3 Committee discussion

Increased access to FibroScan may improve early detection of liver disease

3.1 Clinical experts explained that bringing FibroScan testing closer to patients improves attendance which could help with earlier detection of liver disease. They highlighted that there is a need to easily enable early detection of liver disease to reduce the number of cases being identified late in the disease course, and that fibrosis is reversible at early stages. Experts commented that patients generally have a positive opinion of FibroScan and could be motivated by the test results to make behavioural changes that can reverse the course of their liver disease if detected early. However, they clarified that there was no evidence showing long-term behavioural change after FibroScan use.

There may be benefits to local testing

3.2 Patient experts reported that people often have to travel long distances for FibroScan, especially in rural areas. Easier access to the test could reduce time and costs associated with travelling longer distances. It could also help people with disabilities that make it difficult to travel. The committee commented that these benefits may not be seen if use by staff who are unable to give specialised advice leads to multiple appointments being needed to first do the FibroScan and separately deliver lifestyle advice.

Clinical effectiveness

There is uncertainty about the performance of FibroScan when used outside of secondary or specialist care

3.3 There was no evidence comparing the accuracy of FibroScan for measuring liver fibrosis when it is used in primary or community care with when it is used in secondary or specialist care.

Performance of FibroScan may depend on the experience of the user

3.4 Clinical experts explained that how well FibroScan works depends on the experience of the user. They stated that if FibroScan is used often enough to maintain competence with the device, performance between settings would be comparable.

It is unclear how often FibroScan would need to be used to maintain competence

3.5 The committee considered the level of use that would be needed for users to maintain competence with FibroScan. The company commented that it encouraged users to ensure that competency is validated in practice, but that it does not provide guidance on requirements for the level of use. Clinical experts highlighted that there is no independent accreditation scheme for users. They explained that FibroScan users in primary or community care in their areas had close links with local hepatology departments which could provide support where needed. The company explained that pilot schemes in primary care networks typically saw 20 to 30 people a month. The committee noted that it is unclear how many FibroScan tests are currently done in the NHS (see section 3.8). Clinical experts highlighted that there is no clear evidence to define a number or frequency of tests that need to be done to achieve and maintain expertise. The committee concluded that if used in primary or community care, it would be important to ensure that operators used the FibroScan often enough to maintain ability to accurately use the test, and for centres to consider having an accreditation framework in place. It noted that sufficient levels of use may not be achieved if the test was available in individual GP practices, but use in locations which covered larger numbers of people, such as community diagnostic hubs, might test enough patients to maintain operator proficiency.

FibroScan should be used as part of a clear pathway

3.6 Clinical experts and GP committee members emphasised that clear guidance on what to do with the results of FibroScan is vital, particularly if testing is done outside a specialist setting. FibroScan done outside secondary or specialist settings could reduce the number of unnecessary referrals to hepatology services. However, if there is uncertainty about what to do based on a result, a referral to specialist services, or contact with these services to ask advice, may still be made. Experts highlighted that this could be a common occurrence if multiple conflicting test results (including FibroScan) were available. Liver pathways should be designed in agreement with primary and secondary centres, and incorporate all tests used for detection and characterisation of liver disease, not just FibroScan. The committee concluded that establishing clear pathways, with advice and guidance on what to do based on a FibroScan result, would be essential to ensure appropriate clinical management of people who have FibroScan tests done outside secondary or specialist settings.

Cost effectiveness

The time horizon of the company's model does not consider potential long-term impacts of testing

3.7 The company's model used a 1-year time horizon. The committee commented that this omits potential costs or cost savings that would only appear many years after testing, such as the costs of treating previously undetected liver disease. The committee noted that increased attendance at FibroScan appointments outside of secondary or specialist care increased costs in the model, because more people were referred for follow-up appointments in hepatology. However, any potential cost savings or health benefits of greater detection of liver disease were not considered (see section 3.1). The committee noted that the effect of lifestyle advice may differ depending on who provides it, for example a GP compared with a liver specialist, but experts said that there was no evidence on this. Clinical experts commented that referrals to hepatology services may go up after adoption of FibroScan in primary or community care, but this may mean that more people who would benefit from specialist care are able to access it. However, clinical experts also commented there was uncertainty about the long-term impact of using the test outside secondary or specialist care, for example on levels of hospitalisation. The committee concluded that a longer time horizon considered in the model would have been preferable to help assess impact of the test.

There is uncertainty around whether costs used in the model in either setting reflected NHS practice

3.8 The committee discussed the costs used in the model submitted by the company, and the revised costs used by the external assessment centre (EAC). The EAC removed a cost from the company's model for staff time to do and evaluate FibroScan in secondary or specialist care because this time was already incorporated within an existing cost used in the model. This meant that, using the figure proposed by the company for testing in this setting, the cost of doing the FibroScan was greater per scan when done outside secondary or specialist care. The company used Health Resource Group (HRG) bundled costs for ultrasound elastography to estimate the cost of FibroScan in secondary or specialist care, at £43.93 in the base case, and this cost was also used by the EAC. The company highlighted that a scenario analysis done by the EAC in which a higher cost per use in secondary or specialist care (£61.98) was used, based on a weighted average of 2 different costs attributed to the HRG code, and suggested that this might be more appropriate. The EAC commented that the results of this scenario still indicated that use of FibroScan outside secondary or specialist care was cost incurring. In their report, the EAC highlighted difficulties in evaluating the costs of doing FibroScan in the different settings that were a consequence of comparing a bundled HRG cost from secondary care with a cost obtained by micro-costing in a non-hospital setting where an HRG code does not currently exist. The committee noted that the HRG code for ultrasound elastography was used only 3,561 times for outpatients in 2019 to 2020, which likely underestimated the number of FibroScan tests done in the NHS. Further scans may be done during outpatient appointments and recorded as such, potentially at higher cost. The committee also noted that the cost the company has provided for FibroScan in primary or community care is higher (£58.00 per scan, plus £10.50 staff time to do and evaluate FibroScan result) than the HRG code cost used in the EAC's base case and scenario analysis for FibroScan in secondary or specialist care. The committee recalled that moving FibroScan testing to primary or community care would potentially move workload to other settings for activities that happen based on test results, such as lifestyle advice, and questioned whether the time taken by healthcare professionals to do this has been adequately captured in costs of doing the test outside secondary or specialist care. They further highlighted that even if a person is not referred to a specialist service after a test done outside this setting, advice from staff in these services may be sought. Any need for further appointments to explain the results of testing done in primary or community care and provide lifestyle advice (see section 3.2) should also be considered in the costs of doing testing. The committee also questioned whether the full costs of a referral for testing in secondary or specialist care had been incorporated. Missed appointments were included as a separate cost in the model. A clinical expert commented that the cost of missed appointments was likely to already be captured in the cost of doing scans used in the company's model. If so, including an additional cost for missed appointments was not appropriate. The committee concluded that there was considerable uncertainty about whether the costs of doing the FibroScan in and outside secondary and specialist care used in the company's model were accurate reflections of the true cost of testing.

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