Lenalidomide for the maintenance treatment of multiple myeloma after autologous stem cell transplantation
 
Status In progress
Process STA pre-2018
ID number 475
Referral date 01 July 2011
Topic area
  • Cancer

Provisional Schedule

Closing date for invited submissions / evidence submission: TBC
1st appraisal committee meeting: TBC
Committee meeting: 1 13 August 2020
Expected publication 28 October 2020

Project Team

Project lead Jeremy Powell

Email enquiries

Consultees

Companies sponsors Celgene (lenalidomide)
Others Department of Health and Social Care
  NHS England
  NHS Islington
  NHS Liverpool
  Welsh Government
Patient carer groups African Caribbean Leukaemia Trust
  Anthony Nolan
  Black Health Agency
  Bloodwise
  Cancer Black Care
  Cancer Equality
  Cancer 52
  DKMS
  Helen Rollason Heal Cancer Charity
  Independent Cancer Patients Voice
  Leukaemia Cancer Society
  Leukaemia CARE
  Leukaemia UK
  Lymphoma Action
  Macmillan Cancer Support
  Maggie’s Centres
  Marie Curie
  Muslim Council of Britain
  Myeloma UK
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Tenovus Cancer Care
Professional groups Association of Cancer Physicians
  British Blood Transfusion Society
  British Committee for Standards in Haematology
  British Geriatrics Society
  British Psychosocial Oncology Society
  British Society for Haematology
  British Transplantation Society
  Cancer Research UK
  ESPIRIT
  NHS Blood and Transplant
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society and College of Radiographers
  UK Clinical Pharmacy Association
  UK Myeloma Forum
  UK Oncology Nursing Society

Commentators

Associated public health groups Public Health England
  Public Health Wales
Comparator companies Accord (Lenalidomide Accord)
  Amgen (carfilzomib)
  Aspen (melphalan)
  Aspire Pharma (Bortezomib)
  Celgene (thalidomide)
  Janssen (bortezomib)
  Sun Pharma (melphalan)
General commentators 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
  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
Relevant research groups Cochrane Haematological Malignancies Group
  Genomics England
  Institute of Cancer Research
  Leuka
  Leukaemia Busters
  MRC Clinical Trials Research Unit
  National Cancer Research Institute
  National Cancer Research Network
  National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
12 December 2019 Invitation to participate
08 July 2019 In progress, Following on from advice received from Celgene, the timelines for this appraisal have been revised and the appraisal is now anticipated to formally begin in early December 2019.
16 April 2019 Suspended, NICE have been in contact with Celgene about a revised submission date and will be in a position next month to provide an update about rescheduling the Single Technology Appraisal for lenalidomide as maintenance treatment of multiple myeloma after autologous stem cell transplantation (ID475).
08 December 2016 Suspended, NICE have agreed to reschedule the Single Technology Appraisal for lenalidomide as maintenance treatment of multiple myeloma after autologous stem cell transplantation (ID475). Celgene have advised NICE that they do not yet have access to the required data and therefore their submission is still in development. We will provide an update once we can confirm rescheduling dates
10 August 2016 In progress, We have recently received advice from the company that they have now re-submitted their regulatory dossier to the EMA and this appraisal has therefore been rescheduled back into the work programme.
10 July 2012 The Manufacturer has informed NICE that it has withdrawn its application for the new licence indications for Lenalidomide and that it now plans to re-submit with more mature data. Therefore, we are suspending this appraisal whilst we consider the next steps and the Appraisal Committee meeting scheduled for Wednesday 11 October has been cancelled.
12 January 2012 Following on from advice received from the manufacturer, this appraisal has now been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during early May 2012 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately early July 2012.

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance