As competition from biosimilars intensifies in the United States, payers have more tools at their disposal to manage these agents.
When the first biosimilars came out in the US, there wasn’t much uptake, but as biosimilar competition increases and prices drop, more and more management tools are being implemented , said Leslie Fish, RPh, PharmD, senior vice president of clinic pharmacy, IPD Analytics, during a session at Asembia’s Specialty Pharmacy Summit, held May 2-5 in Las Vegas.
When the first infliximab biosimilar hit the market, it was only 15% cheaper than the original product, which shocked people at the time, she recalls. Now payers are using more management tools such as pre-authorization, stages and prioritization. Currently, the primary reason payers prefer biosimilars is lower cost.
A recent study covering the second quarter of 2019 through the third quarter of 2021 found that biosimilars of 3 oncology drugs – trastuzumab, rituximab and bevacizumab – saved the US $4 billion, Fish said.
Another payment tool has been linked to lean tags. A skinny label is when a biosimilar is launched without all the indications of the originator drug if some of the patents have not yet expired. “It’s a legal question; it’s not clinical,” she explained.
For example, the reference product for rituximab, Rituxan, has oncology and non-oncology indications, but when the biosimilars first came out, they didn’t have the non-oncology indications. According to Fish, studies have found that more than half of insurers allow the use of biosimilars for all indications, even if the biosimilar technically has a skinny label and does not yet have all indications.
Biosimilar management is about to get a little more complicated when adalimumab biosimilars start hitting the market in 2023, noted Fish’s colleague Jeff Casberg, MS, RPh, senior vice president of the clinical pharmacy, IPD Analytics.
The branded product, Humira, has 2 formulations: the original at 50 mg/ml and the new at 100 mg/ml. Currently, the new formulation has over 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, to bring its product to market in 2023, but the biosimilar has not yet been approved by the FDA.
According to Casberg, there are several ways for payers to deal with Humira’s loss of exclusivity and the introduction of biosimilars into the US market.
First, there is the option to stay with the originator product and not adopt biosimilars. However, there is a problem with the optics since the personal cost of members could be lower for biosimilars. The advantage of this strategy is that the payer maintains the discounts and does not have to manage conversions.
The second option is to give parity to the brand name product and the biosimilars on the formulary. “It looks really nice but doesn’t really have any bite,” Casberg said. “Will there be a conversion? ” He asked. There is not a lot of motivation to switch patients and he expects that there will not be a large conversion of patients switching from originators to biosimilars.
The final option is to bank on biosimilars and phase out Humira. This would provide the most savings, but there is risk in determining what percentage of patients will need to convert and determining savings opportunities to ensure the plan breaks even upon conversion.
Casberg noted that adalimumab biosimilars aren’t the only big opportunity in 2023: Some ustekinumab (Stelara) biosimilars may launch at the end of the year. IPD Analytics predicts that 1 or 2 biosimilars could be launched by the end of the fourth quarter of 2023. There are a total of 7 ustekinumab biosimilars in phase 3 estimated to be launched between 2023 and 2025, and one of these products , ABP 654, is to seek interchangeability.
“So 2023 is going to be very big,” he said. “You have Humira in the beginning/middle of the year; Stellara at the end of the year.