Clinical

Chronic management

NASH and non-alcoholic fatty liver disease

Background

  • NAFLD covers a spectrum ranging from simple steatosis to steato-hepatitis (NASH) and cirrhosis. Of the UK population about 33% have NAFLD, and 2-5% have NASH.
  • It is now the commonest cause of liver disease in the West and accounts for a growing proportion of patients undergoing liver transplantation (15-20%). Most patients commonly present in middle-age.
  • There is a need to increase understanding of liver disease and its many causes, to improve patient outcomes and reduce the stigma many patient’s experience. Currently there is a perception that all liver disease is due to alcohol.

Patient View

  • The potential cardiovascular morbidity associated with NASH should be discussed with patients, and guidance given on diet and exercise, sources of support (including psychological support) as part of ongoing management.
  • These thoughts underpin the policy articulated by the main and highly trusted patient organisation, the British Liver Trust.

Current Practice

  • Prior to the development of end-stage liver disease patients may often be asymptomatic. Symptoms are often non-specific at this stage and include fatigue, features of sleep apnoea and diabetes. Major causes of death in such patients are cardiovascular and liver disease, which are higher in those with more advanced disease (NASH).
  • Medical: Stratification of patients into those with NASH/advanced fibrosis and those with steatosis alone. For those with NASH/advanced fibrosis therapy includes: Appropriate implementation of lifestyle change, Metformin therapy, optimisation and tailoring of diabetic control (use of Metformin and GLP-1 analogues), consideration of Thiazolidinediones (Pioglitazone), Orlistat and Vitamin E. Treatment is usually lifelong. There are many classes of drugs in phase 2/3 clinical trials and there will likely be an expansion of available therapies in the near future. Patients with advanced fibrosis will require surveillance for hepatocellular carcinoma, oesophageal varices and features of decompensation (ascites, jaundice, encephalopathy, protein calorie malnutrition).
  • Surgery: Bariatric surgery has been proven to be highly effective for patients with NASH reducing both liver fibrosis as well steato-hepatitis. There is also a concurrent reduction in diabetic treatment required. Options include gastric balloons, gastric banding, and bypass surgery. Such procedures generate cost-savings rapidly and are cost-neutral within 18 months.
  • Specialist multi-disciplinary management for both in- and out-patients and a well planned programme of surveillance for complications of cirrhosis are very important.

I would say that we want primary care to use markers of fibrosis so we can identify those at risk of liver outcomes. This group only should be refered for complex secondary care interventions. The remainder should eb managed in primary care as their major risk of mortality and morbidity is cardiovascular disease given that fatty liver is a component of the metabolic syndrome. Multi-dscplinary management of tehse patients in primary and secondary care is vital. In primary care the focus should be lifestyle change and therapy to reduce cardiovascular risk. In the secondary care population with more significant liver disease a combined approach is also required but may require different therapies, metformin, bariatric surgery etc.

Recommended Practice and Opportunities for Integrated Working

Our principal recommendation is that patients with risk factors for NAFLD undergo disease stratification in primary care. Those patients with mild NAFLD can be managed in primary care, whereas those with advanced NAFLD, known as NASH should be referred to clinics where there is a specialist interest.

  • A specialist clinic would ideally be a multi-disciplinary team, consisting of consultant hepatologists, diabetologists/diabetic clinical nurse specialists, specialist dietician with access to weight management services including bariatric surgeons.
  • Activity: The team should deliver
    • high quality care, working with regular team meetings
    • a pathway for initial referral, access to lifestyle intervention
    • arrangements for safe and effective use of established and novel treatments. This should include high levels of patient involvement in clinical trials.
    • high quality bariatric surgery by tertiary referral if necessary
    • With education and support for patients
  • Disease stratification. There are several methods by which this can be undertaken, requiring a combination of blood tests and clinical information. The precise method to be used can be determined locally and will allow for the development and implementation of a NAFLD referral/management strategy.
  • Underpinned by Information technology: Commissioners should require those in Primary and Secondary Care to maintain a shared register of all patients with NAFLD/NASH to ensure timely use of key activities (eg surveillance). Patients should hold a summary record to assist integration of care.
  • Chronic Management. After establishment of a diagnosis of NASH/advanced fibrosis a majority of cases are managed in Secondary Care because of the specialised nature of management and monitoring. Patients with less severe disease should be looked after in primary care where lifestyle interventions can be co-ordinated by General Practitioners.
  • Monitoring Drug Therapy. There should be a Primary/Secondary shared care protocol. For clarity, individual responsibilities should be identified on the patient held record.

Desirable changes in practice:

  • Patient held record. This would contain, on a single page or equivalent, enough practical information about history, treatment, adverse effects, monitoring, responsibilities and key dates (eg liver biopsy, surveillance endoscopy) to enable decisions to be taken instantly. The record could be electronic, on paper or a paper copy of an e-record.
  • Shared records: Ultimately a patient held record automatically extracted from General Practice and (if possible) hospital records and accessible and modifiable in real time by the GP, the hospital and by the patient would be a logical and desirable extension of the patient held record which should be seen as an imperfect compromise. Commissioners should challenge IT departments to establish such a system.

Opportunities for Savings

  • There is major potential for improving care and also saving money.
  • Identification of patients with more severe disease (NASH), will allow for a reduction in referrals of patients with mild NAFLD.
  • Prevention of progression to end stage disease and reduced complications of liver disease, reduced hospitalisation, reduced incidence of HCC and reduced requirement liver transplantation

Quality Indicators (Outcomes)

Outcome measures

  • These are still in evolution and will soon be supplemented by patient PROMs (satisfaction and/or disease specific quality of life) which are under development and an update of the EQ5-D (generic quality of life, DH).

Process metrics likely to impact on outcomes

There are few established standards at present although groups have been commissioned to develop them. These are likely to include:

  • An accurate register of all patients in the locality
  • Providers participate in national audits
  • Stratification of disease severity
  • Clear and documented targets for weight and exercise
  • Consensus on treatment regimes including use of surgery
  • High level of inclusion in clinical trials

Social Policy & Understanding

  • This has a major economic impact on sufferers reduced employment options and shortened life expectancy .
  • The lifelong nature of NAFLD means that patient involvement in development of services is very important. It also means that patients should be provided with realistic choices about how care is delivered.
  • Patients with NAFLD suffer difficulties and discrimination because of perceptions that alcohol is the cause of their liver disease. The public and employers should be made aware of these issues.