EAMS makes Novartis heart failure medicine available to NHS

Heart failure medicine LCZ696 (sacubitril valsartan) will be available to the NHS under the Early Access to Medicines Scheme (EAMS) 

It is the first non-cancer drug that has been recognised under the EAMS.

Novartis’ investigational heart failure treatment LCZ696 (sacubitril valsartan) has been given a positive scientific opinion under the Medicines and Healthcare products Regulatory Agency (MHRA) Early Access to Medicines Scheme (EAMS).

This allows LCZ696 (sacubitril valsartan) to be made available to eligible patients before a final European licensing decision is made.

Heart failure affects around 550,000 people in the UK and has a very poor prognosis: around 60% of patients diagnosed with heart failure die within five years and survival rates are worse than certain cancer such as breast and prostate.

Data from the PARADIGM-HF study that showed LCZ696 (sacubitril valsartan) significantly improved patient outcomes compared with the current gold standard treatment, including a reduction both in cardiovascular deaths and hospitalisations due to heart failure.

Iain Squire, professor of cardiovascular medicine, University of Leicester said: “The EAMS positive scientific opinion ensures patients with this debilitating condition [heart failure] 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.”

Hugh O’Dowd, general manager at Novartis UK & Ireland, said: “It’s very encouraging that LCZ696 (sacubitril valsartan) will be available via the EAMS, allowing patients in the UK with this debilitating condition to gain benefit.”

Life sciences minister George Freeman said: “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.”