The technology

LiverMultiScan imaging software is used for characterising liver tissue. It is designed to be used with MRI to help clinicians to diagnose and stage liver disease. MRI is sensitive to subtle differences in tissue composition. It can scan the entire liver to provide measurements to help in the diagnosis and management of liver disease. No contrast agent is needed.

LiverMultiScan software uses patented technology to process MRI data for quantitative characterisation of the liver, providing standardised imaging markers as measures of liver tissue. The technology acquires measurements for the estimation of extracellular fluid (T1 map) and liver iron (T2* map). The presence of an increase in extracellular fluid is an indicator for inflammation and fibrosis in the liver. The presence of iron, that can be measured from T2*, can interfere with the assessment of extracellular fluid. An algorithm has been developed that allows for the bias introduced by elevated iron to be removed from the measurement of extracellular fluid, generating the iron-corrected T1 (cT1). LiverMultiScan also generates proton density fat fraction maps to quantify liver fat content.

LiverMultiScan is compatible with a range of MRI scanners and field strengths. The technology should not be used for pregnant women, people with a cardiac pacemaker, metal implants or fragments and tattoos (some tattoos are a contraindication for MRI if the ink used contains traces of metal).

Innovations

Unlike liver biopsy, LiverMultiScan is a non-invasive procedure. It produces maps showing the correlations of liver fibrosis or inflammation and the content of iron and fat. The company claims that a single scan with LiverMultiScan for liver tissue assessment takes about 15 minutes.

Current care pathway

Liver biopsy and transient elastography are the most common methods of assessing fibrosis in people with chronic hepatitis B and chronic hepatitis C in the NHS. The NICE Pathway on liver conditions includes interactive flowcharts for people with liver conditions. The positioning of LiverMultiScan in the pathway may differ depending on the referral pathway for specific liver conditions including alcohol-related liver disease, cirrhosis, hepatitis, liver cancer and non-alcoholic fatty liver disease when other tests (non-invasive or invasive) have been recommended.

NICE's guideline on hepatitis B (chronic) recommends transient elastography as the first test for liver disease in adults newly referred for assessment, and liver biopsy is offered or considered on the basis of a transient elastography score.

NICE's guideline on cirrhosis in over 16s recommends transient elastography for the diagnosis of cirrhosis and either transient elastography or acoustic radiation force impulse imaging (whichever is available) for the diagnosis of cirrhosis in people with non-alcoholic fatty liver disease and advanced liver fibrosis. Liver biopsy is considered for the diagnosis of cirrhosis in people for whom transient elastography is not available.

NICE's guideline on non-alcoholic fatty liver disease (NAFLD) recommends a liver ultrasound to test children and young people for non-alcoholic fatty liver, and to consider using the enhanced liver fibrosis test in people who have been diagnosed with non-alcoholic fatty liver disease to test for advanced liver fibrosis.

Population, setting and intended user

LiverMultiScan is intended to be used with MRI in a secondary care setting to help diagnose people with suspected or confirmed liver disease. The MRI based on the LiverMultiScan imaging protocol would most likely be done by radiologists in the radiology department. The scan is transferred through a secure portal (Edison) and is processed externally by the company (Perspectum Diagnostics) in the UK. Once the data have been analysed and reviewed, the report is returned within 48 hours to the clinicians (usually hepatologists). The company states that data processing is compliant with the Health Insurance Portability and Accountability Act, which sets the standard for sensitive patient data protection. Reports are checked by 2 independent assessors.

Costs

Technology costs

The company claims that LiverMultiScan is delivered based on a 'software as a service' model and does not need any additional hardware at the clinical site. The protocol for obtaining images for use with LiverMultiScan is based on standard, clinically available MRI sequences. The cost of LiverMultiScan is £200 per scan, which covers image processing and reporting.

Costs of standard care

The company states that the cost of a liver biopsy is between £497 and £553. The cost of an MRI scan of 1 area of the body without contrast, ranges between £116 and £133 depending on age. An ultrasound scan costs between £40 and £49, and the cost of ultrasound elastography is £32 (NHS national tariff 2018/2019).

Resource consequences

LiverMultiScan is increasingly used in research. It has the potential to reduce the need for invasive liver biopsy.

A model based study (Blake et al. 2016) assessed the effect of non-invasive techniques in the diagnosis of non-alcoholic fatty liver disease in the diagnostic pathway. Three diagnostic pathways were compared in the study: LiverMultiScan, transient elastography, and transient elastography plus LiverMultiScan. A decision-tree model analysis suggested that the use of LiverMultiScan alone expected a 16% reduction in the number of biopsies needed, and there was an estimated reduction in the number of liver biopsies by 66% when LiverMultiScan was used with transient elastography.

A recent model analysis (Eddowes et al. 2018) evaluated the cost effectiveness of LiverMultiScan in the assessment of non-alcoholic fatty liver disease (n=56). The study reported LiverMultiScan could save an estimated £150,218 per 1,000 patients compared with biopsy. Combined transient elastography and LiverMultiScan provided additional savings over multiparameter MRI alone. The estimated cost per correct diagnosis was £554.26 using LiverMultiScan alone, which reduced to £307.92 using LiverMultiScan with transient elastography.