Suggested remit: To appraise the clinical and cost effectiveness of erythrocyte encapsulated asparaginase within its marketing authorisation for treating acute lymphoblastic leukaemia.
As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal (STA) of erythrocyte encapsulated asparaginase within its marketing authorisation for treating acute lymphoblastic leukaemia. For information, the company have now advised that they will not be pursuing a marketing authorisation application for erythrocyte encapsulated asparaginase from the European Medicines Authority for this indication at this time. Therefore, NICE has decided to cancel the consultation for this topic at this time and suspend this appraisal on its work programme. As the appraisal has been referred, NICE will continue to monitor any developments and provide an update as and when the situation changes.
 
Status Suspended
Process STA 2018
ID number 864

Project Team

Project lead Michelle Adhemar

Email enquiries

Evidence Review Group / Assessment Group Centre for Reviews and Dissemination and Centre for Health Economics, University of York

Consultees

Companies sponsors Orphan Europe
Others Department of Health
  NHS England
  NHS Cumbria CCG
  NHS Redditch and Bromsgrove CCG
  Welsh Government
Patient carer groups Leukaemia CARE
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists

Commentators

Associated public health groups None
Comparator companies Shire Pharmaceuticals (pegylated asparaginase)
  Jazz Pharmaceuticals (Erwinia-derived asparaginase)
  Medac GmbH (E.coli asparaginase) (no confidentiality agreement signed not participating)
General commentators British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
27 June 2018 - 25 July 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
06 July 2018 As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal (STA) of erythrocyte encapsulated asparaginase within its marketing authorisation for treating acute lymphoblastic leukaemia. For information, the company have now advised that they will not be pursuing a marketing authorisation application for erythrocyte encapsulated asparaginase from the European Medicines Authority for this indication at this time. Therefore, NICE have cancelled the consultation for this topic and have decided to suspend this appraisal on its work programme. As the appraisal has been referred, NICE will continue to monitor any developments and provide an update as and when the situation changes.
06 July 2018 Suspended, As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal (STA) of erythrocyte encapsulated asparaginase within its marketing authorisation for treating acute lymphoblastic leukaemia. For information, the company have now advised that they will not be pursuing a marketing authorisation application for erythrocyte encapsulated asparaginase from the European Medicines Authority for this indication at this time. Therefore, NICE has decided to cancel the consultation for this topic at this time and suspend this appraisal on its work programme. As the appraisal has been referred, NICE will continue to monitor any developments and provide an update as and when the situation changes.
05 July 2018 As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal (STA) of erythrocyte encapsulated asparaginase within its marketing authorisation for treating acute lymphoblastic leukaemia. For information, the company have now advised that they will not be pursuing a marketing authorisation application for erythrocyte encapsulated asparaginase from the European Medicines Authority for this indication at this time. Therefore, NICE has decided to suspend this appraisal on its work programme. We have therefore cancelled the consultation for this topic at this stage. As the appraisal has been referred, NICE will continue to monitor any developments and provide an update as and when the situation changes.
28 October 2016 Suspended, the company that markets the technology has informed NICE of a delay to regulatory proceedings, therefore they will not provide an evidence submission for this appraisal at this time. NICE will suspend this appraisal and provide further updates when they are available.
08 August 2016 Invitation to participate
01 April 2016 Draft scope documents
15 March 2016 Referral
15 March 2016 In progress, DHSC referral received

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