Reason for request

Inclusion

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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.


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