Suggested remit: To appraise the clinical and cost effectiveness of pacritinib within its marketing authorisation for treating myelofibrosis.
Suspended
 
Status Suspended
Process STA pre-2018
ID number 880

Project Team

Project lead Gemma Barnacle

Email enquiries

Consultees

Companies sponsors CTI BioPharma (pacritinib)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Leukaemia CARE
  MPN Voice
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists

Commentators

Comparator companies Bristol-Myers Squibb (hydroxycarbamide)- confidentiality form not signed, not participating
  Celgene (lenalidomide, thalidomide) - confidentiality form not signed, not participating
  Medac UK (hydroxycarbamide) - confidentiality form not signed, not participating
  Nordic (hydroxycarbamide) - confidentiality form not signed, not participating
  Novartis (ruxolitinib)
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 Cancer Research Institute

Timeline

Key events during the development of the guidance:

Date Update
06 February 2019 Suspended, Suspended
06 February 2019 On 1 February 2019, the company (CTI BioPharma) announced that the they will withdraw its European Marketing Authorization Application (MAA) for pacritinib. This is because the company learned from the regulator that it is likely to formally adopt a negative opinion in its evaluation of pacritinib for this indication. Therefore, this appraisal will be suspended. We will continue to monitor any developments and will update stakeholders if the situation changes.
27 November 2018 Committee meeting: 1
29 June 2018 Invitation to participate
10 April 2018 - 09 May 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
19 May 2017 The company have advised that they will re-submit a Marketing Authorisation Application in June/July 2017 including a recently completed Phase 3 study (PAC326) “A randomized, Controlled Study of Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Mylofibrosis” and be pursuing a licence for pacritinib from the European Medicines Authority for this indication after the re-submission. Therefore, NICE has decided to suspend this appraisal from its work programme at this point.
08 June 2016 Referral

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