The FDA on July 16 approved Kadmon Holdings, Inc.’s Rezurock for the treatment of chronic graft vs. host disease (GVHD) in patients 12 and older. The nod marks Kadmon’s first FDA-approved drug and makes Rezurock the first ROCK2 inhibitor in the GVHD market. While acute GVHD is typically managed using low-cost generic immunosuppressants and steroids (see story, p. 1), the chronic form of the disease is more difficult to treat, with the class including TNF inhibitors (Amgen Inc.’s Enbrel), JAK inhibitors (Incyte Corp.’s Jakafi), BTK inhibitors (Johnson & Johnson and AbbVie’s Imbruvica) and monoclonal antibodies (Roche and Biogen’s Rituxan, Amgen’s Ribani). Among the most advantaged therapies are Enbrel, Jakafi and Imbruvica, which hold covered or better status for 69%, 70% and 71% of all insured lives, respectively. The graphics below show how GVHD drugs are currently covered among commercial health plans, health exchanges and Medicare and Medicaid programs, plus their utilization management restrictions.
NOTES: Access that requires prior authorization and/or step therapy is represented by the abbreviation (PA/ST). Under the pharmacy benefit, the covered lives under commercial, health exchange, Medicare and Medicaid formularies are 169.6 million, 11.6 million, 48.0 million and 71.8 million, respectively.
SOURCE: Managed Markets Insight & Technology, LLC database as of July 2021.