It may not have yet secured approval, nor reviewed by UK’s price-effectiveness watchdog NICE — but the cholesterol therapy inclisiran at the heart of last year’s Novartis $9.7 billion buyout of the Medicines Company will be made widely available to patients at risk of heart disease in the National Health Service (NHS), the UK agency said on Monday.
NHS England will agree to a population-level commercial arrangement with Novartis to make it widely available to patients as soon as 2021 — in addition, the biannual shot will also be tested in UK patients as part of a large-scale NHS clinical trial expected to start later this year.
“Early results from clinical trials suggest that if inclisiran is given to 300,000 patients annually, it could help prevent 55,000 heart attacks and strokes, and has the potential of saving 30,000 lives in the next 10 years,” the NHS said, highlighting that recent trials have shown inclisiran can halve bad cholesterol in two weeks.
Despite the wide adoption of statins, such as Pfizer’s $PFE nearly $13 billion-at-peak Lipitor, hypercholesterolemia and associated cardiovascular disease is a leading global killer, representing fertile ground for fresh, potent therapies to reap lucrative returns. In the UK, heart disease is the second biggest cause of death.
The cholesterol-lowering Repatha from Amgen, and rival Praluent from Regeneron and Sanofi, were approved in the United States in 2015 in post-statin patients amidst much fanfare — their makers flush with blockbuster expectations. Instead, they faced insurer pushback for their high sticker prices ($14,000) that led to lower-than-expected adoption. Later, trials demonstrated the PCSK9 inhibitors also significantly cut cardiovascular risk — data that are now reflected on their labels — as well as safe use in renally-impaired patients, but their manufacturers ended up cutting their prices by 60%, in a bid to boost tepid sales.
Unlike Repatha and Praluent — which work by inhibiting the PCSK9 protein and thereby diminishing LDL-C or “bad” cholesterol — inclisiran is a siRNA therapy designed to curb the production of the PCSK9 protein at its source in the liver to oust LDL-C from the bloodstream. The Medicines Co partnered with RNAi pioneer Alnylam to develop the drug.
Now, analysts expect the twice-yearly (more convenient, and likely cheaper if approved) inclisiran to take a chunk out of once-monthly PCSK9 monoclonal antibody sales and reap the blockbuster returns that the antibodies were originally projected to rake in. A European marketing application for inclisiran is expected to be submitted this year.