Formulary Placement and Outcomes to Drive Physician Use of Humira Biosimilars

Bruce Feinberg, D.O.

It may take 12 months to 18 months to get a true understanding of the impact that the Humira biosimilars have had in terms of formulary placement and clinical and economic outcomes that will drive physician uptake, said Bruce Feinberg, D.O., vice president and chief medical officer at Cardinal Health.

In January, Amgen launched Amjevita, the first of the highly anticipated biosimilars of AbbVie’s blockbuster drug Humira (adalimumab). Humira generated 2022 sales of more than $18.6 billion in the United States. It is indicated to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. This year, at least seven additional Humira biosimilars are expected to become available, creating a significant change in the marketplace and the treatment landscape in way not seen previously.

“Because of the market size of adalimumab, we’re going to see a lot of changes that we didn’t see when biosimilars were introduced in oncology,” Feinberg said in an interview with Formulary Watch. “This is a large market, and we have to see how companies translate both their research and their pricing policy as they negotiate with payers and with PBMs. And we have to see how payers will control the formulary. There are a lot of moving pieces, which leads me to believe that I don't think we’re going to see dramatic changes initially.”

Physician uptake of the Humira biosimilars, he said, will be controlled by the things beyond their control, such as formulary placement and utilization management efforts. Physician use of biosimilars also will likely differ by specialist, according to Cardinal Health’s new Biosimilars Report, which surveyed gastroenterologists, dermatologists and rheumatologists. Among rheumatologists, 76% stated that they are very familiar with biosimilars and 62% said that they would be very comfortable with prescribing. But there was some ambivalence among rheumatologists about the opportunities with biosimilars. Only about half (54%) agreed or strongly agreed that biosimilars would positively impact care.

Many providers would be motivated by the discount from the reference product. Among gastroenterologists, 40% of those surveyed felt there should be a discount of 21% to 30%, and 11% believed there should be discount of 31% to 40%. Almost one-third of rheumatologists and dermatologists surveyed felt the discount should be 21% to 30%. But 21% of rheumatologists and 17% dermatologists believed the discount should be 31% to 40%.

Feinberg said providers also will be concerned about the clinical outcomes of biosimilars versus the branded product. “Not all patients with rheumatoid arthritis are the same,” he said. “There are patients who have early, rapidly progressive disease, and there are patients who get the disease at an older age. I want to see where providers are more inclined to use the different drugs, especially if they have choice within the formulary.”

Cardinal Health’s survey found that the product attributes of biosimilar adalimumab that rheumatologists rated as very important were a citrate-free formulation (62%) and an interchangeability designation (60%).

Among gastroenterologists, nearly all (93%) of the physicians surveyed indicated they are at least somewhat comfortable prescribing an adalimumab biosimilar once it becomes available. Among dermatologists surveyed by Cardinal Health, 48% were concerned about the efficacy of biosimilars, and nearly 50% said the economics of biosimilars are not favorable enough to switch.

Regarding the biosimilar of adalimumab, an average of 64% of providers across specialties surveyed agreed or strongly agreed with the statement that they will only feel comfortable prescribing an adalimumab biosimilar if it has an interchangeability designation.

In July 2023, Boehringer Ingelheim is expected to launch the low-concentration Cyltezo. (n 2018, AbbVie reformulated Humira and began offering a version that was higher concentration, removed the citrate buffers and uses a thinner needle.) Cyltezo was approved with an interchangeable designation, which may help with uptake among physicians. Organon’s Hadlima in both a low- and high-concentration will likely have an interchangeable designation after its initial launch, and Pfizer’s application for Abrilada is under consideration for an interchangeable designation. Other Humira biosimilars expected to launch later this year include Fresenius Kabi’s Idacio, Coherus BioSciences’ Yusimry, Viatris’ Hulio, and Sandoz’ Hyrimoz but none of these are expected to have such a designation.

At least 40% of the providers across specialties in Cardinal Health’s survey indicated that real-world evidence, both international and domestic, followed by acceptance into clinical guidelines for practice management would help to support their use of biosimilars.

These considerations, Feinberg, said will likely motivate drug companies to do head-to-head testing of the biosimilar and the reference product. “I want to know how many of them are going to be aggressive in their rebates with the PBMs in order to get positioning,” he said.

But he said that Amgen has not been clear the two different price points for Amjevita. It is launching with a two-tier program: the first is 5% below the current Humira price and the second is 55% below the current Humira list price. Humira’s list price is $6,922 for a four-week supply — almost $90,000 annually.