DEFITELIO

Reason for request

Clinical Benefit

Moderate

the actual benefit of DEFITELIO is moderate in the Marketing Authorisation indication.

Clinical Added Value

minor

In light of the available data which have a low level of evidence even though there are study designs only requiring a few patients, and due to the severity of the disease and the absence of an alternative, the Committee considers that DEFITELIO provides a minor improvement in actual benefit (IAB IV) in the therapeutic strategy for treatment of severe hepatic VOD post-HCST.