To appraise the clinical and cost effectiveness of TYRX within its CE mark for preventing infection from cardiac implantable electronic devices.
The company has informed NICE that it will be withdrawing their evidence submission for this appraisal. Therefore, we are suspending the appraisal while we consider the next steps
 
Status Suspended
Decision Selected
Process STA 2018
ID number 1440

Project Team

Project lead Shonagh D'Sylva

Email enquiries

External Assessment Group Health Economics Research Unit and Health Services Research Unit, University of Aberdeen

Stakeholders

Companies sponsors Medtronic (TYRX Absorbable Antibacterial Envelope)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups A F Association
Professional groups British Cardiovascular Society
  British Society for Antimicrobial Chemotherapy
  Royal College of Physicians
  UK Clinical Pharmacy Association
Associated public health groups none
Comparator companies none
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Welsh Health Specialised Services Committee
Relevant research groups none

Timeline

Key events during the development of the guidance:

Date Update
07 February 2022 Suspended. The company has informed NICE that it will be withdrawing their evidence submission for this appraisal. Therefore, we are suspending the appraisal while we consider the next steps
19 August 2021 Following the appraisal committee meeting on Wednesday Thursday 4 August 2021, NICE has decided to pause this appraisal to allow the company to continue commercial discussions.
04 August 2021 Committee meeting: 1
04 May 2021 Please note that due to operational reasons the committee meeting (scheduled 9 June 2021) has been delayed. The committee meeting has now been scheduled to 4 August 2021.
05 May 2020 Schedule affected by COVID-19. Topic update: this appraisal has not been defined as therapeutically critical. The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide an update when this information is available.
12 November 2019 The Technology appraisal (ID1440) for TYRX Absorbable Antibacterial Envelope for preventing infection from cardiac implantable electronic devices has been suspended. Medtronic have offered a Patient Access Scheme, however, NHS England recently provided feedback that this proposal could not be operationalised. Consequently Medtronic requested NICE to suspend the Technology Appraisal while other options are explored.
29 March 2019 Invitation to participate
29 March 2019 In progress. The invitation to participate went out to the stakeholders.
13 September 2018 (10:00) Scoping workshop (London)
23 July 2018 - 20 August 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators

For further information on our processes and methods, please see our CHTE processes and methods manual