See note
 
Status Suspended
Process STA
ID number 799
Referral date 01 March 2015

Project Team

Project lead Kate Moore

Email enquiries

Consultees

Companies sponsors United Therapeutics (dinutuximab)
Others Department of Health
  NHS England
  Welsh Government
Patient carer groups Children’s Cancer and Leukaemia Group
  Neuroblastoma UK
  Solving Kids Cancer
Professional groups Cancer Research UK
  Royal College of Nursing
  Royal College of Paediatrics and Child Health
  Royal College of Physicians

Commentators

Associated public health groups None
Comparator companies Alliance Pharma (isotretinoin) (CA&U not returned, not participating)
  Roche (isotretinoin)
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 National Cancer Research Institute

Timeline

Key events during the development of the guidance:

Date Update
17 February 2017 The company, United Therapeutics Corporation (UTC) has informed NICE that the commercial and investigational demands for dinutuximab in the United States (US) have significantly exceeded expectations and are outstripping the company’s ability to supply enough medicine to meet all global needs. Therefore, UTC has been taking steps to address this issue. It noted that manufacturing this type of medicine (a monoclonal antibody; also referred to as a biologic) is complicated and must be done in specialized facilities; thus, the amount of medicine that can be produced is currently limited. UTC is in the process of expanding its production capacity and it will take approximately 3 years to complete the new manufacturing facility and gain regulatory approval before the company can begin producing significantly more dinutuximab; the company expects this expansion will quadruple the supply of dinutuximab. UTC has stated that, in the meantime, its priorities are maintaining supply of dinutuximab for the treatment of paediatric patients with high-risk neuroblastoma in the US, where it is already commercially available, and supplying ongoing clinical development programmes. Therefore, dinutuximab will not be available outside of the US until such time UTC is confident it can meet the needs in additional countries. If you have questions or concerns regarding the availability of dinutuximab, please contact UTC’s Global Medical Information department at druginformation@unither.com Given this information, NICE has taken the decision to suspend the ongoing appraisal of dinutuximab until there is certainty about the availability of dinutuximab in England.
17 February 2017 Suspended, See note
29 November 2016 Appeal decision
30 September 2016 Appeal
07 July 2016 - 28 July 2016 Final appraisal determination: 2
26 May 2016 Committee meeting: 3
05 May 2016 The company have requested the opportunity to make a further submission including a patient access scheme, which will be reviewed by the evidence review group (ERG). The company submission and the ERG’s review will be considered at a committee meeting discussion on 26 May 2016.
14 April 2016 A final appraisal determination (FAD) for the technology appraisal of dinutuximab for treating high-risk neuroblastoma [ID799] was sent to consultees and commentators on Thursday 24 March 2016. In the time period since issuing the FAD to consultees and commentators, the company that markets dinutuximab (United Therapeutics Corporation), has requested to make a further submission including a patient access scheme. In recognition of the exceptional nature of this request, NICE has agreed that the appraisal can be referred back to the appraisal committee. The appeal stage of this appraisal topic has been suspended. This will allow the company to submit, and the appraisal committee to consider, the new evidence. We are withdrawing the FAD, it will not be published on our web site and its content remains confidential.
27 January 2016 Committee meeting: 2
05 November 2015 - 25 November 2015 Appraisal consultation
06 October 2015 Committee meeting: 1
07 May 2015 Invitation to participate

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