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The National Institute for Health and Clinical Excellence (NICE) has today (7 March), opened a consultation on its draft medical technology guidance on the use of a test to rule out myocardial infarction (heart attack) in patients who have acute chest pain. The medical technology guidance draft, produced by the independent Medical Technologies Advisory Committee (MTAC), concludes that the BRAHMS copeptin assay shows potential to reduce the time taken to rule out myocardial infarction but more evidence on its impact in clinical practice is required to support the case for its routine adoption in the NHS.

The BRAHMS copeptin assay is intended to be used in conjunction with standard cardiac troponin testing (a biochemical marker, raised levels of which might indicate a heart attack) to reduce the time needed to exclude acute myocardial infarction. MTAC was asked to consider whether the combination of the values resulting from the copeptin test and first troponin test may provide a reliable basis for earlier ruling out of myocardial infarction in patients, thereby reducing the need for intensive in-patient monitoring and further tests. Currently, the exclusion of myocardial infarction requires at least two troponin tests 9 -12 hours apart.

Dr Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: "The Committee considered that there was evidence that the BRAHMS copeptin assay could be used to help rule out a heart attack. The potential for cost savings and improvements to the patient experience depend largely on how much time is saved in the early ruling out of a heart attack, but, unfortunately, the trials did not evaluate outcomes such as time taken to discharge and time taken for patients to receive access to appropriate treatment. The uncertainty about this time saving meant that the case for routine adoption in the NHS could not be made at this time.

Dr Longson continued: "It is very important to note that this draft outcome doesn't mean that the BRAHMS copeptin assay should not be used. One of the functions of NICE's medical technologies guidance is to indicate where we believe that a technology has plausible potential of providing substantial benefits to patients and the NHS, and to suggest what research is required to help address the gaps in the available evidence of these benefits. In the case of the BRAHMS copeptin assay, the Committee wished to give strong encouragement to further research to support this potential benefit."

More information on the medical technology draft guidance consultation for BRAHMS copeptin assay is available at http://guidance.nice.org.uk/MT/99. The consultation closes on 4 April 2011.

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Notes to Editors

About the Medical Technologies Evaluation Programme

1. Established by NICE in 2009, the focus of this new area of work is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory.

More information is available at http://www.nice.org.uk/MT.

About the draft guidance

2. The BRAHMS copeptin assay is manufactured by Brahms UK Ltd - Thermo-Fisher Scientific).

3. There was insufficient clinical evidence provided to enable MTAC to arrive at any clear conclusions on how much time would be saved by using the BRAHMS copeptin assay to rule out a diagnosis of acute myocardial infarction.

4. Final guidance on the BRAHMS copeptin assay is expected to be published in June 2011.

About NICE

5. The National Institute for Health and Clinical 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.

6. 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.

7. 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

8. 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.