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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?

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1 Recommendations

1.1

Ruxolitinib is not recommended, within its marketing authorisation, for treating acute graft versus host disease that has an inadequate response to corticosteroids in people 12 years and over.

1.2

This recommendation is not intended to affect treatment with ruxolitinib 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 healthcare professional consider it appropriate to stop. For young people (less than 18 years), this decision should be made jointly by the healthcare professional, the young person, and their parents or carers.

Why the committee made these recommendations

Standard care for acute graft versus host disease (GvHD) is corticosteroids. If corticosteroids have not worked well enough, subsequent treatments can include extracorporeal photopheresis, mycophenolate mofetil, etanercept and infliximab. Ruxolitinib is an alternative to these second-line treatments.

Clinical trial evidence shows that acute GvHD is more likely to improve with ruxolitinib than with standard care. People who have ruxolitinib are also less likely to need another treatment, have a relapse of their underlying disease, or die. But, this is uncertain because of the design of the trials.

There are uncertainties in the economic evidence. This is because of assumptions used by the company in its economic model. These include the total costs incurred with ruxolitinib and the quality of life of people who develop chronic GvHD. Because of these uncertainties, it is not possible to determine the most likely cost-effectiveness estimates for ruxolitinib. So, more analyses are needed, and ruxolitinib is not recommended.