Background

The client­ is a global manufacturer of personal healthcare products that have a number of CE marked medical devices and accessories on the market. One of their products, launched in 2003, had acquired a body of evidence (both published and unpublished) from clinicians and patients, and a review of this data suggested that this product could be suitable for inclusion into NICE guidelines.

The CHEATA Solution

The client engaged with CHEATA to undertake the following work

  • 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 and to generate an economic model within the defined patient segment and care pathway.
  • Advise on the commercial benefits and risks in making a submission to NICE.
  • Preparation of the Briefing Notification submitted to NICE
  • Preparation of the Sponsors Submission of Evidence Form
  • Completion of the NICE Evaluation process – still on-going

Outcome

The submission to the NICE Medical Technology Evaluation Programme was successful and CHEATA are continuing to work with the client to complete the process by collating and preparing the information requested by NICE to enable a full assessment on the device to be carried out and a decision to be made on whether to include the product in updated Guidelines.

The potential benefit for the client is anticipated to be increased awareness of the product and associated sales should their product be included in the updated Guidelines when they are published.