08 January 2024

A new tailored treatment for chronic graft-versus-host disease (chronic GVHD) has won UK approval for the first time, it has been announced.

The treatment is expected to benefit a small number of patients who do not respond to standard treatment.

In final draft guidance, the National Institute for Health and Care Excellence (NICE) recommends belumosudil mesilate (also known as Rezurock) for individuals over the age of 12 who have received at least two therapies.

In 2019, there were 1,506 allogeneic transplants in England and between 2016 and 2020, 713 people were diagnosed with extensive chronic GVHD. It is estimated about 66 people would be eligible to receive this treatment.

The usual treatment for chronic GVHD after two or more systemic treatments is steroids and it can also include ciclosporin to reduce a person’s immune response. Other treatments are available, depending on the part of the body affected.

The new treatment is an immunosuppressant that blocks an enzyme involved in the immune system. It is given as a daily tablet.

NICE found that, when compared indirectly, clinical trial evidence showed belumosudil improves symptoms more than best available therapy.

The company has a confidential commercial arrangement in place which makes belumosudil available to the NHS with a discount.

The news was welcomed by experts in haematology.

Henny Braud, chief executive of Anthony Nolan, said: “This is a significant milestone in the management of chronic graft-versus-host disease.”

Dr Ram Malladi, a haematologist specialising in bone marrow transplants at Cambridge University Hospitals, it was “a welcome new treatment option for patients who have failed to respond to current therapies and otherwise would have few further options remaining.”

Source: NICE

Link to guidance: https://www.nice.org.uk/guidance/indevelopment/gid-ta11136

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