GE Healthcare’s Discovery CT750 HD scanner has been included in the first ever fully positive recommendation from the UK’s National Institute for Health and Clinical Excellence (NICE)’s Diagnostic Assessment Programme.
The Diagnostic Assessment Programme was set up in 2009 and aims to ensure the UK’s National Health Service (NHS) can rapidly and consistently adopt clinically and cost effective technologies.
To date no assessment in NICE’s Diagnostic Assessment Programme has resulted in a fully positive recommendation, primarily due to the challenges that diagnostics face in demonstrating clinical and cost effectiveness compared with the more direct evidence generated by pharmacological treatments.
However in this case NICE recommended the Discovery CT750 HD as a clinically and cost effective option for both first line cardiac imaging of the coronary arteries in people with suspected coronary artery disease (CAD) – and for evaluating known CAD patients’ disease progression to establish the need for revascularisation (an augmented blood supply) – in people deemed difficult to image using earlier generation CT scanners.
CAD, which in 2007 was estimated to have caused 91,000 deaths in the UK, is characterised by the narrowing of the coronary artery leading to a reduction in blood flow to the heart, and angina. NICE’s recent clinical guideline on chest pain (CG95) cites an estimated 2.6 million people in the UK with CAD. It is also estimated that one per cent of the general population in the UK consults their General Practitioner (GP) with chest pain.
The benefits of new generation technology
Historically, factors including patient obesity, high levels of coronary calcium, high heart rates of over 65 beats per minute, the presence of stents (tubes placed in the coronary arteries to keep them open in the treatment of CAD) or arrhythmias (problems with the rate or rhythm of a heartbeat) have caused difficulties in imaging patients with earlier generation CT scanners.
However, NICE has stated the latest technology in new generation scanners overcomes these difficulties such that significant stenosis – the narrowing of a blood vessel – in ‘difficult to image’ patients can now be reliably ruled out without the need for less comfortable and more costly investigations such as invasive coronary angiography (ICA).
The DiscoveryCT750 HD was the world’s first high definition CT scanner. In a cardiac CT exam spatial resolution directly translates into accurate, clear images giving the physician data to help correctly establish the extent of CAD. Aside from improving image clarity, the technology in the Discovery CT750 HD allows high quality images to be acquired faster and with a reduced radiation dose, which means less exposure and less time in a scanner for patients.
What effect will the new guidance have?
Performing non–invasive imaging with these patient groups will potentially reduce the number of unrequired invasive diagnostic catheterisations.
Geoff Wilson who leads the European Health Economics team at GE Healthcare explains: “It’s clear from the NICE guidance that following its recommendations in these cases will help facilitate not only an improved patient experience, but also potential savings in terms of time for patients and clinicians, and money for the NHS.”
Dr Stephen Harden, Consultant Cardio-Thoracic Radiologist, Southampton General Hospital, says: “This is an important guidance which will have a positive impact on the practice and growth of cardiac CT. It demonstrates that cardiac CT is an established, clinically useful technique which, according to current evidence, can be used even with difficult to image patients. It is likely that more cardiac CT scans will be performed because of increasing referrer confidence in the technique. It is also likely that this increased demand will encourage more units to consider starting their own cardiac CT programme.”
What makes the Discovery CT750HD special?
The GE Discovery CT750 HD was introduced in 2008 as the world’s first high definition CT system. Powered by the first new CT scintillator material in two decades, the system generates exceptional, high definition image quality, a key asset for the difficult to image patients assessed as part of this guidance. The image chain, redesigned from X-ray source through reconstruction, spectral imaging capability and dose reduction features, combine to offer patients quicker scans, and lower exposure, while providing physicians with the tools to achieve faster, more confident diagnoses.
The Discovery CT750HD’s industry leading cardiac CT spatial resolution of 18.2lp/cm enables reduced calcium ‘blooming’, improved stent visualization and helps accurately quantify stenosis in coronary vessels.
What is NICE?
National institute for Health and Clinical Excellence is a Special Health Authority funded by the UK’s Department of Health and was set up in 1999 to reduce variation (or the so called ‘postcode lottery’) in the availability and quality of NHS treatments and services.
The Health and Social Care Bill of 2011 set out plans for NICE to become a non departmental public body and for its remit to expand to include quality standards for the social care sector.
The Role of NICE
NICE produces evidence-based guidance to help resolve uncertainty about which medicines, treatments, procedures and devices represent the best quality care and offer the best value for money for the NHS.
In addition to guidance, NICE also produces quality standards which set out a vision of what high-quality care should look like in the NHS. NICE is working towards 150 quality standards assessed by specific disease, condition or clinical area and will indicate when a particular treatment or procedure is considered highly clinically effective, cost effective and safe as well as being seen by patients as a quality experience.
Every piece of NICE guidance and NICE quality standard is developed by an independent committee of experts including clinicians, patients, carers and health economists.
While NICE has historically produced guidance on the use of medicines and interventional procedures within the NHS via its long established technology appraisal programme, two new programmes were introduced in 2009 to assess diagnostics and medical technologies, namely the Medical Technologies Evaluation Programme (MTEP) and Diagnostic Assessment Programme (DAP).
Impact of NICE technology appraisal programmes around the world
As there is an increasing need to support newly launched products with evidence of their clinical efficacy, so too is there a requirement to prove the cost effectiveness of those new technologies. In the UK in particular, the development of an evidence-based decision making culture within healthcare has increased over the last 20 years.
While NICE guidance is not a requirement for market access in the UK, in practice those products with a positive NICE guidance will find market access a smoother road than those with a restricted or negative guidance. Furthermore, NICE has an international reputation for rigorous Health Technology Assessment (HTA) such that its guidance is often reviewed by HTA bodies outside the UK when considering similar assessments.
The new generation cardiac CT diagnostic assessment is the third guidance produced via this new assessment pathway and the first fully positive guidance.