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NICE to approve ‘game changer’ twice-yearly cholesterol-lowering injection

NICE to approve ‘game changer’ twice-yearly cholesterol-lowering injection

GPs will be able to administer a new ‘game changer’ injectable anti-cholesterol drug to patients with high cholesterol who have previously suffered a cardiovascular event, to lower the likelihood of them having another.

NICE has issued draft final guidance for the injectable anti-cholesterol drug inclisiran, made by pharmaceutical company Novartis, as an option for patients with primary hypercholesterolaemia or mixed dyslipidaemia who have had a previous cardiovascular event, for example a heart attack or stroke. 

NHS England and NHS Improvement will commission the rollout of inclisiran with ‘immediate effect’, and predict that it will help to prevent 55,000 heart attacks and strokes in three years, with the potential to save 30,000 lives in 10 years.

Inclisiran can be given twice a year in primary care settings, and can be used on its own or in conjunction with statins or other cholesterol-lowering drugs. Following an initial dose, inclisiran will be administered again after three months and then twice-yearly.

The drug is the first of a new kind of cholesterol-reducing treatment which uses gene silencing to improve the liver’s ability to get rid of harmful cholesterol from the blood.

It follows a ‘population-level commercial deal’ between NHS England and NHS Improvement and Novartis giving a discount on inclisiran’s list price, which is £1,987.36 per 284-mg dose pack.

Meindert Boysen, NICE deputy chief executive and director of the Centre for Health Technology Evaluation, said: ‘Inclisiran represents a potential game-changer in preventing thousands of people from dying prematurely from heart attacks and strokes’.

Mr Boysen added that the deal, enabling NICE to ‘recommend it as a cost-effective option on the NHS’, 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 three years.’

Chief executive of the NHS Amanda Pritchard said: ‘Heart disease is still one of the major killer conditions so it is fantastic that we now have such an effective and convenient treatment for those living with dangerously high cholesterol levels.

‘This world-leading deal for the rollout of inclisiran will save lives and enable hundreds of thousands of people to benefit from this revolutionary treatment, while also being fair to taxpayers.’

Professor Kosh Ray, professor of public health in the department of public health and primary care at Imperial College London, told Pulse the new drug is a ‘game changer’.

‘The challenge we have at the moment is that with pills, they require daily dosing, and over time people become less adherent, they forget to take the medication or don’t get refills. 

‘On top of statins, this drug gives you an annualised deduction of LDL-C levels of 50% with two injections a year. It’s very convenient for patients and can be administered by a GP, a nurse, a healthcare professional, or a pharmacist.’

Professor Ray said that while the drug does not mean patients should forget to take the statins and medications, it reduces the ‘medication burden’. 

It will provide people with ‘much better control of cholesterol for longer’, he said. ‘In time, that will translate into significant reductions in cardiovascular events.’

More than two in five (40%) people in England have high cholesterol, putting them at significant risk of getting heart disease, and roughly 6.5 million adults in England are currently receiving treatment such as statins.

Heart disease is the biggest cause of death globally, causing for a quarter of total deaths in England annually, with 140,000 people dying from the condition every year.

Professor Ray said the drug will initially be for people who have established cardiovascular disease, who have ideally been tried on a statin and ezetimibe before.

In future, people with genetically elevated cholesterol might also be eligible, he said.

‘NICE have said it will be made available to people whose cholesterol levels are above 2.6 millimoles and can’t be reduced enough with statins alone,’ he said.

‘This is great news for the UK. Particularly the fact that the NHS will actively try and identify these people at high risk to work with GPs and get people onto these treatments, because the bulk of our patients in primary care are oblivious to the dangers – uncontrolled cholesterol doesn’t give you any symptoms until you’ve had a heart attack or stroke.’

‘The fact it can be administered in primary care is really attractive,’ Professor Ray added.

It follows the large-scale clinical trial which assessed the drug in 2020.

Last week, NHS England announced that all pharmacies in England will be able to offer targeted cardiovascular (CVD) screening to patients aged over 40 from this autumn.

And last September, researchers calculated the NHS could save £68bn if all patients at high risk of cardiovascular disease in England were identified and treated at current levels of care


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Vinci Ho 1 September, 2021 11:54 am

Interesting but I respect some may have cynical views on this .😈

Vinci Ho 1 September, 2021 12:03 pm

One thing I always find it annoying is the gold post being shifted as far as targets of cholesterol in both primary and secondary prevention .
If I am correct , the current target of LDL post MI is 50% if baseline LDL is between 1.8-3.5 mmol/L
This is a big ask in some patients 😳🤨

Chris GP 1 September, 2021 2:00 pm

More than half a billion quid? (plus the cost of the extra 600,000 clinical encounters it will precipitate) Lets hope it is effective.

Paul Attwood 1 September, 2021 2:18 pm

“Game changer?” Save me from the Daily Muppet headlines. So this drug reduces LDL levels. Several other drug groups do too but regarding these, longer term studies do not show reduction in CVD or reduction in mortality.

Have these studies been done on inclisiran? Probably a bit early I would think seeing as it takes years to demonstrate reduction, if any.

Is it a reasonable use of this drug or a desperate punt on its efficacy? A £500m gamble? Remember BloJo is known for spaffing up a wall.

Nicholas Sharvill 1 September, 2021 3:48 pm

Interesting and one hopes promising but as yet this drug has not been shown too prevent deaths in anything like the scale the daily Mail and the press release says (-that assumes everybody on it will live for ever and that statins (plus ace aspirin etc) are of no benefit which we know to be not true) Either way net cost to the NHS will be vastly higher than just the cost of jabs as if it works many people will go on to consume other health care for decades if not dying of their MI.

terry sullivan 1 September, 2021 4:15 pm

another scam–probably find it increases mortality–part of gates plan?

remember clofibrate?

what is normal cholesterol?

Michael Mullineux 1 September, 2021 5:04 pm

Ezetimibe Prof Ray? Now there is an evidence based drug with end point data if ever there was one. Aren’t ivory towers fantastic?

Andrew Bamji 1 September, 2021 5:28 pm

The NICE recommendation starts from a presumption that the more you can lower LDL-C the better the cardiac protection. This is total nonsense, as I pointed out last year (see “Do PCSK9 inhibitors do anything more than reduce LDL cholesterol? BMJ 2020; 368 doi: The original inclisiran drug trial was terminated early. It showed that there was a massive reduction of LDL-C, but up to the point of termination if anything (and one cannot use data from trials where the protocol has been breached) that there was an increase in cardiovascular events.

Statins have an anti-inflammatory action and lower cholesterol with a small cardiac benefit

Inclisiran does not have an anti-inflammatory effect, lowers cholesterol more than statins, but does not appear to influence cardiac events.

The only conclusion I can draw from these pieces of evidence is that cholesterol levels have nothing to do with cardiac risk, but inflammation does.

Dave Haddock 1 September, 2021 8:12 pm

Any suggestion what Practices can expect to be paid for taking on this extra work?

Decorum Est 1 September, 2021 11:37 pm

@Andrew Bamji
‘The NICE recommendation starts from a presumption that the more you can lower LDL-C the better the cardiac protection. This is total nonsense, as I pointed out last year…..
The only conclusion I can draw from these pieces of evidence is that cholesterol levels have nothing to do with cardiac risk, but inflammation does.’
But the ‘medical industry’ won’t flourish with your cynicism???

David jenkins 8 September, 2021 3:54 pm

game changer eh ?

it’ll certainly change our game !

“‘The fact it can be administered in primary care is really attractive,’ Professor Ray added.”

extra work for hard pressed GPs for a few peanuts i’ll guess !