Reason for request

Re-assessment of the IAB

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Clinical Benefit

Substantial

the actual benefit of DAUNOXOME 2 mg/ml, liposomal dispersion for injection is substantial only in patients at an advanced stage of the HIV infection (CD4 < 200/mm3) with Kaposi's sarcoma with extensive skin and mucous membrane or visceral involvement who have an incomplete response to ARVs.

 


Clinical Added Value

no clinical added value

In patients at an advanced stage of the HIV infection (CD4 < 200/mm3) with Kaposi's disease with extensive skin and mucous membrane or visceral involvement who have an incomplete response to ARVs, DAUNOXOME (daunorubicin) does not provide any improvement in actual benefit (IAB V, non-existent) compared with CAELYX (doxorubicin).