Novartis has teamed up with the UK’s NHS in a novel partnership which will see patients receive accelerated access to its groundbreaking cholesterol-lowering drug inclisiran.
Novartis gained inclisiran from its $9.7bn acquisition of the drug’s developer The Medicines Company, which completed last week.
The small, interfering RNA (siRNA) drug – which works by blocking the synthesis of PCSK9 in the liver – is set to be studied in UK patients as part of a large-scale NHS clinical trial. According to Health and Social Care Secretary Matt Hancock (pictured left), “this collaboration has the potential to save 30,000 lives over the next ten years”.
The clinical trial will utilise NHS data to identify patients across the country who are at risk of heart disease, and who have had no luck with conventional treatment regimens, including statins.
In phase 3 trials of the gene-silencing drug, inclisiran was able to significantly reduce levels of LDL cholesterol – so-called ‘bad cholesterol’ – and demonstrated absolute change in LDL cholesterol at various time points between three and 18 months after treatment started.
It has been tested for use in patients with atherosclerotic cardiovascular disease (ASCVD) who were unable to control their LDL cholesterol levels despite being on the maximum doses of statin drugs, with or without Merck & Co’s add-on therapy Zetia (ezetimibe).
The Department of Health and Social care has not revealed the agreed price for access to the drug, which will gain accelerated access for review by the UK’s cost-effectiveness watchdog NICE once it receives approval from the European Medicines Agency (EMA). At that point, Novartis will negotiate with NICE on the final price for inclisiran to be used on the NHS.
Inclisiran is not yet approved in any market, but it has been submitted for review with the FDA, and Novartis has said the drug is also set for submission with the EMA in the next few weeks.
Although the DHSC did not comment definitively on whether Novartis’ drug will eventually be manufactured in the UK 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 UK can manufacture for this form of innovative medicine.”
Novartis will be hoping that the partnership will foster impressive sales of inclisiran across the globe, as well as giving it a fast-tracked approval in the UK where heart disease is a significant public health issue.
“Novartis is excited to partner with the UK 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,” said Vas Narasimhan (pictured right), CEO of Novartis.
Novartis will also be looking to follow the success of its CHF therapy Entresto (sacubitril / valsartan), which became the first non-cancer therapy to be made available to patients under the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA) Early Access to Medicines Scheme (EAMS). It was also backed for NHS use by NICE, which said Entresto “represented a cost effective use of NHS resources”.
Heart failure affects nearly 550,000 people in the UK and costs the NHS around £2.3bn ($3.2bn) per year.