On 24 August, the UK’s National Institute of Health and Clinical Excellence (NICE) released a draft guidance updating its previous recommendations on the use of alteplase (Actilyse, Boehringer Ingelheim) for the treatment of acute ischaemic stroke. NICE has recommended alteplase within the NHS as long as treatment is started as early as possible within 4.5 hours after onset of stroke symptoms, and after intracranial haemorrhage has been excluded by appropriate imaging techniques.
The update was prompted by a change in the drug’s licence which allows an extension in the time period it can be used, from within 3 hours to within 4.5 hours of the onset of symptoms.
According to the UK Stroke Association, more than 130,000 people in England and Wales have a stroke each year. Mortality statistics from 2009 indicate that approximately 43,000 people died from stroke in England and Wales. More than 450,000 people in England live with severe disabilities as a result of stroke.
Carole Longson, NICE Health Technology Evaluation Centre director, said: “We know that strokes are 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. The benefits of alteplase in reducing long term disability caused by stroke are well recognised. However, because alteplase needs to be given within 4.5 hours of the onset of symptoms, these benefits can only be realised if brain imaging to confirm a diagnosis of acute ischaemic stroke is received as soon as possible, and certainly within one hour of arrival at the hospital, as per the NICE Quality Standard for Stroke. To that end the independent Appraisal Committee heard from clinical specialists that Accident and Emergency departments of all acute care hospitals in England and Wales must have access to 24-hour, 7-day a week brain imaging facilities. Today’s draft guidance recommending the use of alteplase within the extended time frame for which it is now licensed has the potential to have a significant impact on the treatment of thousands of patients.”
The draft guidance is now with consultees, who have the opportunity to appeal against it. The deadline for appeals is 8 September 2012. Until NICE issues final guidance, which is expected in November 2012, NHS bodies should make decisions locally on the funding of specific treatments.
For more information on the guidance click here.