Status In progress
Process STA 2018
ID number 981

Provisional Schedule

Expected publication 20 November 2019

Project Team

Project lead Thomas Feist

Email enquiries


Companies sponsors Pierre-Fabre Ltd (from April 2019)
  Puma Biotechnology (until March 2019)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Breast Cancer Care
  Breast Cancer Now
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists
  UK Breast Cancer Group


Evidence review group Kleijnen Systematic Reviews Ltd (KSR)
  National Institute for Health Research Health Technology Assessment Programme (NETSCC)
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Department of Health and Social Services and Public Safety, Northern Ireland (DHSSPSNI)
  Healthcare Improvement Scotland
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research
  National Cancer Research Institute (NCRI)


Key events during the development of the guidance:

Date Update
11 September 2019 Committee meeting: 2
07 August 2019 - 28 August 2019 Appraisal consultation
16 July 2019 Committee meeting: 1
15 November 2018 Invitation to participate
19 October 2018 Draft scope documents
18 October 2018 Please note that during February 2018 the company advised NICE that the Committee for Medicinal Products for Human Use (CHMP) had adopted a negative opinion for neratinib in this indication. Therefore, NICE decided to suspend this appraisal on its work programme. The company advised that they would be appealing the decision and had submitted a re-examination application to the European Medicines Agency. CHMP granted a positive opinion during June 2018 and therefore, this appraisal has been rescheduled into the work programme. The appraisal is anticipated to begin in mid-November 2018 with an evidence submission deadline to NICE of early February 2019.
22 November 2017 In progress, This appraisal has been rescheduled to allow the company to include important data to be presented in their submission. This delay means that this appraisal will be removed from the NICE’s reporting targets for timeliness. In addition, through this request for delay the company accepts that this drug will not be eligible to receive interim CDF funding from the date of marketing authorisation.
15 February 2017 Suspended, The Appraisal Committee was due to meet on 05 July 2017 to discuss the use of neratinib for treating early HER2-positive breast cancer after adjuvant trastuzumab. The company has informed NICE that they are unable to provide an evidence submission for this appraisal within the required timelines. Therefore, we will suspend the appraisal whilst we consider the next steps. Consequently the discussion of this appraisal at the committee meeting on 05 July 2017 has been cancelled. Please be assured we will update you on our progress and next steps as soon as possible.
26 January 2017 Invitation to participate
08 June 2016 Referral

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