A new anti-cholesterol drug that could save up to 30,000 lives has been approved by NICE to be administered in primary care to people who have hypercholesterolaemia or mixed dyslipidaemia to prevent premature death. 

The new injectable drug, named inclisiran, will be rolled out across primary care with ‘immediate effect’, NHS England has said.  

The drug — which can be administered by healthcare professionals including pharmacists — works by lowering bad fat in the blood when other cheaper drugs, like statins, have not worked well, the new draft advice says. 

NICE is recommending it as an option for patients who have already had a cardiovascular event, such as a stroke or heart attack, and are not responding to other cholesterol-lowering treatments. 

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

Inclisiran, was made available to the NHS for a discounted price after NHS England and NHS Improvement came to an agreement with its manufacturer Novartis back in January. 

A Royal Pharmaceutical Society (RPS) spokesperson on cardiovascular medicine and consultant pharmacist, Sotiris Antoniou, said: ‘It’s fantastic to see that the anti-cholesterol drug inclisiran will be made available as a twice-yearly injection to help prevent people with high cholesterol from dying prematurely from heart attacks and strokes. 

‘It works by helping the liver absorb more ‘bad’ LDL cholesterol from the blood,’ he explained.  

‘It’s a big step forward on existing injections that have a similar action which must be given every two weeks, a regime which can be difficult to remember. Inclisiran has proved very effective in clinical trials and will help reduce the burden of taking therapy that people with high cholesterol can face. 

‘It will be easy to administer for pharmacists who work in general practice, as they will be able to give the injection to patients who have already had a stroke or heart attack and are not responding to other cholesterol-lowering treatments as part of their regular check-ups. It’s a real game-changer for them.’ 

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.  

‘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.’ 

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 The Pharmacist’s sister title 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.’

Back in January, the twice-yearly cholesterol-lowering injection underwent an NHS clinical trial.