Novartis earns provisional NICE yes for Entresto
pharmafile | December 11, 2015 | News story | Sales and Marketing | Entresto, NICE, Novartis, chronic heart failure, heart failure
NICE has indicated it is likely to recommend Entresto, a novel drug manufactured by Novartis, as a treatment option for some people with heart failure.
In draft guidance the UK’s healthcare watchdog says Entresto (sacubitril valsartan) is recommended for treating chronic heart failure. It applies to people with reduced ejection fraction in people with New York Heart Association class II to III symptoms, who are on a stable dose of ACE inhibitors (or angiotensin II receptor blockers for people who are intolerant of ACE inhibitors) and who have a left ventricular ejection fraction of 35% or less.
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.
In the UK NICE says that “given the innovative nature of sacubitril valsartan, the most plausible incremental cost-effectiveness ratio (ICER) of £29,500 and £30,100 per QALY gained” for Entresto, compared with current heart failure treatment with heart drugs called ACE inhibitors and angiotensin-receptor blockers. As such, Entresto “represented a cost effective use of NHS resources.”
Meindert Boysen, programme director, technology appraisals at NICE, says: “Drugs to treat heart failure have been available for many years. Despite this, people with this life-threatening and often debilitating condition have a poor prognosis, especially those with reduced ejection fraction. Sacubitril valsartan is an innovative drug that will offer people with this condition a further important treatment option with the potential to prevent deaths and reduce hospital admissions.”
In a statement Novartis says it welcomes the decision – but said it work work to support a recommendation for all patients with symptomatic heart failure and reduced ejection fraction.
“We hope that in the future more patients would benefit from this medication with the inclusion of the entire population considered by the European Medicines Agency.
“The EMA Committee for Medicinal Products for Human Use granted a license for Entresto on the basis of robust evidence that supports its use in adult patients with symptomatic chronic heart failure with reduced ejection fraction. We will, therefore, work closely with NICE and participate in the consultation to demonstrate the value of Entresto in patients who meet the licensed indication but would be excluded from receiving this medication based on NICE’s draft guidance.”
Heart failure affects about 900,000 people in the UK, and it is associated with significant ill-health and mortality. In 2012/13 over 30,000 people were admitted to hospital in England with heart failure with reduced left ventricular ejection fraction, and around 30-40% of patients diagnosed with heart failure die within a year.
Lilian Anekwe
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