Advice

The technology

The technology

LIVERFASt (Fibronostics) is a blood test for detecting and staging the fibrosis (scarring), activity (inflammation) and steatosis (fat build-up) of the liver. It can be used to help diagnose and monitor non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), hepatitis B and hepatitis C.

People with suspected or diagnosed liver disease would be referred for a LIVERFASt test. The test can be done in any laboratory. Results are then inputted into the LIVERFASt online portal. This uses an artificial intelligence-based algorithm to analyse 10 biomarkers along with age, sex, weight and height to determine if someone has steatosis, fibrosis and steatohepatitis. Biomarkers include alpha‑2 macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, gamma‑glutamyl transferase, alanine transaminase, aspartate transaminase, fasting glucose, triglycerides and total cholesterol. The test has individual panels for fibrosis, activity and steatosis. For each panel, results are scored from 0 to 1 with higher scores meaning more severe disease. Scores are also mapped to histopathology classification stages and colour coded from green (healthy liver) to red (severe damage). The LIVERFASt report provides a qualitative interpretation of results. Results from the online portal are returned immediately.

Innovations

The biomarkers included are specific to each lesion. This allows LIVERFASt to discriminate fibrosis from steatosis and inflammatory activity, without the bias that may occur in other tests. LIVERFASt simplifies diagnosing and monitoring liver disease and damage. It may improve disease management and understanding of disease progression.

Current care pathway

NAFLD is caused by a build-up of fat in the liver. It develops in 4 main stages: steatosis, NASH, fibrosis and cirrhosis. Early stage NAFLD may not have symptoms and may only be detected when testing for other reasons. Liver disease is assessed using clinical examination, clinical history and various tests to identify the presence of risk factors and rule out other causes. People with suspected NAFLD should be offered first-line testing to assess the level of fibrosis, such as Fibrosis‑4 (FIB‑4) or NAFLD Fibrosis Score (NSF). People with a low score on these tests can have their condition managed in primary care and tested again in 3 years. In children and young people, NAFLD is diagnosed if a liver ultrasound shows fatty liver and if other suspected causes of fatty liver have been ruled out. NICE's guideline on NAFLD does not recommend routine liver blood tests to rule out NAFLD or to test for advanced liver fibrosis.

People with NAFLD are offered regular testing for advanced liver fibrosis. If advanced disease is not ruled out with first-line testing, people should be offered further testing using an enhanced liver fibrosis test or transient elastography such as FibroScan. This may be done in primary or secondary care depending on the locality.

Young people and adults with NAFLD, advanced liver fibrosis or other risk factors are also offered non-invasive testing for cirrhosis. This includes transient elastography or acoustic radiation force impulse imaging. Transient elastography may be offered to everyone at risk of cirrhosis, whereas acoustic radiation force impulse imaging is recommended only for NAFLD and advanced liver fibrosis. People who cannot have transient elastography may be offered a liver biopsy. Liver biopsy may also be used if there is diagnostic uncertainty after non-invasive testing. Liver biopsy is used to confirm NASH activity grade and fibrosis stage. It may also be used to confirm the level of fibrosis in some people with hepatitis B.

The following publications have been identified as relevant to this care pathway:

Population, setting and intended user

LIVERFASt is indicated for people with suspected or diagnosed liver disease or damage. About 20% of the population have NAFLD and in around 5% of patients, their condition will progress to NASH. In England and Wales, about 600,000 people have liver disease, of whom 60,000 have cirrhosis. It is estimated that 10% to 20% of people with NAFLD, alcohol-related liver disease and chronic viral hepatitis develop cirrhosis over a period of 10 to 20 years.

LIVERFASt would be used in primary care for the early detection of NAFLD and NASH in people with risk factors including type 2 diabetes, metabolic syndrome, insulin resistance, high blood pressure, high cholesterol and obesity. It can also be used in primary and secondary specialist care to help diagnose fibrosis and cirrhosis. People have an increased risk of cirrhosis if they have hepatitis B, hepatitis C, type 2 diabetes, if they misuse alcohol or are obese. LIVERFASt can also be used in regular surveillance to monitor disease progression and to assist in disease management.

Costs

Technology costs

LIVERFASt costs £55 per test excluding VAT. This includes use of the online portal and any training needed.

Costs of standard care

Costs of standard care vary depending on the test used. FIB‑4 and NSF are both available online and calculate scores using results from several routine blood tests. NICE's guideline on NAFLD, published in 2016, reported unit costs for these tests of about £5 per test (about £6 when inflated to December 2022). Average costs per test of other tests are:

  • enhanced liver fibrosis test: £136 (NICE's guideline on NAFLD from 2016, inflated to December 2022)

  • ultrasound elastography, elective (cost code RD48Z): £57 (based on 1,857 cases)

  • percutaneous liver biopsy, outpatient (cost code YG11A, YG11B): £358 (based on 569 cases)

  • percutaneous liver biopsy, day case (cost code YG11A, YG11B): £1,068 (based on 6,434 cases)

  • transvenous liver biopsy, outpatient (cost code YG10Z): £1,160 (based on 43 cases); transvenous liver biopsy, day case (cost code YG10Z): £1,038 (based on 203 cases).

Costs are from the national schedule for NHS costs 2020/21 and NICE guidelines. NHS costs include all taxes payable by the NHS, including VAT when applicable.

Resource consequences

LIVERFASt is not currently used in the NHS. It would be an alternative to tests for diagnosing or monitoring liver disease and damage. LIVERFASt could be used to detect NASH in people with NAFLD. NICE's guideline on NAFLD states that detecting and reducing the severity of NASH would reduce the risk of progression to fibrosis and advanced liver disease. LIVERFASt may help identify people who need treatment earlier, which could reduce their risk of developing fibrosis and severe liver disease. This could lead to cost and resource savings by avoiding more intensive and costly treatments.

The company said LIVERFASt is more accessible to healthcare professionals and patients than liver biopsy. It is quicker, less invasive and cheaper to perform. LIVERFASt can also be done in primary care settings, which may result in fewer hospital visits. There is currently no evidence on the resource consequences of using LIVERFASt.