Shire's Onivyde has been turned down by the National Institute for Health and Care Excellence as an NHS-funded treatment for pancreatic cancer.
The drug was cleared for use in Europe to treat metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine-based therapy.
The decision was based on clinical data showing that Onivyde (pegylated liposomal irinotecan hydrochloride trihydrate) combined with 5-FU/LV significantly boosted overall survival compared to the latter alone, with median overall survival of 6.1 months vs 4.2 months, respectively.
However, NICE has issued draft guidance rejecting the drug, which costs £1,846.05 per two-week treatment cycle, after concluding that it does not fall within the range of what is normally considered cost effective for routine NHS use.
The committee agreed that the criterion for short life expectancy was met, but that end-of-life weighting could not be applied because criterion for extension to life was not met for the comparison with either 5-FU plus LV or oxaliplatin plus 5-FU and LV.
"We know that people with pancreatic cancer have very limited treatment options, so it is disappointing that the cost of pegylated liposomal irinotecan means that it is too expensive for us to recommend," said Professor Carole Longson, director of the centre for health technology evaluation at NICE.
But she also said that further discussion with Shire on how the drug could be made available to patients on the NHS would be welcome.