NHS England will be offering a novel cholesterol-lowering injectable drug to hundreds of thousands of patients, following its first ‘population health agreement’ with the drug's manufacturer, Novartis.
The novel drug inclisiran, is administered as an injection twice a year and can be used as an adjunct to statins, thereby helping patients to better manage their cholesterol levels. The treatment will be available through GP surgeries across England. The second dose will be administered 3 months after the initial dose, and patients will subsequently receive it twice a year.
About 300,000 patients with dyslipidaemia and a history of cardiovascular disease (CVD) are likely to benefit from the drug over the next three years, and nearly half a million individuals could benefit beyond that. The revolutionary drug is expected to prevent an estimated 55,000 heart attacks and strokes, thus saving 30,000 lives over the next 10 years.
Health and Social Care Secretary Sajid Javid said: “This ground-breaking new drug further demonstrates the UK’s excellent track record for identifying the world’s most innovative treatments and ensuring NHS patients are able to access them at the earliest opportunity.”
CVD accounts for a quarter of all deaths in England annually, with 140,000 individuals dying from it each year. High cholesterol is a major risk factor for CVD and nearly 6.5 million adults in England are believed to be currently receiving lipid-lowering therapies such as statins
Inclisiran uses RNA interference to inhibit PCSK9 synthesis, resulting in lower low-density lipoprotein-C (LDL-C) concentration in individuals with high cholesterol. In the pivotal ORION-10 and ORION-11 trials, inclisiran demonstrated a placebo-adjusted LDL-C reduction of 52.3% and 49.9%, respectively at 17 months, and time-adjusted reduction of 53.8% and 49.2%, respectively from 3-18 months.
According to Prof Kausik Ray, professor of public health and director of the Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, the drug could be a game-changer for both patients and the NHS.
He said: “We know that despite the use of statins, patients with established CVD have an average LDL-C of about 2.6 mmol/L, and a 10-year residual risk of cardiovascular events of 29%. In order to achieve lower cholesterol levels, combination therapies are needed in addition to statins.
Twice-a-year dosing will safely provide an average annualised reduction in population level LDL-C of approximately 50%. Lowering population level LDL-C from 2.6 to about 1.3 would reduce cardiovascular events by about 30%, and bring 10-year risk down from 29% to around 20%.”
Professor Sir Nilesh Samani, medical director, British Heart Foundation, said: “Inclisiran is particularly attractive because it only needs to be given twice a year by a simple injection under the skin. More research is needed to confirm the full extent of its benefits, but I anticipate that in the future it will also be approved to lower cholesterol for a much wider group of people to prevent them from having a heart attack or stroke in the first place.”
This article originally appeared on Univadis, part of the Medscape Professional Network.
