As biosimilar competition heats up in the United States, payers have more tools at their disposal to manage these agents.
When the first biosimilars came out in the United States, there was not a lot of uptake, but as biosimilar competition increases and prices fall, there are much more management tools being implemented, said Leslie Fish, RPh, PharmD, senior vice president of clinical pharmacy, IPD Analytics, during a session at Asembia’s Specialty Pharmacy Summit, held May 2-5 in Las Vegas.
When the first infliximab biosimilar came to market, it was only 15% cheaper than the originator, which made people quite upset at the time, she reminisced. Now, payers are utilizing more management tools such as prior authorization, step throughs, and tiering. Currently, the number one reason payers are preferring biosimilar agents is the lower cost.
One recent study that looked at the second quarter of 2019 through the third quarter of 2021 found that the biosimilars for 3 oncology drugs—trastuzumab, rituximab, and bevacizumab—saved the United States $4 billion, Fish said.
Another payer tool has been related to skinny labels. A skinny label is when a biosimilar launches without all the indications of the originator drug if some of the patents haven’t expired yet. “This is a legal issue; it is not a clinical one,” she explained.
For instance, the reference product for rituximab, Rituxan, has both oncology and nononcology indications, but when the biosimilars first came out, they did not have the nononcology indications. According to Fish, studies have found that more than half of insurers are allowing the use of biosimilars for all indications even if the biosimilar technically has a skinny label and does not have all the indications yet.
Biosimilar management is about to get a little more complicated when the adalimumab biosimilars start hitting the market in 2023, noted Fish’s colleague, Jeff Casberg, MS, RPh, senior vice president of clinical pharmacy, IPD Analytics.
The branded product, Humira, has 2 formulations: the original 50 mg/ml and the new 100 mg/ml. Currently, the new formulation has more than 80% of the market, but the approved adalimumab biosimilars coming to market in 2023 are all for the original formulation. Alvotech has a biosimilar for the new formulation and has reached an agreement with AbbVie, the maker of Humira, for its product to come to market in 2023, but the biosimilar has not been approved by the FDA just yet.
According to Casberg, there are a few ways payers can manage Humira’s loss of exclusivity and the introduction of biosimilars to the US market.
First, there is the option to stay with the originator product and not adopt any biosimilars. However, there is a problem with the optics since member out-of-pocket cost could be lower for biosimilars. The advantage of this strategy is that the payer maintains rebates and doesn’t have to deal with conversions.
The second option is to give the branded product and biosimilars parity on the formulary. “That seems really nice but doesn't really have any teeth,” Casberg said. “Will there be any conversion?” he asked. There is not much motivation to switch patients and he expects there would not be a big conversion of patients moving from the originator to the biosimilar.
The final option is to go all in on the biosimilars and remove Humira. This would provide the most savings, but there is a risk in figuring out what percentage of patients will have to convert and determining the savings opportunities to ensure the plan breaks even on the conversion.
Casberg noted that the adalimumab biosimilars are not the only big opportunity in 2023: it’s possible some ustekinumab (Stelara) biosimilars may launch at the end of the year. IPD Analytics is predicting that 1 or 2 biosimilars could launch in the late fourth quarter of 2023. There are a total of 7 ustekinumab biosimilars in phase 3 that are estimated to launch between 2023 and 2025, and one of those products, ABP 654, is seeking interchangeability.
“So, 2023 is going to be very big,” he said. “You’ve got Humira early/mid-year; Stelara late year.”