Belumosudil is recommended, within its marketing authorisation, for treating chronic graft-versus-host disease in people 12 years and over after 2 or more systemic treatments. It is recommended only if the company provides it according to the commercial arrangement.
Why the committee made these recommendations
Usual first-line treatment for chronic graft-versus-host disease (GVHD) is corticosteroids with or without a calcineurin inhibitor. Second-line treatment is extracorporeal photopheresis, pentostatin, rituximab or imatinib. Treatment for chronic graft-versus-host disease after 2 or more systemic treatments can include imatinib, mycophenolate mofetil, pentostatin, pulsed corticosteroids and sirolimus. In this evaluation, this range of potential treatments is referred to as 'best available therapy'.
Clinical trial evidence suggests that taking belumosudil improves people's symptoms, but it was not compared directly with best available therapy. When compared indirectly, the results suggest that belumosudil improves symptoms more than best available therapy.
The most likely cost-effectiveness estimates are uncertain, but they are likely within the range that NICE considers an acceptable use of NHS resources. So, belumosudil is recommended.