Biosimilars face utilization uptake barriers in the U.S. market which could delay their use for years, even after approval. Managed care pharmacists play an important role to address and educate about biosimilars to promote cost effective, evidence-based medicine that will reduce drug spend.
During a session at AMCP Nexus 2020 Virtual, Jay Pauly, PharmD, BCPS, CPh, system clinical pharmacy manager; Matt Moser, PharmD, CPh, lead clinical hematology/oncology pharmacy specialist; and Gene Terkoski, PharmD, senior managed care pharmacist, all of Health First Health Plans, discussed barriers to biosimilar adoption and the role of the pharmacist in surpassing these barriers.
U.S. specialty spending has increased fourfold since 2006. It is estimated that there could be a savings of $250 billion in the next decade if the following 11 biosimilars are approved and adopted: bevacizumab, epoetin alfa, trastuzumab, adalimumab, interferon alfa-2a, pegfilgrastim, peginterferon alfa 2-b, and infliximab rituximab. Other countries, including the European Union, Japan, Canada, and India, have shown that biosimilar adoption drives down costs.
Dr. Pauly talked about the hospital system perspective related to biosimilars. Decreased costs were a driving factor for biosimilar implementation in their organization. “Pharmacists were one of the largest advocates for this across our organization,” he said. Barriers to biosimilar adoption include evidence required for approval; understanding of safety, efficacy, and indication extrapolation; education; product interchangeability; and location of administration.
Biosimilar product development spends a lot more time in analytical and preclinical phases since they are based on clinical trial data from the reference product. “Biosimilar safety and efficacy are “a big sticking point” in the lack of understanding,” he said. “A biosimilar product can be approved for an indication without direct studies related to that indication. FDA reviews this study for indication extrapolation—which cuts down on the time and cost but ensures the quality and safety.”
Provider education and training are necessary to promote biosimilar use. Automatic substitution of the biosimilar on the formulary or electronic medical record (EMR) may also help increase adoption. Encouraging outpatient administration of biosimilars will promote use as well. “From a cost standpoint … the biosimilar is always less expensive than the reference, and outpatient [administration] is always less expensive than the inpatient,” said Dr. Pauly.
Dr. Moser then talked about the infusion clinic perspective of biosimilars, noting that biosimilars promote competition, which can further reduce costs. “The more competition and products you have, the more likely you’re going to maximize your savings,” he said. Barriers related to biosimilars can include evidence for required approval, insurance preferences, lack of interchangeability, lack of education, and transitioning between products. Generally, the FDA states that you can swap from one product to another, but they do not recommend swapping back and forth continuously, Dr. Moser advised.
Biosimilar are not generics—they carry significantly different molecular weight and have a complex manufacturing process. “Biosimilars are quite sensitive; they are derived from live organisms. They require special storage and handling conditions, which can be a complication,” he said.
Drift is the inherent changes in the molecule caused by changes in manufacturing, which result in inherent differences in the cell of origin, cell growth or expansion, and miniscule changes in conditions within the bioreactor. Thus, biosimilars cannot be identical to the reference product in the way that generics can.
Biosimilars save money because they do not require phase III trials nor testing of all indications. They require non-inferiority clinicals trials in a prespecified margin (usually within 15%), and if they pass the non-inferiority trial, they can extrapolate the remainder of indications with reference product and use clinically relevant and sensitive endpoints in the right population.
Finally, Dr. Terkoski discussed the health plan perspective. Barriers to biosimilar acceptance include concerns over billing and reimbursement, reimbursement eligibility, education, member cost burden, and transitioning between products.
He said once a biosimilar is approved, as a payer, they will remove prior authorization requirements and implement step therapy requirements for the originator products. “One of the most common concerns from physicians is reimbursement,” he said. “We try to highlight how the Centers for Medicare & Medicaid Services is working hard to promote the use of biosimilar. They’re really not trying to cut down on the physician’s margins, they’re just trying to promote the use of these lower-cost products.”
Another common concern is that member copays will increase. “The beauty of a coinsurance is that as the cost of the medication decreases, so does the member’s copay,” he said.
Filgrastim was the first FDA-approved biosimilar. “For years, it was hard to gain traction, but as we’ve turned our attention to it, we’ve been able to turn this into the market-leading product. Our goal in these is to give biosimilars a larger share of the market, which is what we’ve done with filgrastim,” said Dr. Terkoski.
“At our current market shares, we’ve calculated that we will save the plan almost $1.5 million annually” with biosimilars, Dr. Terkoski reported, noting that the infusion clinics have reported $1.4 million in savings, while hospitals have reported savings of more than $54,000, and member savings are about $200,000.
Presentation: D1 Overcoming Barriers to Biosimilar Adoption through Coordinated Efforts. AMCP Nexus 2020 Virtual.