Novartis strikes landmark deal with NHS to speed up inclisiran access

Novartis and NHS England have forged a pact to accelerate the access of its new cholesterol-lowering drug inclisiran for primary prevention of cardiovascular disease.

Health Secretary Matt Hancock says that the agreement means inclisiran will “be coming to the UK first” – thanks to the NHS’ position as the biggest purchaser of medicines in the world – and could save “tens of thousands” of lives over the next decade.

The three-part deal consists of an access agreement for high-risk patients, a large-scale trial of the gene-silencing PCSK9 inhibitor that is due to get underway this year, and the creation of a consortium with academic groups to try to improve the manufacturing of oligonucleotide drugs like inclisiran in the UK.

Novartis has inherited the deal from The Medicines Company, which originally developed inclisiran and was acquired by the Swiss pharma group late last year in a $9.7 billion deal.

The “population-level” agreement – billed by Novartis as a “world-first” – would see the twice-yearly injectable drug made available to people with atherosclerotic cardiovascular disease (ASCVD) as early as next year, according to Novartis.

That would steal a march on rival, once-monthly PCSK9 inhibitors – Amgen’s Repatha (evolocumab) and Sanofi/Regeneron’s Praluent (alirocumab) – which have been available for some years but still aren’t being widely used.

Inclisiran is currently in phase 3 testing as an add-on to statin therapy in ASCVD patients, with a European filing due late this quarter, but the new agreement means it will be made available in the UK as quickly and widely as possible after regulatory approval and review by cost-effectiveness watchdog NICE.

Financial terms of the agreement aren’t being divulged, but Hancock insisted yesterday that the UK has been able to secure a very low price for inclisiran, which shows that having the NHS “means that we can drive good value.”

The large-scale trial will explore the use of inclisiran as primary prevention, in other words to stop high-risk patients from having their first cardiac event. Novartis will provide the drug free of charge for that study, which will be carried out by NHS investigators.

It is estimated that all told up to 40,000 NHS patients could be eligible for that trial, although for the moment that will only be an option for people in England because of the devolved health system in the UK.

NHS England said the “game-changing” deal would make a major contribution towards its objective of preventing 150,000 cardiovascular deaths over the next 10 years.

If inclisiran were to be given to 300,000 patients annually, it could help prevent 55,000 heart attacks and strokes and save 30,000 lives over 10 years, it suggested.

Novartis’ chief executive Vas Narasimhan trumpeted the deal from the JP Morgan Healthcare Conference yesterday.

Inclisiran is a rare example of a medicine with the potential to transform population health, he told the meeting, and “has the potential to be one of the largest, if not the largest, medicine…in our history”.

The agreement has been welcomed by UK trade body the BioIndustry Association (BIA), which said that the UK is being recognised as a "destination of choice for innovation" at the JP Morgan conference.

“It’s great that Novartis sees the UK as an innovation crucible for access, clinical trials and next generation manufacturing," said BIA chief executive Steve Bates.