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NICE knocks-back Shire's pancreatic cancer drug Onivyde

Final guidance rules it's not a cost-effective use of NHS resources

NICE (National Institute for Health and Care Excellence)

NICE has ruled that Shire’s pancreatic cancer drug Onivyde (pegylated liposomal irinotecan) is not a cost-effective use of NHS resources.

The watchdog was reviewing the treatment’s use in England and Wales for metastatic pancreatic cancer that has progressed after gemcitabine-based therapy.

NICE’s appraisal committee considered the use of Shire’s Onivyde alongside the 5-fluorouracil (5-FU) and leucovorin (LV) chemotherapy regimen and found a statistically longer survival rate than for 5-FU plus LV alone, with an overall median survival rate of 6.1 months versus 4.2 months respectively.

But in its final guidance it concluded the incremental cost-effectiveness ratio (ICERs) for Onivyde with 5-FU and LV exceeded £100,000 per quality-adjusted life year (QALY) gained.

Noting that established NHS clinical practice in this setting is actually for oxaliplatin plus 5-FU and LV, NICE also considered this and found Onivyde with 5-FU and LV has a similar median overall survival, with no additional gains in health-related quality of life.

NICE said in a statement: “Although this analysis was subject to considerable uncertainty, the committee was confident that pegylated liposomal irinotecan plus 5-FU and LV is not deemed cost effective for routine NHS use.”

The UK sees almost 10,000 new cases of pancreatic cancer diagnosed each year, but only 3% of these patients will survive for five years or more. Furthermore, metastatic pancreatic cancer has limited treatment options and survival “may be less than six months”, NICE said.

Onivyde received European regulatory approval in October 2016 as a second-line treatment for metastatic adenocarcinoma of the pancreas, making it the first treatment to be licensed in the region for that patient group.

Article by
Dominic Tyer

28th March 2017

From: Regulatory



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