By John Miller
ZURICH (Reuters) – Novartis and Britain’s National Health Service (NHS) on Monday announced a pact that will clear the way for accelerated review by the country’s health watchdog NICE for heart drug inclisiran, which could make it broadly available as soon as 2021.
Novartis hopes the NHS deal will boost sales of cholesterol-lowering inclisiran, which the Swiss drugmaker bought in a deal announced last year for nearly $10 billion and predicts will be a top seller.
Inclisiran was submitted to U.S. regulators last year, and Novartis expects a European submission in coming weeks.
The pact also calls for a UK clinical trial, based on proprietary NHS data, to identify patients at risk of heart disease for whom conventional treatment has not worked, as well as a collaboration on manufacture of cutting-edge drugs like inclisiran, which targets “bad cholesterol”, a culprit behind heart attacks and strokes.
Heart disease or hardening of the arteries is a big killer in Britain and the NHS has made fighting cardiovascular disorders one of its long-term priorities.
“If licensed, it will allow the drug to be put through the NICE approval process at the earliest opportunity possible, making it available to NHS patients much earlier,” Britain’s Department of Health and Social Care (DHSC) said, in response to Reuters questions.
Should inclisiran win U.K. approval, as expected, the deal calls for the NHS to pay for it as an add-on therapy for those patients whose cholesterol levels do not respond adequately to statins, at a significantly reduced price.
The DHSC did not release the agreed price, citing commercial confidentiality. It also declined to comment on whether Novartis would be required to make inclisiran in Britain.
British health minister Matt Hancock said: “This collaboration has the potential to save 30,000 lives over the next ten years.”
Novartis bought inclisiran with its $9.7 billion acquisition of The Medicines Co., announced in late November, to expand a cardiovascular medicines portfolio that already includes heart failure drug Entresto, a billion-dollar-per-year seller.
Novartis Chief Executive Vas Narasimhan has predicted inclisiran will become one of Novartis’s most-lucrative medicines but has warned of “a few years of slow ramp” before sales take off.
Narasimhan has said inclisiran’s price tag would be in the “cost-effective range” to compete with rival medicines, Amgen’s Repatha and Praluent from Regeneron and Sanofi.
They list at some $5,800 annually in the United States, following price cuts undertaken to boost slumping sales. [https://reut.rs/2NiOj72] [https://reut.rs/2FKb0Nt]
Inclisiran is a twice-yearly injection, while Repatha and Praluent are injected every two weeks.
(Reporting by John Miller. Editing by Jane Merriman)