Payer Coverage of Biosimilars Always Shifting, Says Dr Tasmina Hydery

Payers are covering multiple biosimilars of reference products and always reevaluating those coverage choices, explained Tasmina Hydery, PharmD, MBA, BCGP, associate director in digital solutions, Cencora. The decisions of payers might have a stronger sway in uptake of certain biosimilars than being first to market or even having interchangeability, although this could change as more interchangeable biosimilars come to market.

There are currently only 8 biosimilars that have gained the interchangeability designation in the United States, with the most recent being Simlandi, an adalimumab (Humira) biosimilar.¹ The designation is strictly in the United States, with other countries and regulatory agencies considering all biosimilars to be inherently interchangeable with their reference product. In the US, the designation allows a biosimilar to be automatically substituted for the prescribed reference product, depending on state pharmacy laws.²

However, despite the purpose of the interchangeability designation, there persists confusion around it. The designation is “only relevant to dispensing and not prescribing,” noted Joseph Park, PhD, and Gillian Woollett, MA, DPhil, both of Samsung Bioepis, in an article published in Pharmacy Practice in Focus: Health Systems^®.³ They wrote that some believe that biosimilars without the designation cannot be switched for the reference product, which is incorrect.

Hydery will discuss the latest updates on biosimilars and their coverage and adoption in the US during a session at the Asembia Specialty Pharmacy Summit, being held April 28 to May 2 in Las Vegas, Nevada. She will be joined by her colleague Lakesha Farmer, PharmD, MBA, senior director of ION Oncology Practice Network, Cencora; and Cate Lockhart, PharmD, PhD, executive director, Biologics and Biosimilars Collective Intelligence Consortium.

Transcript

How are insurers managing biosimilars when there are multiple available?

With the biosimilars marketplace maturing in key therapeutic areas, we’re oftentimes seeing several biosimilars per reference product; it's not just one-to-one competition between a biosimilar and a reference product. The findings from our research suggest that the majority of payers will be covering at least 2 biosimilars or in some cases 3 or more per reference products. Payers are also continuing to reevaluate reference products and their associated biosimilars when new market entrants become available. And what this shows that even if a biosimilar isn't the first to the market, there's an opportunity for manufacturers to gain market share.

Is the interchangeability designation actually making a difference?

From a regulatory perspective, interchangeability is unique to the United States. It actually doesn't exist in Europe. So, the EMA [European Medicines Agency] doesn't regulate interchangeability. The benefit of interchangeability status is that these products can be substituted without requiring prescriber intervention. So, this can lessen the administrative burden on health care providers and make it easier to switch patients to biosimilars at the pharmacy level.

In order to obtain this interchangeability status, there are additional development costs to consider for the manufacturers. So, of the biosimilar launches that we've seen over the years, only 5 or so have the interchangeability designation. In our research that we conducted, payers and providers ranked clarity around biosimilar substitution as very high in facilitating biosimilars adoption. So, time will really tell how this particular designation helps, overall, shift the market share compared to biosimilars that don't have the interchangeability status.

Overall, I think easing any administrative burden can help improve traction for biosimilars and help realize the cost savings that they can bring.

References

1. Jeremias S. FDA approves 10th adalimumab biosimilar, Simlandi. The Center for Biosimilars®. February 24, 2024. Accessed April 29, 2024. https://www.centerforbiosimilars.com/view/fda-approves-tenth-adalimumab-biosimilar-simlandi

2. Humphreys S. Understanding interchangeable biosimilars at the federal and state levels. Am J Manag Care. 2023;29(suppl 7):SP545-SP548. doi:10.37765/ajmc.2023.89419

3. Park J, Woollett G. Confusion persists around the interchangeability designation for biosimilars. Pharmacy Practice in Focus: Health Systems. 2023;12(6):38-40.