Kashyap Patel, MD, discusses biosimilars and other potential cost-controlling measures in cancer care.
Kashyap Patel, MD
The rising issue of drug prices is going to take time to resolve, but there are cost-effective strategies oncologists can practice in the meantime, said Kashyap Patel, MD.
Patel, president of the Carolina Blood and Cancer Center and medical director of the International Oncology Network, said that biosimilars are crucial to unsustainable costs in oncology. But before these agents can become part of routine practice, significant skepticism will have to be addressed.
However, biosimilars are gradually entering the pipeline. For example, in December 2017, the FDA approved the first trastuzumab (Herceptin) biosimilar, MYL-1401O (Ogivri; trastuzumab-dkst), for the treatment of patients with HER2-positive breast cancer or metastatic gastric adenocarcinoma. There are also FDA-approved biosimilars for bevacizumab (Avastin) and filgrastim (Neupogen).
While researchers further test the biosimilar waters, Patel noted that there are low-hanging fruit in practice that can be modified for cost purposes. Among these are reducing unnecessary hospitalization and reforming end-of-life care.
In an interview with OncLive at the 2018 NCODA Fall Summit, Patel discussed biosimilars and other potential cost-controlling measures in cancer care.Patel: People keep talking about the drugs as a big part of the cost. But when you look at multiple studies, there are other areas that are low-hanging fruit in healthcare that can be addressed a lot more quickly. First of all, when you look at unnecessary hospitalization, this is something that can be reduced. We can see patients only when they need to be seen. That is one component of cost that has not been discussed.
The second piece is appropriate end-of-life care. Currently, about 9% of patients [who die of cancer] die in the hospital or in the intensive care unit. That probably should not be happening. The third thing is site of care delivery. If you look at recent published studies, they all show that the physician's office is a much more cost-effective place to deliver therapy.
There are some areas where steps can definitely be taken to bring in new strategies. Of course, we don't want to hurt innovation. Drug prices are always a challenge, but they bring in innovation. Without innovation, we would not be able to cure cancer. There are simple practices that can become priority to addressing drug prices.Oh, now you are going to get me going. How much time do we have? Biosimilars are actually my favorite topic. I testified in front of the FDA about 2 weeks ago in terms of ODAC to support approved biosimilars. These are the real solution to driving down drug prices. If you have one possible solution for the future, it is biosimilars.
But there are challenges—payers do not recognize their role and our patent litigation system is conducted in a way that even if biosimilars are approved, they are sometimes delayed by 6 to 9 months. At the end of the day, biosimilars definitely position themselves as a very rational and realistic strategy.For those who are purists in science, if you look at the manufacturing process of the biologics—I am talking about the originators—if they were manufactured in, say, 2004, it is different from today. The current version of an originator drug is a biosimilar of itself. When you have the batch-to-batch variation and the process has evolved in manufacturing, if we are not worried about change of the same drug, why are we worried about biosimilars? They are just one more new biologic.
In addition, the FDA has put together a very strong process called the Totality of Evidence standard, so they review the clinical efficacy, molecular similarities, and tolerability of these agents. This ensures the equivalence of biosimilars.It is not just globally, I think biosimilars will even become more prominent in the United States. If we continue to see the growth of biologics and an increased number of patients living longer, we will have to face the problem of biologics alone. In Europe, they market biosimilars very well. I think we are getting there in the United States. Importantly, I think the system might be unsustainable if biosimilars do not succeed in our country.