Recommendation for NHSScotland

CCE-2 should not replace optical colonoscopy, but should be available as a diagnostic option in the current pathway for patients who present with lower gastrointestinal signs and symptoms suggestive of colorectal cancer and have a positive faecal immunochemical test (FIT). Evidence on clinical effectiveness and economic analysis indicate that CCE-2 should be reserved for patients at lower risk of colorectal cancer.

Communication with patients needs to be very clear in setting out why they are being offered CCE-2. Shared patient decision-making should take into account the relative risks of incorrect diagnoses in each available investigative procedure, and should acknowledge that a substantial proportion – approximately half - of CCE-2 recipients will require a follow up procedure.

Support should be provided to patients undergoing bowel cleansing to ensure the efficacy of CCE-2, recognising the increased requirements surrounding the CCE-2 bowel preparation regimen compared with colonoscopy and computed tomographic colonography.

The full cost effectiveness of CCE-2 remains unknown. Based on the SHTG cost analyses, CCE-2 appears to increase financial cost for the health and care system.

SHTG supports the introduction of a registry to continuously and consistently collect relevant patient outcome and cost data, and this should inform future service delivery.

The COVID-19 pandemic has had a considerable impact on access to existing optical colonoscopy services. The provision of a CCE-2 service may offer additional capacity to help meet colonoscopy demand.

NHSScotland is required to consider the Scottish Health Technologies Group (SHTG) advice.

What were we asked to look at?

We were asked to assess the clinical and cost effectiveness of PillCam™ Colon-2 (second-generation colon capsule endoscopy (CCE-2)), compared with optical colonoscopy or computed tomographic colonography (CTC), for identifying colorectal polyps in adults with signs or symptoms of colorectal cancer or at increased risk of colorectal cancer.

Why is this important?

In 2018, Evidence Note 86 examined the evidence for CCE-2. Since then further evidence assessing the effectiveness of CCE-2 has been published.

A project between the Scottish Government and CCE-2 industry colleagues, called the Scottish Capsule Programme (SCOTCAP), aimed to ease pressure on waiting times for optical colonoscopy. SCOTCAP was delivered in the North of Scotland and was a feasibility and acceptability trial of the use of CCE-2 in the community. In order to inform decision making surrounding the rollout of SCOTCAP across Scotland, the Scottish Government asked SHTG to reassess the CCE-2 evidence.

Referred by

Scottish Government