New, FDA-Approved Multiple Sclerosis Drug

American pharmaceutical manufacturer Biogen Idec, Inc. of Weston, Massachusetts, recently announced it would offer a substantial discount for its new multiple sclerosis (MS) drug Tecfidera, approved for use March 27, 2013 by the US Food and Drug Administration. The medication is also known as BG-12.

A Disease Caused By An Overactive Immune System

MS affects about 400,000 people in the United States and about 2,000,000 people worldwide, most of them in northern Europe and the northern half of the United States along with all of Canada. Typically striking its victims in their 20's, MS results from a hyperactive immune system's attack on the myelin insulation of nerve cells, also known as neurons, causing difficulty walking, loss of vision, and severe fatigue.

Highly effective treatments for MS have been available for several years, but the most effective treatments, until now, have presented unacceptable side effects.

Tecfidera does not seem to cause life-threatening side effects. Even better, it is one of just three medications for MS that can be taken orally, no IVs required. And its mode of action is particularly on point for multiple sclerosis sufferers.

How Does Tecfidera Work?

Tecfidera acts as a particularly potent antioxidant. MS researchers have known for a long time that one of the ways the disease attacks the central nervous system is by the release of overly reactive free radicals of oxygen and nitrogen. These free radicals cause the release of hydrogen peroxide and peroxynitrite, which in turn damage the myelin coating of nerves in the brain, in the spinal column, and throughout the body.

The damage caused by this inflammatory process is usually not absolute. Neurons recover from inflammation, only to be attacked by free radicals all over again, causing a pattern of relapses and remissions that make tracking real progress in treating MS very difficult.

The way Tecfidera interrupts the free radical-driven process of inflammation that causes the symptoms of MS is by activating the nuclear 1 factor (erythroid-derived 2)–like 2 (Nrf2) antioxidant response pathway. This is one of the primary ways neurons protect themselves against the inflammation caused by free radicals. 

How Well Does Tecfidera Work?

The BG-12 study group recruited over 1,200 people with relapsing-remitting multiple sclerosis, the variant of the disease in which symptoms periodically get better and periodically get worse, in 28 countries. MS patients in the study were aged 18 to 55. One-third of the volunteers for the study received a placebo, one-third received 240 mg of BG-12 twice a day, and one-third received 240 of BG-12 three times a day, for an average of 84 weeks. Neither the participants in the trial nor the researchers knew who was receiving the actual medication until the study was complete.

The study found that:

• Taking the medication twice a day reduced the risk of progressive disability by 38%. Taking the medication three times a day reduced the risk of progressing disability by 34%. (Twice a day was more effective than thrice a day.)
• Taking the medication twice a day reduced the risk of developing a brain lesion that could be detected with a brain scan by 90%. Taking the medication three times a day reduced the risk of developing a new brain lesion that could be detected by scan by 73%.

Tecfidera isn't a silver bullet for MS, but it definitely helps, and most commentators expect it to become a blockbuster, $3 billion a year drug. But is there a downside to using it? And if you need it, how can you afford it?

How To Get Help With Tecfidera

Tecfidera does not pose some of the unacceptable risks presented by earlier MS drugs--such as death. But that doesn't mean that Tecfidera is free of side effects.

Fewer than 1% of participants in the study died during the trial, fewer than 2% of participants in the study were diagnosed with cancer during the trial, but among the participants taking two doses of the drug daily:

• 2% experienced a serious infection.
• 4% experienced leukopenia, a potentially dangerous decline in white blood cell count. (The average decline in white blood cell count in the twice-a-day group, which was not considered to be "serious," was 28%.)
• 10% experienced vomiting.
• 10% experienced itching.
• 11% experienced abdominal pain.
• 13% experienced nausea.
• 38% experienced facial flushing, and most significantly,
• 27% experienced a relapse of the underlying disease.

Two Pills a Day Cause More Side Effects than Three

For the most part, participants in the trial who took three doses of the medication per day had fewer side effects, but also fewer benefits. And since MS often causes most of the symptoms listed here, except facial flushing, only leukopenia (lowered white blood cell counts) and relapses of the disease itself were considered "serious."

Inteferon-beta and glatiramer acetate, which often cause flu-like side effects (glatiramer acetate can also cause lumps to form at the injection site, as well as facial flushing and rapid heartbeat), are effective in only about 30% of cases. Drugs like Tysabri are effective in 60 to 70% of cases, but can cause death. Tecfidera seems to work about 50% of the time, with relatively few serious side effects. Among the drugs for MS that on the market now, it is is clearly one of the best--but at $80 a pill for a medication that has to be taken twice a day, how could anyone pay for it?

Paying for Tecfidera After Obamacare

When the Affordable Care Act kicks in on January 1, 2014, every American health insurance plan will have to cover MS even if it is a pre-existing condition, and out-of-pocket drug costs, for most consumers, will be drastically reduced.

Families that earn less $46,000 per year will be able to apply for Medicaid coverage of their insurance premiums. These plans will cover essentially the entire cost of medications such as Tecfidera.

Families that earn up to $90,000 per year will be able to get health insurance at reduced rates. They can buy health insurance that covers almost the entire cost of medications such as Tecfidera.

The Biogen Idec Access Program

And in the meantime, the Biogen Idec Access Program will help with the costs of the medication for people who do not otherwise have the resources to pay for it. If you have a diagnosis of MS, a prescription for Tecfidera, you are a citizen or legal resident of the United States and its territories, you do not have health insurance, you are not eligible for Medicare Part D, and you meet an undisclosed income guideline (you will have to ask the company for details), then you may be able to get the drug at a cost of $25 for a 90-day supply (a discount of over $14,000 every three months). Call 1-800-456-2255 for more information. And don't forget to send a thank-you note when you get the drugs.