[Ip-health] UK to subsidize large trial of Novartis cholesterol medicine

Baker, Brook b.baker at northeastern.edu
Tue Jan 14 06:10:00 PST 2020

The article below neglects to specify the costs to UK’s NHS of a clinical trial involving 40,000 people even though Novartis will be “donating” the medicine.  Although Novartis will have to negotiate a price with NICE at the end, there is no detail on any requirement that Novartis must give price concessions to the UK because of the UK’s research investments.  Could this become yet another example of governments paying up front for research and at the end for privatized monopolies?  Shouldn’t the UK consider a compulsory or crown use license if Novartis is intractable in price negotiations?

Professor Brook K. Baker
Northeastern U. School of Law
416 Huntington Ave., Boston MA 02115
Affiliate Center on Health Policy and Law
Affiliate and Resident Fellow Center on Law, Innovation, and Creativity
Affiliate Center for Public Interest Advocacy and Collaboration
Co-director, Program on Human Rights and the Global Economy

Senior Policy Analyst Health GAP (Global Access Project)

Office:  617-373-3217
Skype: brook_baker
b.baker at northeastern.edu<mailto:b.baker at northeastern.edu>


NHS to trial twice-yearly injection alternative to statins
Mass trial of drug inclisiran comes after health service strikes deal with Novartis
Sarah Boseley Health editor
Mon 13 Jan 2020 18.00 GMT

The NHS is to launch a mass trial of an as-yet unapproved twice-yearly cholesterol-lowering injection, which it hopes will save lives and cut medical bills for thousands of people who do not take statins.

About 40,000 people with high "bad" or low-density lipoprotein cholesterol will be invited to join the trial of inclisiran by NHS England via their GPs. The NHS has struck a novel deal with drugmaker Novartis, which will provide the injections free in exchange for the results of the five-year trial, which will be run by the NHS staff.

The trial will get the drug to many of those at risk of heart attacks and strokes before it is licensed and has gone through the cost-effectiveness assessment of the National Institute for Health and Care Excellence (Nice), which is expected in 2021. At that point, a price will have to be negotiated with the company.

Smaller trials have shown the injectable drug to be very effective in lowering cholesterol. Statins, which perform the same job in a different way, are also very effective, but many people fail to take them on a daily basis - whether because they forget, they do not like taking pills or they are anxious about potential side-effects, even though these are generally mild.

NHS England says up to 30,000 lives could be saved over the next 10 years if inclisiran works as well as expected. If it is given to 300,000 people a year, it could help prevent 55,000 heart attacks and strokes, it says.

More than 3 million people in the UK suffer from atherosclerosis, the build-up of plaque in the arteries which causes cardiovascular disease and can lead to a heart attack or stroke. Two and a half million are taking statins to lower their cholesterol and reduce their risk. Trials have shown the potential of inclisiran to halve "bad" cholesterol levels in two weeks.

The health secretary, Matt Hancock, said he was "determined to find ways to save as many lives as possible, and to do my best to stop terrible conditions like heart disease from taking people from their family and friends far too soon".

The partnership with the drug company was, he said, "fantastic news and is a huge stride forwards in helping to achieve this". It was proof "that the UK continues to be the world-leading destination for revolutionary healthcare".

The deal was announced by the chair of NHS England, Lord Prior, at a healthcare investment conference organised annually by JP Morgan in San Francisco. He positioned the NHS as a suitable large-scale testbed for innovative medicines.

"This innovative and groundbreaking collaboration could transform the health outlook of tens of thousands of people suffering from heart disease, by bringing together in a unique combination our ability to organise large-scale clinical trials, to address highly complex manufacturing issues, and to reach a large population of patients," he said.

"It is a great illustration of how the UK life sciences strategy can help both NHS patients and the wider economy, and shows that the UK can be the centre of a dynamic life sciences ecosystem whilst delivering great care."

Naveed Sattar, professor of metabolic medicine at the University of Glasgow, was among those who said they thought the new injectable drug was very promising. but he warned that so far only short-term trials had been carried out.

"Doctors are excited by inclisiran and the potential to 'vaccinate' against high cholesterol in some patients, with obvious benefits to compliance and uptake," he said. "However, many would also like to see longer-term safety data from ongoing trials and to be told the cost of this new drug before they consider implications for care."

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