Tecfidera Goes on Formulary
Jul 29, 2014
By Trevor Shewfelt, Pharmacist at the Dauphin Clinic Pharmacy
I dont have to notice if my wife gets her hair done every again. And I can thank a horse and a big black dog named Blue. I was riding my bike home from work and was going through Vermillion Park. There was a family on the trail walking a big black dog. The teenaged son was saying, Sit Blue but having trouble holding the big boy back. So the Dad had to hold Blue as I passed. There is something dogs just dont like about bicycles. After I passed Blue and his family, and the store cell phone went off. It was Dr. Roxane Neufeld from the Dauphin Vet Clinic. She was headed out of town to do farm call for a horse with an eye problem. We discussed which eye drop would work and I agreed Id go back to the store. I said Id meet her at the pharmacy and get her the drops to take out to the horse. I turned my bike around and had to cycle past Blue and his family again. I apologized for getting Blue excited and continued back to the pharmacy. I met Dr. Neufeld at the drive thru and got her the eye drops she needed.
Eye drops can be essential for some people to be able to read. I read some exciting news last week. The new medication Tecfidera for relapsing remitting MS went on the Manitoba formulary. Since that whole sentence doesnt make much sense to anyone who isnt a pharmacist, lets break it down.
Every time a new drug comes out, I get asked the same question, Health Canada approved it. My doctor prescribed it. Why isnt it covered? The answer is because it is new. Manitoba Health has a list of medications they will pay for and they call that list a formulary. New drugs take a year or more before Manitoba Health will consider if they will pay for them. And because they are the government it isnt as simple as when the government will pay or not. There are Part 1 drugs that any doctor can prescribe without stating their reasons and Manitoba Health will cover them. Then there are Part 2 drugs that a doctor must state their reasons like, I tried a cheaper antibiotic already, Id now like to try a more expensive one. Then there are Part 3 EDS or exceptional drug status medications. These drugs will only be covered if the doctor completes some very specific paperwork and conditions. And to keep things good and confused, even if your drug gets all the right paperwork done for it, Manitoba Health still wont pay until you spend more than your pharmacare deductible.
Tecfidera was approved by Health Canada on April 9, 2013. If your doctor prescribed it for you last year, it wouldnt have been on the formulary at all, so there is no way Manitoba Health would have paid for it. As of July 17, 2014, Tecfidera is on the Manitoba Formulary, but with conditions. It is a Part 3 EDS drug. So now your doctor can get it covered, if they meet the right conditions and complete the right paperwork. Before we go through that process, lets back track a little.
What is MS or multiple sclerosis? It is an unpredictable and often debilitating disease of the brain and spinal cord. Some of the long nerves in the brain and spinal cord have a covering called myelin. Myelin works a like the plastic covering around a telephone cord. Without the insulating plastic cover, some of the signal that goes down the telephone wire would leak out. The voice on the phone would sound delayed, weakened, garbled or possibly not there at all. In MS, the body mistakenly attacks the insulating myelin sheath around some of the nerve fibers. So the signals from the brain to the body or body back to the brain get weaker, delayed, garbled or go missing altogether.
Compared with big diseases like heart disease, cancer and diabetes, why should you care about MS? While it is true that MS isnt as common or as deadly as heart disease, cancer and diabetes, MS is the most common neurological disease affecting young adults in Canada. In fact, Canada has one of the highest rates of MS in the world. Within our country, Manitoba has one of the highest rates of MS in Canada. Dr. Ruth Ann Marrie, who works at the MS Clinic in Winnipeg, published a paper about MS prevalence in Manitoba in the January 2010 issue of Neurology. She concluded Manitoba has one of the highest prevalence rates of MS in the world. So, Multiple Sclerosis does affect a lot of people in our area.
Lets assume you have relapsing remitting MS and your doctor is thinking about using Tecfidera. She tells you its generic name is dimethyl fumarate. Your overly excited pharmacist says he was fascinated when he heard it was such a relatively simple molecule. Most of the new MS drugs are complicated proteins like interferon or modified antibodies. He goes on to say the researchers dont know exactly how dimethyl fumarate works in MS. They think it may help protect cells from oxidative stress. It has been used in Europe for years to treat psoriasis. Dimethyl fumarate is an oral drug for relapsing remitting MS. It seems to work as well as fingolimod, the other oral drug for MS but with less side effects. It does have side effects, though. It can cause stomach problems like nausea and flushing. If you take dimethyl fumarate with food, that reduces the chances of flushing and the stomach problems. Some have suggested that if you take a regular, non-coated aspirin 30 minutes before the dimethyl fumarate that can reduce the flushing as well. The flushing also just seems to get better the longer the patients are on the dimethyl fumarate. Then your pharmacist tells you dimethyl fumarate is really expensive. It costs over $2000 per month. Now it matters that Tecfidera or dimethyl fumarate is on the formulary. But it is there with conditions. The formulary says Manitoba Health will consider paying for Tecfidera or dimethyl fumarate if the patient is 18 or older, has relapsing-remitting MS and is prescribed by a neurologist from the MS Clinic. That means if your family doctors writes the prescription, Manitoba Health wont pay. You have to see a Neurologist at the MS Clinic in Winnipeg. Finally, you have to be over your pharmacare limit for Manitoba Health to pay.
When I left the pharmacy after getting eye drops Dr. Neufeld and the horse, I decided not to pedal back through Vermillion Park and annoy Blue again. I went home past John Oriskos house. I saw John had a fire going in the back yard, so I stopped for a chat. Jerry Orisko was there shaving Mark Thieles head. Jerry asked if I needed a haircut, so I said,Sure. Jerry shaved my head nearly bald while I tried not to squat mosquitos. I chatted briefly to John and continued on home. After I got home I talked to my wife for 15-20 minutes and she didnt notice anything. I eventually had to point at my head. Doris said, Oh. Youre bald. And that was it. Now I didnt have a lot of hair to begin with, but I did go from hair to no hair. Doris didnt notice at all. That is why I never have to notice my wifes hair do every again.
As always if you have any questions or concerns about these or other products, ask your pharmacist.
The information in this article is intended as a helpful guide only. It is not intended to be used as a substitute for professional advice. If you have any questions about your medications and what is right for you see your doctor, pharmacist or other health care professional.
We now have most of the articles published in the Parkland Shopper on our Website www.dcp.ca
MS Society of Canada www.mssociety.ca
Tecfidera FAQ page: mssociety.ca/en/treatments/treatments_tecfidera_faq.htm