Fibroscan Business Case - NICE



|Report Title: |

|Business case for the purchase of a new fibroscan machine |

|To be presented by: |

|Executive Summary: |

|Liver disease in the UK is growing at an alarming rate and there is an increasing need for early diagnosis of disease and the assessment |

|of fibrosis to identify those patients with significant liver damage who will benefit from the early implementation of disease management|

|programs which reduce emergency admissions and improve mortality. Average age of death from liver disease in the UK is 59 years; at XXX |

|within alcohol related liver death (2011) the average age was 57 years. |

|Key documents have been published (NICE guidance for increased testing for hepatitis B and hepatitis C, appendix 1, NHS outcomes |

|framework 2012/13, Caring for people with liver disease: Nurse competencies, appendix 2, or are currently in draft, due for publication, |

|(NICE Liver related quality improvement measures and quality standards, NHS specialist commissioning for hepatobiliary and pancreas |

|services, NCEPOD report: Alcohol related liver disease) which have significant implications for the continued increased need and |

|therefore access to the specialist services in the liver unit at XXX and care of patients with liver disease throughout XXX and XXXX |

|London. fibroscanning is now the first recommended assessment for patients with liver disease and a fundamental service providing |

|immediate and risk free assessment of a patients liver fibrosis being used with other investigations. |

| |

|Fibroscanning is a service now being sort by a considerable number of health providers, local General Practitioners. Due to the limited |

|number of machines and trained scan staff with liver knowledge this places XXX as one of the largest providers of this service in the |

|country and the main provider in XXXX London. |

| |

|As the largest provider of liver services in North West London, the business case below sets out the reasoning and need to continue to |

|support and expand the Fibroscan service and the Nursing specialist resources for the improvement of patient care, outcomes, experience |

|and mortality and better management of the direct costs associated with this increasing burden which is currently £0.5 billion per annum |

|to the NHS and rising at 10% a year. |

| |

|XXX experienced a XX.XX% increase in inpatient liver disease related admissions in the year 2011-2012 which is significantly greater than|

|the year on year forecasted increase of 10% (British Association of Liver Disease). If this is repeated for 2011 – 2012, admissions to |

|the three hospital sites for 2012 will reach XXXX. |

| |

|At of the end of March 2012; XXXX inpatient admissions for a liver ICD-10 code had been recorded in ICH giving a renewed forecast for the|

|trust of XXXX admissions which is an increase of XX.X% on 2011. |

|Key Issues for Discussion: |

|To approve the one off expenditure of £XX,XXX for the purchase of a new fibroscan machine |

|To approve the annual cost of £X,XXX for on-going servicing and maintenance of the machine |

|To assist in providing Fibroscan services, educating and assisting in the earlier recognition and management of Liver disease in the |

|community, ward and outpatient setting. |

|Link to the Trust’s Principal Objectives: |

|Provide the highest quality of healthcare to the communities we serve improving patient safely and satisfaction. |

|Work together for the achievement of outstanding results in all our activities |

|Conduct world-class research and deliver benefits of innovation to our patients and population. |

|Respect our patients and colleagues |

Business case for the purchase of a Fibroscan machine

XXXX 2013

Background

Liver disease is a growing epidemic in current healthcare and is now the fifth largest cause of mortality in the UK, with an average age at death of 59 years.

Liver disease is the only one of the major diseases on the increase and as such poses a significant risk to future healthcare burden and mortality (Appendix 3). It is forecast to cost the NHS in excess of £1 billion by 2015 (BASL, 2004, 2009). The three largest contributors to this burden are:

• Viral hepatitis

• Alcohol

• Obesity (including non-alcoholic fatty liver disease)

Clinical outcomes for liver disease are greatly improved if the condition is detected early and appropriate treatment courses begun. The most effective and convenient way of assessing the condition of a patient’s liver is via a fibroscan, and XXXXXXXXXXXX NHS Trust is currently providing this service out of the XXXXXX XXXXXX at the XXXXXXX site.

The assessment of disease stage is a key component of all patient assessments in hepatology. Disease stage which generally equates to the degree of fibrosis (between normal and cirrhosis) can only be measured using investigations such as fibroscan and liver biopsy. International guidelines require staging prior to treatment for both hepatitis B virus infection and hepatitis C virus infection. Both sets of guidelines accept fibroscan as an acceptable assessment of fibrosis stage. A position paper on Fibroscan will be published next year with the approval of all International Liver Societies supporting the use of fibroscan as an assessment tool across a wide range of liver diseases.

This business case proposes the purchase of an additional Fibroscan machine in order to increase the number and speed with which patients can have their livers assessed. In the care setting, the only alternative to Fibroscanning is to undertake a liver biopsy which may be painful and conveys a small but significant risk or morbidity and mortality (1/10000). Liver biopsy requires a day case admission causing significant anxiety and inconvenience to the patient.

As fibroscan is a fibrosis assessment tool, not a diagnostic one. As the rate of liver disease continues to increase (UK forecast is 10% per year) and within XXXX this was demonstrated with a XX.XX% increase in liver related inpatient admissions for the year 2010 – 2011. The requirement for liver biopsy to diagnose the underlying cause will therefore not diminish and is demonstrated in figure: 1. the need once diagnosed to assess fibrosis and rate of progression will increase substantially year on year

Figure 1: XXXXX Unit daycase liver biopsy

[pic]

Fibroscanning is a 20 minute non-invasive, painless assessment that furthermore does not require an inpatient admission and gives ‘real time’ results. The patients’ liver may be assessed in ambulatory care rather than daycase, and the availability of portable machines increases the flexibility for this service to be provided in the most convenient location for patients such as lager GP practices or within the inpatient ward environment. Early assessment of and diagnosis of liver disease and complex multisystem disease are key outcomes set out in the hepatobiliary NHS specialist commissioning framework being published in 2013 in order to treat earlier and affect mortality rates.

As well as improving physician’s knowledge, improved disease management planning, reducing anxiety and delivering on outcome PHQ14: assisting people with long-term conditions to feel independent and in control of their condition it improves patient experience. The fibroscan can ensure that all current access and many outcome targets are met and minimising the number of required bed days for the Trust, at present. Currently there is an inability to assist in meeting targets set such as PHQ15: Unplanned hospitalisation for chronic ambulatory care sensitive conditions (adults) in the 2012/13 operating framework as we are unable to assess the level of liver fibrosis in those with hepatitis B with or without Delta who could be managed in ambulatory care if cirrhosis was detected earlier an management plans in place to reduce non-elective admissions for complications of cirrhosis. Current wait is XX weeks for a fibroscan.

An increase in Fibroscanning represents a core part of the Hepatology strategy to increase access for early assessment of liver damage and activity. It is also significant in developing better integrated care pathways with Clinical Commissioning Groups (CCGs) following increased NICE guidance to test for and detect more viral hepatitis.

Patient experience

Fibroscans improve patient experience, both when in the care setting and also from a much broader life experience perspective.

From a quality of life perspective, early identification of liver disease through use of Fibroscanning enables the condition to be assessed and managed much earlier in the process, reducing the likelihood and severity of complications and mortality and greatly improving their management and patient’s quality of life. This is a Key outcome in the NHS specialist commissioning proposals for Hepatobiliary and pancreas services.

Proposal

It is proposed that XXXX purchase another Fibroscan with immediate effect. However, in May the research machine was transferred to XXXXXX. In order to mitigate against the loss of one machine we successfully increased the number of cases between Jan and May 2012 by 32% to reduce any waiting list before the second machine was lost. However, despite further increases in the Fibroscan activity with increased sessions in the remaining machine the waiting list continues to grow as demand significantly exceeds capacity (42% more scans have been performed in 2012 than in 2011), figure 2.

Figure 2: XXXXX Unit fibroscan list year on year

[pic]

Links with Hepatology, CPG1 and Trust strategy

Expanding provision of Fibroscanning is an integral part of the Hepatology Strategic Plan.

As well as bringing short-term benefits to XXXX by increasing activity to the levels agreed in the contract with commissioners, which has been overachieved with the increased extra clinical sessions being made available when trained staff can be released for other clinical duties, improving the waiting time, it will likely yield strategic benefits and despite this has a XX week wait for a scan. These benefits are in two principle ways: An increase in referrals or expansion in market share, owing to a developing community presence; and a reduction in inpatient bed days and Length of Stay relating to liver disease, with earlier detection of severe disease, appropriate management can be implemented reducing non-elective admissions and early mortality as a result. The current age of death for a liver related ICD-10 code is XX years within XXX.

The service is now receiving referrals for fibroscan directly from GP’s and has been approached by the XXXX XXXXX Hospital to provide a fibroscan service. None of this can be performed in a timely manner if at all with the current level of equipment or specifically trained staff.

The only reduction in the list will take place for the servicing or calibration of the probe which is now required 4 times per year rather than the 2 previously. This is done on the number of procedures undertaken by the individual probe. Should the one remaining probe be damaged which is a significant risk with the increased number of procedures the service will cease until repair can be undertaken (this requires collection and removal of the probe to Paris).

Current position:

• Current sessions per week X

• Number of scans performed per week: XX

• Current referral rate 75-95 per month

• XXX patients currently on the waiting list

• Next available appointment for a fibroscan XXXXXXX,

• Delayed follow up in Consultant outpatient awaiting results

• Increased scans offered in 2012 up 42% on 2011.

Fibroscanning is aligned to the current Ambulatory Care agenda and can lead to a reduction in inpatient stays of 30) £

Paediatric probe £

TOTAL £

Recurrent costs:

12-month maintenance agreement for probe £

12-month maintenance agreement for Fibroscan £

12-month maintenance agreement for Portable Fibroscan £

TOTAL £

Note: First year’s recurrent costs included in purchase price

Income

The Fibroscan has potential to garner additional income; however, it is recognised that this will either need to go through the ‘counting and coding’ process or will need to be factored into any negotiations with other Trusts (where referrals are from Secondary or Tertiary Care). Such proposals are likely to be accepted, as they represent a saving to the CCGs of £XXX per patient per procedure (compared to biopsies) and reduce the long-term cost of this cohort of patients with chronic conditions.

The immediate financial benefits of the Fibroscan are:

• Ensuring that activity levels agreed for XXXXX, based on performance in XXXXX, will be met

• Avoid financial penalties for non-delivery of six-week diagnostic pathway

The New CNS post in being able to deliver increased community services and Fibroscan clinics will directly generate income for XXX, the position allows patients within the inpatient environment greater access evidence based practice, improved clinical care and access to clinical research opportunities.

Associated benefits

• Essential for developing close working relationships with CCGs

• Expands patient cohort for whom participation in research trials may be appropriate, delivering the XXXXX XXXXX vision and increasing research income

• Delivers better integrated care with long-term benefits to the Trust’s non-elective inpatient admissions

• Aligns with model for Ambulatory Care to reduce admissions with Length of Stay of ................
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