On May 23, Drs. Chris Phillips and Rebecca Shepherd, chairs of the ACR’s Committee on Rheumatologic Care and Insurance Subcommittee, respectively, and members of the ACR’s advocacy staff team met with officials from the Centers for Medicare & Medicaid Services to discuss concerns on underwater biosimilars and restrictions on billing G2211.
The FDA has approved tocilizumab-aazg (Tyenne), the first tocilizumab biosimilar, for treating rheumatic diseases, as well as the new drug application for CB-101, a chimeric antigen receptor T cell therapy, for treating lupus nephritis and extra-renal lupus.
Three commercial health insurance payers have increased reimbursement for infliximab biosimilars in response to concerns that formulary requirements are leaving practices underwater.
The FDA has approved the first interchangeable biosimilars for denosumab.
On April 1, UnitedHealthcare updated reimbursement for infliximab biosimilars in response to concerns that formulary requirements are leaving practices underwater.
A proposal for biosimilar use in the 2025 budget would allow substitution of any biosimilar for its reference product without an interchangeable designation. The hope is to increase biosimilar uptake, with the subsequent potential to increase product “competition, access and affordability.”1 In the 2025 budget proposal, the Biden administration noted that the legal distinction between…
Reimbursement has fallen below acquisition price for some biosimilar versions of infliximab, forcing practices and patients to make difficult decisions. The ACR is working to change this.
In late October, the FDA approved the first biosimilar to ustekinumab to treat patients with psoriasis, psoriatic arthritis and other conditions. Ustekinumab-auub is expected to be available in the U.S. by 2025.
The ACR is engaging with payers regarding formulary requirements that would leave practices underwater when treating patients with rheumatic diseases.
This year, tocilizumab biosimilars have been approved to treat adult and pediatric patients with rheumatic disease, including rheumatoid arthritis, juvenile idiopathic arthritis and more, in both Europe and the U.S.