Suggested remit: To appraise the clinical and cost effectiveness of vadadustat within its marketing authorisation for treating anaemia in adults with chronic kidney disease.
 
Status In progress
Technology type Medicine
Decision Selected
Process STA Standard
ID number 3821

Provisional Schedule

Evidence submission received 22 April 2024
Committee meeting: 1 11 September 2024
Expected publication 20 November 2024

Project Team

Project lead Vonda Murray

Email enquiries

Stakeholders

Companies sponsors MEDICE Arzneimittel PĆ¼tter GmbH & Co
  Akebia Therapeutics Inc
Others Department of Health and Social Care
  Health Technology Wales (HTW)
  NHS England
Patient carer groups Kidney Care UK
  Kidney Patient Involvement Network
  Kidney Research UK
  National Kidney Federation
  Polycystic Kidney Disease Charity
  South Asian Health Foundation
  Specialised Healthcare Alliance
Professional groups Anaemia Nurse Specialist Association
  Association of Nephrology Nurses
  Association of Renal Technologists
  British Association of Urological Nurses
  British Association of Urological Surgeons
  British Committee for Standards in Haematology
  British Geriatrics Society
  British Society for Genetic Medicine
  British Society for Haematology
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Radiologists
  Royal College of Pathologists
  Royal College of Physicians
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society for DGH Nephrologists
  UK Clinical Pharmacy Association
  UK Forum on Haemoglobin Disorders
  UK Kidney Association
  UK National Screening Committee
  UK Renal Pharmacy Group
  United Kingdom Primary Immunodeficiency Network
  Urology Foundation
Associated guideline groups NICE - National Guideline Centre
  NICE - National Guideline Alliance
  National Institute for Health and Care Excellence
Associated public health groups Public Health Wales
  UK Health Security Agency
Comparator companies Amgen UK (darbepoetin alfa)
  Janssen-Cilag (epoetin alfa)
  Pfizer (epoetin zeta)
  Roche Products UK (epoetin beta, methoxy polyethylene glycol-epoetin beta)
Evidence review group Peninsula Technology Assessment Group (PenTAG)
  National Institute for Health Research Health Technology Assessment Programme (NETSCC)
General commentators All Wales Therapeutic and Toxicology Centre
  Allied Health Professionals Federation
  Association of Renal Industries
  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
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Alliance
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups Cochrane Kidney and Transplant Group
  Cochrane UK
  Genomics England
  MRC Clinical Trials Unit
  National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
12 February 2024 Invitation to participate
15 December 2023 - 12 January 2024 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 2
11 December 2023 Draft scope documents
13 September 2023 Please note that following on from information received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin during mid-March 2024 when we will write to you about how you can get involved.
25 July 2023 Please note that following on from advice received from the company, further information regarding the timelines for this appraisal will be available in due course. In the meantime, NICE will continue to monitor the situation and will provide an update as and when the situation changes.
16 May 2023 Following the changes to remove technical engagement as standard from appraisal timelines, the timelines for the appraisal of Vadadustat for treating anaemia in people with chronic kidney disease [ID3821] have been revised. It is anticipated that the appraisal will begin in early-August 2023 when we will write to you about how you can get involved.
13 September 2022 As you will be aware, the Department for Health & Social Care has asked NICE to conduct an appraisal of Vadadustat within its marketing authorisation for treating anaemia in people with chronic kidney disease. 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 early-August 2023. 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.
28 March 2022 - 27 April 2022 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
18 February 2021 In progress. DHSC referral received

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