A four year battle to win Medicare funding for the faecal calprotectin test to identify IBD has hit a setback with an application rejected by the Medical Services Advisory Committee (MSAC).
According to deliberations recently made public on the health department’s website, MSAC acknowledged that there was a clinical need for a diagnostic triage test to differentiate IBD from IBS and avoid more invasive subsequent investigations such as colonoscopies.
However, after considering an application initially submitted by Taylor Bio-Medical Pty in 2014, the committee ruled that while the test may have value, the submission lacked evidence for cost effectiveness in low prevalence settings.
“MSAC considered that measurement of faecal calprotectin as a marker of bowel inflammation for IBD had reasonable diagnostic accuracy in a high prevalence population, but uncertain clinical effectiveness to improve health outcomes, unfavourable and highly uncertain cost-effectiveness, and likely large financial implications with little confidence that utilisation can be kept within the intended purposes and consequences,” the MSAC statement says.
The committee also noted that clinical benefit for faecal calprotectin testing had not been shown for monitoring of disease activity, and it encouraged any future application for a Medicare rebate to focus on its potential role in the differential diagnosis of IBD.
“MSAC advised that the [MBS] item descriptor for differential diagnosis should be narrowed to target the patient population in which the test has real value (for example, patients without alarm symptoms, in whom colonoscopy could be avoided) if the submission is to be reconsidered.”
The committee also recommended that GESA and the RACGP be approached regarding the development of guidelines for faecal calprotectin testing.
“These organisations may also be able to assist in better defining the current clinical management algorithms which would be influenced by more clearly targeted FC testing for differential diagnosis and monitoring and thus support any resubmission.
The decision was a setback for supporters who, as reported recently in the limbic, find faecal calprotectin both clinically and cost effective in reassessing disease activity.
Dr Daniel van Langenberg, head of IBD at Eastern Health, Melbourne, found faecal calprotectin could substantially reduce costs for payers and inconvenience for patients without comprising the quality of care
“The MSAC decision to reject calprotectin was disappointing and shortsighted given as in our study, faecal calprotectin in the real world clinical scenario is likely to be cost saving to health payers and improve quality of care to IBD patients. Hopefully our study and other will help convince the MSAC at next attempt,” he said.
The MSAC noted that point of care faecal calprotectin testing, which comprised part of the application, was more expensive and generally of lower quality than laboratory testing. It also queried the rationale for the point of care testing and ruled it out of scope.
The proposed fee for faecal calprotectin testing was $80 with an estimated total cost of $102 million for differential diagnosis and monitoring.