NICE issues draft guidance on the use of drug to reduce the long term impact of strokes

NICE, the healthcare guidance body, has today (24 August) issued draft guidance updating its previous recommendations on the use of alteplase (Actilyse, Boehringer Ingelheim) for the treatment of acute ischaemic stroke.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.

Ischaemic strokes, which account for 80% of strokes, happen when the normal blood supply to part of the brain is cut off. This starves the cells of oxygen in the area affected, causing them to become damaged or die. 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.

Standard treatment for stroke includes supportive and medical management in a specialist centre during the acute (early) phase, measures to prevent the damage to the brain from getting worse, and appropriate rehabilitative and physiotherapy programmes during the post-stroke period. Alteplase is a tissue plasminogen activator. It is administered during the acute phase of the stroke and activates the production of plasmin, an enzyme that degrades fibrin clots thereby helping to restore blood flow through the blocked artery.

Professor 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. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.


Notes to Editors

About this guidance

1. The draft guidance will be available on the NICE website from 00:01 hrs on Friday 24 August 2012.

Embargoed copies are available on request; please contact the press office.

2. Final guidance is expected in November 2012.

3. Because the recommendations from the Appraisal Committee on the use of alteplase are not restrictive and do not limit its use further than the licence for the indication for which it is being appraised, NICE has issued a FAD rather than an ACD. Normally, formal consultation (when an ACD is produced) takes place only if the recommendations from the Appraisal Committee are restrictive or if the manufacturer or sponsor is requested to provide further clarification on their evidence submission.

4. Treatment with alteplase must be started as early as possible within 4.5 hours of onset of the stroke symptoms and only once bleeding in the brain has been ruled out with a brain scan.

5. The cost of alteplase is £135 per 10 mg pack, £180 per 20 mg pack and £300 per 50 mg pack (excluding VAT; ‘British national formulary' [BNF] edition 63). The cost per course of treatment depends on the body weight of the patient. Based on a recommended dose of 0.9 mg per kilogram of body weight, this cost can range from £300 to £600. Costs may vary in different settings because of negotiated procurement discounts.

6. The Committee noted that alteplase either dominated standard care or had an ICER below £10,000 per QALY gained depending on the time-to-treatment window considered.

About NICE

1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

2. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS

3. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

This page was last updated: 23 August 2012

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.