September 10, 2016
My most recent post discussed ways in which medical insurance companies limit doctors’ choices about prescribing disease-modifying drugs (DMDs) for people diagnosed with multiple sclerosis. The post was titled, “I don’t want my insurance company to decide how my doctor can treat MS,” and you can read it here:
As a follow-up, I present myself as an example of why insurance companies shouldn’t limit doctor’s choices when it comes to MS DMDs. People with MS can’t necessarily take all of the disease-modifying drugs (DMDs) on the market — for a number of reasons. In my case, I have had to change DMDs four times because of side effects. I am now on my fifth DMD in the 18 years since my diagnosis.
The first FDA-approved DMD, Betaseron hit the market in 1993. The demand for this injectable drug was so great that a lottery determined who would receive it. Only one in every five MS patients who entered the lottery was able to get it. It was some time after the lottery before Betaseron was available to all those who wanted it.
I began taking Betaseron in 1998, immediately after my diagnosis. Starting an injectable drug for the first time isn’t for sissies, but after I got used to the injections, everything went according to plan for a few years. Then, one day, I turned the color of a school bus, and I was hospitalized for elevated liver enzymes.On the advice of my doctor, I stopped taking Betaseron immediately.
After six months of recuperation and oral steroids, my liver enzymes returned to normal. My doctor suggested I begin taking Copaxone, another injectable DMD. Again, things went well for a few years, but then Copaxone began causing injection-site reactions, including redness, swelling and pain. After a while, the reactions became too painful, so I stopped taking Copaxone.
Let’s back up a minute so I can explain about a problem that occurred with Tysabri, the first MS DMD to be administered by infusion instead of injection.
According to WebMD, “After the FDA first approved Tysabri, the drug’s manufacturer took it off the market [in 2004] due to reports of a rare but serious brain infection called PML (progressive multifocal leukoencephalopathy). The drug company introduced a program that requires everyone taking the medicine to register and follow-up in order to find any possible cases of PML as soon as possible. With these safety programs in place, the drug went back on the market [in 2006].”
At about the same time the FDA put Tysabri back on the market, I stopped taking Copaxone. My doctor suggested I start Tysabri, and I did. Then, in accordance with the new safety programs, she tested my blood immediately after my first infusion, and that test revealed antibodies for the John Cunningham (JC) Virus.
According to the Tysabri website, the risk of getting PML is tied to multiple factors, including having antibodies to the JC Virus. The JC Virus is common and harmless in most people—about 50 to 60 percent of the general public has antibodies to the JC Virus in their blood (an indication of infection by the virus)—but it can cause PML in people who have weakened immune systems, such as people taking Tysabri. Because of the antibodies, my doctor took me off Tysabri immediately.
It is important for MS patients to stay on a DMD. When you stop taking one of these drugs and don’t start another one as soon as possible, you increase your risk of an exacerbation and disease progression. But after my experience with Tysabri, I got cold feet about trying other DMDs. I didn’t try another one until seven years later, when the FDA approved Tecfidera, the first oral MS therapy.
Tecfidera wasn’t a walk in the park, either. It was a pill, which was great — no more needles! But it came with a couple of side effects that sidelined me. One was flushing. And by flushing, I don’t mean my face turned slightly pink as if I were embarrassed; I mean my red, blotchy skin felt like it was on fire. Not only did it burn, it itched. All day and all night.
I called my doctor’s office and told the nurse about the flushing, and she suggested taking an aspirin a day would help. As soon as I started doing that, the flushing subsided.
The second, longer-term, side effect was nausea–24 hours a day. I hung in there as long as I could, hoping the nausea would subside. The prescribing information indicated it “may” subside within a month. But mine didn’t. So I stopped taking Tecfidera.
In the meantime, my MS began to progress; my gait problems and other symptoms began to worsen, so my doctor suggested I try Aubagio, another oral therapy. Unlike other DMDs, Aubagio had been shown to slow the progression of the disease. But when I did the preliminary testing to start the drug, I grew concerned by the need to be tested for tuberculosis. So I chickened out.
During the next year, my gait continued to worsen. Physical therapy didn’t help. I increased the amount of exercise I did, but my gait didn’t get any better. So I decided to try Aubagio.
The drug was known to have a couple of side effects that concerned me. One was nausea and a second was hair loss. I have been fortunate and haven’t experienced either of them.
But I don’t expect to continue to take Aubagio for a long time. My doctor has already identified another drug expected to be approved by the FDA in the next six months that she thinks will benefit me more than Aubagio, and she wants to move me to that drug when it is approved.
THE BOTTOM LINE
After using five DMDs in 18 years, I don’t think insurance companies should be able to remove them from formularies or to change protocols for their use. We need all of the treatment options we can get. The DMDs are all we have to help minimize relapses and limit the progression of this debilitating disease. There is no cure for MS — at least not yet.
The bottom line is I think it’s wrong for insurance companies to make treatment decisions for MS patients. Those decisions should be left to those with more medical expertise — our doctors.
I am troubled by two articles published recently on websites about multiple sclerosis (MS). The articles concern actions that insurers are taking to limit the number of MS disease-modifying drugs (DMD) they cover.
On August 15, Multiple Sclerosis News Today reported that CVS Caremark has dropped three MS DMDs — Avonex, Plegridy and Extavia — from its 2017 formulary.
On the same date, MS News and Views reported that Blue Cross/Blue Shield of Alabama has changed its policy concerning the use of two other MS DMDs — Lemtrada and Tysabri. This change went into effect August 1.
The article stated that previously, “BCBS of Alabama, like most payers (insurers), followed FDA (Federal Drug Administration) protocol labeling for MS medication.” Prior to that change, Lemtrada could be prescribed only if a patient “had used at least two other FDA-approved mainstream medications, and the requirement for Tysabri was that the patient had to use two other mainstream MS therapies or Lemtrada.”
The new ruling “requires that for a patient to be insured for Lemtrada therapy, that they first must use three other mainstream MS medications and for those wanting to use Tysabri, they must now use two other mainstream medications and have not used Lemtrada previously. So if Lemtrada does not work, you are not even allowed to use Tysabri.”
What does this mean to people with MS?
These actions mean that insurance providers, not doctors, are making treatment decisions for people with MS. Insurance providers do not have the medical expertise that doctors have, and I do not think they should be allowed to make decisions about which FDA-approved drugs they cover and which ones they don’t cover.
In the first article, Multiple Sclerosis News Today states: “If your prescription insurance is through CVS Caremark, and you want one of those drugs or one of the other 130 that were announced as off their formulary for next year, you can still get it, but you will have to pay full price. Your CVS Caremark insurance will no longer cover those costs unless your doctor is able to successfully appeal the formulary decisions.”
Bear with me while I repeat a part of that last quotation. It says: “…you can still get it, but you will have to pay full price. …” As a part of the research I did for this post, I scanned websites that made reference to the full prices of the DMDs that are available to people diagnosed with MS. I found that on average, the full price of these drugs is about $60,000 a year, or $5,000 a month. If I didn’t already have your attention, do I have it now?
The author of the article then echoes my sentiments about this situation: “It concerns me that decisions on treatments are being made based on costs and not doctor recommendations. I want me and my neurologist to decide what might be my best treatment and not my insurance company.”
The author of the second article asks the question, “Why the heck is this insurance company messing with your health? Why would they want you to worsen before slowing the course of the disease progression. What basis do they have to not allow you to take Tysabri or Lemtrada more quickly (for quality of life purposes), rather than waiting for another medication to first be used.”
He continues: “Who loses? The answer is pretty simple. We (the MS patients) are those who lose. Not necessarily you or me, but yes, us, being the MS patients. Patients who might need to be switched from a medication treatment therapy (or having been on two) that might not be working for them and instead of that person then having the option to be switched to a treatment plan of either Tysabri or Lemtrada, they may be denied due to the new BCBS policy.
“Then what? Where does it stop that these payers (insurers) are not thinking of your health and instead thinking of their own pockets. What is then to stop other insurers from doing the same thing and what if they decide that you cannot switch your current treatment option because they come up with new protocols for those medications as well”?
I have had to change my DMD more than once because of side effects or other factors. I have already been on five DMDs during the 18 years since my diagnosis. And that will be the subject of my next post. Stay tuned!
In the meantime, if you are a patient or practitioner in Alabama, please consider telling BC/BS what you think about the new protocol that limits the use of Lemtrada and Tysabri.
Check out the links below to the articles quoted in this post. You can click on the second link to get information about contacting BC/BS of Alabama.
By the time Amtrak gets to Union Station in Chicago, our connecting flight has left Midway Airport without us. The train station is about to close for the night at 1 am, and the airport won’t reopen until 3. So that we won’t be stranded, Amtrak puts us in a sleeper car on the tracks inside the station until 5 am, when we are awakened and led to a taxi that will take us to the airport. We check the bags and the scooter at Midway and get on a short flight home to the Deep South.
When we pick up our bags at the airport back in God’s country, the scooter is nowhere to be seen. Seems it never made it out of Chicago. After a brief delay in baggage claim, I sign a form verifying that I did not pick up the scooter.That evening at home, I get a call from the airport. The scooter has been located! It is delivered to my house, and all is well.
Thinking back on the past 10 days, I realize this experience has taught me that I can enjoy myself much more when I don’t expend all of my energy walking. It hasn’t been an easy transition, but I am sold on the benefits of using a scooter on occasion, rather than walking long distances.
I want to thank my friends who use scooters and who had assured me that it would be a vast improvement over walking everywhere on my recent vacation.
They were right. It took me awhile to warm up to the idea, but now that I’m comfortable with it, I plan to take a scooter with me on future trips that may require a lot of walking.
Using a scooter requires me to be flexible and admit my limitations, but in the long run, it is one more way to keep MS from controlling what I can and can’t do. I plan to purchase a scooter by year-end.
July 21, 2016
We leave Vancouver the next day and drive back to Seattle with the scooter in the trunk of the rental car. From Seattle, we begin the next leg of the trip, during which we will travel by Amtrak to Glacier National Park and spend a few days there.
TC drops me off at the Amtrak station in downtown Seattle with the scooter and bags, and he returns the rental car. When the train arrives, I drive the scooter up a metal ramp and onto the train without a problem. I drive down a hallway to a handicapped sleeping compartment.
It’s my first overnight train trip, and while I don’t sleep well, I am able to walk back and forth to the dining car without a problem. I am happy to report that the train ride to Glacier goes off without a hitch — more than I can say for the final leg of the trip.
We have a fun weekend at the park, including a boat ride and an eight-hour, 50-mile bus tour of the entire park that includes a stop at the Continental Divide. The scenery is majestic, and the weather couldn’t be better – blue skies and sunshine with temperatures in the 60s and 70s during the day.
On the following day — our last full day at the park — we learn that our train to Chicago is running late; we were supposed to leave the park around 11 am, but now it looks like we won’t get out of here before 6:30 pm. We could miss our plane out of Chicago and get home a day late.
I tool down the road on the scooter from the lodge at Glacier to the nearby Amtrak station with no problem. As I enter the station, the front wheel of the scooter shakes, and I see that a chunk of sidewalk beside the threshold is missing. As I leave by the same door, the scooter’s front tire turns sideways in the gap between the sidewalk and the threshold. The scooter falls to the right, taking me with it.
TC rights the scooter and I get back on it. Uninjured, I continue to the platform and wait for the train.
TO BE CONTINUED
July 17, 2016
When TC comes back from his conference that afternoon, I’m still sitting in the room with the scooter. I tell him what has happened, and he fixes the problem by removing the battery from the scooter and reseating it. He turns the key, and the scooter works perfectly.
We have dinner plans that evening in downtown Vancouver. I leave the scooter in the room, and we drive to the restaurant. Long story short, my cane and I enjoy a lovely meal with TC and two other conference goers. I don’t know why I didn’t take my scooter. I could have. But I seem to be getting cold feet (figuratively) about riding it.
The following evening, we are expected at a banquet on campus, which marks the end of the conference. TC tells me the location of the banquet is “a couple of blocks” away. He asks if I want to take the scooter. I decline, ensuring him wholeheartedly that I can easily walk that distance.
That was not the right decision. So why did I decline? Well, I’m still working through that. But in hindsight, I suspect it had something to do with accepting my limitations. Or maybe I don’t want others to see my limitations.
As we head out for dinner, I find it difficult to lift my right leg, despite the Walk Aid that helps me raise the front of my foot. My pace gets slower and slower as we approach our destination, and the “couple of blocks” seem longer and longer. By the time we reach our location, my pace has slowed considerably, and I trip with every two or three steps. I am quite fatigued when we finally reach the restaurant, and I wish I had taken the scooter. The return trip – from the restaurant to the room – is even worse. I walk even more slowly, tripping more often and becoming even more fatigued. After that trek, I finally admit to myself I need the scooter.
TO BE CONTINUED
July 11, 2016
In preparation for the trip , I borrowed a three-wheel mobility scooter from a friend. My traveling companion (TC) installed a new battery in the scooter the next day, and I went for a test run.
On the following Saturday morning, when we got to the airport, I rode the scooter from the curb to the counter, where we checked the scooter as baggage. (A hint from the scooter’s owner: When you check a scooter at the airport, keep the key with you. You don’t want the key to get lost in the baggage hold and have to put your vacation on pause while you wait for a baggage handler to find the key.)
When we arrived at the Seattle airport, the scooter was brought around to the baggage area, and I rode it out of the airport to a rental car. TC disassembled the scooter and put it in the trunk of the car — along with our suitcases — and we headed out for the Canadian border.
As I write this, we have maneuvered through Seattle in heavy traffic (on a Saturday afternoon –who knew?), crossed the border into Canada and arrived at Ponderosa Commons at the University of British Columbia in Vancouver.
On Monday morning, TC leaves for the day to attend a scientific conference, at which he will speak on Tuesday. The weather is sunny and mild, so I’m thinking of tooling around outside on the scooter until I find a pleasant, sunny spot, and then stopping to do a little reading.
I turn the scooter on, and it beeps loudly a whole bunch of times. I turn it off and try again, but it beeps again. When I press the handle to move the scooter forward, it won’t move an inch. According to the trouble-shooting guide, I am supposed to count the beeps and then refer to a chart to find out what the beeps mean. (Thanks to my friend for emailing that information to me before we left on our trip!)
But I don’t really want to deal with problem right now, so I decide to behave like any other self-respecting procrastinator and turn my attention to something else. Did I mention how pleasant it is this morning in Vancouver, where the temperature is 25 degrees lower than it is at home in Alabama?
TO BE CONTINUED
July 8, 2016
I was diagnosed with multiple sclerosis 18 years ago, but I’m still learning to be flexible when MS rears its ugly head and makes my life difficult. I have found that the most challenging parts of living with MS are being flexible and accepting my limitations.
Since my diagnosis, foot drop and muscle weakness have caused me to have problems with walking and balance. I used to furniture-walk to help with my balance. Then, on the advice of my doctor, I began using a cane to keep from falling.
I began wearing an AFO (an ankle\foot brace) to help with foot drop, but the AFO caused additional muscle weakness in my foot and ankle. So, two years ago, I purchased a Walk Aide device and found that is better than an AFO at correcting foot drop. And it helps strengthen my muscles instead of making them weaker. (For those of you who don’t follow my blog regularly, a Walk Aide is functional electric simulator that is worn on the calf and improves the walking ability of people living with foot drop.)
However, I can no longer walk for long distances without fatigue, even with my cane and Walk Aide. The time has come to consider other accommodations.
In some instances I can make adjustments so I don’t have to walk long distances. For example, I can shop online instead of spending my energy walking around in big-box stores. But in other instances, I have had to limit or stop participating in activities I enjoy — activities such as traveling –and I don’t like that. I don’t want MS to control what I can or can’t do.
So once again, it’s time to be flexible in the face of MS and admit my limitations. I am planning a trip to Glacier National Park. My choices are clear: (1) don’t go, or (2) use a scooter so I can travel long distances without walking. I don’t like the first choice, so I have decided to use a scooter — for the first time. Now using a scooter may not seem like a big step to you, but it does to me. I don’t need to use a scooter every day, and I don’t intend to become dependent on a scooter, at least for now. But for this trip, it will be a necessity.
TO BE CONTINUED