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Biosimilars to pave the way for cheaper cancer treatment in the US
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ORLANDO — Biosimilars will prove essential to the future of oncologic and hematologic care in providing affordable treatment options for patients with cancer, according to a panel of presenters at Community Oncology Alliance Conference.
“Biosimilars are very important to not only reduce the cost of payers, but also for patients who oftentimes face huge out-of-pocket expenses,” Steven D’Amato, BScPharm, executive director of New England Cancer Specialists, said during the panel. “Twenty percent of $5,000 is different than 20% of $10,000 and, to the patients, that makes a big difference. For us to bring down the total cost of care, we as an oncology community really need to accept biosimilars into this equation because it will improve our ability to provide value-based care moving forward.”
The first biosimilar approved by the FDA, in 2015, was filgrastim-sndz (Zarxio, Novartis), a drug used to help prevent infections during chemotherapy.
The FDA has since approved 10 other biosimilars, including trastuzumab-dkst (Ogivri, Mylan) and bevacizumab-awwb (Mvasi, Amgen) for the treatment of multiple types of cancer. These biosimilars will be available in the U.S. in 2020, according to the NCI.
In May 2018, the FDA also approved a biosimilar to treat anemia caused by chronic kidney disease, chemotherapy or the use of zidovudine in patients with HIV.
The process of developing a biosimilar and getting it approved is different than that of an original drug.
The manufacturer does not need to conduct large clinical trials to prove the drug’s safety. Instead, the manufacturer must demonstrate that the drug has no meaningful difference in its chemical makeup and biological function than the approved originator product.
“The biosimilars approval is an expedited [process] that allows us to rely on information that’s already out there,” Sonia Oskouei, PharmD, DPLA, vice president of innovation and solution development at Premier Inc., said during the panel. “The goal of the biosimilar approval pathway is to establish similarity to the reference biologic. This is what allows these products to come to market sooner.”
One problem with biosimilars moving forward, panelists said, is the tendency for manufacturers to approach insurance companies to have their biosimilars become the preferred agent.
Specifically, experts said they are concerned that if there are a number of similar biosimilar agents, insurance companies could strike a deal with one of the manufacturers and force doctors to use only one of the biosimilars, even if a different biosimilar is cheaper.
“That limits our ability to contract effectively and limits the [group purchasing organization’s] ability to hit target marks,” D’Amato said. “It also puts a huge burden on the practice. ... Physicians should be allowed to pick the agents they want to use for their patients. It should not be dictated by payers and manufacturers.”
Because the idea of biosimilars in the oncology community is still relatively new, it will be up to doctors and other medical professionals to educate patients on the benefits of biosimilars and how they can help them save money while still getting the same effective treatment.
“Some key characteristics of the early adopters we’ve seen that utilize biosimilars is that they are very proactive in doing communication and education upfront,” Oskouei said. “We’ve had organizations that have done complete switches to biosimilars, whether patients are already being treated or are about to start treatment, and they had a very proactive educational process from the providers to the patients. ... It’s a spectrum from utilization to acceptance.” – by John DeRosier
Reference:
D’Amato S, et al. The era of biosimilars: Clinical and reimbursement issues and challenges. Presented at: Community Oncology Alliance Conference; April 4-5, 2019; Orlando.
Disclosures: HemOnc Today could not confirm panelists’ relevant financial disclosures at the time of reporting.