The UK’s health technology assessment body, the National Institute for Health and Care Excellence (NICE), has approved the use of Novartis’ novel anti-cholesterol drug Leqvio (inclisiran) for people with primary hypercholesterolaemia or mixed dyslipidaemia who have already had a cardiovascular event such as a heart attack or stroke.
The decision follows the agreement of a “population-level commercial deal” between the NHS and Novartis to make Leqvio “available with a discount to its list price”, said NICE.
Given as a twice-yearly injection and usually prescribed alongside statins, Leqvio reduces the chances of people with high cholesterol who have already had a cardiovascular event from having another.
The drug is a PCSK9 inhibitor, a novel mechanism of action that uses RNA interference (RNAi) to boost the liver’s ability to remove harmful cholesterol from the blood.
“Inclisiran represents a potential game-changer in preventing thousands of people from dying prematurely from heart attacks and strokes,” said NICE deputy chief executive, Meindert Boysen. “We’re therefore pleased to be able to recommend it as a cost-effective option on the NHS supported by the ground-breaking deal between NHS England and NHS Improvement and Novartis – a deal that could see as many as 300,000 people with high cholesterol or mixed dyslipidaemia who have already had a previous cardiovascular event receive the drug over the next 3 years.”
The decision was widely welcomed by clinicians. Professor Sir Nilesh Samani, medical director at research charity, the British Heart Foundation, said: “The approval of inclisiran is good news for heart patients in the UK. Inclisiran is particularly attractive because it only needs to be given twice a year by a simple injection under the skin. I anticipate that in the future it will also be approved to lower cholesterol for a much wider group of people to prevent them from having a heart attack or stroke in the first place.”
Professor Kausik Ray of Imperial College London, who was lead investigator on the pivotal ORION-10 and ORION-11 trials for Leqvio, said that the drug brought LDL-C levels down from 2.6 to 1.3 in the designated high-risk population, which means that “if 300,000 patients are treated, that’s about 30,000 events averted in a 10-year period”.
Uncertainties remain around the clinical data for Leqvio, with NICE pointing to the lack of data directly comparing it to other treatments, Organon’s cholesterol absorption blocker Ezetrol (ezetimibe) and Regeneron and Amgen’s PCSK9 blockers Praluent (alirocumab) and Repatha (evolocumab).
In highlighting the lack of long-term evidence of the drug’s effect on cardiovascular outcomes, NICE also announced a clinical trial to study Leqvio’s effect on cardiovascular events in people who have never had a cardiovascular event.