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
Process STA 2018
ID number 3748

Provisional Schedule

Committee meeting 08 December 2021
Expected publication 02 March 2022

Project Team

Project lead Shonagh D'Sylva

Email enquiries

Consultees

Companies sponsors Janssen (daratumumab)
Others Department of Health and Social Care
  NHS England
  NHS Leeds CCG
  NHS Vale Royal CCG
  Welsh Government
Patient carer groups Action on Pain
  Addenbrookes Liver Transplant Association
  Arthritis and Musculoskeletal Alliance
  British Liver Trust
  Cardiomyopathy UK
  Cardiovascular Care Partnership
  GUTS UK
  Kidney Care UK
  Kidney Research UK
  Liver4Life
  Muslim Council of Britain
  Myeloma UK
  National Kidney Federation
  Pain Concern
  Pain Relief Foundation
  Pain UK
  Polycystic Kidney Disease Charity
  Pumping Marvellous Foundation
  South Asian Health Foundation
  Specialised Healthcare Alliance
  UK ATTR Amyloidosis Patients’ Association
  UK Primary Immunodeficiency Network
  WMUK
Professional groups Association of Renal Technologists
  British Association for the Study of the Liver
  British Association of Urological Nurses
  British Geriatrics Society
  British Institute of Musculoskeletal Medicine
  British Liver Nurses Forum
  British Myology Society
  British Orthopaedic Association
  British Pain Society
  British Renal Society
  British Society of Rehabilitation Medicine
  British Society for Haematology
  British Society for Heart Failure
  Neuromodulation Society of UK and Ireland
  Physiotherapy Pain Association
  Renal Association
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society for DGH Nephrologists
  UK Clinical Pharmacy Association
  UK Renal Pharmacy Group

Commentators

Assessment group Public Health England
  Public Health Wales
Comparator companies ADVANZ Pharma (dexamethasone)
  Aspen (dexamethasone, melphalan)
  Aspire Pharma (bortezomib)
  Baxter Healthcare (cyclophosphamide)
  Consilient Health (dexamethasone)
  Dr Reddy’s Laboratories (bortezomib)
  Glenmark Pharmaceuticals Europe (dexamethasone)
  Hameln pharmaceuticals (dexamethasone)
  Hospira UK (dexamethasone)
  Martindale Pharma (dexamethasone)
  Novartis Pharmaceuticals (dexamethasone)
  Janssen-Cilag (bortezomib)
  Panpharma UK (dexamethasone)
  Rosemont Pharmaceuticals (dexamethasone)
  Sandoz (cyclophosphamide)
  Sun Pharmaceutical (melphalan)
  Thame Laboratories (dexamethasone)
  Thea Pharmaceuticals (dexamethasone)
  Thornton & Ross (bortezomib)
  Tillomed Laboratories (melphalan)
  Wockhardt UK (dexamethasone)
General commentators All Wales Therapeutics 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
  Hospital Information’s 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
  Welsh Health Specialised Services Committee
  Welsh Kidney Patients Association
Relevant research groups Bone Research Society
  Cochrane Kidney and Transplant Group
  Cochrane Hepato-Biliary Group
  Chronic Pain Policy Coalition
  Cochrane Musculoskeletal Group
  Foundation for Liver Research
  Genomics England
  Orthopaedic Research UK
  MRC Clinical Trials Unit
  National Institute for Health Research
  Pain Relief Foundation

Timeline

Key events during the development of the guidance:

Date Update
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 how we develop guidance, please see our page about NICE technology appraisal guidance