Suggested remit: To appraise the clinical and cost effectiveness of axicabtagene ciloleucel within its marketing authorisation for treating relapsed or refractory low-grade non-Hodgkin’s lymphoma.
 
Status In progress
Technology type Medicine
Decision Selected
Process STA 2018
ID number 1685

Provisional Schedule

Committee meeting 05 July 2022
Expected publication 14 September 2022

Project Team

Project lead Gavin Kenny

Email enquiries

External Assessment Group Health Economics Research Unit and Health Services Research Unit, University of Aberdeen

Stakeholders

Companies sponsors Kite, a Gilead company (axicabtagene ciloleucel)
Others • Department of Health and Social Care
  • NHS England
  • Welsh Government
Patient carer groups Lymphoma Action
Professional groups • Association of Cancer Physicians
  • Cancer Research UK
  • Royal College of Physicians
  • Royal College of Radiologists
Comparator companies • Accord Healthcare (bendamustine, fludarabine, doxorubicin, etoposide, mitoxantrone, prednisolone) (confidentiality agreement not signed, not participating)
  • Actavis (prednisolone) (confidentiality agreement not signed, not participating)
  • Advanz Pharma (prednisolone) (confidentiality agreement not signed, not participating)
  • Aspen (chlorambucil) (confidentiality agreement not signed, not participating)
  • Baxter Healthcare (cyclophosphamide, mitoxantrone) (confidentiality agreement not signed, not participating)
  • Bristol-Myers Squibb Pharmaceuticals (lenalidomide) (confidentiality agreement not signed, not participating)
  • Cheplapharm Arzneimittel GmbH (etoposide) (confidentiality agreement not signed, not participating)
  • Dr. Reddy’s Laboratories (bendamustine) (confidentiality agreement not signed, not participating)
  • Hospira UK (mitoxantrone, vincristine) (confidentiality agreement not signed, not participating)
  • Janssen-Cilag (doxorubicin)
  • Logixx Pharma Solutions (prednisolone) (confidentiality agreement not signed, not participating)
  • Medac GmbH (doxorubicin, etoposide) (confidentiality agreement not signed, not participating)
  • Napp Pharmaceuticals (rituximab) (confidentiality agreement not signed, not participating)
  • Pfizer (doxorubicin, rituximab) (confidentiality agreement not signed, not participating)
  • Phoenix Labs (prednisolone) (confidentiality agreement not signed, not participating)
  • Roche Products (obinutuzumab, rituximab)
  • Sandoz (cyclophosphamide, rituximab) (confidentiality agreement not signed, not participating)
  • Sanofi (fludarabine) (confidentiality agreement not signed, not participating)
  • Seacross Pharmaceuticals (bendamustine, doxorubicin) (confidentiality agreement not signed, not participating) (confidentiality agreement not signed, not participating)
  • Teva UK (fludarabine) (confidentiality agreement not signed, not participating)
  • Wockhardt UK (prednisolone) (confidentiality agreement not signed, not participating)
  • Zentiva (bendamustine, prednisolone) (confidentiality agreement not signed, 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
  • 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
25 October 2021 Invitation to participate
07 June 2021 - 05 July 2021 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
21 May 2021 Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during mid-August 2021 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately late October 2021.
28 May 2020 The National Institute for Health and Care Excellence (NICE) has been asked to conduct an appraisal of axicabtagene ciloleucel for treating relapsed or refractory low-grade non-Hodgkin lymphoma ID1685. We have recently invited stakeholders to respond to a written consultation on the draft scope. On receiving updated regulatory timing information from the company that is developing axicabtagene ciloleucel, NICE has agreed that holding a scoping exercise at this time would not be appropriate. Consequently, the consultation on the draft scope will be closed. The scoping exercise will be rescheduled to take place in line with anticipated regulatory approval timings. We apologise for any inconvenience this may cause. If you have any comments or concerns please contact the project manager for this proposed appraisal Emily Richards on (44 (0)161 413 4070 or via email on emily.richards@nice.org.uk).
24 January 2020 In progress. DHSC referral received 18/10/2018

For further information on our processes and methods, please see our CHTE processes and methods manual