Suggested remit - To appraise the clinical and cost effectiveness of mogamulizumab within its marketing authorisation for treated mycosis fungoides or Sézary syndrome cutaneous T-cell lymphoma
 
Status In progress
Process STA 2018
ID number 1405

Provisional Schedule

Committee meeting: 1 07 July 2020
Expected publication 16 September 2020

Project Team

Project lead Louise Jafferally

Email enquiries

Evidence Review Group / Assessment Group Kleijnen Systematic Reviews Ltd

Consultees

Companies sponsors Kyowa Kirin (mogamulizumab)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Lymphoma Action
  Leukaemia CARE
Professional groups Association of Cancer Physicians
  British Association of Dermatologists
  British Society for Haematology
  Cancer Research UK
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists

Commentators

Comparator companies Takeda (brentuximab vedotin), (CAU form received, participating)
  Accord Healthcare (methotrexate), (CAU form not received, not participating)
  ADVANZ Pharma (methotrexate) (CAU form not received, not participating)
  Cipla EU (methotrexate) (CAU form not received, not participating)
  Eisai (bexarotene) (CAU form not received, not participating)
  Hospira UK (methotrexate) (CAU form not received, not participating)
  medac (methotrexate) (CAU form not received, not participating)
  Nordic Pharma (methotrexate) (CAU form not received, not participating)
  Orion Pharma (methotrexate) (CAU form not received, not participating)
  Pfizer (methotrexate) (CAU form not received, not participating)
  Roche Products (interferon alfa-2a) (CAU form not received, not participating)
  Rosemont Pharmaceuticals (methotrexate) (CAU form not received, not participating)
  Sandoz (methotrexate) (CAU form not received, not participating)
  Therakind (methotrexate) (CAU form not received, not participating)
General commentators All Wales Therapeutics & Toxicology Centre
  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
24 October 2019 Invitation to participate
09 May 2019 - 07 June 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
27 March 2019 As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of mogamulizumab for previously treated cutaneous T-cell lymphoma (mycosis fungoides or Sézary syndrome). Please note that following on from advice received from the company the timelines for this appraisal have been revised. We now anticipate that the appraisal will begin during early October 2019 when we will write to you about how you can get involved.
07 June 2018 This appraisal has been rescheduled following an update from the company. The appraisal is now anticipated to begin in early July 2019 with a submission deadline anticipated late August/early September 2019. 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 authorization.
12 March 2018 - 11 April 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
05 December 2017 In progress, Topic referred

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