Suggested remit: To appraise the clinical and cost effectiveness of bulevirtide within its marketing authorisation for treating chronic hepatitis D.
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.
 
Status Suspended
Process STA 2018
ID number 3732

Provisional Schedule

Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators 25 November 2021 - 16 December 2021
Expected publication 28 July 2022

Project Team

Project lead Shonagh D'Sylva

Email enquiries

Evidence Review Group / Assessment Group BMJ Technology Assessment Group (BMJ-TAG), BMJ

Consultees

Companies sponsors MYR Pharmaceuticals (bulevirtide)
Others Department of Health and Social Care
  NHS Barking & Dagenham CCG
  NHS England
  NHS Northumberland CCG
  Welsh Government
Patient carer groups Addenbrookes Liver Transplant Association
  African Health Policy Network (AHPN)
  Black Health Agency for Equality
  British Liver Trust
  Compass UK
  GMFA - The Gay Men’s Health Charity
  Hepatitis B Positive Trust
  HIV i-Base
  Lifeline Project
  Liver4Life
  NAM publications
  National AIDS Trust
  Release
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Terrence Higgins Trust
  The Hepatitis B Foundation UK
  UK Harm Reduction Alliance
  We Are With You
Professional groups Association of Clinical Biochemists – Microbiology Section
  Association of Surgeons of Great Britain and Ireland
  British Association for Sexual Health and HIV
  British Association for the Study of the Liver
  British Blood Transfusion Society
  British Committee for Standards in Haematology
  British Geriatrics Society
  British HIV Association (BHIVA)
  British Infection Association
  British Liver Nurses Association
  British Society for Haematology
  British Society of Gastroenterology
  British Viral Hepatitis Group
  Hepatitis Nurse Specialist Forum
  Infection Prevention Society
  Microbiology Society
  National Association of Primary Care (NAPC)
  NHS Blood and Transplant
  Primary Care Society for Gastroenterology
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Surgeons of England
  Royal Pharmaceutical Society
  Royal Society of Medicine
  UK Clinical Pharmacy Association
  UK Clinical Virology Network
  UK Harm Reduction Alliance

Commentators

Assessment group Cochrane Hepato-Biliary Group
  Cochrane Infectious Diseases Group
  Foundation for Liver Research
  MRC Clinical Trials Unit
  National Institute for Health Research
  UCL Centre for Sexual Health & HIV Research
  UK National Screening Committee
Associated public health groups Public Health England
  Public Health Wales
Comparator companies Roche (Peginterferon alfa-2a)
General commentators Alcohol and Drugs Action (ADA)
  All Wales Therapeutics and Toxicology Centre
  Allied Health Professionals Federation
  Board of Community Health Councils in Wales
  British National Formulary
  Care Quality Commission
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Hepatitis Scotland
  Hospital Information Services - Jehovah's Witnesses
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Alliance
  NHS Confederation
  Scottish Medicines Consortium
  Scottish Society of Gastroenterology
  Welsh Health Specialised Services Committee

Timeline

Key events during the development of the guidance:

Date Update
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.
09 March 2021 Invitation to participate
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 how we develop guidance, please see our page about NICE technology appraisal guidance