Pancreatic cancer patients will not be able to get routine access to Shire’s Onivyde on the National Health Service following a final rejection from cost regulators.

The National Institute for Health and Care Excellence has now published final guidance rejecting the drug’s use, in combination for 5-fluorouracil (5-FU) and leucovorin (LV), for metastatic pancreatic cancer that has progressed after gemcitabine-based therapy.

Onivyde (pegylated liposomal irinotecan) was cleared for use in Europe in October, based on clinical data showing that it significantly boosted overall survival compared to 5-FU/LV alone, with median overall survival of 6.1 months vs 4.2 months, respectively.

However, NICE concluded that, compared with established clinical practice of oxaliplatin plus 5-FU and LV, the median overall survival of the Onivyde-based regimen would be similar.

It calculated that the Committee concluded that the ICER for pegylated liposomal irinotecan plus 5-FU and LV compared with 5-FU plus LV was over £100,000 per quality-adjusted life year (QALY) gained, and thus well outside the realm of what is considered value for money for the NHS.