2 The technology

Description of the technology	Pegylated liposomal irinotecan (Onivyde, Shire) consists of the anticancer drug irinotecan contained within tiny fat particles called nanoliposomes. The nanoliposomes accumulate in the tumour and release irinotecan slowly. Irinotecan blocks an enzyme called topoisomerase I, which causes DNA strands to break. This stops the cancer cells dividing and they eventually die.
Marketing authorisation	Pegylated liposomal irinotecan, in combination with 5‑fluorouracil (5‑FU) and leucovorin (LV), has a marketing authorisation for treating metastatic adenocarcinoma of the pancreas in adults whose disease has progressed after gemcitabine-based therapy.
Adverse reactions	The company submission includes the following as common adverse events for pegylated liposomal irinotecan plus 5‑FU and LV: diarrhoea, nausea, vomiting, decreased appetite, neutropenia, fatigue, asthenia, anaemia, stomatitis and pyrexia. For full details of adverse reactions and contraindications, see the summary of product characteristics.
Recommended dose and schedule	Intravenous infusion of 80 mg/m² pegylated liposomal irinotecan, 400 mg/m² LV, followed by 2,400 mg/m² 5‑FU over 46 hours given every 2 weeks.
Price	£615.35 per 50 mg vial (company submission). Cost per 2‑week treatment cycle for pegylated liposomal irinotecan is £1,846.05 based on 3 vials per dose. The company has agreed a patient access scheme with the Department of Health. If pegylated liposomal irinotecan plus 5‑FU and LV had been recommended, this scheme would provide a simple discount to the list price of pegylated liposomal irinotecan plus 5‑FU and LV with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme would not constitute an excessive administrative burden on the NHS.