NASHIDA
NASH Itinerary for early Detection and care: a medico-economic Assessment
The objectives of this study are to:
- compare patient-reported outcomes of the three strategies (article 1)
- assess costing of each strategy (article 2)
- identify the most cost effective strategy (article 3)
- verify which is the most-effective model for specific subgroups (i.e. late diagnosis, social vulnerability, etc.)
Project period
-
Main investigator
Patricia Marino, Patrizia Carrieri
SESSTIM member(s) of the project:
Non-SESSTIM member(s) of the project
Manuel Romero Gómez (University of Seville); Jeffrey Lazarus (ISGlobal)
Sponsors:
Financeur: Barcelona Institute for Global Health (ISGlobal)
Partners:
Barcelona Institute for Global Health (ISGlobal)
Research topics:
Research question:
NAFLD is a growing health concern and liver fibrosis severity determines its prognosis. The burden of this disease has been estimated in a quarter of the European population and is even higher in diabetic patients, where it raises significantly and can reach up to 80%.
Non-alcoholic fatty liver disease (NAFLD) prevalence currently ranges from 20-30% of the overall population and is expected to reach up to 50% by 2030 due to the large epidemic of diabetes and obesity - two major drivers for this disease. NAFLD progresses to cirrhosis over 20-30%, although there are different patterns of progression depending on the underlying risk factors. Diabetes mellitus, insulin resistance, arterial hypertension, obesity, waist circumference, and age have been proposed to shorten the fibrosis evolution rate.
The fact that only 10% of these patients will develop significant fibrosis, the strongest predictor of liver-specific morbidity and overall mortality, leads to an overwhelming situation in primary care and endocrine units, where physicians need to screen large numbers of patients to identify individuals with a high risk for developing fibrosis that should be derived to a specialized hepatology unit. New free and accurate non- invasive tests need to be available to be used in primary care and non-hepatologists units to fight against this disappointing situation.
Accurate fibrosis assessment by primary care or non-hepatologists physicians is limited by a reliance on liver function tests, which correlate poorly with fibrosis, and limited access to discriminatory fibrosis tests. Patients with advanced fibrosis or cirrhosis who would benefit from NAFLD specific interventions often remain undetected until they present with complications of cirrhosis, including hepatocellular carcinoma. This ineffective management contributes to the poor outcomes associated with liver disease and the increasing trends in NAFLD- related morbidity and mortality.
Method:
The NAFLD pathway evaluation was conducted during two years (from June 2020 to May 2022) with the main aim of determining the impact of a new implemented pathway.
Direct costs of the strategies will include the costs of each diagnostic test, pharmaceutical costs, and other related clinical costs, such as laboratory costs. Indirect costs include those to the patient, such as missed income, co-pays and co-insurance, and costs of travel. Other indirect costs to the patient will be developed following a literature review of patient-reported costs for NAFLD treatment in Phase 1. Estimated costs will be compared against the benefits produced by each strategy through a cost-benefit and/or a cost-effectiveness analysis.
Research prospects:
The global expected outcome of NASH-PI will be the development of a new specific stepwise NAFLD algorithm that improves the selection of patients with advanced fibrosis and cirrhosis for referral to secondary care, reducing unnecessary referrals, enhancing the use of healthcare resources and immediate cost-savings, and improving patient experiences by avoiding unnecessary clinic appointments and tests. The use of freely available non-invasive tests will most likely facilitate its implementation and use in countries with low-income.
Results:
This study will produce standard statistical comparisons of ICER ratios across the three strategies that will help countries and researchers estimate the cost-effectiveness of the sequential use of clinical prediction rules for NAFLD in their health systems and additional findings on patient reported outcomes and the cost-effectiveness of each strategy that will contribute to the evidence base for improving NAFLD care pathways.
