Humira Biosimilar Hadlima Making Coverage Inroads on Formularies

In its first month on the market, Hadlima (adalimumab-bwwd), the Humira biosimilar that launched July 1, 2023, has been added to several national formularies. Hadlima, developed by Organon and Samsung Bioepis, is available in both citrate-free high concentration and citrate-containing low concentration. A carton including two pre-filled pens or two pre-filled syringes is available at a list price of $1,038, which is 85% off the Humira price.

Jon Martin

“We’re proud that all major wholesalers have placed orders for Hadlima and Organon is emerging as one of the few players earning spots on formularies,” Jon Martin, U.S. commercial lead of biosimilars at Organon, told Formulary Watch. “The market is still evolving, and we believe that product attributes and real-world evidence – on both of which Hadlima is positively positioned – will be critical in PBM decision-making. This launch represents an important step toward reaching our ultimate goal of improving health care economies and treatment access by providing high-quality biosimilar medicines to health care systems, providers, and patients.”

Hadlima in both high and low concentrations have been added to the following formularies:

• UnitedHealthcare Health Plans (Commercial); effective July 1, 2023

• UnitedHealthcare Community Plans (Managed Medicaid) in Colorado, Hawaii, Maryland, New Jersey, Nevada, Pennsylvania CHIP and Rhode Island; effective July 1, 2023

• Prime Therapeutics (Commercial) - excludes BCBS Rhode Island and BCBS Nebraska; effective July 1, 2023

• Cigna (Commercial); effective Sept. 1, 2023

• Centene (Commercial, Managed Medicaid); effective Oct. 1, 2023

Hadlima is a tumor necrosis factor (TNF) blocker indicated for appropriate patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Hadlima’s PushTouch autoinjector was designed with a thin 29G needle, a latex-free needle cover, and a buttonless device with a sure-grip shape and a non-slip surface. Organon also is planning to submit an application for Hadlima to be interchangeable with Humira, and this could be available in the third quarter of 2024.

Cigna announced last month that it would add several of the biosimilars alongside Humira. These include Hadlima in both high- and low-concentrations, Boehringer Ingelheim’ Cyltezo, the first FDA-approved interchangeable biosimilar in low-concentration formulation; Sandoz’s unbranded adalimumab-adaz in a high-concentration formulation; and Sandoz’s Hyrimoz in a high-concentration formulation.

Prime’s formulary shows Amgen’s Amjevita and Hadlima as preferred alongside Humira, but all adalimumab products are subject to prior authorization, quantity/dispensing limits and specialty designations.

Earlier this year, Optum Rx, United Health’s PBM, indicated that that it would offer access to Hyrimoz, Cyltezo and Amjevita. They would be offered on parity with Humira. All four products on will be on Tier 2 of standard formularies with prior authorization required and quantity limits. A spokesperson for Optum Rx said that UHC is a health plan with its own formularies and has made different decisions about the Humira biosimilars.