This appraisal has formally started now, in line with the anticipated regulatory timelines. However, the Gilead has informed us that they will not provide an evidence submission for this appraisal. NICE will therefore suspend this appraisal with immediate effect.
 
Status Suspended
Decision Selected
Process STA pre-2018
ID number 839

Project Team

Project lead Stephanie Yates

Email enquiries

External Assessment Group BMJ Evidence Centre, BMJ Group

Stakeholders

Companies sponsors Gilead Sciences (idelalisib)
Others Department of Health
  NHS England
  Welsh Government
Patient carer groups Leukaemia CARE
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists
Comparator companies Accord Healthcare (fludarabine) (not participating, confidentiality agreement not signed)
  Actavis (fludarabine) (not participating, confidentiality agreement not signed)
  Allergan (fludarabine) (not participating, confidentiality agreement not signed)
  Aspen Pharma (chlorambucil) (not participating, confidentiality agreement not signed)
  Baxter Healthcare (cyclophosphamide) (not participating, confidentiality agreement not signed)
  Genzyme (fludarabine) (not participating, confidentiality agreement not signed)
  GlaxoSmithKline (chlorambucil,) (not participating, confidentiality agreement not signed)
  Hospira UK (fludarabine) (not participating, confidentiality agreement not signed)
  Janssen (ibrutinib)
  Pfizer (cyclophosphamide)
  Roche Products (rituximab) (not participating, confidentiality agreement not signed)
  Sandoz (cyclophosphamide) (not participating, confidentiality agreement not signed)
  Sanofi (fludarabine) (not participating, confidentiality agreement not signed)
  Teva UK (fludarabine) (not participating, confidentiality agreement not signed)
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 Institute of Cancer Research
  National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
10 May 2018 The company have now advised that have withdrawn their marketing authorisation application from the European Medicines Authority (EMA) for this indication at this time. Therefore, this appraisal will remain suspended. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes. For more information, please see the EMA website: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2018/02/WC500244301.pdf
03 May 2017 Suspended. This appraisal has formally started now, in line with the anticipated regulatory timelines. However, the Gilead has informed us that they will not provide an evidence submission for this appraisal. NICE will therefore suspend this appraisal with immediate effect.
03 May 2017 Invitation to participate
08 June 2016 Referral

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