NICE is consulting on draft guidance on a device that aims to diagnose and monitor liver damage, without the need for surgery. The provisional recommendations support using the device, Virtual Touch Quantification (VTq), 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 infections such as chronic hepatitis B or C, inflammation and injury. Other causes of liver fibrosis (not considered in this guidance) can include 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 The draft guidance advises that VTq is as accurate as transient elastography in diagnosing and staging liver fibrosis, and may offer additional benefits in terms of allowing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.
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“This draft guidance, developed by the independent Medical Technologies Advisory Committee (MTAC), proposes supporting VTq for diagnosing and monitoring liver fibrosis in adults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 is available at: https://www.nice.org.uk/guidance/indevelopment/gid-mt210. The consultation closes on 19 January 2015.
For more information call Dr Tonya Gillis at the NICE press office on 0300 323 0142.
Notes to Editors
Explanation of terms
 The standard methods of assessing whether there is damage in the liver include ultrasound scans, transient elastography, and biopsy. Transient elastography is a procedure which measures the stiffness of the liver tissue based on patterns of distortion created in the tissue when nearby skin is vibrated. Biopsy is an invasive procedure where a small sample of liver tissue is removed using a fine needle and then assessed for changes.
About the NICE draft guidance
1. The draft medical technologies guidance, “Virtual Touch Quantification to diagnose and monitor liver fibrosis”, is available at https://www.nice.org.uk/guidance/indevelopment/gid-mt210 from 17 December 2014.
2. Virtual Touch Quantification (VTq) is manufactured by Siemens. The VTq software application uses acoustic radiation force impulse (ARFI) imaging technology to measure the elasticity of liver tissue. VTq is used in combination with a Siemens Acuson S2000 or S3000 ultrasound platform. Liver tissue can be damaged by inflammation, causing high levels of collagen to be deposited in the liver cells (fibrosis), which become stiff. ARFI imaging involves generating a shear wave by applying an acoustic ‘push pulse’ lateral to the area of interest identified during a conventional ultrasound scan. The speed of the shear wave is proportional to the stiffness of the tissue.
3. Cost modelling suggests that using VTq is cost saving compared with transient elastography and liver biopsy, whether or not a compatible Siemens ultrasound machine needs to be purchased. The estimated overall cost saving per patient compared with transient elastography, including the purchase of an ultrasound machine for which VTq assessment of liver fibrosis accounts for 10% of the patient throughput, is around £53. Compared with liver biopsy, the corresponding saving is around £434.
4. The cost of the VTq software stated in the company’s submission is £4415. A compatible Siemens Acuson S2000 ultrasound system costs £59,700, with yearly maintenance costs, starting from year 2, of £2246. All costs are excluding VAT.
5. In the UK, chronic hepatitis B affects an estimated 170,000 people (British Liver Trust), and around 214,000 individuals have long-term (chronic) infection with hepatitis C (Public Health England).
About the Medical Technologies Evaluation Programme
6. The focus of Medical Technologies Evaluation Programme is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory.
More information is available at http://www.nice.org.uk/MT.
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