EU Leads in Biosimilar Market Access While US Lags Behind, Faces Challenges in Adoption

The European Union (EU) has created a competitive, sustainable market dynamic for biosimilars that has successfully brought 22 molecules to market, explained Andre Harvin, PharmD, MS, MBA, chief pharmacy officer of Cone Health, during a session at the 2024 Advanced Topics for Oncology Pharmacy Professionals (ATOPP) Summit in St Louis, Missouri. Conversely, the US has only had 15 molecules approved by the FDA, only 10 of which have been brought to market.

“The EU is just flat out leading us right now,” Harvin said during the ATOPP session. “We're substantially behind. In the EU, they have 79 competitors in the biosimilar space, which means that it is an active market.”

Comparatively, within the US, there are only 38 competitors in the biosimilar space, Harvin explained. “And that's great. It's much higher than where we were when ATOPP started about 4 years ago. But we are significantly lagging behind the EU.”

Currently, biosimilar development is critical because of the high cost of cancer treatment in particular, Harvin explained. “Drugs are really expensive. I mean, really, really expensive,” Harvin said. “We spend a ton of money when it comes to oncology treatment and support.”

Harvin explained that 44% of commercial medical benefit is spent on oncology and supportive care, while 55% of Medicare Part B drug spend is on oncology and supportive care. However, the number of patients actually being treated by that high cost of care is only 5.5% of patients.

“That’s 5.5% of our patients nationwide accounting for upwards of 50% of the total drug spend. And we all know that it's not slowing down,” Harvin said. “This becomes why we need to focus on biosimilars because we need to find a way to drive cost savings into our system, because the pipeline is going to make it a bit unsustainable if we’re paying this much to cover such a small number of patients. The great thing though is that biosimilars have really lived up to their overall promise.”

Harvin explained that between 2015 and 2022, biosimilars have resulted in more than $20 billion in cost savings in the US health care system. Notably, this is with less biosimilars available in the US than in the EU.

“We also see that those savings are accelerating over time, with 2022 alone [saving] almost $10 billion—that's almost 50% of those savings realized just within the last full year on record that we have,” Harvin said. “They're predicting that by 2027, as a health system, we should realize over $180 billion in savings just because of biosimilars. But there's a level of threat there, as we have to ensure that the market is sustainable and can be long lasting.”

Additionally, Harvin noted that 4 years ago, a significant portion of the conversation around biosimilars was based around whether they were efficacious and safe. In 2024, these questions no longer arise in the conversation.

“We're confident. We know that they're efficacious and safe. Now we can focus on things like how they've increased overall patient access,” Harvin said. "They've been used almost 700 million times, and half of those days are additional patient therapy days, [meaning] that without a competitive biosimilar market, patients would not have had access to those medications."

Furthermore, Harvin explained that biosimilars have cut the growth rate in oncology spending by nearly half. However, outside oncology, adalimumab biosimilar uptake has been slow compared to other recent biosimilar launches, likely due to favored use of high list price products, which ultimately benefits pharmacy benefit managers (PBMs), according to Harvin.

“Adalimumab is a flashing warning sign for us right now. It has been very surprising for me as a person that has a role in our health plan and oversees our specialty pharmacies as well, that we have really struggled to have any uptake within the adalimumab market because of tactics that payers have taken on, as well as some of the other overall reimbursement dynamics that sometimes don't make it advantageous for us to switch to a lower cost product. I mean, that's just the reality, we have to address the economics of it,” Harvin said.

According to Harvin, these challenges can be traced back to decisions made by PBMs.

“There was one point in time when we thought PBMs were going to save us. They were supposed to be our friends against pharma,” Harvin said. “We thought they were going to come in and really help drive down the price of drugs.”

However, Harvin explained that PBMs instead have played a significant role in further inflating the cost of drugs.

However, Harvin explained that PBMs instead have played a significant role in further inflating the cost of drugs. Image Credit: © Dilok - stock.adobe.com

“[PBMs] artificially inflated costs not only for patients, but for employers, health systems, pharmaceutical companies, and the overall health care system as a whole,” Harvin said. “The reason is that their compensation model is based on [wholesale acquisition cost (WAC)]. So the higher the WAC means the higher the rebate they get.”

Harvin explained that an easy way to understand this model is that if PBMs were negotiating a 60% savings on $1000 drug, or 60% savings on a $900, they'd rather that drug be $1000.

“This [model] is keeping those prices up a lot higher, because everyone's trying to make sure that they sustain specific profit margins,” Harvin said. “They are making sure that they are also driving their patients and customers towards those higher cost medications, so that they can collect those fees and percent discounts back into their pockets, which drive their overall profits. It's a very perverse, misaligned incentive that is going on right now in the US health care system.”

Additionally, with PBMs owning specialty pharmacies and some requiring patients fill prescriptions at those specialty pharmacies, they will continue to drive patients away from cheaper biosimilar therapies and toward more expensive options.

“It's frustrating, but this is a reality. Again, those tactics are really just accelerating,” Harvin said. “Unless a provider goes through extraordinary lengths to say, ‘No, I absolutely want this patient on the biosimilar over the originator,’ payers have so many tactics to drive those prescriptions to their preferred medications, and then use those tactics constantly… That's just overall unfortunate, but the reality of what we're looking at.”

REFERENCE

Harvin A. Biosimilars at the Crossroads: Assessing the Current Landscape and Future Policy for Advancing Biosimilars Access in the US. 2024 ATOPP Summit; St Louis, Missouri; June 27-29, 2024.