A potentially ‘game-changing’ new heart failure drug has been approved for NHS prescription to patients worst-affected by the condition.
The treatment, called LCZ696 (sacubitril valsartan) has been given the green light by the Medicines and Healthcare products Regulatory Agency (MHRA) Early Access to Medicines Scheme (EAMS).
This means that the drug, which has been shown to significantly reduce cardiovascular deaths and heart failure hospitalisations when compared with ‘gold-standard’ treatment with enalapril, can be offered to eligible patients with ‘significant unmet medical need’ before a final European licensing decision is made.
Last year GP experts told Pulse that, if approved, the drug could be a ‘game changer’ in the management of heart failure, because it appears to be much more effective than established treatments. This is also the first time a drug not intended to treat cancer has been recognised under EAMS.
A spokesperson for the drug’s manufacturer Novartis said: ‘The early access to medicines scheme for LCZ696 is live and up and running throughout the UK. Heart failure specialists request access to LCZ696 from Novartis and, provided the patient meets the criteria in the treatment protocol on the MHRA website, Novartis will send stock to the hospital pharmacy where the patient can pick up his or her supply.’
The drug will ‘eventually’ go to NICE for appraisal and recommendation, added the spokesperson.