To assess the safety, effectiveness and cost‐effectiveness of the monitoring and quantification of iron levels in the liver by R2‐MRI data analysis in patients with, or suspected of, systemic iron overload due either to hereditary (primary) haemochromatosis; or secondary iron overload (commonly a consequence of repeated blood transfusions).
The pattern of distribution of iron varies between patients with iron overload due to primary haemochromatosis (increased iron from the gastrointestinal tract) or transfusional iron overload. For this reason these populations were treated separately in the assessment report. The current direct method to assess the extent of iron overload in the liver is by liver biopsy. Patients with primaryhaemochromatosis who have iron overload in the liver are at high risk of liver disease (e.g., cirrhosis) an important prognostic implication for risk of hepatocellular carcinoma and survival. Patients who require routine monitoring of liver iron levels due to repeated transfusions are, because of the pain and side effects associated with liver biopsy, usually monitored by indirect methods, such as serum ferritin levels. R2‐MRI data analysis is unlikely to have an impact on the utilisation of indirect methods.