- Only 20,000 patients have been offered the lifechanging injection
- The twice-yearly jab slashes the level of so-called 'bad' cholesterol by 50%
A row has erupted between cardiology experts and GP leaders over prescribing a breakthrough heart drug that could save tens of thousands of lives.
The medicine, called inclisiran, is a twice-a-year jab that slashes levels of so-called ‘bad’ cholesterol by more than 50 per cent after just two weeks. It has been approved for use on the NHS since 2021 for patients with stubbornly high cholesterol levels who have already suffered a heart attack.
NHS England say the drug could prevent 55,000 heart attacks and strokes within the next decade, saving 30,000 lives, at a cost of just £45 a dose.
But the Royal College of General Practitioners (RCGP) and British Medical Association (BMA) have refused to back plans to allow GPs to directly prescribe inclisiran. The organisations – two of the UK’s largest bodies representing doctors – argue that their members don’t have enough time to offer the drug, as patients on it have to be carefully monitored, and also claim there’s not enough proof that it’s effective and safe.
This means that most inclisiran prescriptions are written by a specialist, forcing some patients to travel hundreds of miles to see the relevant doctor or wait as long as a year for an appointment.
Click on this week's Medical Minefield podcast to hear why doctors are at war over a £45 cholesterol-busting drug
Specialists have hit back, labelling the RCGP and BMA as ‘Luddites’. Speaking to the MoS, Professor Derek Connolly, consultant cardiologist at Sandwell and West Birmingham Hospitals NHS Trust, said: ‘More than 200,000 patients worldwide have taken inclisiran over the past seven years. We have clear data that it is safe, that it reduces cholesterol and that this will cut the risk of heart attacks and strokes.
‘Doctors delaying the rollout of inclisiran are Luddites – they don’t like change and are needlessly depriving patients of a potentially life-saving drug.’
Inclisiran, also known as Leqvio, is a new breed of drug that reduces LDL, or ‘bad’ cholesterol, which damages artery walls, leading to a build-up of plaque which can block blood supply and trigger a heart attack or stroke.
In contrast, ‘good’ cholesterol, known as HDL, helps remove other forms of cholesterol from your bloodstream. Higher levels of HDL are associated with a lower risk of heart disease.
Inclisiran is known as a small interfering RNA, or siRNA, which works on a genetic level to inhibit the production of PCSK9, a protein involved in the regulation of LDL. Reducing PCSK9 helps the liver remove more LDL from the blood.
And the need for the drug is clear. For decades, statins – daily pills which reduce LDL levels by 30 to 50 per cent – have been the gold standard treatment for high cholesterol. The tablets, offered to anyone found to be at greater than a ten per cent risk of a heart attack or stroke over the next ten years, are taken by more than eight million Britons.
But research shows about half of those taking them fail to reach healthy cholesterol levels. Some stop taking the medication, while others find they’re unable to take a high enough dose, often blaming side effects such as muscle aches.
Inclisiran is designed to be taken alongside statins or other cholesterol-lowering medication, including ezetimibe and bempedoic acid, in order to reduce levels sufficiently.
Last year, broadcaster and menopause campaigner Mariella Frostrup revealed she suffers from heart disease and was ‘on medication you inject twice a year’ which was ‘a life-saver as statins didn’t work for me.’ Although she didn’t name the drug as inclisiran, she said it ‘dramatically affected my cholesterol’.
Experts say that, all told, around 300,000 people in the UK – with stories similar to Mariella’s – could be eligible for inclisiran, but just 20,000 have been offered it so far.
In a bid to increase uptake, earlier this year inclisiran maker Novartis cut the cost of the injection from about £2,500 to £45.
‘The plan was to get 100,000 people on to the drug every year,’ says Professor Kausik Ray, a consultant cardiologist at Imperial College London and lead investigator on a major inclisiran trial. ‘It was on this basis that the drug firm gave the UK such a good discount.’
Inclisiran was approved in 2021 for high-risk patients by drug watchdog the National Institute of Health and Care Excellence (NICE) after trials showed it drastically cut LDL levels and there were no safety concerns. It pointed out there was a clear need for more cholesterol-lowering medicines to reduce the number of heart attacks and strokes the NHS tackles – each accounts for about 100,000 hospital admissions every year in the UK.
But the RCGP and BMA almost immediately released a joint statement calling into question the decision. It said that, from the trial data, it was unclear how much inclisiran reduced heart attack and stroke numbers. It also raised concerns over ‘as yet potential unknown long-term side effects’ and the ‘possible additional capacity or resources’ on GPs if they prescribed it.
NICE categorised the drug as a ‘black triangle’ medicine, which means it requires enhanced surveillance due to limited long-term safety data. Any clinician who prescribes inclisiran has to report all suspected adverse reactions to health authorities.
These measures are not unusual for new NHS treatments. Currently there are more than 500 licensed drugs used in the NHS which are part of the black triangle scheme. No safety concerns about inclisiran have been raised through the scheme since its approval two years ago.
However, when we contacted the RCGP it said its position on the drug remains unchanged. It does not plan to update its stance until 2026, when the results of a major long-term trial showing how many heart attacks and strokes the drug prevents are expected to be released. But experts argue that this shows a misunderstanding of the science behind inclisiran.
‘Every single cholesterol-lowering drug, including statins, has been approved before the long-term benefits were shown,’ says Prof Ray. ‘We know the drug drastically cuts the amount of LDL cholesterol in the body, which is directly linked with the rate of heart attacks and strokes, and is safe for use.
‘It is ridiculous to argue that we need to wait until 2026 to offer it to patients. This position is simply being used as a shield for inaction and patients are getting caught in the middle of the dispute.’
NICE has also hit back. Last night, the watchdog told the MoS that, prior to the approval of inclisiran in 2021, the RCGP was invited to raise any concerns it had. ‘No appeals were received,’ said a spokesman.
Experts say this disagreement has had a chilling effect on the rollout of inclisiran. Since its approval, local medical committees across the country have said they will not prescribe it, according to a report in the British Medical Journal.
A senior GP, who asked to remain anonymous, said: ‘This resistance from GPs to prescribe inclisiran is a direct result of the RCGP and BMA letter.
‘Practices claim they are not offering the drug because of the lack of data – but really most of them don’t want to take on the additional workload as they don’t see it as an essential service.
‘Most GPs have got used to offering statins for high cholesterol and are resistant to giving injections for the condition, even though it’s no harder than a simple flu jab or Vitamin B12 injection.’
Some patients told the MoS that they have to travel hundreds of miles to access inclisiran because their local GP will not offer it.
Chris Crick, 53, from Cheshire, was told he would have to see a local cholesterol specialist – known as a lipidologist – to receive the jab after he suffered a heart attack last year. However, he was warned the wait for an appointment would likely be more than a year.
‘I’m intolerant to statins – they cause pain all over my body and leave me incredibly weak – so I need another option,’ says the construction site manager.
The father-of-two was eventually able to find a consultant who would prescribe him the medicine. However, starting next month, he will have to make the 400-mile round-trip to London to get the jab – which takes less than two minutes to administer.
‘If I don’t take drugs to keep my cholesterol down I could be at risk of another heart attack,’ he says. ‘It doesn’t make sense that I have to travel so far to get this treatment.’
Another patient, 61-year-old John Fuller, a banker from East Sussex, has suffered from stubbornly high cholesterol despite being on statins since his 30s. He says his local GP practice refused to prescribe him inclisiran.
‘I take the very highest dose of statins but my cholesterol levels are still too high, particularly since I also have kidney disease, which can get worse if you have too much LDL,’ he says. ‘The GP said he’d never heard of the drug [inclisiran] so couldn’t prescribe it.’ John was able to find a cardiologist in London who would prescribe him inclisiran and he began taking it earlier this year. However, he says he still wants his GP to prescribe it to him.
‘It takes a whole day for me to go and get this treatment because I have to travel into London,’ he says. ‘Why on earth am I being forced to go to this effort when the NHS has already agreed that my GP should be administering it?’
Experts say a major reason why many GPs refuse to offer inclisiran is that they believe they are not being paid enough to give the jab. Following drug firm Novartis’s decision to bring down the cost per dose, the NHS also reduced the amount GP practices are paid for each jab from £10 to £5.
Andy Parkin, medical director of the Kent Local Medical Committee, told the British Medical Journal that practices ‘would lose money’ by prescribing inclisiran. He claims this is as the reduced payment does not cover the cost of administering the jab and then monitoring patients.
Experts say they are frustrated that a disagreement over a £5 charge is impacting the medical care of thousands and argue that NICE will have to rethink the situation if GPs continue to resist.
‘There’s no reason this could not be handled by pharmacists,’ Prof Connolly says. ‘It’s just as simple to administer as a flu jab and doesn’t require any follow-up checks, other than an occasional cholesterol test which GPs surely can’t object to doing.
‘I regularly prescribe this drug to patients. It gets their cholesterol levels down and there are no major side effects. But there aren’t enough specialists like myself to administer this drug to everyone who needs it. There are hundreds of thousands of people whose cholesterol is dangerously high in this country – it doesn’t make any sense that GPs are resisting attempts to tackle this national health issue.’
Last night, Dr Michael Mulholland, Honorary Secretary of the Royal College of GPs, reinforced its position on inclisiran.
He said: ‘GPs absolutely want to do our best for patients and to reduce their cardiovascular risk. However, inclisiran is still a black triangle drug – one for which full safety data is not yet available – and there are insufficient resources within primary care to monitor its effects.
‘We’d usually expect such a drug to first be prescribed at specialist hospital clinics, where patients can be more easily monitored.
‘Before GPs become responsible for prescribing inclisiran, we need assurance that the evidence base on its safety is secure, and for the risks and benefits to patients to be clearly established.’
An NHS spokesman said: ‘Supporting people to lower their cholesterol is one of the key ways in which GPs and their teams can prevent heart attacks and strokes and save lives, and inclisiran is an effective, NICE-recommended cholesterol drug that provides an additional treatment option for NHS patients.
‘While inclisiran is one of several NICE recommended therapies GPs have in their toolbox, the majority of primary care networks are using it and thousands of patients are benefiting.’
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2023-12-09 22:00:46Z
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