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NICE does not recommend Novartis' Rydapt for AML

December 8, 2017 9:05 PM UTC

The U.K.'s NICE issued draft guidance recommending against the use of Rydapt midostaurin (CGP 41251, PKC412) from Novartis AG (NYSE:NVS; SIX:NOVN) to treat newly diagnosed, FMS-like tyrosine kinase 3 (FLT3; CD135)-mutant acute myelogenous leukemia (AML) in combination with daunorubicin and cytarabine or as monotherapy following complete response.

The committee said clinical trial data that Novartis submitted did not reflect how the drug would be used in clinical practice. NICE said Rydapt does not meet its criteria for a life-extending treatment at the end of life because people with FLT3-mutant AML normally have a life expectancy of over 24 months. The committee concluded the most likely incremental cost-effectiveness ratio (ICER) for Rydapt plus chemotherapy compared with chemotherapy alone is more than £62,818 ($84,444) per quality-adjusted life year (QALY) gained, which is higher than the range NICE normally considers to be cost-effective. The committee said Novartis did not make a case for Rydapt to be included in the Cancer Drugs Fund...