The UK’s National Institute for Health and Care Excellence (NICE) finalized its determination that Shire’s Onivyde treatment for advanced pancreatic cancer is not cost-effective, and should not be covered by the National Health Service.
Onivyde (pegylated liposomal irinotecan) is approved in the European Union for metastatic adenocarcinoma of the pancreas in combination with chemotherapy, following disease progression after gemcitabine therapy. A two-week treatment cycle, based on three vials per dose, costs £1,846 ($2,300). The NICE determination does not affect patients who have already begun treatment.
A committee review found that while the Onivyde combination was more effective than chemotherapy alone, it was associated with more adverse events. The committee said the company’s approach for modeling survival “gave clinically implausible results and lacked robustness for decision-making.”