NICE encourages more research on new test for heart attacks
The National Institute for Health and Care Excellence (NICE) today (22 June), publishes medical technology guidance on the use of a test to rule out myocardial infarction (heart attack) in patients who have acute chest pain. The conclusions highlight that the BRAHMS copeptin assay shows potential to reduce the time taken to rule out myocardial infarction when used alongside a current test. The guidance recommends that more research is needed on the impact of the BRAHMS copeptin assay in clinical practice, before it can be supported for routine adoption in the NHS. This recommendation does not mean that the NHS shouldn't use the test but that they should help with the collection of the further evidence required for future NICE evaluation.
The BRAHMS copeptin assay is a blood test to help clinicians decide if patients presenting to hospital with acute chest pain have had a heart attack. It's intended to be used in conjunction with standard cardiac troponin testing (where raised levels of the biochemical marker troponin might indicate a heart attack) to reduce the time needed to exclude a heart attack. At present, at least two troponin tests 9 -12 hours apart are needed to rule out a heart attack. Copeptin is a surrogate marker for a hormone that is present at higher levels within 4 hours of a heart attack occurring, whereas troponin levels peak at 12 hours after symptoms appear. If the result of both the copeptin test and troponin test are negative, this has the potential to be used to support clinical findings in ruling out heart attack sooner after patients present with acute chest pain.
Dr Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “The Medical Technology Advisory Committee (MTAC) thought that the BRAHMS copeptin assay is a promising new development for ruling out heart attack at an earlier stage in patients presenting with chest pain. There was uncertainty about the proportion of patients presenting with chest pain who would benefit from its use, and about the amount of time and resources that would be saved in routine practice. This meant that, at this stage, MTAC could not recommend that the NHS should consider routinely adopting the Brahms copeptin assay.
“However it is very important to note that this recommendation doesn't mean that the BRAHMS copeptin assay should not be used. MTAC concluded that it would be useful to undertake good quality clinical studies to confirm the potential of the BRAHMS copeptin assay to offer advantages to patients and the NHS. MTAC wished to give strong encouragement to further research in NHS clinical settings on using BRAHMS copeptin assay for ruling out heart attacks earlier.”
Notes to Editors
About the guidance
1. The medical technologies guidance, “BRAHMS copeptin assay to rule out myocardial infarction in patients with acute chest pain”, is now available on the NICE website.
2. The BRAHMS copeptin assay is manufactured by Brahms UK Ltd - Thermo-Fisher Scientific.
3. The independent Medical Technology Advisory Committee (MTAC) considered that there is currently insufficient evidence on its use in clinical practice to support the case for routine adoption in the NHS. However MTAC recommended research in the UK clinical setting to compare the BRAHMS copeptin assay in combination with cardiac troponin testing against sequential cardiac troponin testing for ruling out heart attack. NICE will review this guidance when new and substantive evidence becomes available.
4. 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.
5. The cost of the BRAHMS copeptin assay stated in the manufacturer's submission is £15 per assay. In the manufacturer's cost analysis, the cost savings of using the BRAHMS copeptin assay combined with a troponin test were £58.24 per patient compared with using two sequential troponin tests.
About the Medical Technologies Evaluation Programme
6. 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.
7. 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.
8. 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 sevices 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.
9. 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
10. 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: 22 June 2011