NICE Consults on Non-Surgical Device for Liver Diagnosis

UK healthcare advisor NICE is consulting on draft guidance on a device that aims to diagnose and monitor liver damage, without the need for surgery. The consultation closes on 19 January 2015.

Background

The National Institite for Health and Care Excellence (NICE) is provisionally supporting the use of the Virtual Touch Quantification (VTq) device in adults and children with chronic hepatitis B or C who need assessment of liver fibrosis. Liver fibrosis occurs when there is a lot of scar tissue in the liver. The scar tissue can result from damage to liver cells caused by these infections as well as heavy alcohol consumption, toxins and some rare inherited diseases.

The standard methods of assessing whether there is damage in the liver are ultrasound scans, transient elastography, and biopsy.

The draft guidance advises that VTq is as accurate as transient elastography in diagnosing and staging liver fibrosis, and may offer additional benefits in terms of allowing liver imaging as well as sampling selected areas. Using VTq may also create greater savings for hospitals where liver biopsy is the primary method for diagnosing and monitoring liver fibrosis.

VTq is a software application which assesses the stiffness of the liver based on readings of a high intensity ultrasound wave which is transmitted through the liver. The wave travels at different speeds through liver tissue depending on whether the liver is flexible and healthy, or whether it is stiff due to fibrous scar tissue caused by damage. The device measures the speed of the sound waves to determine the condition of the liver tissue and allows the liver to be imaged at the same time. The company which manufactures the system claims that the benefits of VTq include the procedure being painless and possibly safer than liver biopsy, and reduced costs.

The cost modelling suggests that using VTq could save around £434 per patient compared with liver biopsy and around £53 per patient compared with transient elastography.

NICE comments

Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “Liver fibrosis can result from infections such as chronic hepatitis B and C – conditions which affect hundreds of thousands of people in the UK. Diagnosing and monitoring any liver damage caused by these infections is important for ensuring that an affected person receives appropriate care and treatment.

“This draft guidance, developed by the independent Medical Technologies Advisory Committee (MTAC), proposes supporting VTq for diagnosing and monitoring liver fibrosis in adults and children with hepatitis B or C. The evidence examined by MTAC indicates that VTq may avoid the need for surgical biopsy – which could mean no pain for the patient, and potentially save the health service over £400 compared to performing a biopsy. It could also be used for patients where obesity or other factors mean that the standard form of non-invasive fibrosis testing – transient elastography – isn’t suitable.

“MTAC also considered that VTq is likely to be used in an outpatient setting as part of the initial referral from primary care for people who test positive for chronic hepatitis B or C. Clinical experts advised that there is also potential for VTq to be done in future in primary care settings, if performed by staff with specialist training in ultrasound imaging and its interpretation. We welcome comments on the draft guidance during this consultation.”

More information on the medical technology draft guidance consultation for VTq can be found here.

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