Stakeholders Joust Over Biosimilar Availability at PCOC20

A flood of biosimilar products can be anticipated over the next 5 years, including insulins, completely reshaping the current biosimilar landscape of 28 approved and 17 marketed products, with a consequent shifting of the sands for originator drug products and their dominance, predicted Sean McGowan, MBA, senior director of Biosimilars for AmerisourceBergen, a drug wholesaler.

However, McGowan and other panelists in a discussion at The American Journal of Managed Care®'s Patient-Centered Oncology Care® 2020 virtual conference agreed that there’s a lot of disconnect when it comes to harmonizing the objectives of multiple stakeholders to ensure biosimilar access at lowest-cost.

The biosimilar revolution is gathering speed and mass, and many of its systemic problems have to do with the growing competitiveness of the market and the inability to engineer solutions fast enough, McGowan said.

“I’m very optimistic about the biosimilar product category and its ability to deliver the same level of efficacy and safety [as innovator products] from a clinical perspective, but then also to drive significant cost savings for providers, patients, and the health system as a whole,” he said.

Bhavesh Shah, RPh, BCOP, a senior director in specialty pharmacy and oncology at Boston Medical Center Health System, agreed with McGowan that solutions to these problems are in the works. “Biosimilars are actually pretty important in the minds of many institutions because these are the low-hanging fruit that are going to bring a lot of savings to institutions immediately.” At Boston Medical, an estimated 90% of patients in oncology have been converted to biosimilars where biosimilars are available as treatments, he said.

Coronavirus disease 2019 (COVID-19) has stressed finances, causing major losses for the health care system and also a painful hit to the wallet for patients, but these factors may stimulate biosimilar uptake, panelists said. “I do think COVID-19 is actually going to bring up more aggressive biosimilar adoption because of the financials we’re seeing,” McGowan said.

Kashyap Patel, MD, panel moderator and co-chair of PCOC20, said the evidence backing that statement is seen in the patients who have lost jobs and insurance coverage and have not been able to continue with routine care or access screening owing to distancing precautions. Cancer progression is one unfortunate consequence of this interruption in care. “I do see that getting worse over the next 3 to 4 months as we enter the second wave [of COVID-19],” he said.

Patel is CEO of the Carolina Blood and Cancer Care Associates in Rock Hill, South Carolina, and said 6 months from now he expects biosimilars to have shaved 20% off his total drug spending, based on the discounts that are already available by using them. But operations would be less complicated if payer policies on biosimilars were better aligned with practice realities, he said. CMS will cover any approved biosimilar, but that doesn’t go for private payers, who tend to narrow the range of biosimilars available to providers based on the sourcing deals they have been able to obtain.

Speaking for the payer side of the argument was Karina Abdallah, PharmD, a strategist and outcomes expert with Blue Cross Blue Shield of Michigan. COVID-19 has been a distraction in terms of working to improve biosimilar access, she said, adding that formulary decisions must be based on business realities as well as clinical needs. “Most of our decisions have been based on, at the minimum, the inclusion of 1 biosimilar or 2 biosimilar options to kind of open up that market, but we take rebates into consideration, of course, because that does include getting it down to how much are we paying per claim, which then ultimately comes back to how we handle all of our premiums and also of our savings to make it affordable for patients.”

Payer decisions to restrict biosimilar access to a small number of available biosimilar products creates a problem for practices, Patel said. “If I have to keep 20 vials of each different biosimilar, it becomes difficult for us to manage.” Why can’t payers and providers sit down cooperatively and hammer out these problems? he asked.

McGowan said payer restrictions on biosimilar are an almost universal complaint among health care centers that administer biosimilars to patients. “I don’t think anybody was really talking about this when there were very few biosimilars in the market for several years. We really didn’t see competitive markets emerge until late 2018, early 2019, down into 2020. So, it’s kind of a double-edged sword, where there is choice, there is access, but then at the same time it’s on the clinicians and those who are directing pharmacy activities to have to manage carrying multiple biosimilars for the same indications.”

That said, widespread concern and discussion on this topic have led to some creative solutions, “where practices and health systems are getting more savvy and leveraging their technology, their IT infrastructure, their [electronic medical records], to kind of alleviate and address these issues,” McGowan said. “I think it’s just the complexity of the market and how fast the market is evolving, and how much more competitive each of these markets is becoming, and how quickly some of these products are coming to market. The speed of the evolution is happening a lot faster than I think the solutions can kind of address or alleviate them.”

Shah said a lot of education is needed on all sides to educate the different stakeholders on what kinds of dynamics are at play. “You know, providers are so busy trying to remember which trastuzumab they ordered for which patients last. It’s just not optimal. Then what happens is that we’ll get more denials, and it’s now impacting the provider negatively financially when we’re trying to promote cost savings.”

“But if we get ahead of it and talk to the payers, I think that really would be helpful,” he said. Further, there have been legislative actions that have attacked this problem from another angle. “What I’ve seen recently come about is certain states are putting together regulations or already have regulations that prevent payers from preferring one biosimilar over another and prevent a payer from preferring a reference product over a biosimilar. California is one of those states. There definitely are changes going on across the country, because we’re seeing this gaming of the system that’s happening for rebates, and it’s definitely not good for biosimilar adoption.”

Abdallah said Blue Cross Blue Shield is open to those discussions, but she defended the payer’s actions on biosimilars and said it, too, is working to create a market for these lower-cost drugs. “We were actually one of the first to really disrupt the market and go with a biosimilar-first approach. A lot of times we do forgo a very hefty rebate the originator product [company] is offering because we are looking to have adoption of biosimilars. I think that collaboration [with all stakeholders] is definitely something that a lot of payers are open to.”