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Draft guidance consultation

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1 Recommendations

1.1 Belumosudil is not recommended, within its marketing authorisation, for treating chronic graft-versus-host disease in people 12 years and over after 2 or more systemic treatments.

1.2 This recommendation is not intended to affect treatment with belumosudil that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. For children or young people, this decision should be made jointly by the clinician, the child or young person, and their parents or carers.

Why the committee made these recommendations

Usual treatment for chronic graft-versus-host disease after 2 or more systemic treatments can include extracorporeal photopheresis, imatinib, mycophenolate mofetil, pentostatin, pulsed corticosteroids and sirolimus. In this evaluation, this is called 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. But the results are uncertain.

There are uncertainties in the economic model because of the assumptions it included. Because of the uncertainties in the economic model and clinical evidence, the cost-effectiveness results are not sufficiently robust. Further analyses are needed to address this uncertainty. So, belumosudil is not recommended.