1146.3 – Capsule Endoscopy for the Diagnosis of Suspected Small Bowel Crohn Disease (resubmission)

New MBS item.

Capsule endoscopy (CE) is a non-invasive diagnostic test, usually conducted in an outpatient setting, in which the gastrointestinal system is visualised via a camera inside an ingested capsule. The test visualises the gastrointestinal (GI) tract in order to diagnose and assess GI mucosal changes resulting from CD in the small bowel (SB). While the capsule passes through the patient's digestive tract, images are transmitted to a data recorder worn on a waist belt. After the procedure, a colour video taken from the capsule is viewed. This technology is especially useful for visualising the mucosa of the small bowel, which is difficult to access with endoscopic examination.

The proposed application requests the use of capsule endoscopy in two distinct indications:

1. The diagnosis of suspected isolated small bowel Crohn’s Disease in patients with non-diagnostic findings from prior investigations including colonoscopy with ileoscopy and imaging with MR Enterography
2. Assessment of patient with Known Isolated Small Bowel Crohn’s disease: - Evaluation of exacerbations/suspected complications of known small bowel Crohn’s disease patients with non-diagnostic findings from prior investigations - Assessment of response to change to therapy in patients with known isolated non stricturing small bowel Crohn’s disease patients with non-diagnostic findings from prior investigations

An economic evaluation of the first (diagnostic) indication was previously assessed by MSAC (Applications 1146 and 1146.1), while the second (assessment) indication has not yet been reviewed.

Crohn’s disease (CD) is a chronic inflammatory bowel disease that may affect any portion of the gastrointestinal (GI) tract. In cases of small bowel (SB) involvement, CD typically affects the terminal ileum. The condition is becoming more prevalent, severe and complex and in particular is diagnosed in young patients. Approximately 20-30% of all patients with CD present when they are younger than 20 years old. In addition to common Gastrointestinal (GI) symptoms, children with CD often experience growth failure, malnutrition, pubertal delay, and bone demineralization. CD is largely unpredictable with significant variation in the area of the GI tract affected, as well as the degree and pattern of symptoms affecting each patient. The relapsing, unpredictable and chronic nature of CD has broader impacts on a person’s emotional, physical and social wellbeing. Hence, early diagnosis and assessment modalities to optimise treatment for tight disease control are crucial. However, existing investigative tools can fail to provide a definitive, timely diagnosis and/or assessment. Despite the widespread prevalence of CD, it should be noted that the proposed application relates to the diagnosis or assessment of patients with suspected or known isolated small bowel CD with non-diagnostic findings on prior imaging. This population accounts for a small fraction of the total CD population, but has a high clinical need for effective diagnostic and assessment options.

• PASC meeting: -
• ESC meeting: 5 October 2017
• MSAC meeting: 23 November 2017