Biosimilars Gain Ground in U.S.
If there were a top 10 pharmacy buzz word list, “biosimilars” would certainly be included. While they are not new to the pharmaceutical industry, there is still a lot of confusion on their place in clinical practice and the downstream financial impact on healthcare facilities. The United States has been slower to adopt biosimilars than the rest of the world. As specialty prices continue to rise, adopting biosimilars may be a great strategy for not only reducing pharmaceutical spend but also maximizing reimbursement.
A biosimilar product is a highly similar biological product that has demonstrated no clinically meaningful differences compared to the reference or branded product. It is a different approval process than the generic approval process with the FDA. The FDA has introduced another term to the market: “interchangeability.” Unlike generics, biosimilars are not always interchangeable. The FDA requires additional data reporting to earn interchangeability status. Learn more from the FDA:
There are several factors why U.S. adoption of biosimilars has lagged behind the rest of the world including brand loyalty, commitment programs and the payor (insurance) industry. There is still a lingering perception that branded products are superior to biosimilar products. There may be reluctance for switching therapy on patients who have been stabilized on the brand product. Payor reimbursement and conversion limitations also play a role in adoption.
While adoption of biosimilars in the U.S. has been slower, there has been some movement towards biosimilar utilization in recent years. In order to retain market share, pharmaceutical companies have released unbranded versions of their products at lower price points. This has added to the confusion. These products are not generics, they are not biosimilars, they are the exact same product made by the same company with the exact same HCPCS code but without the brand name.
When considering biosimilars or unbranded products that compete with biosimilars, it is important to create an interdisciplinary team including stakeholders from pharmacy, revenue cycle, financial assistance, scheduling and impacted clinical departments. HealthTrust publishes a biosimilar guidance tool that summarizes biosimilar/unbranded options, costs and projected revenue from different payor sources. This tool is updated quarterly and can be found in the HealthTrust Member Portal on the Pharmacy Homepage under the Member Services banner. Each molecule has a reimbursement calculator that compares biosimilars/branded/unbranded products. Sites can enter GPO, 340b or WAC pricing to project CMS reimbursement. Each molecule also includes a payor landscape tab which provides insight as to which products may require prior authorization. This tool can be used to develop scripting that can be used during the insurance verification step to identify the most favorably reimbursed product. For example, instead of simply asking “is this medication covered?” asking if there is a competing product that is “preferred” or has higher reimbursement.
As healthcare facilities continue to look for ways to minimize inflationary supply and labor costs, there may be value in considering biosimilars. There is an opportunity to decrease pharmaceutical spend, but also to maximize reimbursement.