Suggested remit: To appraise the clinical and cost effectiveness of glofitamab with gemcitabine and oxaliplatin within its marketing authorisation for treating relapsed or refractory diffuse large B-cell lymphoma.

Status:
In progress
Technology type:
Medicine
Decision:
Selected
Reason for decision:
Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Process:
STA Standard
ID number:
6202

Provisional Schedule

Draft guidance: 1:
29 July 2025 - 19 August 2025

Project Team

Project lead
Leena Issa

Email enquiries

If you have any queries please email [email protected]


External Assessment Group:
Southampton Health Technology Assessment Centre (SHTAC), University of Southampton

Stakeholders

Companies sponsors
Roche Products (glofitamab)
Others
Department of Health and Social Care
 
NHS England
Patient carer groups
Blood Cancer UK
 
Lymphoma Action
Professional groups
Association of Cancer Physicians
 
Cancer Research UK
 
Royal College of Physicians
 
Royal College of Radiologists
Associated public health groups
None
Comparator companies
AbbVie (epcoritamab) (confidentiality agreement signed, participating)
 
Bristol-Myers Squibb Pharmaceuticals (etoposide) (confidentiality agreement signed, participating)
 
Kite, a Gilead company (axicabtagene ciloleucel) (confidentiality agreement signed, participating)
 
Swedish Orphan Biovitrum (loncastuximab tesirine) (confidentiality agreement signed, participating)
 
Accord Healthcare (bendamustine, etoposide, gemcitabine, prednisolone, oxaliplatin) (confidentiality agreement not signed, not participating)
 
Actavis (bendamustine, etoposide, gemcitabine, 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, ifosfamide) (confidentiality agreement not signed, not participating)
 
Consilient Health (dexamethasone) (confidentiality agreement not signed, not participating)
 
Dr Reddy’s Laboratories UK (bendamustine) (confidentiality agreement not signed, not participating)
 
Eli Lilly and Company (gemcitabine) (confidentiality agreement not signed, not participating)
 
Hospira UK (gemcitabine, oxaliplatin) (confidentiality agreement not signed, not participating)
 
Medac UK (bendamustine, etoposide, lomustine, oxaliplatin) (confidentiality agreement not signed, not participating)
 
Napp Pharmaceuticals (bendamustine, rituximab) (confidentiality agreement not signed, not participating)
 
Pfizer (gemcitabine, vincristine) (confidentiality agreement not signed, not participating)
 
Ranbaxy (UK), a Sun Pharmaceutical Company (gemcitabine) (confidentiality agreement not signed, not participating)
 
Roche (glofitamab, polatuzumab vedotin, rituximab) (confidentiality agreement not signed, not participating)
 
Sandoz (cyclophosphamide, rituximab) (confidentiality agreement not signed, not participating)
 
Seacross pharmaceuticals (bendamustine) (confidentiality agreement not signed, not participating)
 
Teva Nederland B.V. (bleomycin) (confidentiality agreement not signed, not participating)
 
Zentiva (bendamustine, prednisolone) (confidentiality agreement not signed, not participating)
General commentators
All Wales Therapeutics and Toxicology Centre
 
British National Formulary
 
Department of Health – Northern Ireland
 
Healthcare Improvement Scotland
 
Medicines and Healthcare products Regulatory Agency
 
NHS Wales Joint Commissioning Committee
 
Scottish Medicines Consortium
 
Welsh Government
Relevant research groups
Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
08 July 2025 Committee meeting
25 November 2024 Invitation to participate
26 July 2024 Please note that following on from information received from the company this appraisal has been rescheduled to align with latest regulatory expectations and the appraisal is now anticipated to begin in late November 2024.
19 March 2024 - 18 April 2024 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6202
19 March 2024 In progress. Scoping commenced.
08 February 2024 Please note that following on from information received from the company, the timelines for this appraisal have now been revised and the appraisal is now anticipated to begin in late July 2024.
16 October 2023 Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in mid-June 2024. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission.
25 October 2022 Awaiting development. Status change linked to Topic Selection Decision being set to Selected

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

Consultation in progress

Consultation documents