Sunday, September 25, 2016

The Letter

A few weeks go I got a letter, saying that to keep receiving Ampyra, I needed to do  timed 25 foot walking test.  My response was... what?!! 

We are in a time when costs of prescriptions are being questioned.  But it seems to me that the patient is the one who is "targeted" - a medicine is expensive, so make patients prove they really need the medicine...   or whenever possible, find a cheaper alternative. This is concerning - whether we stick in the long-term with insurance, or whether we go to some kind of universal healthcare - decisions to use costly medicines will be questioned - and patients will find themselves in a place where they just want something to work, and when they find that something - they want to stay on it and not have to prove it works.

Here are excerpts from the letter I wrote  regarding all this.

My Story

In 2010, Ampyra became available and I was one of the first patients to go on it with the help and advice of my physician.  "Disease modifying therapies" (DMTs) have not worked for me and I have tried many of them.  Ampyra works for a small subset of people with MS and there are a few people for whom Ampyra has astonishing results.  I am one of those people.  Within a day I noticed differences.  I have not had any relapses in the six years I have been on Ampyra.  No one really knows why, but a clue could be that my lesions are only in my spine and Ampyra works to connect potassium channels. Ampyra is my miracle drug and my improvements, while on this drug, still astonish me and many others who know me to this day. 

I returned as a patient to my physician in 2016.  I have not had good experiences, as a patient, since being back, and it all surrounds pharmaceuticals. One of those experiences has been getting an ambiguous letter fthat I needed to do a walking test for Ampyra.  I have had a baseline walking test, so my walking improvement on Ampyra can't be measured, and a baseline at 6 years is not a baseline. I did have do a timed test for me back in 2010, so I know exactly how slow I was back then and how much I have improved, both in speed but also in endurance.  In fact, I wouldn't have even qualified to receive Ampyra given the guidelines  for a baseline walking test which is concerning.

It is not just in walking where I have had improvements: My balance is much better since I started taking Ampyra. I have noticed this, but other people have also noticed, telling me that I used to cling to chairs for balance.  I used to have a lot of difficulty writing and was working on speech recognition software as an alternative, but now I can write with a pen or pencil, without any special grips, and people can actually read my writing. I imagine professionals may doubt this, but small studies, like the one I have attached for your reference, support Ampyra being associated with improved hand dexterity.  You may or may not know this, but for the subset of us for whom Ampyra works, there is a “kick in” effect that occurs 15-20 minutes after taking it.  This effect also occurs again about three hours after taking it and is when I am at my strongest.

Of course there are very few of us who have such great results, but I have shared my successes with the media, the drug company, and the MS Society, for which articles have been written. 

My hope is that you will find my story enlightening and useful, and you take it seriously because others who have taken the time to know my story are excited at each success I have.


My reaction to getting an ambiguous letter, in my second month back as a member and patient, felt threatening and confusing because it stated that the Neurology department required me to do a walking test because I use the prescription Ampyra. Welcome back? That certainly didn’t feel like a welcome.

No one knows my story behind Ampyra and to be told there is a need to think of how it is important to use every member’s money wisely when I called to ask questions appeared judgmental and felt threatening. I just had an appointment where it was assessed that I am doing well.  Now more was wanted.

I understand the need to do certain screening tests for people, but perhaps a bit of homework should be done before sending ambiguous letters to unsuspecting patients.  It has been a daunting journey for me to be a member again and I’m concerned because I am doing really well in terms of my health because of Ampyra.  Did anyone even open my medical record to see my most recent visit?  Is this being done this for research?  What are the guidelines?  I was told there are “all these new guidelines” that must be followed and it sounded, as if, the guidelines are coming from outside.  I called the drug company, only to learn that the guidelines are not being made by the FDA, so I’m assuming they are insurance guidelines. 

Clinical trials for Ampyra measured a very finite period of time for improvements and post-marketing studies have been limited to showing that improvements are maintained strictly for walking. What is the goal for the walking test?  I have not been given specifics on how this test will be done, other than that I need to do three, 25 foot walks. 

My story has been on the news, the drug company tracks my great success with Ampyra, I am in constant contact with the MS Society to tell them my story, and I have been keeping a blog about my continued successes which is followed by people all over the world. Those who have taken the time to listen, read, or talk to me know me, know my story. Yet to measure success, only my walking speed will be measured and that doesn’t encapsulate “my story” even though my walking has greatly improved, both in speed and distance, while I have been on Ampyra. 

Ampyra was approved for walking. I know when a drug company applies for approval with the FDA, they must limit what they request for approval and once approved, the drug company cannot market other benefits the drug may provide to patients unless those go through the rigorous testing process.  Therefore, Ampyra is approved only for walking even though it benefits so much more for a small group of patients, such as me, leading more to the individualized approach to medicine that is gaining traction lately.
Finally, while thre is a focus on walking speed, the only drug found to help with my migraines is not covered.  I have tried numerous medicines; most recently w medications, both as off-label with no studies on migraines, which have been completely ineffective, leading me to have 2-day, debilitating migraines which is a nightmare.  This is not quality care and greatly concerns me and my family.

Thank you for your time in reading my story.  I hope it will help in working with patients like me, especially when we re new.