Takeda UK Ltd., of High Wycombe, U.K., a unit of Takeda Pharmaceutical Co. Ltd., is reporting that the U.K.’s National Institute for Health and Care Excellence (NICE) has recommended Adcetris (brentuximab vedotin) with cyclophosphamide, doxorubicin and prednisone (CHP), within its marketing authorization, as an option for untreated systemic anaplastic large cell lymphoma (sALCL) in adults. The recommendation is based on the results of the phase III Echelon-2 study evaluating brentuximab vedotin in combination with CHP, compared to the current standard CHOP chemotherapy, in patients with CD30+ peripheral T-cell lymphoma. Brentuximab vedotin is already available as a monotherapy for adult patients with relapsed/refractory sALCL in England, Wales and Northern Ireland after failure of at least one chemotherapy agent.
Horizon Therapeutics plc, of Dublin, said the U.S. Centers for Medicare and Medicaid Services (CMS) has assigned a permanent, product-specific Healthcare Common Procedure Coding System (HCPCS) J-code (J3241) for Tepezza (teprotumumab-trbw), the first and only FDA-approved medicine for the treatment of thyroid eye disease. The permanent J-code, which enables reimbursement in all outpatient treatment settings, will go into effect on Oct. 1. In the interim, between July 1 and Oct. 1, a temporary C-code (C9061) has been established.