England's patients will soon be able to receive a new drug called "Gamechanger" that doctors claim will save tens of thousands of lives and reduce the incidence of stroke or heart attack.
Inclisiran works by increasing the liver's ability to lower bad cholesterol levels, even for those who have tried statins before.
After clinical trials, the National Institute for Health and Care Excellence has approved the drug for NHS use in England.
It will be made immediately available after Novartis, which makes the drug, has agreed to lower its price through a deal with NHS England. This will allow 300,000 patients to use inclisiran over the next three-years.
A 284mg dose package of the drug typically costs 1,987.36. Although the size of the discount the NHS received is not known, Novartis' decision to reduce its price opened the door for Nice to accept inclisiran value-for-money and NHS England to make it widely accessible.
Inclisiran could be a gamechanger in the prevention of thousands of premature deaths from strokes and heart attacks, according to Meindert Boysen (nices deputy chief executive) and director of its centre of health technology evaluation.
It will be offered to people who have either primary hypercholesterolaemia or mixed dyslipidaemia which both involve dangerously high levels of low-density lipid (LDL-C) or bad cholesterol and create the risk of heart attack or stroke and who have previously had a cardiovascular collapse.
The drug will be administered to patients by a nurse at the GP surgery as a two-year injection.
Inclisiran, the first drug to treat high cholesterol in the world, uses RNA interference to help the body eliminate it from the bloodstream. Doctors believe the drug will be beneficial for those who haven't been able control cholesterol with statins. It can be used alone or in combination with statins.
Professor Kausik Ray, director of the Imperial Centre for Cardiovascular Disease Prevention said that inclisiran would decrease the chance of someone suffering from high cholesterol or a history heart disease having a stroke or heart attack within the next 10 years, from 29% to 20%. This is great news for patients. Ray stated that it will ease their medication burden and provide convenience.
Inclisiran and statins are complementary. Ray stated that statins increase cholesterol receptors while inclisiran stops the production of a protein called PCSK9. This makes these receptors more durable or longer-lasting. LDL-C is reduced by approximately 75% to 80% with these two treatments compared to the non-treatment.
Dosing twice a year will provide a safe and steady reduction of population-level LDLC by approximately 50%. This would result in a decrease of cardiovascular events by around 30%.
He said that if the drug is administered to the 300,000 patients as it was planned, there would be about 30,000 less strokes and heart attacks in the next three-years.
Amanda Pritchard was the NHS England's chief executive and hailed inclisiran for being a revolutionary treatment. She stated: Heart disease remains one of the most deadly conditions. It is amazing that we now have an effective and simple treatment for people with high cholesterol.
ProfSir Nilish Samani, medical director at the British Heart Foundation, stated that he expects the drug to be available in the future to more patients suffering from heart disease.
He said that more research is required to confirm its full benefits. However, I believe it will be approved in the future to lower cholesterol for a wider range of people, to prevent strokes or heart attacks.
Sajid Javid (the health and social care secretary) said that the new life-saving treatment was a major step in the fight against heart disease, which kills thousands each year.
