A Swiss pharmaceutical group has scrapped plans to conduct a major drug trial in the UK, damaging government efforts to showcase the country as an attractive destination for investment in life sciences after Brexit.
Three years ago Novartis’s decision to collaborate with the NHS on rolling out inclisiran, a twice-yearly injectable drug for lowering cholesterol, was announced to fanfare, after the UK’s slow take-up of innovative medicines compared with peers was criticised.
Matt Hancock, health secretary at the time, described it as “a strong vote of confidence in our world-leading life sciences sector”.
But the sixth-largest pharma company by global sales in 2022 has dropped the idea of a pivotal trial involving 40,000 UK patients, “after a careful evaluation of several factors that drive investment decisions in research and development activities and plans for inclisiran in the UK”.
An initial rollout via GPs had resulted in low take-up, leading Novartis to rethink, people familiar with the decision said. It will now run a similar trial itself around the world.
Sir Martin Landray, professor of medicine and epidemiology at Oxford university, whose team had been due to run the trial, said Novartis’s decision was a “huge disappointment”.
“It is not a great advert for the UK’s life sciences ambitions and it is driven not because of a weakness of the life sciences system, but a failure of implementation,” he said.
Novartis said its “pioneering” partnership with NHS England — which aims to identify patients across the population with cardiovascular disease who could benefit from the treatment — would continue, along with a drive to improve manufacturing processes.
The group added that there had already been “significantly faster patient uptake of inclisiran in the UK relative to the launch of other lipid-management therapies used in combination with statins”. However, it admitted that challenges had been experienced at the height of the pandemic.
The medicine has been recommended by the National Institute for Health and Care Excellence, which assesses the cost-effectiveness of drugs.
But people close to the programme said many GPs had been reluctant to prescribe it, believing the rollout should be led by hospital doctors with more capacity to monitor side effects.
In December 2021, the Royal College of GPs and the British Medical Association formally discouraged family doctors from initiating or overseeing the treatment. They cited a lack of data on long-term safety and outcomes, and resource implications at a time when GPs were under great pressure.
Michael Mulholland, honorary RCGP secretary, said: “While we absolutely want to be doing our best for our patients who have raised lipids, and to reduce the cardiovascular risk, this is just a drug that we don’t know enough about.”
Landray lamented that patients were missing out on the equivalent of a twice-yearly vaccine for heart disease, which he described as an “incredibly powerful opportunity”.
“There’s a huge opportunity cost. People are having heart attacks that almost certainly could have been avoided if they had had inclisiran, which is licensed, approved and essentially in stock,” he said.
One official close to the programme — whose terms have never been disclosed — said the NHS rollout had been “a disaster”. While the health service remained focused on the importance of preventing heart disease, the drive would in future probably centre on long-established statins, the person suggested.
John Bell, regius professor of medicine at Oxford university, said the setbacks with the inclisiran programme were “bad for patients, bad for Novartis, and bad for the health system”, but that the NHS could learn lessons.
The Department of Health and Social Care said NHS England and Novartis “continue to work closely together to roll out this treatment to those who need it”. It added that it was “committed to working with industry to develop cutting-edge medicines”.
NHS England said its “first-of-its-kind population health agreement” with Novartis remained in place and was “a pioneering approach to improving treatment for eligible patients with cardiovascular disease across the country”.