Status In progress
Process STA pre-2018
ID number 910

Provisional Schedule

Expected publication 22 August 2018

Project Team

Project lead Kate Moore

Email enquiries


Companies sponsors EUSA Pharma
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Children’s Cancer and Leukaemia Group
  Neuroblastoma UK
  Solving Kids Cancer Europe
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists


Comparator companies Alliance Pharma (isotretinoin)
  Roche (isotretinoin)
  United Therapeutics (dinutuximab)
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
Relevant research groups Institute of Cancer Research
  National Cancer Research Institute
  National Institute for Health Research


Key events during the development of the guidance:

Date Update
12 July 2018 - 26 July 2018 Final appraisal determination
12 June 2018 Committee meeting: 3
04 May 2018 - 29 May 2018 Appraisal consultation: 1
11 April 2018 Committee meeting: 2
28 February 2018 Further to our request, the company (EUSA Pharma) have provided further information related to this appraisal, which has been sent to the Decision Support Unit for review. This evidence and review will be considered by committee at the technology appraisal committee meeting on 11 April 2018.
17 January 2018 NICE has requested further information from the company, EUSA Pharma, before the committee can make a decision on this technology and we have been working with the company on this data request. The company are not in a position to provide this information in time for it to be considered at the meeting we provisionally scheduled in February 2018. As a result, the discussion of this topic has been taken off the February agenda. We are working on re-scheduling this discussion, and will update you as soon as we have more information.
23 November 2017 Committee meeting: 1
04 August 2017 We have been made aware of a key meeting in the field of neuroblastoma that clashes with the first appraisal committee meeting, originally scheduled for 26 October 2017, which has severely limited the availability of clinical and patient experts for this appraisal. Given the importance of participation from both clinical and patient experts at the first committee meeting, the decision has been made to move the first discussion to 23 November 2017.
20 February 2017 Towards the end of 2016, the ownership of APN311 (also known as dinutuximab beta) transferred from Apeiron Biologics to EUSA Pharma. As a result of this, EUSA Pharma has regretfully had to inform NICE that it is unable to provide an evidence submission for this appraisal in line with the scheduled timelines. Therefore, we have had to cancel the scheduled committee meetings. Please be assured that EUSA Pharma and NICE are actively engaging in discussions to establish updated timelines for the company submission, so that we can re-schedule this appraisal accordingly. We will provide a further update as soon as we have more details.
26 August 2016 Invitation to participate
02 June 2016 Draft scope documents
13 May 2016 Referral

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