The UK’s National Institute for Health and Care Excellence (NICE) has recommended Daiichi Sankyo’s cholesterol drugs Nilemdo and Nustendi for use on the NHS, benefitting around 70,000 adults in England with high cholesterol.
NICE has recommended the use of Nilemdo (bempedoic acid) with ezetimibe or in the fixed-dose combination form – Nustendi.
Patients with primary hypercholesterolaemia or mixed dyslipidemia – high cholesterol – will be offered treatment with bempedoic acid with ezetimibe when statins cannot be taken or have not worked.
The current treatment for these patients includes dietary changes aimed at lowering low-density lipoprotein cholesterol (LDL-C) levels.
NICE also advises that individuals may be treated with ezetimibe and either Regeneron’s Praluent (alirocumab) or Amgen’s Repatha (evolocumab), when their cholesterol levels are not lowered enough with the maximally tolerated statin doses.
“High cholesterol, if left untreated, can lead to a range of serious health conditions. Although statins and other treatments are used successfully by a large portion of the population, some people may require other options to control their cholesterol,” said Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE.
“We are pleased to be able to recommend bempedoic acid with ezetimibe as a new treatment option for these individuals,” he added.
In its final guidance, NICE said that clinical trial evidence suggests bempedoic acid with ezetimibe could help to lower LDL-C levels, when other lipid-lowering therapies have not worked.
The cost-effectiveness watchdog added, however, that there is no data directly comparing Daiichi's drugs with either Praluent or Repatha.
NICE said that indirect comparisons of trials suggests that Nilemdo/Nustendi may not be as effective at reducing LDL-C levels as Praluent or Repatha.
NICE ultimately concluded that “despite the uncertainty, the cost-effectiveness estimates for bempedoic acid with ezetimibe are within what NICE normally considers an acceptable use of NHS resources. So, bempedoic acid with ezetimibe is recommended.”