Background

Coloplast develops products and services to make life easier for people with deeply personal and private chronic conditions. One of their products, Peristeen®, a transanal irrigation system, was launched in 2003, and has since accumulated a body of evidence (both published and unpublished) from clinicians and healthcare workers. A review of this data suggested that Peristeen could be suitable for review by the NICE Medical Technology Evaluation Programme (MTEP) for inclusion into medical technologies guidance.

 

The CHEATA Solution

Coloplast engaged with CHEATA to undertake the following work in close collaboration with their product team:

  • To review their product evidence and data pack
  • To confirm and define the proposed Value Proposition including:
  • Identification of the specific patient segment
  • How the product would fit into the current patient care pathway.
  • To undertake an economic impact assessment on the health economic model within the defined patient segment and care pathway
  • Advise on the commercial benefits and risks in making a submission to NICE
  • Preparation and submission of the Briefing Notification to NICE
  • Preparation and submission of the Sponsor’s Submission of Evidence form to NICE
  • Responding to NICE and External Assessment Centre (EAC) comments and correspondence
  • Support and attendance at NICE Committee meetings including registration as a product stakeholder
  • Ongoing support until the conclusion of the NICE process

Outcome

The submission of the Briefing Notification to the NICE Medical Technology Evaluation Programme was successful and the product progressed into the MTEP pathway for review by an External Assessment Centre before review by the Medical Technologies Advisory Committee (MTAC).

The outcome of the MTAC review was a positive recommendation and NICE have now published MTG36: Peristeen transanal irrigation system for managing bowel dysfunction.

The Committee’s top line recommendation was:

“The case for adopting Peristeen for transanal irrigation in people with bowel dysfunction is supported by the evidence. Peristeen can reduce the severity of constipation and incontinence, improve quality of life and promote dignity and independence.”

Feedback from Coloplast

Bruno Gallo Santa Cruz, International Medical Specialist (Bowel Management): Your guidance, support and expert advice has been outstanding.

Coloplast press release – https://www.coloplast.co.uk/about-us/news/2018/#section=NICE-publishes-Peristeen%c2%ae-guidance-to-treat-constipation-and-faecal-incontinence---_431292

Story on the Nursing Times – https://www.nursingtimes.net/news/policies-and-guidance/nice-backs-irrigation-device-for-constipation-and-incontinence/7023411.article

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