Last week Sanofi SA’s oral drug for Multiple Sclerosis, Aubagio (also known as Teriflunomide and A77 1726), was approved by the FDA. Somehow this one snuck under my radar and here we are with it scheduled to be prescribed by October 1st!
First, the bad news: studies show that it’s no more effective than Rebif (and maybe less effective). With Gilenya already on the market and BG-12 looming, I doubt that this drug will make a huge impact. It is related to an existing arthritis drug, leflunomide.
The good news is that it does work compared with placebo and is generally safe and well-tolerated. Because it acts differently than interferons, it may also make patients less susceptible to infections. The more choices we have for treatment, the better.
BG-12 (Dimethyl Fumarate) has not yet been approved for use, but trials have been overwhelmingly positive for this low-risk oral drug. Approved for Fast Track (10 months of review) by the FDA on February 28 2012, BG-12 should be available to Relapsing-Remitting MS patients and possibly for individuals with rheumatoid arthritis as a pill taken 2 or 3 times daily before 2013. The European Union, Canada and Switzerland are also currently reviewing this drug.
In addition to rheumatoid arthritis, Dimethyl Fumarate (DMF) is also being studied for its effects on lupus and cancer. DMF is a Fumaric Acid Ester which has been used to treat psoriasis since 1959.
Neurologists around the world are already planning to make this their go-to first line treatment for patients with Multiple Sclerosis even though Biogen Idec (the company behind Avonex and Tysabri) has not yet released a price profile of the drug. Why is BG-12 expected to quickly become the world’s leading MS treatment?
My one year anniversary of taking Gilenya occurred in May, but my first MRI results and latest blood test since beginning treatment occurred only recently. Multiple Sclerosis can be a very unpredictable disease, but prior to treatment with Gilenya I averaged 2 – 3 relapses per year. My neurologists have told met hat the average gap between relapses is 18 months which I have never achieved. However, I am getting closer every day as this is the longest relapse-free period I have ever had since diagnosis. My Gilenya test results during my last office visit were overwhelmingly positive.
Happy anniversary to me! One year ago today I took my first dose of Gilenya. My heart rate waxed and waned that day, but in the 12 months since my life has steadily improved. I don’t expect roses today, but I am ecstatic that the drug is working for me. Until this time last year, I was in a pattern of a relapse every few months. I have now been relapse-free for one year and counting! So far, Gilenya results have been fantastic.
I began the journey secretly hopeful that I might be one of those few people who miraculously have so many of their lesions shrink and heal on Gilenya, but I was also reasonable. Most of my damage is well over a year old, and most neurologists will tell you to stop expecting any improvement after one year. May 5 2011, deep down I believed that I was stuck with what I had in spite of any contradictory fantasies.
On The Pill!
YES! At my Gilenya followup today I learned that blood tests confirm I can continue Gilenya!
Although my current neurologist isn’t a fan of letting his patients view any of their test results I stole my paperwork for a quick read during the 3 hour wait to see him.
What I read initially sent me into a panic.
- Page 1: My immune system has been decimated. I am one germ away from sudden death.
- Pages Everything Else: Greek.
Several months have passed since I began taking Gilenya on May 5. Today I’m focusing on the drug’s possible side effects and how I have personally been affected. The good news is that I seem to be mostly fine so far. In spite of this year’s gloomy start with 2 separate attacks within it’s first few months, I have had no attacks since beginning this treatment. In hindsight I really do feel that Rebif, and probably interferons in general, are just not right for my body. Now that I have begun the drug I have started to focus on Gilenya side effects.
With my Gilenya followup appointment looming in a couple of weeks, I’ll soon find out if Gilenya suits me in the long run. As you can see, I do have my fingers crossed!
Money Money Money!
Typical Insurance Business Model = Avoid Providing Service? I’ve glimpsed the battle between insurance and Gilenya.
Several weeks ago I got the call from Novartis that I had been rejected by my insurance for Gilenya. When I ask why, she reads to me “Cost exceeds limit per patient. No further review.” My insurance coverage has no limit on the cost of a prescribed medication – it is technically covered and my insurance company has just chosen not to.
Within seconds, I began an exacerbation. For the last few weeks I have been experiencing something that is commonly called “The MS Hug.” I can’t print the things I call it in my head. At its worst, it’s the kind of pain you don’t want to live through.
The battery of tests begins!
Some good news in my quest to start Gilenya – which is really starting to feel like a quest for the holy grail. I’ve written previously about my hopes for Gilenya and of my frustrations with the slow process. On the day I ceased Rebif I also saw a gastroenterologist for my elevated liver enzymes. The tally so far is $800 for the consult, $600 for the results, and forthcoming bills for some blood tests and an abdomenal ultrasound. Results are that I am clear of all liver diseases – he seemed disappointed. With the liver investigation closed, I am set to begin the Gilenya approval tests required by my neurologist, by my insurance provider, and by Novartis.
Tick Tock, Gilenya, Tick Tock
Almost two weeks ago I posted that I was in the process of switching to Gilenya. Not so fast, I suppose. My neurologist’s office staff was eager for me to let Gilenya set up all of my doctor appointments for me to undergo the necessary tests. By their accounts they faxed in my information the morning I was in their office, and then a few days later when they hadn’t heard anything back. And then again when I called them after a very unproductive phone call with Gilenya. With such a new drug, I should have expected Gilenya process problems.
Several months ago I switched positions within the company to work in a 24/7 network surveillance group. We rotate weekends, leaving me with a “weekend” during the week for a month here and there. I had hoped that I could use these days to get through all of my doctor appointments this month. But the opportunity to accomplish that is rapidly vanishing.
As it turns out, similarly to my father’s results with Avonex, Rebif has caused my liver enzymes to shoot up to about 3X the upper limit of normal in the span of slightly less than 2 years. My options?
1) Tysabri : the risk of PML is too severe for me to brave this drug – reputed to be a risk of death or severe disability as high as 1 in 200 for some individuals and 1 in 2000 for others
2) Copaxone : statistically slightly less effective than interferons – works great for my father but I truly don’t want to do a daily injection except as a last resort
3) Gilenya : aka Fingolimod – when this was approved by the FDA I wrote a blog post to summarize all the information I could find – it is the only oral disease modifying drug for Multiple Sclerosis – DING! DING! DING!
I have chosen to switch to Gilenya.