Suggested Remit - To appraise the clinical and cost-effectiveness of tagraxofusp within its marketing authorisation for treating patients with blastic plasmacytoid dendritic cell neoplasm
 
Status In progress
Process STA 2018
ID number 1556

Project Team

Project lead Louise Jafferally

Email enquiries

Evidence Review Group / Assessment Group Kleijnen Systematic Reviews Ltd

Consultees

Companies sponsors Stemline Therapeutics (tagraxofusp)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Leukaemia Care
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians

Commentators

Comparator companies Pfizer (cytarabine, idarubicin) (confidentiality agreement signed, participating)
  Accord Healthcare (azacitidine, cytarabine, fludarabine, idarubicin) (confidentiality agreement not signed, not participating)
  Celgene (azacitidine) (confidentiality agreement not signed, not participating)
  Chugai Pharma UK (lenograstim) (confidentiality agreement not signed, not participating)
  Sanofi (fludarabine) (confidentiality agreement not signed, not participating)
  Seacross Pharmaceuticals (azacitidine) (confidentiality agreement not signed, not participating)
General commentators British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
10 March 2021 As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of tagraxofusp for treating blastic plasmacytoid dendritic cell neoplasm. The company that makes tagraxofusp has requested that NICE pause this appraisal. This is because it is in the process of merging with another company. As such technical engagement will not take place at this time and the appraisal committee meeting will not be in May 2021 as previously scheduled.
30 September 2020 As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of tagraxofusp for treating blastic plasmacytoid dendritic cell neoplasm. Please note that following on from advice received from the company the timelines for this appraisal have been revised. We now anticipate that the Technical Engagement stage of this appraisal will begin during the first half of February 2021 and we will write to stakeholders then about how they can contribute to this.
07 May 2020 Invitation to participate
28 November 2019 This appraisal will be 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 NICE’s reporting targets for timeliness. In addition, as the delay will mean a NICE recommendation will not be available at the point of marketing authorisation, the company accepts that this drug will consequently not be eligible to receive interim CDF funding from the date of marketing authorisation as no NICE recommendation will be made at that point. For information, this appraisal is now anticipated to begin during early May 2020 when we will write to you about how you can get involved.
07 October 2019 (10:00) Scoping workshop (Manchester)
16 August 2019 - 16 September 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
08 May 2019 In progress. Referred 17 October 2018

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