Markman Outlines Biosimilars and Cost-Effective Oncology Practices

Maurie Markman, MD

The rising cost of oncology treatments is a natural result of the rapid advancements in the field, said Maurie Markman, MD. However, he added, unless it is addressed quickly, patients will not be able to access the therapy they need.

Biosimilars are gradually moving through the pipeline in the United States, and their use is likely to become more prominent as several patents for reference products near expiration. Most recently, in November 2018, the FDA approved the rituximab (Rituxan) biosimilar CT-P10 (Truxima; rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma, as a single agent or in combination with chemotherapy. There are also FDA-approved biosimilars for trastuzumab (Herceptin), bevacizumab (Avastin), and filgrastim (Neupogen).

Conceptually, biosimilars offer an effective solution to the current financial straits of oncology, but cost-related data have not yet had much impact, said Markman, who is the president of Medicine and Science at Cancer Treatment Centers of America, editor-in-chief of OncologyLive, and the 2018 Giants of Cancer Care^® award winner for Gynecologic Cancers. However, Markman explained that precision medicine is properly addressing this issue.

OncLive: What is your opinion on the use of biosimilars?

In an interview with OncLive, Markman discussed the evolution of biosimilars and ongoing efforts to make treatments more affordable for patients with cancer.Markman: Biosimilars are a very interesting concept. Obviously, at the highest level, you look at them and say, "Wow, they will really lower the cost of expensive drugs." It's like “mom and apple pie”—how could you possibly disagree with that? However, I understand that biosimilars are not the same as small-molecule generic drugs. Safety and efficacy are obviously critical endpoints, but based on the additional data we have seen so far, we are not seeing much cost reduction yet. I couldn't tell you the reason why that is, because I am not an economist.

How much of a problem is cost in oncology?

One would hope that the industry would eventually embrace this concept, and as patents expire for the generic drugs, biosimilars would become more prominent in the landscape. [Before this can happen], they need to be proven effective in various settings. Then we would move on to the so-called next generation of biosimilars, as we see with other classes of drugs. Biosimilars are part of a much larger topic, which is the current price of antineoplastics. It is the price of success, but it is a price that society can no longer continue to bear. We have to figure this out. It would be so simple if there was a magic bullet, but there just isn't. As a healthcare industry, as medical oncologists, as citizens of the United States, we have to come together for a solution.

We are talking about some incredible advances made in the treatment of [patients with] cancer and specifically gynecologic cancer, which is my interest. There is no question regarding the [overall] progress that we have made [in the space].

As we move to this concept of precision medicine in various cancers, is this the best cost-effective strategy, because you are essentially giving therapy with a high probability to work?

However, then someone could come in and say, "Well, it doesn't matter because patients will not be able to afford it." They will not be able to receive these drugs because the people paying the bills for them—the employers or whoever—will not be able to afford it. The insurance companies will not be able to afford it. How could that possibly be a good thing? We have to figure this out. It is a really wonderful question. I will tell you that most of the pundits are opposed to precision medicine because they simply don't understand it. These pundits point out that precision medicine is not actually saving money because the treatment is more expensive. In fact, it is the case that, as a conceptual framework, precision medicine very much supports cost effectiveness.

Precision medicine turns the treatment of [patients with] cancer into a process. We start with step 1, move on to step 2, and we know the impact each step will have. For example, in chronic myeloid leukemia, no one today would argue that we shouldn't treat these patients with imatinib (Gleevec). By the way, that drug is generic right now. However, the fact of the matter is that precision medicine addresses this issue. You are giving the right drug to the right patient at the right time. Nice slogan, right? It just makes sense.

If you have a 98% probability that you are hitting a meaningful target and the patient will be able to continue to go to work and live a normal lifestyle, who would argue against that? Again, we still have to deal with the pricing issue, but it just makes the most sense. Conversely, if we have a drug with a 0% probability benefit in a patient and the patient asks, "Why would I take this?" and the payer asks, "Why would I pay for this?" that makes sense too. I am giving you the 2 extremes: 98% probability benefit versus 0% probability benefit. It seems easy, right? But we are far away from that.

Conceptually, it is just as valuable to say that a drug will be effective in a specific setting compared with saying that it will definitely work. Is it going to be effective for 6 months, 6 years, or 6 decades, assuming a patient is diagnosed at a young age and is living a normal quality of life? I am a firm believer that precision medicine has a tremendous value from an economic sense. However, my focus as a clinician is on the individual patient. I want to get the necessary treatment to a patient no matter what, but obviously, from a societal perspective, we have to figure out how to pay for it. These are 2 very related topics, but my own personal responsibility is to that patient who I am treating today and tomorrow. We all have to figure this issue out together.