Even before I was diagnosed with MS in 2005, I researched the different treatment options. I learned about the ABC’s (Avonex, Betaseron, Copaxone), which soon became known as the CRAB’s with the addition of Rebif. I learned that each of these medications were administered by shots which the patient has to give himself at home. I had yet to learn about Tysabri, Novantrone, or Low-Dose Naltrexone (which is used off-label by some to treat various autoimmune diseases).
One thing which was discussed as a far-off option (in the future) would be oral disease-modifying medications. Drug companies have been studying the use of oral medications in multiple sclerosis for several years and the first one has finally been approved by the US Food and Drug Administration (FDA).
First Approved Oral Disease-Modifying Drug for MS
On September 22, 2010, the FDA approved Gilenya capsules (FTY720 or Fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis.
“Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to currently available injectable therapies,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, according to the FDA’s press release.
As soon as the FDA gave Gilenya the approval nod, speculation in the MS community has been 1) when will the drug be available for patients, 2) what will it cost, 3) how many patients will switch from their current therapy to try it? We now know the answer to two of these questions.
Gilenya will be available for sale in the United States this week, according to a recent Bloomberg report. It takes time for marketing materials to be approved (which is also done by the FDA) so we might not be seeing ads for Gilenya just yet. But what better marketing is there with a new drug launch than to read a series of articles and blog posts regarding the new oral medication? It is our word-of-mouth which will prove to be the most effective marketing, I believe, that Novartis can count on right now.
The biggest concern I have heard from other patients is WHAT IS THE COST? A spokesman from Novartis informed a Bloomberg reporter that the wholesale price has been set at $4000 per month for the daily pill. My initial response, and those of other bloggers I follow, was one of outrage and astonishment. Why in the world would Novartis set a price considerably more expensive than the current self-injections?
I don’t have an answer as to why, but I did reach out to someone I have met from Novartis and expressed my own shock, including personal opinion (gained from experience) that qualifying for prescription assistance programs is a hellish experience. He’s not a spokesperson for Novartis and couldn’t respond directly to my question, but he did counter with a question of his own. “What would be best practices for any Prescription Assistance Program for patients?”