Suggested remit: To appraise the clinical and cost effectiveness of daratumumab within its marketing authorisation in combination for newly diagnosed systemic amyloid light-chain amyloidosis.
 
Status In progress
Decision Selected
Process STA 2018
ID number 3748

Project Team

Project lead Shonagh D'Sylva

Email enquiries

External Assessment Group Centre for Reviews and Dissemination and Centre for Health Economics, University of York

Stakeholders

Companies sponsors Janssen (daratumumab)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Cardiomyopathy UK
  Myeloma UK
Professional groups British Cardiovascular Society
  British Society for Heart Failure
  Renal Association
  Royal College of Pathologists
  Royal College of Physicians
Associated public health groups Public Health England
  Public Health Wales
Comparator companies ADVANZ Pharma (dexamethasone) - not participating
  Aspen (dexamethasone, melphalan) - not participating
  Aspire Pharma (bortezomib) - not participating
  Baxter Healthcare (cyclophosphamide) - not participating
  Consilient Health (dexamethasone)- not participating
  Dr Reddy’s Laboratories (bortezomib) - not participating
  Glenmark Pharmaceuticals Europe (dexamethasone) - not participating
  Hameln pharmaceuticals (dexamethasone) - not participating
  Hospira UK (dexamethasone) - not participating
  Martindale Pharma (dexamethasone) - not participating
  Novartis Pharmaceuticals (dexamethasone) - not participating
  Janssen-Cilag (bortezomib)
  Panpharma UK (dexamethasone) - not participating
  Rosemont Pharmaceuticals (dexamethasone) - not participating
  Sandoz (cyclophosphamide) - not participating
  Sun Pharmaceutical (melphalan) - not participating
  Thame Laboratories (dexamethasone) - not participating
  Thea Pharmaceuticals (dexamethasone) - not participating
  Thornton & Ross (bortezomib) - not participating
  Tillomed Laboratories (melphalan) - not participating
  Wockhardt UK (dexamethasone) - not participating
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
09 March 2022 The company has requested a delay to the second committee meeting to allow them time collect more information to address concerns highlighted in the appraisal consultation document. We have accepted this request and are looking to reschedule the committee meeting for the summer 2022. We will provide a further update when a meeting date has been set.
20 January 2022 - 10 February 2022 Draft guidance: 1
08 December 2021 Committee meeting
20 April 2021 Invitation to participate
20 November 2020 The Department for Health and Social Care has asked NICE to conduct an appraisal of daratumumab (in combination) for untreated systemic amyloid light-chain amyloidosis. 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-Apr 2021 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately late June 2021. These timelines are based on a request from the company for a three month delay to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive submission.
20 November 2020 In progress. Topic is in progress
14 September 2020 (10:00) Scoping workshop
15 July 2020 - 12 August 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators

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