NICE Medical Technology Guidance: Devices and Diagnostics
NICE Medical Technology Guidance: Devices and Diagnostics
In a previous issue of Heart, I described the NICE Medical Technologies Evaluation Programme. The Medical Technologies Advisory Committee (MTAC) started its work at the end of 2009, selecting devices and diagnostics notified by manufacturers, and routing them for guidance development. Products are selected on the basis of evidence of claimed advantages to patients and/or to the health service compared with current management. Published evidence and the advice of nominated clinical experts are fundamental to the selection decision. Technologies are then routed for the most appropriate type of evaluation, including evaluation by the new NICE Diagnostics Assessment Programme. The most usual route is to MTAC itself, for publication of medical technologies guidance. Among the early technologies to have had MTAC evaluation, three relate to the heart, and each helps to illustrate the challenges of producing this novel type of NICE guidance.
The Sequent Please paclitaxel-coated balloon catheter (B Braun Medical, B Braun Vascular systems, Berlin, Germany) was the first product to be evaluated by MTAC. The resulting medical technology (MT) guidance supported the case for its adoption in the NHS for specific groups of patients—namely, patients with in-stent stenoses of bare metal stents; patients in whom only a short duration of clopidogrel treatment is desirable; and in situations where placement of further stents is not possible.
It is important to emphasise that MT guidance deals only with the case for adoption in the NHS of single products. In selecting Sequent Please and in routing it for medical technologies guidance, the Committee was mindful that various paclitaxel and other drug-eluting balloon catheters are available. However, it considered that Sequent Please had promise and that its claimed advantages over standard care were plausible and worth evaluating. This kind of evaluation is not a multiple technology appraisal, which has a different purpose and takes much longer to complete. Another fundamental principle is the need to define what 'current management' Sequent Please would replace, as a basis for both clinical and cost comparisons. The Committee accepted advice that the most appropriate comparator was a paclitaxel-eluting stent.
The amount of published evidence on new medical technologies is likely to be limited and this was the case with Sequent Please. The available trials were considered to justify recommending its adoption only for the indications described above. The Committee considered that it might well offer advantages in other situations, such as stenoses in drug-eluting stents (not just bare metal ones) and for some stenoses in native coronary arteries. There was insufficient evidence to support a recommendation for use in these circumstances, but sufficient likelihood of benefit for the Committee to recommend research. If that research were to produce positive results then the number of patients who might benefit would increase significantly. UK-based research was recommended: this was considered to offer important advantages for informing future evaluations. The Committee debated the fact that the available trial evidence was not UK-based, recognising that there might be differences between the generality of UK cardiology practice and that in the countries where studies had been done.
Limited duration of follow-up in trials of new interventions also poses problems. In this case the maximum reported follow-up was 1 year but the Committee considered that the consistent trend towards reduced need for re-treatment and lack of major adverse cardiac events was sufficiently likely to be sustained in the longer term to justify making that assumption in the cost modelling. Based on this assumption and on a shorter duration of clopidogrel treatment, a saving of £467 per patient compared with the use of a paclitaxel-eluting stent was accepted as credible. These kinds of assumptions and judgements will always be open to debate, but they are explicit. The cost consequences methodology, comprising the assumptions and sensitivity analyses, are open to scrutiny through the availability of the detailed assessment reports during public consultation on the Committee's provisional recommendations.
The NICE MT guidance on the CardioQ-ODM oesophageal Doppler monitor (Deltex Medical Ltd, Chichester, UK) was highly publicised in the media. Its support for adopting the device for patients who would otherwise need invasive cardiovascular monitoring during surgery was based on evidence of reduced postoperative complications and hospital stay. When combined with the likely reduction in use of central venous catheters, a saving of about £1100 per patient was calculated (based on a 7.5-day hospital stay).
The Committee recognised that technologies for monitoring cardiac output during anaesthesia have been in use for some time but it was advised that barriers to their widespread adoption include cost and also training and motivation. Lack of 'motivation' flags up an area of challenge for MTAC and its guidance—namely, recommending technologies which are supported by evidence and much expert opinion, but which a substantial number of specialists are reluctant to adopt. That reluctance may be because they are using a similar technology, based on similar evidence: the guidance therefore includes an explanation 'box' above the recommendations to emphasise that, if the alternative technology offers similar clinical and cost benefits to those demonstrated in evaluation, then their use is entirely reasonable.
Evaluation of the benefits of CardioQ-ODM provided an example of the judgements required in extrapolating evidence. Use of CardioQ-ODM was associated with reduced length of stay in studies of a number of different types of surgery. However, reduction in complication rates was shown only in studies on bowel surgery (and in bowel complications after cardiac surgery). The Committee had to judge whether these data were sufficient to support the expectation of benefits both for patients and for the NHS. It is likely to be commonplace in evaluating newer technologies that evidence will not be available on every aspect of their benefits in everyday practice.
The third technology—BRAHMS copeptin assay (Brahms UK Ltd, Thermo-Fisher Scientific, Bottisham, UK) to rule out myocardial infarction in patients with acute chest pain—provides a good example of a technology for which the Committee wanted more research on 'real-world use'. The evidence to show that this blood test has high sensitivity (used in combination with one cardiac troponin test) was quite convincing. The rapidity with which the test can be done was also well documented. However, the Committee judged that there was insufficient evidence that these merits would necessarily translate into benefits for the NHS—for example, by avoiding admission from emergency departments to inpatient wards. They were advised that there are many potential factors which might delay getting results of the test; that clinicians might decide not to discharge patients on the basis of the test results; and that in many hospitals patients with chest pain are 'admitted' in the first instance.
In the light of a diagnostic test which appeared to offer promise of benefit, but inadequate information about whether use of the BRAHMS copeptin assay would result in fewer admissions and/or quicker discharge, the Committee recommended clinical research in the UK. This should compare the BRAHMS copeptin assay, combined with cardiac troponin testing, against sequential cardiac troponin testing alone. It is hoped that the ability of the NICE Medical Technologies Evaluation Programme to foster this kind of research will allow studies to be established speedily, so that the results can contribute to review of the guidance before long.
The Committee was mindful of the advances in troponin testing, with the availability of high-sensitivity troponin tests, but did not consider that these ought to militate against clinical utility research on the BRAHMS copeptin assay.
These three technologies have provided valuable experience for MTAC: each evaluation presented singular challenges and lessons. In parallel with the Committee learning those lessons, it is important that clinicians and the wider NHS gain an understanding of the purpose of this new and different type of NICE guidance.
Abstract and Introduction
Introduction
In a previous issue of Heart, I described the NICE Medical Technologies Evaluation Programme. The Medical Technologies Advisory Committee (MTAC) started its work at the end of 2009, selecting devices and diagnostics notified by manufacturers, and routing them for guidance development. Products are selected on the basis of evidence of claimed advantages to patients and/or to the health service compared with current management. Published evidence and the advice of nominated clinical experts are fundamental to the selection decision. Technologies are then routed for the most appropriate type of evaluation, including evaluation by the new NICE Diagnostics Assessment Programme. The most usual route is to MTAC itself, for publication of medical technologies guidance. Among the early technologies to have had MTAC evaluation, three relate to the heart, and each helps to illustrate the challenges of producing this novel type of NICE guidance.
The Sequent Please paclitaxel-coated balloon catheter (B Braun Medical, B Braun Vascular systems, Berlin, Germany) was the first product to be evaluated by MTAC. The resulting medical technology (MT) guidance supported the case for its adoption in the NHS for specific groups of patients—namely, patients with in-stent stenoses of bare metal stents; patients in whom only a short duration of clopidogrel treatment is desirable; and in situations where placement of further stents is not possible.
It is important to emphasise that MT guidance deals only with the case for adoption in the NHS of single products. In selecting Sequent Please and in routing it for medical technologies guidance, the Committee was mindful that various paclitaxel and other drug-eluting balloon catheters are available. However, it considered that Sequent Please had promise and that its claimed advantages over standard care were plausible and worth evaluating. This kind of evaluation is not a multiple technology appraisal, which has a different purpose and takes much longer to complete. Another fundamental principle is the need to define what 'current management' Sequent Please would replace, as a basis for both clinical and cost comparisons. The Committee accepted advice that the most appropriate comparator was a paclitaxel-eluting stent.
The amount of published evidence on new medical technologies is likely to be limited and this was the case with Sequent Please. The available trials were considered to justify recommending its adoption only for the indications described above. The Committee considered that it might well offer advantages in other situations, such as stenoses in drug-eluting stents (not just bare metal ones) and for some stenoses in native coronary arteries. There was insufficient evidence to support a recommendation for use in these circumstances, but sufficient likelihood of benefit for the Committee to recommend research. If that research were to produce positive results then the number of patients who might benefit would increase significantly. UK-based research was recommended: this was considered to offer important advantages for informing future evaluations. The Committee debated the fact that the available trial evidence was not UK-based, recognising that there might be differences between the generality of UK cardiology practice and that in the countries where studies had been done.
Limited duration of follow-up in trials of new interventions also poses problems. In this case the maximum reported follow-up was 1 year but the Committee considered that the consistent trend towards reduced need for re-treatment and lack of major adverse cardiac events was sufficiently likely to be sustained in the longer term to justify making that assumption in the cost modelling. Based on this assumption and on a shorter duration of clopidogrel treatment, a saving of £467 per patient compared with the use of a paclitaxel-eluting stent was accepted as credible. These kinds of assumptions and judgements will always be open to debate, but they are explicit. The cost consequences methodology, comprising the assumptions and sensitivity analyses, are open to scrutiny through the availability of the detailed assessment reports during public consultation on the Committee's provisional recommendations.
The NICE MT guidance on the CardioQ-ODM oesophageal Doppler monitor (Deltex Medical Ltd, Chichester, UK) was highly publicised in the media. Its support for adopting the device for patients who would otherwise need invasive cardiovascular monitoring during surgery was based on evidence of reduced postoperative complications and hospital stay. When combined with the likely reduction in use of central venous catheters, a saving of about £1100 per patient was calculated (based on a 7.5-day hospital stay).
The Committee recognised that technologies for monitoring cardiac output during anaesthesia have been in use for some time but it was advised that barriers to their widespread adoption include cost and also training and motivation. Lack of 'motivation' flags up an area of challenge for MTAC and its guidance—namely, recommending technologies which are supported by evidence and much expert opinion, but which a substantial number of specialists are reluctant to adopt. That reluctance may be because they are using a similar technology, based on similar evidence: the guidance therefore includes an explanation 'box' above the recommendations to emphasise that, if the alternative technology offers similar clinical and cost benefits to those demonstrated in evaluation, then their use is entirely reasonable.
Evaluation of the benefits of CardioQ-ODM provided an example of the judgements required in extrapolating evidence. Use of CardioQ-ODM was associated with reduced length of stay in studies of a number of different types of surgery. However, reduction in complication rates was shown only in studies on bowel surgery (and in bowel complications after cardiac surgery). The Committee had to judge whether these data were sufficient to support the expectation of benefits both for patients and for the NHS. It is likely to be commonplace in evaluating newer technologies that evidence will not be available on every aspect of their benefits in everyday practice.
The third technology—BRAHMS copeptin assay (Brahms UK Ltd, Thermo-Fisher Scientific, Bottisham, UK) to rule out myocardial infarction in patients with acute chest pain—provides a good example of a technology for which the Committee wanted more research on 'real-world use'. The evidence to show that this blood test has high sensitivity (used in combination with one cardiac troponin test) was quite convincing. The rapidity with which the test can be done was also well documented. However, the Committee judged that there was insufficient evidence that these merits would necessarily translate into benefits for the NHS—for example, by avoiding admission from emergency departments to inpatient wards. They were advised that there are many potential factors which might delay getting results of the test; that clinicians might decide not to discharge patients on the basis of the test results; and that in many hospitals patients with chest pain are 'admitted' in the first instance.
In the light of a diagnostic test which appeared to offer promise of benefit, but inadequate information about whether use of the BRAHMS copeptin assay would result in fewer admissions and/or quicker discharge, the Committee recommended clinical research in the UK. This should compare the BRAHMS copeptin assay, combined with cardiac troponin testing, against sequential cardiac troponin testing alone. It is hoped that the ability of the NICE Medical Technologies Evaluation Programme to foster this kind of research will allow studies to be established speedily, so that the results can contribute to review of the guidance before long.
The Committee was mindful of the advances in troponin testing, with the availability of high-sensitivity troponin tests, but did not consider that these ought to militate against clinical utility research on the BRAHMS copeptin assay.
These three technologies have provided valuable experience for MTAC: each evaluation presented singular challenges and lessons. In parallel with the Committee learning those lessons, it is important that clinicians and the wider NHS gain an understanding of the purpose of this new and different type of NICE guidance.
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