Tenecteplase is recommended, within its marketing authorisation, as an option for the thrombolytic treatment of an acute ischaemic stroke in adults:
within 4.5 hours of the onset of stroke symptoms, and
when intracranial haemorrhage has been excluded.
Use the least expensive option of the available treatments (including tenecteplase and alteplase). Take account of administration costs, dosages, price per dose and commercial arrangements. If the least expensive option is unsuitable, people with the condition, their family or carers, and their healthcare professional should discuss the advantages and disadvantages of other treatments.
Why these recommendations were made
Standard care to break up blood clots or prevent new blood clots from forming (thrombolytic treatment) after an acute ischaemic stroke is alteplase. Once bleeding in the brain (intracranial haemorrhage) has been ruled out, thrombolytic treatment is started within 4.5 hours of the onset of stroke symptoms. Tenecteplase is an alternative to alteplase.
Based on clinical trial evidence, tenecteplase is at least as effective as alteplase for the thrombolytic treatment of an acute ischaemic stroke. The evidence includes preliminary results from a large ongoing UK trial and published results from completed trials.
A cost comparison of tenecteplase with alteplase suggests that it costs less. Administration, adverse-event and other resource-use costs are expected to be similar for the 2 treatments.
So, tenecteplase is recommended.
For all evidence, see the committee papers. To see what NICE did for alteplase, see the consideration of the evidence section in NICE's technology appraisal guidance on alteplase for treating acute ischaemic stroke.