Britain’s National Institute for Health and Care Excellence (NICE) has published draft guidance against prescribing the Sanofi (Euronext: SAN)/Regeneron’s (Nasdaq: REGN) Praluent (alirocumab) for people with high cholesterol.
The drug pricing watchdog for England and Wales accepted the injectable medicine could help lower “bad” cholesterol in patients. But said it could not be sure of the extent of the treatment’s success in reducing heart disease and was therefore not a cost-effective use of Natioinal Health Service resources.
People with high concentrations of cholesterol in their blood can suffer hypercholesterolemia and mixed dyslipidemia.
Non-familial hypercholesterolemia occurs when genes combine with dietary and other factors such as smoking and lack of exercise to cause high cholesterol levels and affects around 1.5 million people in England.
Long-term raised cholesterol levels accelerate the build-up of fatty deposits in the arteries, leading to angina, heart attacks and strokes. Cardiovascular disease claimed around 150,000 lives in 2012
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.
Alirocumab is an antibody that targets a specific protein, called PCSK9, which reduces the number of receptors on the liver that remove low-density lipoprotein (LDL), or “bad,” cholesterol from the blood.
By blocking PCSK9’s ability to work, more receptors are available to get rid of LDL cholesterol from the blood and, as a result, lower LDL cholesterol levels.
Praluent was approved by the US Food and Drug Administration in July 2015 and in Europe in September last year.
The director of NICE’S Centre for Health Technology Evaluation, Carole Longson, said: “The committee noted that the trials were not able to provide robust information on important cardiovascular outcomes. They concluded that, although it was reasonable to infer that alirocumab would reduce cardiovascular events, the extent of this reduction was uncertain.”
Prof Longson continued: “The committee further recognized that most of the value-for-money analyses resulted in ICERs that exceeded the range normally considered to be a cost-effective use of NHS resources. In view of these concerns, the committee concluded that alirocumab could not be considered a cost effective use of NHS resources for people with hypercholesterolemia.”