Ginsberg: All right, welcome back, this is Seth Ginsberg filling in for Lisa Wexler. You are listening to ‘The Highway to Health.” That’s what I’m calling the show today because were talking health reform and we’re talking about some of the intricacies that the Obamacare health legislation covered but may not have necessarily been discussed in the mainstream media because it’s more exciting to focus on the shiny objects and on the phone now is somebody who knows a great deal about some of these intricacies. Steve Marmaras, Steve, hey you there?
Marmaras: How are you Seth?
Ginsberg: Hey, good afternoon. Steve, you are the manager of state and national advocacy for the Global Healthy Living Foundation. How’s that going?
Marmaras: It’s going great. I’m based in Washington, D.C. In the role, I’m really the liaison between policy and regulations that impact access to care, and most importantly, the patients who are affected by the decisions.
Ginsberg: Excellent. So full disclosure here, Steve. We work together (laugh) and as the co-founder of the Global Healthy Living Foundation and patient advocate since the age of 13 when I was diagnosed with a form of arthritis called spondle arthropathy, I definitely appreciate the great work you do in the importance of educating policymakers and regulators about the issues that we face as patients living with chronic diseases. So how important is this subject of biosimilars?
Marmaras: Well, it’s a very important subject Seth. Since GHLF has many communities of patients with chronic diseases, including complex conditions like rheumatoid arthritis. Our communities rely heavily on biologics to manage these conditions. So when policies and regulations are proposed, that threaten access to the therapeutics, we have to mobilize our communities, to first understand what’s happening and then participate in a solution.
Ginsberg: Right, cause when we are talking about these communities and these chronic diseases while these complex biologics to treat them may seem scary at the end of the day, if we don’t take them because, ya know, all we take are say Lipitor or some pain medicines like Advil, chances are we have a relative who’s got cancer and mass rheumatoid arthritis, psoriasis, Crohn’s, you name it. Is that fair to say?
Ginsberg: Wow. So here we are talking about what’s going to happen with these biosimilars and the fact that they could be substituted without us knowing. They might have the same name as the innovator of the original biologic and we won’t know which is which. What is the solution, Steve?
Marmaras: Well, I think the solution has to do with transparency and communication between patients and the treatment teams. We really feel that transparency and communication are paramount, and we go by a set of core principles laid out first by the biotechnology industry organization. And if you don’t mind, I’ll lay out some of those principles.
Ginsberg: Yeah, you’ve got to do it in a hurry though. We’ve got to run.
Marmaras: Ok. The first one is that the substitution of a biosimilar for a biologic should only occur when the FDA has designated a biologic product as interchangeable. The second is that prescribing physician should always be able to prevent the substitution. The prescribing physician should be notified of the substitution in a patient or the patient’s representative should, at a minimum, be notified of the substitution as well. And lastly, the pharmacist and the physician should keep records of the substitution.
Ginsberg: And where do patients go to get more information about this?
Marmaras: Well, they can go to our website, HealthyBiologics.org to keep updated on the issue. And they can also join our 50-state network of super advocates. It’s important that patients and physicians have a voice in this discussion because it’s going to be directly affecting them.
Ginsberg: Steve Marmaras for the Global Healthy Living Foundation.