The NICE guidance supports the NHS using the device, Virtual Touch Quantification (VTq), in people with chronic hepatitis B or C who need liver fibrosis assessment. Using this device could mean these patients can avoid having a biopsy – where a small piece of the liver is removed for examination.

Liver fibrosis occurs when there is a lot of scar tissue in the liver, and makes the liver’s texture stiff. The scar tissue can result from damage to liver cells caused by infections such as chronic hepatitis B or C, inflammation and injury.  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 benefits of VTq include the procedure being painless and possibly safer than liver biopsy, and reduced costs: using VTq could save around £434 per patient compared with liver biopsy and around £53 per patient compared with transient elastography[1].

Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “This new NICE guidance recommending VTq for diagnosing and monitoring liver fibrosis is good news for people with chronic hepatitis B or C, and for the NHS. As well as meaning that these patients could avoid having invasive liver biopsies, the associated savings of more than £400 per person could result in significant savings in hospitals where liver biopsy is the primary method for diagnosing and monitoring liver fibrosis.

“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. The guidance, developed by the independent Medical Technologies Advisory Committee, says that VTq should be considered as an option for assessing liver fibrosis in people with chronic hepatitis B or C. Using the device may have benefits for people who need monitoring for fibrosis progression including  those for whom liver biopsy affects their quality of life. We hope that this guidance leads to wider use of VTq in the NHS to improve the care of patients with chronic hepatitis B or C.”

Welcoming the NICE guidance, Andrew Langford, Chief Executive of the British Liver Trust, said: “Liver disease is the third main cause of premature death and of the top five causes is the only one that continues to increase. It is vital that early diagnosis is increased so that each person can make the necessary lifestyle changes or receive treatments that will prevent progression and possibly reverse or cure their disease. VTq is an invaluable addition to making diagnosis and on-going monitoring as easy and patient centred as possible, so it’s good that the NICE guidance encourages its use.”

The guidance on the VTq device is available at http://www.nice.org.uk/mtg27.

ENDS

For more information call Dr Tonya Gillis at the NICE press office on 0300 323 0142, or out of hours on 07775 583 813.

Notes to Editors

Explanation of terms

[1] The standard methods of assessing whether there is damage in the liver are ultrasound scans, transient elastography, and biopsy. Transient elastography is a procedure which measures the stiffness of the liver tissue based on measuring the time it takes for a wave generated at the skin surface to travel to a point within the liver. Biopsy is an invasive procedure where a small sample of liver tissue is removed using a fine needle and then assessed for changes. The guidance recommendations say that VTq is as accurate as transient elastography in diagnosing and staging liver fibrosis, and may offer other benefits in terms of imaging the liver and sampling selected areas to assess fibrosis and identify associated pathologies.

About the NICE guidance

1. The medical technologies guidance, “Virtual Touch Quantification to diagnose and monitor liver fibrosis in chronic hepatitis B and C”, is available at https://www.nice.org.uk/mtg27 from 23 September 2015.

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. Compared with transient elastography, the estimated overall cost saving for VTq is around £53 per person. This saving assumes that 10% of the ultrasound machine capacity would be used for VTq measurements, leaving 90% to be applied to other uses. Compared with liver biopsy, the corresponding saving is around £434 per person.

4. The cost of the VTq software stated in the company’s submission is £4415. A compatible Siemens Acuson S2000 ultrasound system costs from £50,000 with annual maintenance costs, starting in year 2, from £2000. All costs are excluding VAT.

5. In England, chronic hepatitis B affects an estimated 273,000 people (Hepatitis B Foundation, 2007), and around 160,000 individuals have long-term (chronic) infection with hepatitis C (Public Health England, 2014).

6. Other causes of liver fibrosis (not considered in this guidance) can include heavy alcohol consumption, toxins and some rare inherited diseases.

7. NICE is currently developing a clinical guideline on the ‘Assessment and Management of Cirrhosis’ expected to be published in June 2016.

About the Medical Technologies Evaluation Programme

8. 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.