MS & Tecfidera: Considering the Options
What a difference a day makes – that’s about how long it took for the enthusiasm for Tecfidera, formerly known as BG-12, as the next oral agent for Multiple Sclerosis, to go from wonder drug status to another big question mark for so many people with Multiple Sclerosis. Actually it was a bit longer than a day, but it took less than a month for the stellar reputation of Tecfidera to be tarnished by reports that at least four people who took a different form of the chemical that makes up Tecfidera had developed PML.
PML is Progressive multifocal leukoencephalopathy, a fairly rare viral disease that can cause permanent disability or even death. It should be noted that no cases of PML occurred in any patients on Tecfidera during their trials for MS, but one of the drugs (Fumaderm) taken by people who contracted PML is also made by Biogen Idec, the manufacturer of Tecfidera. These cases happened while they were being treated for their Psoriasis and not MS.
PML is not new to the world of MS drugs – Tysabri, the monthly infusion drug that has extremely high efficacy rates, was once pulled from the market entirely because of the deaths from PML associated with the drug. Tysabri is now available through a tightly controlled distribution and administration process and carries a black box warning of possible death. Biogen Idec is the parent company for Tysabri and Tecfidera, as well as Avonex, an injectable interferon drug. And now, two of their three MS drugs have been linked to PML in one form or another.
Biogen is not alone with the question of PML hanging over their drugs – Novartis’ Gilenya has also had a PML case associated with their oral MS drug. It is often difficult, if not impossible, for investigators to determine what caused the PML because the cases involve people with chronic illnesses who are taking multiple drugs over prolonged periods of time.
Tecfidera, aka BG-12, was officially approved by the FDA for use by people with MS on March 27. This is not a new drug, but a new use of a drug that has been used in Europe since 1994 to treat psoriasis. Almost twenty years of use in humans should be long enough to get a sense of any undesirable side effects that might come from its use – there was reported the fairly common problem of flushing but that is supposed to get better over time. The discussion of PML and dimethyl fumarate did not come up until the week of April 22, almost a month after Tecfidera’s FDA approval. What gives me pause is the FDA knew of these cases of PML, but still gave its blessing to Tecfidera – does that mean they don’t anticipate a problem with this formulation? And what accountability should Biogen Idec be held to for not sharing this information with its consumers?
The numbers for Tecfidera are impressive – the annual relapse rate on this drug is reduced to anywhere from 44-53% and is just shy of the rate of 54% shown in studies for Gilenya, another oral MS drug. There is a third approved oral MS drug, Aubagio, but it has not gathered the attention like Gilenya and now Tecfidera.
It is estimated that Tecfidera, taken twice daily, will cost $54,900 a year, which except for Gilenya, is pretty much what the other disease modifying drugs cost. Gilenya, the first oral drug to be approved, is roughly $60,000 per year for treatment. The annual costs of the other leading MS drugs are – Avonex , $50,880; Tysabri, $52,449; and Copaxone at $56,000. Yes, there is a lot of money involved in treating MS but I’ll save that for a different discussion.
I am currently on Tysabri, an infusion drug that I receive once a month in a highly specialized and very regulated clinical setting. As I already mentioned, Tysabri has its own particular set of problems, including the possibility of causing PML. There are screening tests that are done every six months to make sure I am still risk free but there is still the possibility of contracting PML in between these screenings. I am also on a regimen of meeting with my neurologist or one of the nurse practitioners in the MS Clinic every three months. Taking Tysabri requires the patient to make a choice informed of the PML risks and Tecfidera might also fall into that category.
Choosing a disease modifying therapy and sticking with it for the long haul poses challenges for all of us. My MRI tests continue to show my MS is stable on Tysabri. I hear the same positive results from people who take injections of Copaxone, Rebif or Avonex or Gilenya. The advance billing for BG-12 had many of us looking forward to its approval and making the switch, but now that Tecfidera is within my reach, will I want to make that change? The headlines linking this drug to PML has to give us all pause to review the complete information before making any change.
I have to weigh this question and decide if I want to mess with success and switch from Tysabri to Tecfidera, as I had originally intended to do. A twice-a-day pill would be simpler than my monthly day off work to travel to the MS Clinic for the infusion. This is a question many of you reading this will also struggle with and be discussing with your neurologist. I hope whatever decision any of us make, it will be the best one to keep our MS at bay without additional complications.
Wishing you well,