Lee S. Rosen, MD, FACP, discusses the benefits of bevacizumab and how biosimilars could change the field.
Lee S. Rosen, MD, FACP
Although bevacizumab (Avastin) has significantly improved outcomes for patients with metastatic colorectal cancer (mCRC), there is limited access to this therapy in some cases, according to Lee S. Rosen, MD, FACP. Additionally, its cost makes it challenging to have a widespread impact—but more bevacizumab biosimilars could have an effect, he said.
Factors related to insurance coverage, reimbursement, and patient out-of-pocket cost have hindered the availability of bevacizumab, a VEGF monoclonal antibody, in some regions and circumstances, Rosen explained.
“As a result, outcomes for patients with mCRC could be worsened,” he said.
In September 2017, ABP 215 (bevacizumab-awwb; Mvasi) became the first biosimilar to be FDA approved with a cancer indication in the United States. The Amgen and Allergan product was approved for the treatment of adult patients with colorectal, lung, brain, kidney, and cervical cancers.
Moreover, other bevacizumab biosimilars continue to be explored in clinical trials.
In an interview with OncLive, Rosen, director of the Drug Development Program at Ronald Reagan University of California, Los Angeles Medical Center, president of Premier Oncology, discussed the benefits of bevacizumab and how biosimilars could change the field.Rosen: Bevacizumab has been an essential component of mCRC therapy for several years. It really augments how well chemotherapy can work. Bevacizumab, like all biologics, is extraordinarily expensive. There's always a constant conversation of risk and benefit and cost and benefit. This comes into play when you're treating [a patient] with any drug. Expensive drugs are always going to be subject to much more attention on the part of the payer, as well as certain healthcare systems. Bevacizumab is an example of many drugs in that category.
It's also important to note that bevacizumab has the approval to be continued indefinitely, while swapping out the chemotherapy agents in certain patients. You can see where bevacizumab could be used for a longer period of time than other drugs. Biosimilars have been approved not just in oncology, but also in various fields of medicine. The analogous situation is generic medicine, although that's not an appropriate comparison. A generic drug will be approved, and what we all try to understand is whether a biosimilar just means a generic biologic. There is a whole set of criteria that has been developed to answer this question. Essentially, a biosimilar has to be similar. There have indeed been a number of approvals in oncology. There is a bevacizumab biosimilar developed by Amgen that is approved.
There is an issue with efficacy, ease of access, and cost. The process by which biosimilars are approved is hopefully going to give us enough assurance that they are as efficacious as the original product. The FDA has been very clear in saying they are relying on oncologists to use real-world experience to flush out that fund of knowledge about any differences in efficacy and toxicity. Going forward, the expectation is that efficacy will at least be similar, and oncologists will work to guarantee that.
The second consideration is access. Will it be as accessible, or will insurance companies take the position of mandating one or the other? In a perfect world, doctors will make their own choices along with their patients without being restricted one or the other. You can imagine that in many situations with biosimilars, insurance companies are demanding a specific product to be used. I'm not sure that biosimilars would really solve the issue of cost. If companies price the biosimilar at 5 cents below the generic price, it is going to save but not save enough. There are always going to be issues of someone's "expensive" versus someone else's "cheap."
The main driver of cost is going to be the appropriate use of medication. We have to continue to abide by existing guidelines—or come together to participate in the development of guidelines—to use drugs that are appropriate rather than using a drug just because it exists. There are a lot of agents in oncology that might not be all that toxic, so doctors will use them a little bit longer than something that is highly toxic. The world of biologics has enabled us to give therapy longer, but we have to demand of ourselves the data and ask questions to justify use. Efficacy versus toxicity is the important comparison.