trabectedin (Yondelis)

following a full submission

trabectedin (Yondelis) is not recommended for use within NHS Scotland.

Indication under review: Trabectedin in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian
cancer.

In an open-label randomised controlled study trabectedin in combination with PLD was significantly superior to PLD monotherapy in terms of progression free survival. There was a
significant difference in an exploratory interim analysis of overall survival in the sub-group of patients with partially platinum-sensitive disease.

The manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC and in addition, the manufacturer did not present a
sufficiently robust economic case to gain acceptance by SMC.