NICE says Boehringer stroke drug 'could save millions'

In new guidance, NICE has cleared NHS use of Boehringer Ingelheim's clot-busting therapy Metalyse as a treatment for acute ischaemic stroke in adults.

The healthcare cost-effectiveness watchdog has published final guidance that finds Metalyse (tenecteplase) is as effective as the current therapy alteplase at breaking up blood clots or preventing new clots from forming.

Alteplase is also sold by Boehringer in the UK under the Actilyse brand. According to NICE, Metalyse costs less than alteplase, so could save the NHS millions of pounds when used as a stroke treatment.

So-called thrombolytic therapies like alteplase and tenecteplase can be used in the very early stages of a stroke – within a few hours of the onset of symptoms and after a haemorrhagic stroke caused by a bleed in the brain is excluded using imaging techniques.

Metalyse is a fibrin-specific plasminogen activator and a genetically modified version of alteplase, offering a higher specificity for fibrin and increased resistance to being inactivated, which extends its half-life in the body.

It was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in April for ischaemic stroke, within 4.5 hours of the first symptoms appearing, and is also used to treat suspected acute cases of myocardial infarction within six hours of symptoms.

NICE's guidance (PDF) says that the NHS should use "the least expensive option" of the available thrombolytics when factors like administration costs, dosages, price per dose, and commercial arrangements are taken into account.

The agency said it based its recommendations on preliminary results from a large ongoing UK trial (ATTEST-2) – which aims to show tenecteplase is more effective and also safer than alteplase – as well as published results from completed trials.

"We know that stroke is one of the biggest killers and causes of disability, therefore it is important that patients receive treatments that can help to reduce the effects of a stroke as quickly as possible," said Helen Knight, director of medicines evaluation at NICE.

"Today's guidance means that, not only will people who have had an ischaemic stroke be able to access a new treatment option, but the NHS could save millions by switching to it, making it a very effective use of taxpayers' money."

NICE estimates that around 100,000 people in England are admitted to hospital with a stroke annually, the majority of whom – around 85% - are subsequently found to have had an ischaemic stroke. Around 1 million people in England are living with the effects of stroke.

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