In the biosimilar industry, the concepts of “switching” and “interchangeability” are called many different things. In addition to the popular terms “switching” and “interchangeability,” we’ve also been introduced to “medically-guided” or “physician-guided switching,” “nonmedical switching,” “therapeutic substitution,” “automatic substitution,” and “pharmacy substitution.” And if that isn’t complicated enough, these terms can mean different things (or have no meaning) depending on where you are in the world. For instance, as interchangeability is not a regulatory designation in the EU, most countries abroad use the term “physician-guided switching” to describe the process of switching between a reference product and a biosimilar. (However, “interchangeability” is now being used more and more to describe these situations abroad. Many EU health authorities consider biosimilars interchangeable, but still recommend switching to a biosimilar be done under the recommendation and guidance of a physician.)
How other countries approach interchangeability or switching has been a topic of discussion at a number of conferences over the past year — and I anticipate it will continue to fascinate stakeholders as the different markets take shape. We’ve continued to see more data released emphasizing the safety of biosimilar switching abroad. However, as Sue Naeyaert, global head of pricing, market access, and policy, for Merck KGaA Darmstadt Germany, argues, these data alone are unlikely to be the silver bullet to greater biosimilar uptake. In an interview, Naeyaert shared her thoughts about how interchangeability in the U.S. will play out, as well as how biosimilar use could be incentivized in the fragmented American healthcare system.
Why It’s Important To Manage Interchangeability Expectations
When I met Naeyaert at the CBI Biosimilars Summit at the end of January, she had just relocated from D.C. to Switzerland, where Merck KGaA’s (Darmstadt, Germany) biosimilar business is currently based. During her 14-month tenure in the U.S., Naeyaert focused on ensuring the policies taking shape today help create a competitive biosimilar industry. After all, “Many are keeping a close eye on what’s happening in the U.S., as the U.S. is an important market for all of us,” she described.
One aspect of the U.S. market Naeyaert finds disheartening is how much biosimilar education is still needed. And, while many patients and patient advocacy groups support interchangeability, Naeyaert expressed the importance of clearly portraying to patients what interchangeability means. Just because a biosimilar earns an interchangeable designation does not mean the interchangeable biosimilar is of higher quality than a non-interchangeable biosimilar. “The quality doesn’t differ, but if you read the draft guidance, you could read it that way,” she said. “I think we need to ensure the language and, in turn, our educational outreach is very clear about that.”
There is, undoubtedly, a lot of work that needs to be done before the biosimilar market can experience the same amount of confidence we’ve experienced over the past 30 years with the small molecule generic market. In fact, Naeyaert expects that, despite the possibility of pharmacy substitution in some states of the U.S., the biosimilar industry won’t resemble the small molecule market. Because biologics require injections and infusions, they are more complicated than the oral drugs we receive interchangeably at the pharmacy.
“I don’t imagine we’ll see a situation as we would in the small molecule space, in which a patient walks into the pharmacy one day and gets circular pink pills then diamond-shaped green pills a few weeks later,” Naeyaert offered. “The biosimilar space will have different devices for some of the autoimmune products, and you have to consider if it’s going to be the patient or caregivers administering the biologic. This raises the question of how easily you’ll be able to switch patients between devices.”
Though the FDA homed in on the potential need for human-use studies to ensure similar and error-proof methods of administration, not all biosimilars will apply for interchangeability. “I’ve heard there are upwards of 8 adalimumab biosimilars in development,” said Naeyaert. “It could turn into a nightmare for physicians if a large number of these candidates make it to market and each has slightly different ways of administering.”
What Else Can The U.S. Do To Boost Uptake?
In her panel at the CBI Biosimilars Summit, Naeyaert discussed the patchwork landscape of biosimilar uptake and switching practices. While the oft-cited Scandinavian nations (with the exception of Sweden) have often implemented similar discounts and seen large biosimilar uptake in Norway, Denmark, and (increasingly) Finland, this is a rarity when looking at the different European countries. Some countries are exploring the use of reference price groups, so molecules within the same class are reimbursed at the same price. Regional hospitals in Spain and Italy are responsible for negotiating discounts, but this is not a widespread practice and can depend on the product. Another example is Germany, which is exploring the use of a quota so a certain percentage of each physician’s patients must be placed on the biosimilar.
One system garnering perhaps the greatest amount of buzz within the biosimilar space is gainsharing, which has been implemented in the U.K. As Tim deGavre, the chair of the British Biosimilars Association, explained to me in an interview last year, the U.K., local payers, Clinical Commissioning Groups (CCGs), and local trusts work together to distribute savings amongst each other and with the local hospitals. In turn, doctors employed at those hospitals have more incentive to use the lower-cost biosimilar, because they’ll be able to put the savings to use to benefit their workplace. For example, these savings can be used to hire additional nursing staff, purchase an expensive piece of equipment, or conduct a clinical trial in an area of interest to the physician.
“People are creatures of habit,” Naeyaert stated. “Unless you have other policies in place that will provide some incentive to the physicians for prescribing the biosimilar, why would they change?”
Though she was unsure how exactly it could be done, Naeyaert expressed interest at the concept of implementing gainsharing in the U.S. She pointed out the rise of integrated delivery networks (IDNs), for example Kaiser Permanente, which acts as an insurer and operates hospitals, as well as runs medical groups comprising physicians to care for plan members.
“A system such as gainsharing might work in a more integrated health system,” Naeyaert explained. “It’s not just a pharmacy benefits manager (PBM), it’s not just a hospital, but it’s also an insurer. This could be one type of environment in which some form of gainsharing could take shape.”