Flame On: Starting Tecfidera and How I Avoided Becoming a Superhero
Tecfidera, the dimethyl fumarate compound formerly known as BG-12, has been my beacon of hope for the past two years. Since 2011, I’ve kept a watchful eye as it wended its way through clinical trials. It consistently performed well as a means of significantly reducing the number of relapses and new lesions compared to placebo in its test subjects. But efficacy wasn’t my main concern. Drug safety was.
I stopped Tysabri infusions in 2011 partly due to my increasing concern about the PML risk and partly because I had to stop in preparation for gallbladder surgery. I was also getting pretty tired of being the Human Pin Cushion, suffering through numerous futile attempts by the nurse to locate and pierce my tiny, well-hidden veins. I longed for a drug that wasn’t injected or infused and which had a risk profile that didn’t include liver toxicity, multiple organ failures, and fatal brain infections.
In March, 2013, the DMD fairy granted my wish when BG-12 became FDA-approved and was rechristened Tecfidera. During the trial phase, no health risks were demonstrated, and the side effects of flushing, itching, and stomach upset were relatively mild compared to the flu-like symptoms of the interferons Avonex, Betaseron and Rebif. Another bonus is that Tecfidera is a twice-daily capsule, so we are spared the injection site reactions of swelling, pain, necrosis, and lipoatrophy.
Formerly a Copaxone user, I developed lipoatrophy and I still sport four huge dents on the backs of my arms from injecting the drug for five years. Whenever I go sleeveless and someone points at those dents and asks what they are, I readily confess my secret. “Washboard triceps,” I proudly announce, “It’s the latest fitness rage.” Yeah, they didn’t buy it, either.
After some careful thought, I finally decided to give Tecfidera a go.
Within a few days after filling out the paperwork in my neuro’s office, I was contacted by a specialty pharmacy and by Biogen’s MS ActiveSource. Some happy surprises followed. Biogen does have a patient assistance program, but patients like me who have Medicare (as well as those who have any kind of government insurance) do not qualify. Medicare patient applications are automatically forwarded to the Chronic Disease Fund (CDFund.org), a charity organization. All I had to do was fill out an application, declare my household income, and send supporting documents for 2012. I'm on SSDI, so I sent my SSA-1099 income statement along with my mother's financials to the Chronic Disease Fund. (Note: Patient assistance programs have income caps that are far above the federal poverty guidelines, so if you make too much to qualify for Medicaid like I do, have no fear.)
I was approved within days, and they agreed to cover my co-pay one hundred percent. I was behind the curve, though; if I had a co-pay, that meant my Medicare Part D drug plan had covered Tecfidera, something I did not anticipate. I was prepared to petition the plan to add it to their formulary, but I didn’t have to. What a relief.
The specialty pharmacy, OptumRx, is affiliated with my Medicare Part D plan. They readied the shipment as soon as they saw that payment was covered by CDFund. And they knew it right away, before I even called them with a date to ship the titration kit, this is another thing that deeply impressed me. Biogen, CDFund and OptumRx had all communicated with each other seamlessly. I’ve been assigned an OptumRx pharmacist named Sara, and she has already called me to discuss my reactions to the drug. She told me that I will always talk to her and no one else, so I’ll be sure to work with someone who knows my case. Again, I was very impressed.
Now for the impact on my Medicare Part D drug coverage: The cost of Tecfidera is $4,615/month. This amount was enough to knock me clear through the coverage gap (aka the doughnut hole) and into catastrophic coverage, drastically reducing the co-pay amounts of my symptom meds. I pay zero for Tecfidera, $2 for generic meds, and $10 for brand name meds. I can hear the sound of my checking account sighing in relief as we speak.
So on to September 24, 2013, when I swallowed my first Tecfidera capsule. I should mention that during the first week, you take a half dose, 120 mg twice a day. Having first read the instructions, I made sure to take it with a meal and a low dose 81 mg enteric-coated aspirin. I sat back and waited, expecting to feel the oft-reported flushing, itching and nausea. After reading some rather harrowing accounts of several patients' experiences, I half expected to burst into flames. But nothing happened.
Two hours later, I felt some heat come to my face and throat, a prickly feeling, and some mild itching on my hands, but still no spontaneous combustion. I took a second aspirin. The symptoms quickly disappeared. I took the second dose that evening without a meal and without aspirin. Absolutely nothing happened. The rest of that first week, I took the capsules without a meal and without aspirin. Sometimes I felt no affects, and sometimes I developed a very mild prickly sensation in my face an hour or two later that quickly disappeared.
The second week, I started the full dose of 240 mg twice a day and experienced the same side effects: Mild or no prickly sensation an hour or so after taking the capsule.
I have to admit I was disappointed. Having anticipated this experience for two long years, it was rather anti-climactic. Ever the adventurer, I possess a not-so-secret longing to be a medical curiosity. The novelty of having MS has long worn off. And I’ve never been part of a clinical trial, there simply haven’t been any available in my immediate geographical area.
Still, wouldn’t it be fascinating to become, say, the Human Torch, flaming on and off at will, courtesy of Tecfidera? Not only could I impress my friends and perform in the center ring at circuses, I could intimidate bullies, drug lords, terrorists, and obnoxious talking heads with incendiary displays of power. If you’re not familiar with The Fantastic Four comic book heroes, the Human Torch makes up one-quarter of the group. Their back story is that these four were in a spacecraft when they were bombarded with cosmic rays which scrambled their molecules, causing each to acquire a unique set of abilities. But upon their return to earth, they didn't settle for life in a medical facility, a quartet of lab rats studied by the top scientists on the globe. They became vigilantes, fighting tirelessly to maintain moral order in the cosmos.
Sadly, my molecules remain virtually unfazed by Tecfidera. I could market myself as the Prickly Pear, but I don’t think my superhero resume would measure up. I’ll just have to exist in obscurity as a writer coping with MS, battling chaos in my own little micro cosmos. I guess I can live with that.
I have the hardest time with my MS during the following season: