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New heart failure treatment to be made available on NHS

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.

Readers' comments (5)

  • Where is the "game changing" breakthrough? I'm very suspicious of trials when they're stopped early.And why no comparator groups with valsartan alone and placebo?

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  • Valsartan has been available for a few years and is a costlier replacement for Losartan and Irbesartan. Why compare this with an old generation ACE inhibitor and not with existing Angiotensin inhibitors?
    Fashions in medicine are the reason why we go round and round in circles. We had Metoprolol for post- MIs in the 80s- it was gold standard ; then it fell into disrepute and now we have Bisoprolol in trend and even if the patient is falling flat on his teeth with low bp this is not stopped but patient given Bisoprolol 1.25mg every second day - a medicine that actually, as per it's half life, does not last more than 24 hours in your system. So much for fashion in medicine and breakthroughs.

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  • Well said Sanjeev, yet more policy driven by Big Pharma

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  • Vinci Ho

    Art of medicine:
    When it is about dealing science , corporate , fast and furious.
    When it is about treating persons, individualised , slow and continuous .

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  • Just one simple question. Has the manufacturer published all the trial data - I'm not saying they have not but that lack of transparency is the usual problem.

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