A cholesterol-lowering drug is said to be offered to hundreds of thousands of people by the NHS, with estimates predicting it could save 30,000 lives within the next decade.
Inclisiran has been described as a potential “game changer” and it is hoped it could prevent 55,000 heart attacks and strokes and save tens of thousands of people from early death.
The treatment is given to people with high cholesterol or mixed dyslipidemia – abnormally high levels of fat in the blood – who have had a heart attack or stroke.
NHS England said the drug will be rolled out on an unprecedented scale after the healthcare sector and manufacturer finalize a deal that will allow inclisiran to be used at a low cost.
More than two in five people in England have high cholesterol, which puts them at significant risk of developing heart disease, NHS England said, adding that about 6.5 million adults are currently taking lipid-lowering drugs such as statins.
Heart disease accounts for about a quarter of deaths in England each year, NHS England said.
Nice said his recommendation on the drug applies to England and Wales.
Inclisiran is given as an injection by nurses in primary care practices across England, with a starting dose, followed by an additional three months, and then twice a year.
The drug is the first of a new type of cholesterol-lowering treatment that uses RNA interference (RNAi) to help the liver remove harmful cholesterol from the blood it suffices.
The health watchdog said that while there is still no long-term evidence of Inclisir’s effect on cardiovascular outcomes, it is considered cost-effective in people who have previously had a cardiovascular event, such as a heart attack or stroke, and whose cholesterol levels have remained high after receiving other therapies.
Nice said the drug is also recommended for use in research studies with people who have never had a cardiovascular event.
NHS England and NHS Improvement estimate that in three years around 300,000 people will have received the drug, which will help prevent 55,000 heart attacks and strokes and potentially save 30,000 lives over the next decade.
Meindest Boysen, Vice President of Nice and Director of the Center for Health Technology Evaluation, said: “Inclisiran represents a potential game changer to prevent thousands of people from prematurely dying of heart attacks and strokes.
“We’re excited to recommend it as a cost-effective option for the NHS, backed by the groundbreaking agreement between NHS England and NHS Improvement and Novartis – an agreement that could affect up to 300,000 people with high cholesterol. “Or mixed dyslipidemia who have had a previous cardiovascular event, will receive the drug for the next three years.”
NHS chief Amanda Pritchard said: “The NHS is committed to using cutting edge treatments to save and improve patients’ lives.
“Heart disease is still a major killer, so it is fantastic that we now have such an effective and convenient treatment for people with dangerously high cholesterol.
“This world-leading agreement to introduce Inclisiran will save lives and enable hundreds of thousands of people to benefit from this revolutionary treatment while doing justice to taxpayers.”
NHS England said the NHS and drug maker Novartis deal over the “Population Health Agreement” could eventually benefit nearly half a million people from the treatment.
Health and Welfare Minister Sajid Javid said: “This is a huge step forward in combating the scourge of heart disease, which tragically kills thousands each year.
“I would like to thank the NHS, Novartis and Nice for their work in treating one of the world’s deadliest diseases.”
Professor Sir Nilesh Samani, medical director of the British Heart Foundation, described the drug’s approval as “good news for heart patients” and suggested that further research could make it more widely available.
He said, “More research is needed to confirm the full extent of its benefits, but I expect it will also be approved in the future to lower cholesterol for a much wider group of people in order to prevent them from becoming one Heart attack or stroke suffer first place. “
Jules Payne, executive director of the cholesterol charity Heart UK, said: “High cholesterol is very common and a leading cause of cardiovascular disease, but the absence of symptoms means the first sign of the problem is often a heart attack.
“Heart UK aims to save lives and keep families together, and we welcome this new innovative drug as an additional tool to fight cardiovascular disease.”
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