New heart failure drug now available for seriously affected people

29th September 2015

The new heart failure drug Entresto is now available for some people seriously affected by the condition.

The drugmaker Novartis has announced the drug, also called sacubitril-valsartan or LCZ696, is being made available to the NHS under the Early Access to Medicines Scheme (EAMS).

This scheme aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.

Novartis says the drug is the first non-cancer drug to gain the EAMS status under the Medicines and Healthcare products Regulatory Agency’s programme for innovative medicines.

The company says it will now provide Entresto to the NHS for eligible patients enrolled in EAMS before a final European licensing decision is made.  The drug has already has won approval from the Food and Drug Administration in America.

The company says that heart failure affects around 550,000 people in the UK and costs the NHS about £2.3bn a year.

"This is great news for patients with heart failure, “said Prof Iain Squire, Professor of Cardiovascular Medicine, University of Leicester and Honorary Consultant Physician, University Hospitals of Leicester NHS Trust.

“The EAMS positive scientific opinion ensures patients with this debilitating condition can access sacubitril valsartan earlier than expected. Based on what we've seen in clinical trials, access to this new medicine will help patients live longer and keep them out of hospital, compared to currently available treatment.

The MHRA has looked at data from a study that showed patients did significantly better on the drug compared to the current gold standard treatment, and there was a reduction both in deaths and hospital admissions due to heart failure.

Hugh O'Dowd, general manager at Novartis UK & Ireland, said: "We are working closely with the NHS to ensure eligible patients have rapid access under the scheme while we await the final European licensing decision."

Life Sciences Minister George Freeman said: "Heart failure is a devastating condition that affects hundreds of thousands of people in the UK. So I am delighted that patients will now be able to access this life-enhancing treatment. The UK's Early Access to Medicines Scheme is making a real difference in speeding up access to drugs and almost 300 patients with complex conditions have already received innovative treatments earlier than they otherwise would have thanks to the scheme."

See the article on the drug (from the April 2015 issue of My Life).