Novartis Announces NHS Pact to Speed Access $10 Billion Heart Drug

Henrietta Brewer
January 15, 2020

Too much LDL cholesterol can cause cardiovascular disease as blood vessels become clogged.

Prof Ray said: "This has the potential to overcome a huge issue which is non-adherence to medications which must be taken daily".

Inclisiran, a bi-annual injection to lower cholesterol, is set to be studied in United Kingdom patients as part of a large-scale NHS clinical trial expected to start later this year. Novartis will provide the drug free of charge for that study, which will be carried out by NHS investigators.

Inclisiran is now 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 United Kingdom as quickly and widely as possible after regulatory approval and review by cost-effectiveness watchdog NICE.

The collaboration was announced by NHS England chair Lord Prior at the JP Morgan healthcare conference in San Francisco last night. Providing inclisiran to this high-risk population could make a significant contribution towards meeting the NHS long-term commitment to preventing 150,000 cardiovascular deaths over 10 years.

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. It is the single biggest cause of death in the world and kills more people than cancer and diabetes combined.

He continued: "Novartis is excited to partner with the United Kingdom government to leverage innovative models that could potentially lead to generating leading scientific evidence, accelerate access for patients and ensure continuous improvement in manufacturing efficiency and optimisation". Recent trials have shown inclisiran can halve bad cholesterol in two weeks.

Cardiovascular disease is the world's biggest killer, as well as the second biggest cause of death in the United Kingdom with over three million people suffering from atherosclerotic cardiovascular disease.

The Swiss pharma giant is now investigating the bi-annual injection in a Phase III trial, with expected European Medicines Agency (EMA) regulatory filing as a preventative add-on treatment to statins for patients who have already been diagnosed with cardiovascular disease later this year.

Novel and innovative projects such as this put patients in the driving seat of their own futures and is another strong vote of confidence in our world-leading life sciences sector as we leave the EU.

It represents an innovative approach to tackling major public health issues and positions the United Kingdom as a pioneering destination to develop cutting-edge medicines.

Although the DHSC did not comment definitively on whether Novartis' drug will eventually be manufactured in the United Kingdom following its approval, a statement revealed that "the collaboration also includes the creation of an industry and academic consortium to improve the efficiency in which the United Kingdom can manufacture for this form of innovative medicine".

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