Suggested remit: To appraise the clinical and cost effectiveness of bulevirtide within its marketing authorisation for treating chronic hepatitis D.
 
Status In progress
Technology type Medicine
Decision Selected
Process STA 2018
ID number 3732

Provisional Schedule

Committee meeting: 1 13 October 2022
Expected publication 11 January 2023

Project Team

Project lead Daniel Davies

Email enquiries

External Assessment Group BMJ Technology Assessment Group (BMJ-TAG), BMJ

Stakeholders

Companies sponsors MYR Pharmaceuticals (bulevirtide)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups The Hepatitis B Trust
Professional groups British Association for Sexual Health and HIV
  British Association for the Study of the Liver
  British HIV Association (BHIVA)
  Royal College of Pathologists
  Royal College of Physicians
Assessment group None
Associated public health groups UK Health Security Agency
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
  Medicines and Healthcare products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee

Timeline

Key events during the development of the guidance:

Date Update
14 February 2022 Invitation to participate
03 December 2021 In progress. Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in mid-February 2022. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission.
15 September 2021 As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of bulevirtide for treating chronic hepatitis D. Following on from the email that was sent during March 2021 where we informed consultees and commentators that this appraisal was paused due to the company requesting a delay with timelines of this appraisal whilst further clinical evidence was collected. I am now writing to inform that we will be restarting the appraisal in November (invitation to participate will be reissued) with an anticipated deadline for submissions expected in approximately mid- January 2022 and an appraisal committee meeting date anticipated for mid-July 2022.
25 March 2021 Suspended. Following the invitation to participate, the company has requested a delay in the timings of this appraisal while further clinical evidence is collected. Therefore, this appraisal will be paused. We anticipate to re-start the appraisal in October 2021. We will provide updates to stakeholders as work progresses.
22 January 2021 The Department for Health and Social Care has asked NICE to conduct an appraisal of Bulevirtide for treating chronic hepatitis D. Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in mid-March 2021 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately mid May 2021. These timelines are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive submission.
22 January 2021 In progress. Topic is in progress

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