- NICE ruling is preliminary, company and doctors can comment
- No clinical trials showed direct effect on heart risks: NICE
The U.K.’s health-cost regulator turned down Amgen Inc.’s new cholesterol medicine Repatha in a preliminary ruling, saying the drugmaker may have over-estimated the risk of heart disease that results from people having too much cholesterol.
The drug works well to reduce the bad kind of cholesterol, but there’s no evidence showing that by doing that it cuts the number of heart attacks or strokes, the U.K.’s National Institute for Health and Care Excellence said in a statement. The panel that reviewed the drug said Amgen had “used an unrealistically high factor” to estimate the risk of heart incidents among British people and that the analyses it presented had “limitations which called into question the reliability of the cost-effectiveness results.”
Repatha, like Sanofi’s rival medicine Praluent, belongs to an expensive new class of treatments called PCSK9 inhibitors, designed to help patients who can’t get their LDL, or bad, cholesterol under control with older medicines known as statins. The U.K. response comes amid a heated debate on drug prices. The industry has come under fire from doctors, insurers and patient advocates for charging five and even six figures for life-saving treatments for diseases including hepatitis C and cancer.
The guidance is preliminary, and the company, doctors and patients have until Dec. 8 to comment. NICE said it will issue its next opinion after it meets to consider those comments on Jan. 13.