Campbell Rogers, executive vice president and chief medical officer at HeartFlow provides an insider’s perspective into how medtech companies can have their solutions recognised by National Institute for Health and Care Excellence (NICE).
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The UK’s health secretary Sajid Javid has said the easing of the pandemic should not beckon a slowing of the digital transformation within healthcare which was greatly accelerated over the past two years. While the UK is in the “living with the virus” phase of the pandemic, coronavirus cases continue to cause major disruption in the public health service, with NHS England waiting lists recently reaching record highs. Health secretary Javid’s message has been clear: the government wants the NHS to harness new technologies to improve care delivery and patient experience, now more than ever.
Through its Medical Technologies Evaluation Programme, the National Institute for Health and Care Excellence (NICE) looks at innovative technologies that could offer benefits to patients and the health system over current practice. A successful evaluation can mean a company’s technology is rolled out broadly across hospitals in Britain. But what does going through the programme’s process look like, and how can you maximise the chances of success?
NICE’s approach
The UK’s healthcare system supports adoption of innovations, but careful scrutiny is applied before allowing new technologies to be deployed for patient care. This is where NICE’s evaluation plays an instrumental role.
New technology must meet three criteria. First, the technology is evaluated to understand whether there are substantial benefits to patients or the health system over and above current practice. The next stage is to scrutinise whether the benefits are plausible, clearly described, easily understood, and supported by evidence. Finally, there is an evaluation to determine if developing guidance would enable faster and more consistent adoption of the technology.
One new technology which underwent the NICE evaluation process successfully is the HeartFlow Analysis. As clinical data is highly regarded within NICE’s process, HeartFlow worked to build a bank of clinical evidence on our technology as part of the preparation for the process. At the time of application HeartFlow carried out two major literature reviews, provided peer-reviewed publications and developed a large-scale economic model. We also worked closely with physicians from University Hospital Southampton and Newcastle upon Tyne Hospitals, who enrolled patients into the PLATFORM trial, which clearly demonstrated that use of the HeartFlow Analysis could reduce unnecessary invasive procedures and deliver cost savings.
NICE’s medical technologies committee advisory then used King’s Technology Evaluation Centre, an independent external assessment centre at Kings College London, to review and critique the evidence provided.
Make the case for tech
Healthcare has a broad spectrum of stakeholders, across patients, support staff and health practitioners, which NICE takes into consideration. It uses an independent committee made up of a diverse range of members including people who use health and social care services, care providers, and healthcare practitioners to develop and update guidance.
Receiving a recommendation from the committee for the use of technology is the primary goal. Securing this means that they consider there is sufficient certainty the technology has at least equivalent clinical or health system benefits compared with current process, and overall uses less, or similar resources.
The committee reaches this conclusion based on clinical and economic evidence, as well as the contributions from expert advisers and patient and care organisations.
A fair and balanced assessment
There are no set criteria to which each technology being assessed must reach. When considering a technology’s value, the committee will want to understand the strengths of it within the context of its potential viability.
Let’s take the assessment of HeartFlow as an example. The HeartFlow Analysis uses data from a standard, non-invasive coronary CT scan. Leveraging deep learning, an advanced form of artificial intelligence, the HeartFlow Analysis creates a personalised, 3D model of a patient’s coronary arteries. Powerful computer algorithms then solve millions of complex equations to simulate blood flow and assess the impact of blockages in their arteries. Physicians can use this information to determine the right course of action for each patient. As part of our assessment, we supplied evidence that using the information provided by HeartFlow, physicians were able to reduce unnecessary invasive procedures, which reduces risks to patients, and saves on time and resources.
Using HeartFlow’s technology would require a shift in ways of working which have been in place for a long time. The assessment of HeartFlow’s technology therefore meant understanding that the successful adoption of HeartFlow is dependent upon the availability of adequate CT scanners and the number of professionals trained in CT coronary angiography.
What could follow
Once a recommendation is secured, your technology may then qualify as one to receive government funding.
In 2018, HeartFlow was chosen as part of the NHS’ Innovation and Technology Payment programme, which focused on creating the necessary conditions for faster adoption throughout the NHS. In 2021, the NHS launched the MedTech Funding Mandate which supports medical innovations that have been recommended by NICE. The mandate demonstrates the NHS’ commitment to delivering those technologies which can offer both improved treatment and improved use of resources to healthcare.
The HeartFlow Analysis was one of the first four technologies to be included in the mandate. Under the mandate, NHS England financially supports hospitals to use the HeartFlow Analysis if a clinician presents a case that shows the patient will benefit from one of the new technologies.
Final thoughts
Medtech companies should communicate the benefits of their technology to government and the NHS. And one of the best places to start is with NICE. Its guidance carries international weight and is a demonstration that a product supports the delivery of modern healthcare. One of the organisation’s aims is to improve patient access to the best digital health innovations.
Whilst the pandemic has been incredibly challenging for healthcare, it has strengthened the appetite for digital technologies and their efficiencies. NICE is a positive enforcement of this, a body which wants to support the onboarding of new technologies. Preparation for assessment is key, and medtech companies must ensure they have the research and evidence to demonstrate the benefits their technology offers.
