward about an inch too! I started crying tears of joy as I had not been able to move my feet or legs at all since last year, 6/5/05! I could only do this one time, but THANK YOU GOD, I'LL TAKE THAT ONE TIME IMPROVEMENT!!!! I just pray I can do this more and more with each passing day. I'm making very small, slow improvements, but improvements just the same, WOOOHOOO!

Thank you all for your positive comments...I can hardly wait until my next infusion, YeeeeeeeeHaaaaaaaw! :)

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

My Tysabri Diary...

Today 10/17: this am, my caregiver noticed my balance when I was sitting up in my w/c (I did not have to hold on to the arms as much today to sit up) which is about a 60% improvement from yesterday, and I could move my toes very slightly (I haven't been able to do that for months!)...it's not much improvement, but I'm thrilled nevertheless, even if its only a fleeting improvement. I wasn't expecting anything so soon...I hope it lasts.
(((hugs)))
Love, Lauren
A very proud member of www.MSpatientsforchoice.org

My Tysabri Diary...

I'm Infused and I'm Enthused! Wooohoooo!!!

Thank you David, for the phone call, I was hoping to settle in a bit after just getting home late this afternoon from my 11:00 am Tysabri infusion, but my phone hasn't stopped ringing!

Thank you everyone for your well wishes..., I had a few snafoos with my first infusion, but I was assured things will run more smoothly with my second infusion, plus they were being triple cautious with me as I, again, was the first MS patient to receive Tysabri in the Kaiser So. Calif. system, just like in 2005! Whoa..(smiling).

TOUCH protocol, including pre-infusion checklist and taking of vitals took approx. 30 mins. No Benadryl, just on standby if I needed it, a Saline drip with the Tysabri drip, took about an hour, then they watched me for an hour afterwards and took my vials again (total 2 1/2 hrs.) I dozed off twice during the 2 1/2 hr. appt...haha!

I had NO side effects whatsoever (other than being happy and relieved)...I didn't forget to bring doughnuts for the infusion nurses, but I forgot to ask for the Lot # of my vial and the expiration date! (DUH me!) It had been placed in a Sharp's container by the pharmacist and taken away before I got home, but I was told that the pharmacist made a note on my chart that they are to send my empty vial up with each infusion bag (after being mixed by the pharmacist). or at least that information on my chart each time as I'm entitled to it!

My caregiver went to pick up the photos we took today (I requested a disk version so I would not have to scan them), and when he returns, I'll need to try and figure out how to upload them on my computer (did I mention I'm computer challenged?) For now, see tag above, ( courtesy of my friend Roy, who created this for me, thank you my friend!)...

Lauren <---HAPPY CAMPER! I'M JUST SOOOO GLAD THEIR IS JUSTICE AND THE REWARD FOR FIGHTING THE GOOD FIGHT! WOOOOOOHOOOOOOO!

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

My Tysabri Diary...

Thursday...10/12--Tysabri infusion Monday, 10/16, is all confirmed at set to go!

I just called my Kaiser infusion center, that confirmed my vial of Tysabri is at their pharmacy, waiting for me Monday, woooooohooooooo!

I'm getting excited, finally believing all roadblocks have been cleared and I'm going to receive my drug of choice again.........I can hardly wait! Ok, I've waited for 1 year and 10 months for it, what's 4 more days, but it's there!!!

On a side note, I called my case worker at MSActivesource JUST TO BE SURE THERE WAS NO HOLD UP, and when she said, "Lauren, I promise you, everything here is done", she confirmed my patient registry number, and then said, "I can hear the excitement in your voice, good luck Monday!" She is actually very sweet, but I'm thinking, I don't need luck when I have the BEST MS medication waiting for me Monday! Woooohoooo

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

My Tysabri Diary...

The October Remedyfinds MS newsletter just came out and I have received NINE emails already with Tysabri questions! Woohoo!

Both Heather (who also testified and is a member of www.mspatientsforchoice.org) and I are featured: see RemedyFind link to the right sidebar.

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

My Tysabri Diary...

Monday, 10/9--You guys will NOT believe the NIGHTMARE MSactivesource put me through today........ :(

How about I start at the beginning: at 10:00 am, my time...I receive a phone call from Kaiser's infusion center that my neuro won't be available on Friday 10/13, and that either the "TOUCH" program (although I couldn't find any language as such on the enrollment form that she be "available" during my infusion), or that Kaiser Corporate "requires" it (I can't remember what the lady said, all I heard were the words "I need to reschedule your appt", and I started crying).

I then reset it for the next available time (10/16) and called MSActivesource, who told me they still did not have my enrollment form and I asked the girl there to put me on hold and physically walk across the hall to double check with their Data Entry Dept...after a 5-10 min. wait, she came back on the line and told me it was still not received, but once received-it should only take approx. 24 hrs to get all the data in their computer. Okay, now I'm even more upset.

Then I call my neuro again and left her a message that I wanted my enrollment faxed over to MSactivesouce STAT (good thing she was busy making rounds at the hospital, as I was in no mood to be messed with).

THEN, I get another call from the infusion clinic, advising me that the Kaiser pharmacist called MSActivesouce to find out when he could expect receipt of the vial of Tysabri once they had me in their system because the patient (me) had an appt. on Monday. He was told that my infusion appt. set for Monday should be pushed back a few days just to make sure I was in their system, insurance coverage was confirmed, and the med was received. SAY WHAT??? HELL NO!!!! NOW I'm LIVID! I tell the infusion center emphatically KEEP THAT APPT! I DO NOT CARE WHAT THE PHARMACIST TOLD YOU, KEEP IT AND I'LL CALL YOU BACK THIS AFTERNOON TO CONFIRM, BUT DON'T YOU DARE RESCHEDULE ME!

THEN I get a call from my neuro's nurse/sec. that the enrollment form was faxed to MSactivesource LAST FRIDAY, but she re-faxed it again after she rec'd my message this am, and she called them to confirm they received it (also advising me to call them and confirm it too-like I wasn't going to do that anyway?) ...soooooo, then I call MSActivesource AGAIN and was told my assigned case manager was unavailable but they had my paperwork (DUH) and asked me if another case worker could assist me...I said "FINE PUT THEM ON!!!" The lady identified herself as another case manager that wanted to tell me about the TOUCH program. I stopped her mid sentence and said, "LOOK, I KNOW ALL ABOUT THE TOUCH PROGRAM, TYSABRI, THE INFUSION PROCESS..", she then interrupts me and asks, "Do you know about PML?" BIIIIGGGG MISTAKE!!!!!!!! As my friend GTRT says, I gave her the FULL LAUREN.

I said, "Oh, you mean Progressive Multifocal Leukoencephalopathy, which 2 "MS" patients acquired in the trials when combined with AVONEX and 1 Crohn's patient with a severely compromised immune system? The same 6:59 PML patients associated with Biogen's other drug Rituxan? The same PML that never showed up in any of the MS monotherapy trial patients and the 5,000 general pop. patients receiving Ty as a monotherapy from 11/04 - 2/28/05 for a grand total of 0:8000? That PML?" I then said, "PUT A TEAM LEADER (SUPERVISOR) ON THE PHONE, NOW!"

Ok, THEN a team leader gets on the phone and says (paraphrasing), "Well, Ms. Roberts, I understand you know quite a bit about Tysabri (DUH again), but did you know that medication Tysabri has been changed since it was originally released?" (I'm thinking WTF? DO THE EMPLOYEES THERE THINK THAT ALL MS PATIENTS ARE IN THE DARK???) I said (bluntly), "My dear, you are an idiot, the medication has not changed ONE IOTA. You might think that you are speaking to a fool, but I assure you, I probably know more about Tysabri, the risk of PML, the TOUCH program, the Tysabri label indications, AND it's benefits than your entire staff combined! Now explain MSactivesource's conversation (as indicated above) re: the pharmacist and moving my inf. date back a few more days from 10/16!"

Silence....she then wanted to talk about my being on Avonex previously and my relapses since 6/5/05, and wanted permission to contact my neuro as this need to be reported to the FDA. I said, "you guys don't get it, been there done that, and NO-YOU DON'T have permission to contact my neuro about that again, NOW ANSWER MY QUESTIONS BECAUSE I AM NOT RESCHEDULING MY 10/16 APPT!"

She said "I'll try to get ahold of your case manager and have her call you." I said, "NO, you WILL get ahold of her and have her return my call in the next 30 mins, with answers!' 10 mins. later, I get a call from my case manager, who tells me I'm in the system, she just needs to call and confirm that the inf. center and the pharmacist are TOUCH certified (as she did not have their required paperwork), and obtain Kaiser payment approval...not 15 mins. later, she calls me back (after speaking with my neuro) and advises me I'm good to go for my infusion on Monday, 10/16 (but the drug distribution to the pharmacist is not their responsibility, it's Elan's. FINALLY!

Of note: She also told me that Kaiser is only approving Tysabri on a case by case basis (I guess my neuro made sure I was approved for it. I hope that other MS in the Kaiser system, or elsewhere, don't have to experience the nightmare I went through today, but unfortunately, I fear they will.

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

My Tysabri Diary...

Important Alert!!! Medicare restrictions are scheduled to take effect November 15, 2006 regarding mobility devices. (see below) You can do something about it now. Beginning Monday, October 2 through November 8, members of Congress will be in their home districts for the electoral recess. While your legislators are back, call or visit their local offices!

Don't Let People with MS Lose Mobility - Stop the Medicare policy that restricts device coverage and restricts mobility.

People with multiple sclerosis and other disabilities will lose mobility under a new Medicare power mobility device policy. Coverage will be restricted to certain devices, limiting people with MS to lower-quality, poorer-performing mobility devices against their physicians' recommendations. People with MS need adequate mobility devices that meet their level of function and allow them the greatest possible quality of life.

To find your local Congressperson, go to: http://www.house.gov/writerep/ (you can write to him/her, but since time is of the essence, calling their local office would be better). Once you determine who your local Congressperson is, locate their website by going to: http://www.house.gov/house/MemberWWW.shtml and their local telephone number should be listed. If it is not provided there, you can also find your legislators’ local phone numbers in the blue, government section of your local white pages. Or you can call their D.C. office for this information through the Capitol switchboard at: 1-800-828-0498.

You can also find your senator by clicking the link to the right entitled "Find Your Senator" and follow the same steps above for their local phone number.

Urge them to stop the implementation of Medicare’s device policy and to push for a new policy that meets the functional needs of people with MS. Stop this flawed Medicare policy that restricts coverage of power mobility devices and effectively restricts mobility. This policy will result in reverse rehabilitation for people with MS — limiting their health, functionality, recovery, and quality of life.

Medicare is inappropriately using an arbitrary “stand, pivot, and transfer” test — not the functional needs of the individual, as determined by medical experts — to decide the quality of mobility device that is covered.

The new policy also significantly reduces Medicare reimbursement to suppliers across all devices, so availability will be limited even if an individual does qualify.

Members of Congress need to push for a revised Medicare mobility device policy that is clearly defined, medically based, and considers the unique progressive and functional needs of the individual.

Give people with MS the mobility they need and deserve. Call or visit your Congressperson, senators and representatives today!

Industry and patient groups also are speaking out about this serious issue. Click here for more information.

Thank you for caring! :)

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

My Tysabri Diary...

New data released re: Tysabri...wooooooohoooooooo! Links are to the right, but in essence, here is the exciting news (beat this ABCRs, you can't, ha!) :

6 October 2006
New Pharmacoeconomic Data on TYSABRI® Demonstrate Significant Reduction in Steroid Use and Hospitalizations in Patients with Multiple Sclerosis
CAMBRIDGE, Mass. & DUBLIN, Ireland--(BUSINESS WIRE)--Oct. 6, 2006--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that data to be presented today at the Academy of Managed Care Pharmacy's (AMCP) 2006 Educational Conference in Chicago, IL show that in Phase III studies TYSABRI® (natalizumab) therapy significantly reduced corticosteroid use and hospitalizations, and increased the proportion of MS patients with no disease activity. Findings will also be presented that demonstrate the positive impact of TYSABRI on a number of health-related quality of life of measures (QoL) and the cost-effectiveness of MS therapies.

Data Demonstrates TYSABRI Reduced Corticosteroid Use, Hospitalizations and Increases the Proportion of Disease-Free Patients
Data presented today from the AFFIRM monotherapy study (two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide), showed the impact of TYSABRI on two pre-specified endpoints, the annualized rate of relapses requiring corticosteroid use and the annualized rate of hospitalizations due to MS. Data showed there was a 69% relative reduction in the annualized rate of relapses requiring steroids for patients treated with TYSABRI compared to those treated with placebo (0.133 in the TYSABRI group vs. 0.432 in the placebo group(p<0.001)).>Cost Effectiveness of MS Therapies
A model was constructed by Xcenda, formerly Applied Health Outcomes, to compare the cost per relapse avoided among the five approved disease-modifying MS therapies to treat relapsing forms of MS. Overall cost of therapy was calculated using the US wholesale acquisition drug cost, and costs associated with drug administration, patient monitoring and treatment of relapses. The costs associated with adverse events were not assessed as part of this model. Effectiveness was defined as the number of relapses avoided with treatment, which was calculated as the number of relapses for a non-treated population multiplied by published relapse rate reductions for the therapies.(1) Based on the model developed, the cost per relapse per year avoided was lowest for TYSABRI. The cost per relapse avoided for TYSABRI was between $12,730 and $23,274 lower than that of the other approved disease-modifying therapies.
Data Show TYSABRI Had Improvement in Quality of Life Assessments
Quality of Life (QoL) was assessed using three different measures, the Multiple Sclerosis Quality of Life Inventory (MSQLI), the Short Form-36 Health Survey (SF-36), which is a component of the MSQLI, and a Visual Analogue Scale (VAS). The MSQLI is an MS-specific battery of 10 scales that measure disease impact on QoL, including fatigue, pain, sexual function, bowel and bladder function, visual impairment, mental health and need for social support. The SF-36 is comprised of 36 questions designed to assess patients' physical and mental well-being. General well-being was also measured using the VAS.
In data presented today from the AFFIRM study, patients in the TYSABRI-treated group realized a significant improvement in physical measures of the SF-36 compared with a decline in the placebo-treated group (p=0.003). A significant improvement was also seen in the mental component of the SF-36 in patients treated with TYSABRI compared with a decline in the placebo-group (p=0.011). Significant benefits were also seen using the VAS (p=0.007).
About TYSABRI
In the US, TYSABRI is approved as a monotherapy treatment for relapsing forms of MS. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Patients should be monitored at regular intervals for any new or worsening signs or symptoms suggestive of PML. Because of the increased risk of PML, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies. It is available in the US only through a restricted distribution program called the TOUCH Prescribing Program. According to product labeling, after two years, TYSABRI treatment led to a 67% relative reduction (p<0.001)>concurrent immunosuppressants. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.
For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.
(1) The relapse reduction rates used were: TYSABRI was 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%.
SOURCE: Biogen Idec and Elan Corporation, plc
http://www.elan.com/News/full.asp?ID=913012

29 September 2006
New Data Presented at ECTRIMS Congress Show TYSABRI® Has Sustained Effect on Relapse Rate in Multiple Sclerosis Patients Treated for up to Three Years
ZUG, Switzerland and DUBLIN, Ireland--(BUSINESS WIRE)--Sept. 29, 2006--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today new data that show TYSABRI® (natalizumab) has a sustained effect on relapse rate in multiple sclerosis (MS) patients treated for up to three years. These data, presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, were part of long-term follow-up of TYSABRI clinical trial patients.
Patients who participated in the Phase III TYSABRI program were eligible to enroll in an open-label extension study that evaluated the therapy's long-term effects. Approximately 1,900 patients and over 200 sites worldwide participated in the extension study. Approximately 250 of these patients remained on TYSABRI monotherapy for nearly three years. The annualized relapse rate for these patients over the three-year period was 0.23, translating into an average of one relapse every 4.3 years. This was consistent with the 0.23 annualized relapse rate seen in the two-year AFFIRM study, which represented a 68% relative reduction when compared to the two-year placebo annualized relapse rate of 0.73, as published in the New England Journal of Medicine.
"Data from this long-term follow-up study show that TYSABRI has a sustained and compelling effect on relapse rates beyond two years of treatment. The efficacy benefit of TYSABRI when considered with the management of its known risks, offers an important therapeutic option for many patients living with the debilitating effects of MS," said Paul O'Connor, MD, St. Michael's Hospital, Toronto, Ontario, Canada, lead investigator of the extension study.
SOURCE: Biogen Idec and Elan Corporation, plc
http://www.elan.com/News/full.asp?ID=910437

28 September 2006
New Data on TYSABRI® Presented at ECTRIMS Congress Demonstrate Significant Improvement in Cognitive Function in Patients with Multiple Sclerosis
ZUG, Switzerland & DUBLIN, Ireland--(BUSINESS WIRE)--Sept. 28, 2006--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that data from the Phase III AFFIRM monotherapy study demonstrated that treatment with TYSABRI® (natalizumab) significantly reduced the proportion of multiple sclerosis (MS) patients with worsening cognitive function as measured by the 3-second Paced Auditory Serial Addition Test (PASAT 3). These data, presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, contribute to existing data which demonstrate the overall therapeutic benefits of TYSABRI, including its significant impact on relapse reduction, disability progression and MRI measures. TYSABRI has demonstrated a 68% relative reduction in the annualized relapse rate compared to placebo and a 42% reduction in the relative risk of disability progression, as published in the New England Journal of Medicine.
Cognitive deficits are under-recognized and often misdiagnosed as depression, stress or other personality disorders. Studies have shown that approximately 43% to 65% of MS patients show measurable cognitive impairment in formal testing.(1) Cognitive dysfunction can occur early in MS and in patients with relatively mild physical disability. These deficits have a substantial effect on the daily functioning of patients. Areas impacted by cognitive dysfunction include memory, ability to process information and learning. (1),(2)
The AFFIRM study was a two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide, evaluating the effect of TYSABRI on the progression of disability and the rate of clinical relapses. Evaluating the effect of TYSABRI on cognitive function was a pre-specified endpoint of the AFFIRM study. Cognitive function was assessed using the 3-second Paced Auditory Serial Addition Test (PASAT 3), a test of auditory information processing. The study showed that treatment with TYSABRI reduced the risk of sustained cognitive worsening by 43% (p=0.013) when compared to placebo.
These cognitive function data complement the previously presented results of the AFFIRM study, which demonstrated a significant effect of TYSABRI on two-widely accepted health-related quality of life measures, the Short Form-36 Health Survey and the Visual Analogue Scale.
"Neuropsychological dysfunction significantly diminishes quality of life in many patients with multiple sclerosis, impacting everything from employment to social interaction. It is responsible for much hardship experienced by MS patients. The important positive effects of TYSABRI on cognitive functioning and quality of life add to the important benefits already reported on progression of disability and relapses. This provides strong evidence that observed neurologic benefits translate into important improvements as perceived by the patients," said Richard Rudick, MD, Director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic.
(1) Rao SM, et al. Neurology. 1991;41:685-691
(2) Amato MP, et al. Arch Neurol. 1995;52:168-172
SOURCE: Biogen Idec and Elan Corporation, plc
http://www.elan.com/News/full.asp?ID=910099

TYSABRI Impacts Measures of Visual Function
In another analysis of the AFFIRM and SENTINEL data, patients treated with TYSABRI had a reduction in the risk of visual decline as measured by contrast testing compared to control. Loss of visual function is one of the most common causes of disability and lower QoL in MS patients. Low contrast letter acuity was a pre-specified endpoint in both studies. Recent studies have demonstrated that low contrast letter acuity (perception of light gray letters of progressively smaller size on a white background) is a more sensitive measure of visual dysfunction in MS than traditional measures.
TYSABRI Impacts Measures of Disability Progression
The primary efficacy endpoint of AFFIRM and SENTINEL at two years was the rate of disability progression sustained for three months as measured by the Expanded Disability Status Scale (EDSS). Additional measures of disability included the Multiple Sclerosis Functional Composite (MSFC), which consists of three tests that evaluate ambulation, upper extremity dexterity and cognitive function.
In AFFIRM, treatment with TYSABRI led to a 42% reduction in the risk of disability progression compared to placebo (p=0.0002). TYSABRI was also associated with significant delay in progressing to EDSS of 4.0 (ambulatory with moderate disability) and 6.0 (requiring a cane, crutch or brace). TYSABRI treatment also had a significant impact on all subscales of the MSFC, including the Paced Auditory Serial Addition Test (PASAT), a measure of cognitive function (p=0.005).
TYSABRI Phase III Safety
Progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system has been reported in patients receiving TYSABRI. PML occurred in two MS patients who had received TYSABRI with AVONEX and in one Crohn's disease patient who had recently received an immunosuppressant. In placebo-controlled trials of TYSABRI in MS, the incidence and rate of other serious infections were balanced between TYSABRI-treated patients and controls. Serious infections reported in TYSABRI-treated patients included pneumonia, urinary tract infection and appendicitis. The overall incidence and rate of common infections were also balanced between treatment groups. Commonly reported infections included upper respiratory tract infections, influenza, urinary tract infections, and gastroenteritis. Herpes infections were slightly more common in patients treated with TYSABRI. The incidence and rate of other serious and common adverse events in clinical trials were similarly balanced between treatment groups. Serious events that occurred in TYSABRI-treated patients included hypersensitivity reactions, including systemic reactions, depression, and cholelithiasis. Common adverse events reported include infusion reactions, headache, fatigue, and arthralgia.
SOURCE: Biogen Idec and Elan Corporation, plc
http://www.elan.com/News/full.asp?ID=840112

Go Tysabri!

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

My Tysabri appt just got set!!!!!!!!

For next Friday....and Tysabri was being ordered by the Kaiser pharmacist...BUT when I called MSactivcesource for my patient registry #, I was advised I wasn't in their system yet as they did not receive the enrollment form I signed Monday at my neuro's office! GRRRRRR, so I called and left a detailed message for my neuro that included a request for a return phone call to me before the weekend. Hopefully this "glitch" will be worked out soon so my infusion appt. won't need to be rescheduled/postponed...I've waited sooo long already for the BEST MS med there is...TYSABRI!

On a side note, when I asked the infusion lady setting the appt how many other Tysabri patients have been infused there, she said I was their first patient scheduled for same!!!!!!!!! There are other Kaiser certified infusion centers, but this certified one is the closest to me, and this infusion center connected to Kaiser's Main Hospital in P.C. is HUGE!

(((hugs)))
Love, Lauren

A very proud member of www.MSpatientsforchoice.org/

More good news regarding Tysabri!!! ...

Medicare is covering the cost 100% under Part B: Medicare October 1st price adjustment document for natalizumab HPCS Code 4079 (see 540 to the left of spreadsheet or Q4079)
See link to the right. To view, you must accept the Licensing Agreement (that allows you to proceed) then zipped file will download and extract as an Excel spreadsheet, which breaks down as: Covered $7.719 per 1 mg = 7.719 x 300 mg = $2,315.70 or 100% with no pre-authorization required!.

AND it's covered by Medicaide/Medi-Cal too! See: Official bulletin link to the right re: HPCS code update. Each state will receive or has already received a similar notice for the Medicare HPCS quarterly update to the approved Medicare formulary. What happened on Oct 1st was a systematic IMPROVEMENT in the Medicare approval process, not a road block or a traffic jam.

As an aside, listed is an older study that was performed to help determine a U.S. cost analysis of an MS patient receiving managed health care because of a "relapse" or exacerbation that brings the patient into the doctor's office, hospital, ER, or clinic. Cost of managing an episode of relapse in multiple sclerosis in the United States...see link to the right. This study was probably used to determine a cost analysis of a relapse and possible justification for continuing Medicare coverage of then currently FDA approved medications for MS such as the interferons and GA.

With Tysabri now available to the MS community it is my shared opinion with other MS patients that U.S. health care providers and insurers will now be getting thier money's worth as compared to the previously FDA approved MS medications. The better news is that MS patients and their prescribing TOUCH physicians will have a superior first line OR rescue medication available for active or inflammatory MS with outstanding efficacy and genuine quality of life benefit in most cases until the actual cure is discovered for MS.

More updated data just released re: Tysabri coming up in my next post...it's exciting data!!!

(((hugs)))

Love, Lauren

A very proud member of www.MSpatientsforchoice.org

Tysabri Approved in Canada! Woohoo!

Health Canada grants approval of TYSABRI(TM) (natalizumab) for the treatment of multiple sclerosis following priority review MISSISSAUGA, ON, and DUBLIN, IRELAND, Oct. 4, 2006 (Canada NewsWire via COMTEX) -- First new class of treatment in ten years shown to reduce rate of relapses by 68%(1) Biogen Idec Canada and Elan Corporation, plc announced today that following a priority review process, Health Canada has granted approval to TYSABRI(TM) (natalizumab) for the treatment of relapsing-remitting multiple sclerosis (MS).(2) TYSABRI is the first in a new therapeutic class of MS treatments (called selective adhesion molecule inhibitors) and has been shown to significantly reduce the rate of MS relapses as well as the progression of disability associated with the illness.(2) "TYSABRI has demonstrated a major reduction in relapses - by more than two-thirds - in clinical trials," said Dr. Paul O'Connor, AFFIRM Principal Investigator and Chief of Division of Neurology, St Michael's Hospital, Toronto. "Clinical trials that have looked at TYSABRI provide us with impressive evidence that it is a highly effective treatment for patients with MS." A two-year, randomized, multi-centre, placebo-controlled, double-blind study (called AFFIRM) enrolled 942 patients and evaluated the effect of TYSABRI on the rate of clinical relapses and the progression of disability.(3) The results found that TYSABRI reduced the rate of clinical relapses by 68 per cent relative to placebo (p(less than)0.001), and the risk of sustained disability progression associated with MS by 42 per cent relative to placebo (p(less than)0.001).(4) Treatment with TYSABRI also resulted in sustained and statistically significant reductions in brain lesion activity as measured by magnetic resonance imaging (MRI) scans.(4) In Canada, TYSABRI is indicated as monotherapy (i.e. single disease-modifying agent) for the treatment of patients with the relapsing-remitting form of MS to reduce the frequency of clinical relapses, to delay the progression of disability and to decrease the number and volume of active brain lesions identified on magnetic resonance imaging (MRI) scans).(4) TYSABRI is administered once every four weeks by intravenous infusion.(5) "TYSABRI's administration every four weeks also offers an additional benefit compared to the currently available MS therapies, some of which are injected as often as daily," said O'Connor. MS attacks the protective myelin covering of the central nervous system, causing inflammation and often destroying the myelin in patches. In its most common form, relapsing-remitting MS, the illness is characterized as having well defined attacks followed by complete or partial recovery.(6) Relapsing-remitting MS makes up 75% of all MS cases in Canada.(7) TYSABRI works by preventing the body's affected immune cells from migrating from the bloodstream into the brain where they can cause inflammation and potentially damage nerve fibers and their insulation.(8) "Canada has one of the highest rates of MS in the world.(9) The approval of TYSABRI represents an important step forward for Canadians living with this disease," said Deanna Groetzinger, vice president of government relations and policy at the Multiple Sclerosis Society of Canada. "We are pleased there is another approved treatment option for Canadians with relapsing-remitting MS."

Paulette O'Leary, 36, has been living with MS for over half of her life. At one point a relapse left her without the use of her legs and numbness across the left side of her body. After other therapy options failed to help her, O'Leary opted to travel to the United States to receive TYSABRI treatments when it was approved by the Food and Drug Administration (FDA) in the US. "My particular experience with MS was really terrible. The illness hit me very hard, and I went from my normal, everyday life, to feeling awful physically and emotionally. After one relapse I was left in a wheelchair," said O'Leary. "I eventually recovered, but did not escape some permanent residual disability. I tried several other therapies, but when I was on TYSABRI the results were quite impressive. For the first time in a long time, I could walk, I could do the things that I love to do - I could actually live my life again."

Independent safety evaluation published Biogen Idec and Elan Corporation, plc voluntarily suspended TYSABRI from the US market and from all clinical trials in 2005. This was based on three cases of progressive multifocal leukoencephalopathy (PML). A comprehensive, independent safety evaluation of more than 3,000 patients treated with TYSABRI was completed. The detailed safety analysis of the data yielded no new confirmed cases of PML beyond the three previously reported. The results of this safety evaluation were published in the March 2006 issue of the New England Journal of Medicine.(10) "The safety data analysis that was carried out by an independent panel of experts is reassuring. And getting an understanding of the benefit-risk profile of TYSABRI is an important step towards bringing this medicine to Canadian MS patients with confidence," said Dr. O'Connor. "Any treatment decision should be carefully evaluated by patients and their physicians." Patients who are prescribed TYSABRI should enroll in the TYSABRI Care Program. The program ensures that appropriate physicians and infusion centres are able to prescribe or infuse the product.(11) The TYSABRI Care Program is a comprehensive program that will support the safe and effective use of TYSABRI by physicians and patients on an ongoing basis. It will optimize treatment through improved compliance, will standardize infusion treatment at clinics, will support safety through rigorous education and on-going surveillance, and, through support in areas like reimbursement and patient support, will ease the administrative burden of physicians and patients, allowing patients and their treatment team to focus on treating the illness. AFFIRM and SENTINEL Phase III study design and adverse events AFFIRM is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide (including ten sites in Canada with 101 MS patients), evaluating the effect of TYSABRI on the progression of disability as measured by at least a one-point increase on the Expanded Disability Status Scale (EDSS) sustained for three months, and the rate of clinical relapses. Progression of disability is a sustained change that has a long-term impact on a patient's functional and ambulatory performance. Patients in AFFIRM were randomized to receive either a 300 mg IV infusion dose of TYSABRI (n=627) or placebo (n=315) every four weeks.(4) SENTINEL is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 1,171 AVONEX(R)-treated patients in 123 clinical trial sites worldwide. AVONEX-treated patients who continued to experience disease activity were randomized to add TYSABRI (n=589) or placebo (n=582) to their standard regimen.(12) The two-year adverse event profile in AFFIRM and SENTINEL were consistent with previously reported one-year results. Common events included headache, fatigue, urinary tract infection, depression, lower respiratory tract infection, limb and joint pain, and pharyngitis.(4),(12) The rate and incidence of infections in patients treated with TYSABRI and placebo-treated patients were similar. Serious infections occurred in 3.2 per cent and 2.6 per cent of patients treated with TYSABRI and placebo-treated patients, respectively. Use of TYSABRI has been associated with an increased risk of progressive multifocal leukoencephalopathy (PML). PML can cause severe disability or death.(13) Cases of PML included patients who were treated with TYSABRI for over two years or who received intermittent doses of TYSABRI over an 18-month period. In clinical trials, two cases of PML were observed in 1869 patients with multiple sclerosis treated for a median of 120 weeks; the third case occurred among 1043 patients with Crohn's disease after the patient received 8 doses. These patients were concomitantly exposed to immunomodulators (e.g. interferon beta) or were immunocompromised due to treatment with immunosuppressants (e.g. azathioprine).(14) TYSABRI has also been associated with hypersensitivity reactions, including serious systemic reactions that occurred at an incidence of less than 1 percent of patients.(14) About Multiple Sclerosis Multiple sclerosis (MS) is a chronic, unpredictable and potentially disabling disease of the central nervous system that affects approximately 55,000-75,000 Canadians.(11) Canada has one of the highest rates of MS in the world - it is estimated that three Canadians are newly diagnosed with MS every day.(10),(11) It is known as a disease of young adults, with onset, usually in women, between the ages of 15 and 40. It is characterized by symptoms such as vision problems, loss of balance, numbness, difficulty walking and even complete paralysis.(7) About Biogen Idec Biogen Idec (NASDAQ: BIIB) creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For press releases and additional information about the company, please visit www.biogenidec.com. About Elan Elan Corporation, plc (NYSE: ELN) is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.

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(1) TYSABRI Product Monograph 2006, page 18 (2) TYSABRI Product Monograph 2006, page 3 (3) Polman, Chris H. et al. The New England Journal of Medicine. 2006; 354: 899-910. (4) TYSABRI Product Monograph 2006, page 3 (5) TYSABRI Product Monograph 2006, page 12 (6) Multiple Sclerosis Society of Canada website, http://www.mssociety.ca/en/information/faq.htmNo.2 accessed September 21, 2006. (7) http://www.mssociety.ca/en/information/types.htm, accessed on September 21, 2006. (8) TYSABRI Product Monograph, page 13-14

Woooooooooohoooooooo for Canadians with MS, you now have the BEST MS therapy available to help you fight your MS and give you hope for a better and brighter future!

(((hugs)))
Love, Lauren


A very proud member of www.MSpatientsforchoice.org/

My Tysabri Diary...

I qualified for Tysabri!!!!!!!!!!!!!!! Yaaaaaaaaaaaaayyyyyyy!!! .....
My neuro was soooooo funny....she said when she first walked into the room..."Hi Lauren, how are you feeling?" I said, "Reeeeally good thank you, how are you???". She said, "I'm fine thank you, excited to start Tysabri again?" I started crying tears of joy and relief, and then she said, "We'll talk about your recent hospital stay in a minute, but don't cry Lauren, I need to go over a few items with you, like PML...even though you probably already know them."

My caregiver and I started cracking up, and then she told him, "I rarely win an argument with Lauren, especially concerning Tysabri." LOL

There was more involved with my exam, however she then went over the enrollment forms with me, I signed my life away, and she told me, once everything has been faxed to the people hanndling the "TOUCH" program, I'm assigned a case worker and a patient registery #, the med is ordered and received by Kaiser's certified pharmacist and then received by their certified infusion center, and finally depending upon the main infusion center's schedule down in P.C., I should be scheduled within a week to get my infusion of Tysabri! Knowing Kaiser and MSactivesource,it "might" take a 'tad' bit longer to complete the paperwork process......but wouldn't it be nice if I was proven wrong on this point just once?

I'm soooooooooo happy, I think I'm floating on a cloud....wooooooohooooooo!

(((hugs)))
Love, Lauren


A very proud member of www.MSpatientsforchoice.org/