‘Game-Changing’ Heart Disease Drug Approved for Use in England | Medications



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Patients in England will start receiving a ‘game-changer’ drug that doctors say will protect tens of thousands of lives by reducing the number of people who have heart attacks and strokes.

The treatment, inclisiran, works by increasing the liver’s ability to lower the body’s level of “bad” cholesterol, even in those who have tried using statins in the past.

The National Institute for Health and Excellent Care (Nice) approved the drug for use by the NHS in England after clinical trials showed it to be highly effective.

It is made available immediately after Novartis, the company that makes the drug, agreed to lower the price as part of a deal with NHS England that will allow 300,000 patients to use inclisiran over the three coming years.

The drug typically costs £ 1,987.36 for a 284 mg dose. It was not disclosed how much of the discount the NHS got was not disclosed, but Novartis’ decision to charge less opened the door for Nice to endorse inclisiran as value for money and NHS England agreeing to make it widely available.

“Inclisiran represents a potential game changer to prevent thousands of people from dying prematurely from heart attacks and strokes,” said Meindert Boysen, deputy general manager of Nice and director of its center for technology assessment of the health.

It will be offered to people with primary hypercholesterolemia or mixed dyslipidemia – both of which involve dangerously high levels of low density lipids (LDL-C) or “bad” cholesterol and create a risk of heart attack or accident. cerebrovascular disease – and who have had a previous cardiovascular collapse.

Patients will be given the medicine as a semi-annual injection by a nurse in their doctor’s office.

Inclisiran is the world’s first treatment for high cholesterol by using RNA interference to help the body push it out of the bloodstream. Doctors say the drug will help those who haven’t been able to control their cholesterol using statins. It can be taken alone or with statins.

Prof Kausik Ray, director of the Imperial Center for Cardiovascular Disease Prevention, said that inclisiran would reduce the risk that a person with high cholesterol and a history of heart disease will have a stroke or heart attack in the body. over the next 10 years from 29% to 20%. “This is great news for patients. This will reduce their drug load and provide convenience, ”Ray said.

“Statins and inclisiran are complementary. Statins make more cholesterol receptors and inclisiran, by stopping the production of a protein called PCSK9, makes these receptors last or survive longer, ”said Ray. “Both treatments reduce LDL-C by about 75 to 80% compared to no treatment.

“Dosing twice a year will safely provide an average annual population-level reduction in LDL-C of about 50%… [which] would reduce cardiovascular events by about 30%.

If the 300,000 patients receive the drug as planned over the next three years, that would mean about 30,000 fewer heart attacks and strokes would occur, he added.

Amanda Pritchard, chief executive of NHS England, called inclisiran a “revolutionary treatment”. She said: “Heart disease is still one of the leading killer diseases, so it’s fantastic that we now have such an effective and convenient treatment for those living with dangerously high cholesterol.”

Professor Nilesh Samani, medical director of the British Heart Foundation, said he expected the drug to be offered to even more patients with heart problems in the future.

“More research is needed to confirm the extent of its benefits, but I predict that in the future it will also be approved for lowering cholesterol in a much larger group of people to prevent them from having a seizure. heart or stroke in the first place. ,” he said.

Sajid Javid, Secretary of Health and Social Affairs, said that “the new, life-saving treatment … is a huge step forward in the fight against the scourge of heart disease, which tragically kills thousands of people every year “.

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