GPs have been told they can only prescribe a new ‘game-changer’ heart failure drug for second-line use.
The Scottish Intercollegiate Guidelines Network (SIGN) said in new guidance that patients with impaired systolic function can be switched to the new drug, a sacubitril/valsartan combination, but only if they still have symptoms after receiving optimal treatment with an ACE inhibitor or angiotensin receptor blocker (ARB).
Meanwhile, English regulator NICE confirmed it also intends to recommend the drug as a second-line option. NICE experts have said patients who are on a stable dose ACE inhibitor or ARB can be considered for switching onto sacubitril/valsartan.
The new drug, with the brand name Entresto, was previously labelled a ‘game-changer’ by some experts who said it could replace ACE inhibitors and ARBs as the mainstay of treatment, after a trial showed it cut the risk of admissions to hospital for heart failure and mortality significantly when compared with ‘gold-standard’ treatment with enalapril.
But some GP critics warned more research is needed before the drug can be adopted widely, while there are concerns a whole-scale switch to the newer drug could over-stretch primary care prescribing budgets.
SIGN experts said trial evidence showed sacubitril/valsartan reduced hospitalisations and mortality, when compared with enalapril, in patients in New York Heart Association (NYHA) class II-III heart failure with a reduced ejection fraction (left ventricular eject fraction [LVEF] less than 40%), while the benefits in NYHA class IV patients were ‘less certain’.
However, they stopped short of recommending all patients in NYHA class II-III could be started on the drug, or given the option to switch.
The guidelines said: ‘Patients with heart failure with reduced ejection fraction who have ongoing symptoms of heart failure, NYHA class II-III, LVEF <40% despite optimal treatment should be given sacubitril/valsartan instead of their ACE inhibitor or ARB, unless contraindicated.
‘It may be considered in patients with NYHA class IV symptoms.’
GPs are advised to seek specialist advice before initiating the new drug in eligible patients.
The move to reserve the drug for second-line use comes despite the Scottish Medicines Consortium giving the go-ahead for it to be offered to any patients with heart failure and reduced ejection fraction, in line with the drug’s European licence.
The sacubitril/valsartan combination has already been made available on the NHS on a small scale to very sick patients, under an ‘early access’ scheme.