BioPharma, Policy

Novartis, UK’s NHS form population health partnership around new cholesterol drug

The deal will make the Phase III drug inclisiran – which Novartis acquired when it bought The Medicines Company in November – available to patients in the U.K. and include manufacturing and clinical development efforts.

L-R: Novartis CEO Vas Narasimhan, Oxford University chair of medicine Dr. John Bell, NHS Chairman Lord David Prior

Swiss drugmaker Novartis and the U.K.’s National Health Service plan to start a new population health initiative to make an investigational drug for preventing cardiovascular disease available to patients in the country, the two said Monday.

At a press conference during the J.P. Morgan Healthcare Conference in San Francisco, Novartis CEO Vas Narasimhan, NHS Chairman Lord David Prior and Oxford University chair of medicine Dr. John Bell announced the new initiative, for the drug inclisiran.

Inclisiran is an RNA-interference drug Novartis acquired when it bought The Medicines Company in November for $9.7 billion, developed under a partnership with Alnylam Pharmaceuticals. It works by blocking production of the liver enzyme PCSK9, which is involved in regulation of cholesterol in the blood. But unlike PCSK9 inhibitors like Amgen’s Repatha (evolocumab) and Sanofi’s Praluent (alirocumab), which must be administered every two to four weeks, inclisiran is given once every six months, functioning as a sort of vaccine against cardiovascular disease.

Under the NHS-Novartis agreement, inclisiran will be provided to patients in the U.K. through a population-level agreement, upon its regulatory approval and assessment by the National Institute of Health and Care Excellence, or NICE, the body that negotiates drug prices on behalf of the NHS in England. The company has already submitted its application for U.S. Food and Drug Administration approval and plans to seek European approval this quarter.

The drug is currently in Phase III development for secondary prevention patients, meaning those who already have cardiovascular disease. Under the agreement, it will also be tested in a large-scale U.K. clinical trial in primary prevention, the setting in which cardiovascular disease has yet to develop, but in which patients are at risk.

“This is about population health, and as a healthcare system population health is what we’re all about,” Prior said during the press conference. “We’re the National Health Service, not the National Sickness Service – we’ve got to keep people healthy.”

The agreement also includes the creation of an industry and academic consortium to improve manufacturing efficiency of the product.

At a breakout session at the J.P. Morgan conference earlier in the morning following his presentation, Narasimhan alluded to the announcement with NHS and noted how it was The Medicines Company’s data for inclisiran that pushed Novartis to buy the company.

The drug has shown positive top-line data in Phase III studies in heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease.

“If you asked me middle of last year if we’d acquire The Medicines Company, I would have said no,” he said, referring to the period before he saw the Phase III data.

Photo: Alaric DeArment, MedCity News