The National Institute for Health and Care Excellence (NICE) issued a draft guidance on Wednesday, Nov. 18, turning down Amgen cholesterol drug Repatha as a treatment choice for people with high cholesterol levels. The agency said the documents presented by Amgen exudes limitations, which made the drug's reliability of cost-effectiveness questionable.

NICE is the UK watchdog that decides whether or not the National Health Service (NHS) should pay for treatments.

In a statement, NICE explained that prolonged elevation of cholesterol in the blood hastens the formation of fatty deposits in the arteries thus, making people with hypercholesterolaemia develop an increased risk of cardiovascular disease (CVD). Such condition may also result in angina, strokes and heart attacks.

Evolocumab (generic name of Repatha) is an antibody that inhibits the action of PCSK9. PCSK9 decreases the receptors found in the liver that eliminate bad cholesterol in the blood. By hindering PCSK9, more agents are able to get into the blood and remove the bad cholesterol, but its role in reducing CVD risk has not been fully established.

"The Committee concluded that although evolocumab was effective in reducing levels of LDL cholesterol in people with primary hypercholesterolaemia, there have been no clinical trials to measure the direct effect of evolocumab on CVD events," said Meindert Boysen, the program director of NICE. He added that the team also felt that it was not clear whether or not decreasing bad cholesterol levels through evolocumab would cut down heart attacks, strokes and angina.

The committee also noticed that Amgen utilized the Framingham risk equations to come up with CVD risks, instead of the QRISK2 assessment tool, which is recommended by NICE. Framingham risk equations have been recognized to overestimate CVD risk among the UK population.

Another concern that NICE stated in its press release is Amgen's usage of an impractically high factor to adjust CVD risk in people with heterozygous-familial hypercholesterolaemia.

In the end, the committee said that they cannot make firm recommendations about evolocumab due to the high level of uncertainty of the drug's cost-effectiveness proof.

Amgen expressed its disappointment with the verdict, saying evidence clearly implies that high cholesterol is related to strokes and heart attacks, and that it hopes to give more information and analyses to show the cost-effectiveness of the drug.

The list price of Repatha in the UK is around £4,448.60 ($6,769) for annual treatment. The stated cost is said to be less than half of the U.S. price, which is approximately more than $14,000.

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