liposomal irinotecan (Onivyde)

following a full submission assessed under the orphan and end of life process

liposomal irinotecan (Onivyde®) is not recommended for use within NHS Scotland.

Indication under review: Treatment of metastatic adenocarcinoma of the pancreas, in combination with fluorouracil (5-FU) and leucovorin (folinic acid), in adult patients who have progressed following gemcitabine based therapy.

The addition of liposomal irinotecan to 5-FU/folinic acid, compared with 5-FU/folinic acid alone, significantly improved overall survival and progression free survival in patients with metastatic adenocarcinoma of the pancreas who had progressed after gemcitabine based therapy.

The submitting company’s justification of the treatment’s costs in relation to its health benefits was not sufficient and in addition did not present a sufficiently robust clinical or economic case to gain acceptance by SMC.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.