NICE draft guidance says 'no' to Amgen's Repatha

The National Institute for Health and Care Excellence (NICE) the medicines cost watchdog for England and Wales, has today published draft guidance that does not recommend Amgen’s (Nasdaq: AMGN) Repatha (evolocumab) as an option for people with high cholesterol (primary hypercholesterolemia - heterozygous-familial and non-familial) and mixed dyslipidemia.

Primary non-familial hypercholesterolemia affects an estimated 1.5 million people in England. Primary heterozygous-familial hypercholesterolemia is an inherited condition caused by a faulty gene and affects about 106,000 people in England. People with this condition have raised cholesterol levels from birth.

The draft guidance does not recommend evolocumab, alone or in combination with lipid-lowering therapies, for treating primary hypercholesterolemia or mixed dyslipidemia in adults for whom lipid-modifying therapies, in line with current NICE guidance, would be considered.