Part 2: Swaminathan P. Iyer, MD, Discusses Changing the Infrastructure of Drug Access

To watch part 1 of this interview, click here.

The Center for Biosimilars^® (CfB): Hello, I'm Matthew Gavidia. Today on the MJH Life Sciences Medical World News, The Center for Biosimilars^® is pleased to welcome Swaminathan Iyer, MD, professor of medicine in the Department of Lymphoma and Myeloma at the University of Texas MD Anderson Cancer Center.

What are some examples of powerful new originator drugs in blood cancers that are out of reach to many patients because of cost?

Iyer: So, I gave you the example of rituximab [Rituxan]. Rituximab was approved in 1998. But it took at least 10 years for it to make its way into the biosimilar realm in India and be available. There are 3 or 4 companies that did that. And if you look at CLL [chronic lymphocytic leukemia], the drugs that are available include monoclonal antibodies like rituximab. There's a second generation and third generation rituximab called obinutuzumab, which is available but because the cost of Rituxan is so much cheaper than it, [Rituxan is] still preferable. And you have the oral medications that fight against chronic myelogenous leukemia, like Gleevec. There’s the second generation, desatinib [Sprycel]. All of those things are available and some of the most recent entries into blood cancers are agents that have antibodies but also the ability to deliver chemotherapy into the cancer cells specifically. So, these are all targeted drug delivery systems.

Brentuximab vedotin [Adcetris] was one of them and it is an antibody drug conjugate [that targets antigen] CD30. That is an expensive drug. It is available in India and right now, but it's only in the reach of the "haves" and definitely not in the "have nots" because it requires a certain amount of technology and a subsidy. It's possible [for the "have nots" to access it] but we have not seen that happen, [nor have we seen it] with the biosimilar either.

And of course, you have the recently approved drug called polatuzumab vendotin [Polivy], which has not made its way to India, but I know for sure that Genentech and Roche are working together to provide free drugs. I have a few patients in India who get free drug supply by virtue of writing to them and making a case to get it. But not everyone has access to this. So, if you know the right way to do it, have the applications, and doctors there to help you, you are able to get some of the free drug supply as well.

Of course, the latest and the greatest is the CAR T therapy [chimeric antigen receptor T-cell], wherein we take the patient's own cells and reengineer them and give it back to them, but the pricing here is pretty high. It's anywhere from $600,000 to $750,000 dollars per treatment, including the cost of hospitalization.

CfB: You have expressed your belief that development of new generics and biosimilars is necessary and that compulsory licensing would help. Can you explain the Doha Declaration and how that would work?

Iyer: So, the Doha Declaration was essentially an aspect and element that came out of the talks that happened between all the countries beyond the G7 and the G20 countries on how all of those countries can work together. And countries generally work in their interest. There's a certain amount of protectionism with every law and every economic policy that comes across, but there is also the larger good at play. The Doha Declaration allowed for some leeway and flexibility in being able to partner, collaborate, and possibly look into essential medications.

For example, the WHO [World Health Organization] has a list of essential medications that have to be available at no cost and the WHO endorses some of those things and makes them available in some countries for certain diseases.

So, the Doha Declaration is one of the policy frameworks that allow us to do that to make the collaborations happen and there might be some economic help for the countries and also for the participating companies and corporate units. But, essentially, the Doha Declaration allows you to get drugs for a patient population in a particular country and think of the larger good. The goal is not to “make money,” but to help a patient population. You’re saving lives. I think price capping is one way of doing it. Price negotiation is another way of doing it. So, these are all different ways of approaching the problem. The Doha Declaration is a framework that allows us to that.

CfB: What would it take to get the Doha Declaration implemented in the United States and in India?

Iyer: So, in the [United States], I think it's a very different situation and I think the Doha Declaration may or may not necessarily be relevant because there are a lot of forces at work there. I think the market forces are much stronger there, even in health care, and pricing is still an issue, whether it is pricing of the drugs or pricing of hospitalization. I think those are issues that are being addressed at one level or another.

But it's a slow-moving process and it looks like there is an executive order from the president, but at the same time, there are a lot of challenges to that as well. There is still the intent to come up with better pricing in the [United States]. There's even the possibility of importing certain drugs from certain countries.

Of course, it's both policy and politics. So, I don't have the qualifications to talk about that, but that being said, I think countries like India and other Asian countries are in a much better place to implement this because they are at the receiving end. So, they're able to use the Doha Declaration and other global policies to negotiate with companies, talk to them about trying to price down a certain product, and help a larger population. It helps other countries more than [it would help] a country like the [United States], I would say.

CfB: To learn more, visit our website at centerforbiosimilars.com. I'm Matthew Gavidia, thanks for joining us.