The National Institute for Health and Health and Care Excellence (NICE) has recommended FibroScan, a non-invasive hepatic ultrasound scan, as an option for assessing liver damage from fibrosis and cirrhosis in primary care.
The British Liver Trust welcomed the move. It said: "The charity believes this decision is a major step forward in the early detection and treatment of liver disease."
In its medtech innovation briefing published in 2020, NICE explained that FibroScan's proprietary technology to measure liver stiffness was "innovative" and that while it was "already used extensively in specialised care settings", smaller, portable versions of the device could be used in primary care. Doing so, it said in today's announcement, could potentially save "countless lives".
FibroScan (Echosens, Paris) is a type of non-invasive liver elastography that uses ultrasound to measure liver stiffness and fibrosis as well as fatty changes and steatosis . Currently, it is used alongside liver biopsy in secondary care settings to assess fibrosis in people with chronic hepatitis B or C.
It can also assess liver fibrosis and cirrhosis in primary care. NICE said that evidence from two prospective cross-sectional studies and two feasibility studies including nearly 3000 adults in primary care showed that FibroScan could detect liver disease in this population.
Liver Disease a Leading Cause of Premature Death
The number of people dying from liver disease in the UK has increased by 63.6% in the last 20 years, said the British Liver Trust. It is now the third leading cause of premature death, and more than 1 in 5 adults are at risk of developing the condition.
"Alarmingly, cirrhosis, the most advanced form, was one of the leading causes of excess deaths in 2022," the charity noted. "A major reason for these deaths is late diagnosis." Liver disease usually has no symptoms in the early stages and at the moment three-quarters of people are diagnosed with cirrhosis at a late stage, when it is too late for therapeutic intervention. If the disease were diagnosed early, lifestyle changes could halt or sometimes reverse its progress.
Chief Executive Pamela Healy said: "The British Liver Trust has been campaigning for steps to be taken by the Government to improve early diagnosis of liver disease. We are delighted that NICE recognises the importance of liver scanning in primary and community care.
"Having this service available in the community will reduce the need for unnecessary ultrasounds in hospital and mean that patients can access a scan without long journeys to hospital," she said. "This decision has the potential to save many lives, and we look forward to working with healthcare professional and policy makers to ensure that this vital diagnostic tool is available to all those who need it."
GP Helen Jarvis, medical advisor to the Trust, said: "Nine in 10 cases of liver disease are preventable, with the main causes being alcohol, obesity and viral hepatitis, yet late diagnosis of liver disease is unfortunately all too common and can have serious consequences for patients. It’s important that we find people with liver disease early to save lives and improve outcomes.
"Making FibroScans available to assess people at risk as part of routine clinical care nationally – in GP surgeries and community health settings – is a great step in the right direction."
GP Scanning Could Save Resources
The cost of a FibroScan unit is £30,000 to £70,000 excluding VAT .To use the technology, GPs and nurse specialists need training, which is provided by the company and lasts around half a day at a cost of £1,150 for up to 3 people. Supervision from a competent user is needed for around the first 50 uses.
NICE said that each FibroScan device was expected to be used for at least 500 scans per year, which would typically mean use in locations covering larger populations, such as community diagnostic hubs.
The company estimated that use of FibroScan would cost between £50 and £400 a time. However, NICE said that it could reduce laboratory testing for serum fibrosis markers or acoustic radiation force impulse testing, as well as the need for liver biopsies.
"Using FibroScan instead of liver biopsy is likely to be resource-releasing because it is quicker, non-invasive and the procedure cost is cheaper," it said. In addition, using the technology in primary care centres could be resource-releasing if it meant fewer hospital visits and reduced waiting times – something supported by a 2019 cost-effectiveness study.