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

Expected publication 08 January 2025

Project Team

Project lead Vonda Murray

Email enquiries

External Assessment Group Peninsula Technology Assessment Group (PenTAG), University of Exeter

Stakeholders

Companies sponsors MEDICE Arzneimittel Pütter 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 Research UK
  UK Kidney Association
Professional groups Royal College of Radiologists
  Royal College of Physicians
Associated guideline groups None
Associated public health groups None
Comparator companies Amgen UK (darbepoetin alfa) confidentiality agreement not signed, not participating
  Janssen-Cilag (epoetin alfa) confidentiality agreement not signed, not participating
  Pfizer (epoetin zeta) confidentiality agreement not signed, not participating
  Roche Products UK (epoetin beta, methoxy polyethylene glycol-epoetin beta) confidentiality agreement not signed, not participating
Evidence review group Peninsula Technology Assessment Group (PenTAG)
General commentators All Wales Therapeutic and Toxicology Centre
  British National Formulary
  Department of Health - Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups None

Timeline

Key events during the development of the guidance:

Date Update
11 September 2024 Committee meeting: 1
22 April 2024 Evidence submission received
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