Mallinckrodt Launches Acthar Gel Self-Injectable for Autoimmune Conditions

Mallinckrodt has launched Acthar Gel (repository corticotropin injection) as a single-dose pre-filled SelfJect Injector. The FDA had approved the self-injectable version in February 2024.

“The launch of SelfJect is a significant advancement for patients who take Acthar Gel as it is designed to simplify the injection process, help ensure accurate dosing, and has enhanced safety features. SelfJect supports patients by helping to make treatment easier to administer than a multi-dose vial and syringe, particularly for patients with dexterity issues,” Kostas Botsoglou, M.D., managing partner of Rheumatology Center of Western New York, said in a news release.

Acthar Gel is an analog of adrenocorticotropic hormone, which is produced by the pituitary gland, and other pituitary peptides. Acthar Gel is used to treat patients with a range of chronic and acute inflammatory and autoimmune conditions, including as a treatment of acute exacerbations of multiple sclerosis in adults.

SelfJect is for subcutaneous administration by people 18 years of age or older. It has a price of $35,187, for a four-count package of 80 Units/mL. The price for a four-count package of 40 Units/0.5mL is $17,594.

Acthar Gel is also available in a multi-dose vial for injection with a price of about $43,987 for 80 Units/mL. A company official said the price of SelfJect is at parity with the multi-dose vial, and the cost per milliliter is the same with a variation in the three different presentations.

Acthar Gel is accessible to more than 220 million individuals covered by commercial insurance and Medicare, the spokesperson said. Acthar Gel has been prescribed by more than 9,200 healthcare professionals and used by more than 43,500 patients from 2013 to 2021. Mallinckrodt gained access to Acthar Gel when it acquired Questcor Pharmaceuticals in 2014.

Patients with commercial insurance may be eligible for a $0 copay for eligible patients, with a limit of $15,000 per calendar year. The terms indicate that the copay program may not available for patients whose plans have accumulator adjustment or maximizer programs. Additionally, the terms indicate that Mallinckrodt may limit or reduce benefits is a patient’s plan “imposes conditions or requirements on a patient’s ability to receive funding under the Program, requires patient enrollment in the program as a condition of participation in any plan or plan benefit, coverage, or program.”

In a health economics study that Mallinckrodt conducted, Acthar Gel injection when compared with standard of care was found to have an incremental cost-effectiveness ratio (ICER) of $134,796 per quality-adjusted life-year (QALY) and $39,179 per QALY over two and three years, respectively. This analysis of patients with sarcoidosis was presentedat the AMCP Nexus 2023 meeting in October 2023 and was published in ClinicoEconomics and Outcomes Research on Oct. 17, 2023.

Sarcoidosis is a rare, inflammatory condition that can lead to nodules in the lungs, lymph nodes, eyes and skin.