Suggested remit: To appraise the clinical and cost effectiveness of nivolumab in combination with ipilimumab, within its marketing authorisation, for untreated non-small-cell lung cancer in adults who have a high tumour mutational burden.
Suspended
 
Status Suspended
Process STA pre-2018
ID number 1187

Provisional Schedule

Expected publication 02 May 2019

Project Team

Project lead Gemma Barnacle

Email enquiries

Evidence Review Group / Assessment Group Kleijnen Systematic Reviews

Consultees

Companies sponsors Bristol-Myers Squibb (nivolumab, ipilimumab)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Roy Castle Lung Cancer Foundation
Professional groups Association of Cancer Physicians
  British Thoracic Oncology Group
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists

Commentators

Comparator companies Accord Healthcare (carboplatin, cisplatin, docetaxel, gemcitabine, paclitaxel) (Confidentiality agreement not signed, not participating)
  Allergan (docetaxel, gemcitabine, paclitaxel, pemetrexed, vinorelbine) (Confidentiality agreement not signed, not participating)
  Celgene (paclitaxel) (Confidentiality agreement not signed, not participating)
  Dr Reddy’s laboratories (docetaxel) (Confidentiality agreement not signed, not participating)
  Eli Lilly (gemcitabine, pemetrexed) (Confidentiality agreement not signed, not participating)
  Hospira UK (cisplatin, carboplatin, docetaxel, gemcitabine, paclitaxel) (Confidentiality agreement not signed, not participating)
  Medac GmbH (docetaxel, gemcitabine, paclitaxel, vinorelbine) (Confidentiality agreement not signed, not participating)
  Merck Sharp and Dohme (pembrolizumab)
  Pfizer (carboplatin, cisplatin, docetaxel, gemcitabine, paclitaxel) (Confidentiality agreement not signed, not participating)
  Pierre Fabre (vinorelbine) (Confidentiality agreement not signed, not participating)
  Sandoz (cisplatin) (Confidentiality agreement not signed, not participating)
  Sanofi (docetaxel) (Confidentiality agreement not signed, not participating)
  Seacross pharmaceuticals (docetaxel, paclitaxel, pemetrexed) (Confidentiality agreement not signed, not participating)
  Sun Pharmaceuticals (carboplatin, gemcitabine) (Confidentiality agreement not signed, not participating)
  Teva UK (docetaxel) (Confidentiality agreement not signed, not participating)
General commentators All Wales Therapeutic 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 Genomics England
  Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
08 November 2018 Committee meeting: 1
29 October 2018 Suspended, Suspended
29 October 2018 The company (Bristol-Myers Squibb) requested that NICE suspend this appraisal because of a change to its regulatory timelines for this indication. Therefore, the discussion of this topic at the appraisal committee meeting (previously scheduled for 8 November 2018) will be rescheduled. We will provide a further update and rescheduled timelines in due course.
12 June 2018 Invitation to participate
01 May 2018 - 24 May 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
11 September 2017 - 09 October 2017 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
12 September 2017 In progress, In progress

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