Biosimilar adoption can be accelerated or stymied depending on actions taken by the managed care space, explained Sonia Oskouei, PharmD, vice president, biosimilars, Cardinal Health, during a session at Asembia’s Specialty Pharmacy Summit.
The managed care landscape has a significant role to play in biosimilar adoption in the United States and can either accelerate adoption or create barriers, said Sonia Oskouei, PharmD, vice president, biosimilars, Cardinal Health, during a session at Asembia’s Specialty Pharmacy Summit, held May 2-5 in Las Vegas, Nevada.
Utilization management strategies will allow managed care stakeholders to play this important role for biosimilars, and understanding patient access and reimbursement will be critical as products come to market on the pharmacy benefit side, such as the adalimumab (Humira) biosimilars in 2023, she explained.
Next year will be a “monumental year” because there are 7 approved adalimumab biosimilars expected to launch, with the first in January. The introduction of these biosimilars is so important because the originator product is the number one selling drug in the world and of all time.
“This is probably one of the biggest US pharmaceutical events that happened in history,” Oskouei said.
The launch of the adalimumab biosimilars will also be an interesting case study. While there are 7 approved, only 1 of them has been granted interchangeability. There is some confusion about the interchangeable designation, she noted. The purpose of seeking interchangeability is to allow pharmacist-level substitution depending on state laws.
One of the misperceptions of interchangeable products is that they are superior to the other biosimilars without this designation. However, that is not the case—products are granted interchangeability simply by going through the extra step of conducting switching studies. “Interchangeability does not denote clinical superiority in any way,” Oskouei explained.
While pharmacists will be in the driver seat for operationalizing interchangeability, they will need to work within the confines of patient insurance requirements.
A survey of retail pharmacists conducted in 2021 by Cardinal Health found that only 19% were very familiar with the interchangeability designation and 64% were somewhat familiar. Until just last year, this wasn’t particularly important, but now there are 2 interchangeable biosimilars, both on the pharmacy benefit side. In addition to the adalimumab biosimilar Cyltezo, the insulin glargine biosimilar Semglee was the first biosimilar to be granted interchangability.
The Cardinal Health survey also found less than half of the respondents felt very prepared to have conversations with patients on options for insulin biosimilars. According to Oskouei, this highlights how an entire stakeholder group hasn’t been tapped into yet.
“And now there's certain knowledge gaps—the need for more information and resources to optimize the impact of interchangeability as a nation,” she said.
The top concern around substituting biosimilars that was brought up during the survey was efficacy, “highlighting the need to strengthen clinical confidence in these products with education efforts and information to understand the scientific rigor associated with biosimilar approvals.”
Other top concerns were the lack of payer adoption (22%) and understanding when to substitute a biosimilar for a reference product (21%). Finally, half of the respondents said they would be very comfortable substituting a biosimilar for the reference if it meant a lower out of pocket cost for the patient, which “is the whole promise of these agents,” Oskouei said.
The cost savings of biosimilars is key and policy activities are needed to ensure a conducive environment for high-quality, lower-cost treatment options, she explained. In addition to increasing competition and driving down costs, biosimilars can also play a role in driving innovation.
“By having a successful biosimilars market and lowering these health care costs, what you're essentially doing is freeing the health care dollar to invest in the next generation of innovative treatments that we want,” Oskouei said.
For more from Oskouei's presentation, visit The Center for Biosimilars®.