Novartis’s heart failure drug given final recommendation by NICE

pharmafile | March 21, 2016 | News story | Manufacturing and Production, Research and Development Entresto, NICE, Novartis, approval, draft, guidance, heart failure, heart failure drug 

The National Institute for Health and Care Excellence (NICE) has issued its final guidance on Entresto (sacubritil/valsartan), a heart failure drug from Novartis. A NICE committee said the drug was of an “innovative nature” and “could be considered to represent a cost-effective use of NHS resources.”

Echoing the previous NICE endorsement for Entresto, it recommends the drug for use within the NHS as an option for treating symptomatic chronic heart failure with reduced ejection fraction in adult patients with New York Heart Association class II to IV symptoms, a left ventricular ejection fraction of 3% or less and who are taking a stable dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-II-receptor-blockers.

Entresto had previously been available through the MHRA’s Early Access to Medicines Scheme, before it was recommended by the EMA and approved by the European Commission. Entresto has already gone on sale in the US, where Novartis has employed novel pricing arrangements to try and make the price more affordable.

Dimitrios Georgiopoulos, MD, chief scientific officer at Novartis, comments: “Today’s recommendation from NICE represents an important milestone in our ambition to address high unmet need in chronic heart failure. Sacubitril/valsartan is now available for use in the UK for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction.”

Georgiopoulos, however, highlights the recent decision from the Scottish Medicines Consortium to accept Entresto under its full licensed indication with no restrictions and express disappointed at NICE’s decision to limit their recommendation to patients with a left ventricular ejection fraction of 35% or less. He adds: “However, due to NICE’s restrictions on eligible patients, not all patients will have access to this breakthrough treatment on the NHS in England.”

The final draft guidance was based on a thorough review of the PARADIGM-HF Phase III clinical trial. Results from the trial indicated that sacubitril/valsartan reduced the risk of death from cardiovascular-related causes or first hospitalisation for heart failure by 20%, compared to enalapril.

Dr Nigel Rowell, GP in Middlesbrough and primary care lead for the North of England Cardiovascular Network, says: “With proven benefits in reducing the risk of death and hospitalisation, we know that sacubiril/valsartan is effective and GPs and patients will welcome the addition of a new cost-effective treatment.”

Nick Hartshorne-Evans, chief executive and founder of Pumping Marvellous Foundation, adds: “This is a very positive development and we are delighted that NICE has taken on board the level of need and valued the patient input and evidence. Even though this guidance means that now some people with chronic heart failure with reduced ejection fraction will have access to sacubitril/valsartan, we are disappointed that with the restrictions in place not all patients covered by the marketing authorisation will receive this vital treatment option.”

Sean Murray

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