Panel participants (L-R) Marc Earl, PharmD, BCOP; Kashyap B. Patel, MD; Nimer Alkhatib, PharmD, MS, PhD, and moderator Ali McBride, PharmD, MS, BCOP share their perspectives on incorporating biosimilars into the healthcare ecosystem.
Though there are currently only 12 biosimilars
approved by the Food and Drug Administration (FDA),1
there are many more in the pipeline, and the oncology world is bracing itself for their impact. How will they be incorporated into practice? What will it mean
for the healthcare ecosystem?
A panel of experts—including Marc Earl, PharmD, BCOP; Kashyap B. Patel, MD; and Nimer Alkhatib, PharmD, MS, PhD (candidate)—gathered at a preconference presentation at the Association of Community Cancer Centers 35th National Oncology Conference in Phoenix, to exchange their thoughts on the practical and theoretical considerations involved.
Initially, moderator Ali McBride, PharmD, MS, BCOP, clinical coordinator, Hematology/Oncology, The University of Arizona Cancer Center, questioned what the panel’s biggest hindrances were for including biosimilars into their healthcare systems, or if any issues have been raised in addressing biosimilars related to cost models.
Patel, medical oncologist, Carolina Blood and Cancer Care Associates, and Earl, assistant director of Pharmacy-Oncology, Cleveland Clinic, agreed that one of the biggest hindrances was the lack of availability of therapeutic biosimilars in the oncology setting. While supportive care was not an issue, availability was. “I'm interested to see, now that we have multiple therapeutic biosimilars in the market, what that does to our health system,” Earl said.
McBride added that 2019 may be a very active year. “We expect almost an overload of market-based biosimilar shares,” he said. “We are going to have a lot of release dates.”
When asked what problems might arise from an institutional operationalization perspective in trying to incorporate these biosimilars into practice, Earl explained there are 3 major issues to be taken into consideration.
“I have all my protocols built with a reference product. How do we swap that out in the IT system?” he said. “I also foresee some questions for extrapolating to all indications. What will make a provider feel comfortable with a biosimilar if the institution has decided it will use biosimilars. And, I think the third interesting question is: What role does the patient play, and should we be giving them the choice? … You're not going to notice the difference, but it is a different product. Maybe it's administered differently.”
In terms of financial assistance, Patel recognized the possibility that manufacturers’ unwillingness to participate in programs may become a barrier, as well as gaps in patient education and in getting staff on board.
“As a practitioner … patients and insurance companies have trusted me (to act as a trustee) with part of their collective fund and I have to see if I can find ways that are less expensive without compromising the outcome.”
Similarly, practitioners will have to address the overall pharmacoeconomic picture. Alkhatib, a PhD candidate in Pharmaceutical Economics, Health and Policy Outcome at the Center for Health Outcomes and PharmacoEconomic Research (HOPE), College of Pharmacy, University of Arizona, explained that the way healthcare economists calculate value is based on four main considerations:
- cost effectiveness
- cost utility
- cost-benefit analysis
- cost minimization
Alkhatib added that, while these factors are correct, the way they are calculated now is based on a single-payer system used in Europe. The United States uses a multi-payer system model, in which different payers have different budgets, there is a more diverse population, and there are individuals who pay out of pocket. Therefore, Alkhatib suggested that practitioners customize pharmacoeconomic evaluations by payer for greater accuracy.
In addition, practitioners can incorporate the financial concerns of patients into the calculation economic utility—something the European model doesn't do. Alkhatib suggested practitioners measure the patient perspective on financial value, and in turn, patient satisfaction with cost savings will increase utility value, which includes quality of life factors.
"If we evaluate the cost utility to include the financial value of biosimilars, from the US perspective, we would have more real-world analysis and outcomes," Alkhatib summarized in a post-conference interview with Oncology Nursing News.
In closing, Alkhatib shared his hope that the introduction of biosimilars in the market will change the dynamic, in that big pharmaceutical companies will have no choice but to lower their prices to compete with biosimilars.
There are more than 70 biosimilars in development, Alkhatib said, and more biosimilars mean that patients will see the benefit of reduced prices. "I am so excited about the future," he said.
- Biosimilar product information. US Food and Drug Administration website. fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm580432.htm. Updated July 20, 2018. Accessed October 18, 2018.