The first drug to treat an aggressive form of multiple sclerosis has hit the market.
The FDA approved the drug, sold as Ocrevus, two weeks ago. The approval comes after a series of clinical trials across the nation, including at the University of South Florida’s Multiple Sclerosis Center in Tampa.
Health News Florida’s Stephanie Colombini talked with Dr. Janice Maldonado, Assistant Professor of Neurology at the center to learn more about Ocrevus and its development.
Here’s some highlights from their conversation:
MALDONADO: “Multiple sclerosis has two different presentations in which [Ocrevus] was tested. The relapsing form of MS is the form in which patients will have events that take away neurologic function, meaning transient times where they lose function in a limb, their vision, etc. The drug was tested in patients with the relapsing form of MS; and in the other form of MS, which is less common, it occurs in 10-15% of the MS population, and that’s the primary-progressive form of MS. In primary-progressive MS, a patient will start to have a neurologic problem, and it does not get better ever; it accumulates overtime, it progresses.
COLOMBINI: What were patients [in the clinical trials] going through on a daily basis before they started taking this drug? What is life like for people suffering with this disease?
MALDONADO: We almost have to separate them out, because multiple sclerosis of the relapsing type has had many treatments available that have shown some degree of effect. There have been options for [patients with relapsing-remitting MS] since the mid-nineties. There have not been any drugs that have proven any effect or any impact in the disease in the primary-progressive MS patients. And so that’s the revolutionary portion of having this drug now. Now we can offer a treatment that is going to have some impact on their disease, it’s going to delay that progression that they have been living with.
COLOMBINI: So how does Ocrevus work?
MALDONADO: This drug is an IV infusion. [Patients] receive one infusion and then six months later is the next treatment. So it’s a wide gap of time where they really don’t have to take something on a daily basis, or anything like that.
COLOMBINI: What kind of results did you see in patients?
MALDONADO: Things we monitor in these patients are the formation of new lesions in the brain, and there was evidence that lesions formed less often…There was less activity seen on MRI of the brain.
COLOMBINI: So you talk about MRIs and lesions on the brain – things you [and other professionals] would notice but, in terms of everyday function, did you have patients saying, “I feel better than I did before?”
MALDONADO: So patients with the relapsing type of MS (RRMS) did manifest feeling better in terms of their quality of life…and if you think of it, if you are having relapses less often and have the comfort of knowing less lesions that are active are forming in your brain, that also gives you some security; so we could see it in patients.
COLOMBINI: How much does [Ocrevus] cost? Is it something that’s accessible to everyday patients? Does insurance cover it?
MALDONADO: Insurance typically covers standard treatments for MS…this drug is going to be marketed at a price that is equivalent to the drugs that are already available…It is $65,000 a year, that’s the price tag that was quoted.
COLOMBINI: Wow, but you say that’s actually normal for MS drugs?
MALDONADO: True, injectable medications and oral medications can range from $5000-$8000 a month.
COLOMBINI: That must be incredibly tough on patients.
MALDONADO: As an advocate for patients, cost has always been a very difficult topic because we want to make [MS drugs] available to all patients, and that is a struggle. I have to say that pharmaceutical companies have offered patient assistance programs, so I am sure Ocrevus will have that capability as well.
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