From Clinical Use to Reimbursement: An Update on Biosimilars in the US

04/16/18

Robert M Rifkin, MD, FACP, medical director, biosimilars, McKesson Specialty Health, the US Oncology Network, gave an update on the basics, education, and reimbursement of biosimilars, stating that “this will be a huge year” for the the copycat biologics in the United States.

Dr Rifkin presented his research at the 2018 Community Oncology Alliance (COA) Conference (April 12, 2018; National Harbor, MD).

Biosimilars have been bringing vale to the US health care system for a few years now, Dr Rifkin explained, by increasing access to drugs that are needed and by decreasing costs. By the end of 2018, two more biosimilars are expected to become available – including one for rituximab. Dr Rifkin shared a report from Express Scripts that estimates $250 billion in savings as a result of just 11 biosimilars.

Dr Rifkin pointed to the trend in increasing drug prices in recent years as directly related to increasing costs in oncology supportive care and declining patient affordability. From 2010 through 2014, the monthly cost of new cancer drugs rose to a median $10,000, which far surpassed the stagnant median monthly household income of $4000.

The presentation moved into a discussion of the makeup and challenges associated with biosimilars, to which Dr Rifkin alluded to product variability—or “drift”—as a particularly challenging aspect of defining the reference product. However, the largest concern for providers dealing with biosimilars is immunogenicity. All biologics (not just biosimilars) confer a risk of immunogenicity related to patient, disease and product factors, stated Dr Rifkin. Consequences include neutralizing antibodies or cytokine release syndrome, as well as a loss or diminished efficacy or safety.

Additionally, Dr Rifkin acknowledged a complex and intricate FDA approval process for biosimilars, which include demonstration of patients switching trials and subjective perspectives (ie, regulatory, clinical) in extrapolation.

As for the reimbursement side of the conversation, Dr Rifkin noted that many organizations “have skin in the game,” including the American Society of Clinical Oncology, the Institute for Clinical and Economic Review, the Medicare Access and CHIP Reauthorization Act, the Oncology Care Model, the Merit-Based Incentive Payment System, the National Comprehensive Cancer Network, and other alternative payment models.

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There are clinical barriers to reimbursement, which Dr Rifkin posed as questions: is the manufacturer as good as the innovator, is the biosimilar as effective as the original drug, and for what indications can providers use the biosimilar? Furthermore, there are ease-of-use barriers, chief of which remains whether pharmacy benefit managers or the providers themselves have the final say in whether the biosimilars can be used.

In his concluding remarks, Dr Rifkin forecasted a monumental year in oncology biosimilars to come. “There is still a need for payer education regarding biosimilars,” he said, and “the problem providers, regulatory, and Washington are dealing with is how do you differentiate something (biosimilar) that is essentially the same (original drug).”—Zachary Bessette