Status In progress
Process STA
ID number 811
Referral date 01 March 2015

Provisional Schedule

Closing date for invited submissions / evidence submission: 17 August 2015
1st appraisal committee meeting: 18 November 2015

Project Team

Project lead Stephanie Yates

Email enquiries

Consultees

Companies sponsors Bristol-Myers Squibb (nivolumab)
Others Department of Health
  NHS England
  Welsh Government
Patient carer groups Roy Castle Lung Cancer Foundation
Professional groups Association of Cancer Physicians
  British Thoracic Oncology Group
  British Thoracic Society
  Cancer Research UK
  National Lung Cancer Forum for Nurses
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists

Commentators

Associated public health groups Public Health England
  Public Health Wales
Comparator companies Accord Healthcare (docetaxel) (Confidentiality agreement not signed, not participating)
  Actavis UK (docetaxel) (Confidentiality agreement not signed, not participating)
  Dr Reddy’s Laboratories (docetaxel) (Confidentiality agreement not signed, not participating)
  Hospira UK (docetaxel) (Confidentiality agreement not signed, not participating)
  Medac UK (docetaxel) (Confidentiality agreement not signed, not participating)
  Roche Products (erlotinib)
  Sanofi (docetaxel) (Confidentiality agreement not signed, not participating)
  Teva UK (docetaxel) (Confidentiality agreement not signed, not participating)
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
01 November 2017 Expected publication
20 September 2017 - 04 October 2017 Final appraisal determination
15 August 2017 Committee meeting: 5
02 August 2017 The company that markets nivolumab and NHS England have now had the opportunity to progress commercial discussions and as a result new evidence has been submitted to the institute. The appraisal committee will review the new evidence at a committee meeting on 15 August 2017. Due to the confidential nature of the new evidence, the appraisal meeting will be held in private only – consultees and commentators will not be invited to observe the meeting.
26 May 2017 A final appraisal determination (FAD) for the technology appraisal of nivolumab for treating metastatic, squamous, non-small-cell lung cancer after chemotherapy will not be sent consultees and commentators this week. The pause is to allow the company that markets nivolumab and NHS England to progress ongoing commercial discussions. NICE will update consultees and commentators with the next steps for this appraisal within the next 3-4 weeks.
12 April 2017 Committee meeting: 4
08 March 2017 The discussion of this appraisal planned for Thursday 16 March 2017 has been postponed and will be rescheduled in due course.
22 December 2016 The appraisal committee meeting scheduled for Wednesday 18 January 2017 has been cancelled because the company that markets nivolumab (Bristol-Myers Squibb), has requested to make a further evidence submission.
14 October 2016 - 04 November 2016 Appraisal consultation: 2
15 September 2016 We are not in a position to be able to release a document following the committee meeting discussion on Wednesday 10 August 2016. NICE is progressing with internal discussions and will update consultees and commentators with the next steps for this appraisal as soon as possible.
10 August 2016 Committee meeting: 3
01 April 2016 A final appraisal determination (FAD) for the technology appraisal of nivolumab for treating metastatic, squamous, non-small-cell lung cancer after chemotherapy [ID811] was sent to consultees and commentators on Thursday 24 March 2016. In the time period since issuing the FAD to consultees and commentators, the company that markets nivolumab (Bristol-Myers Squibb), has requested to make a further submission including a patient access scheme. In recognition of the exceptional nature of this request, NICE has agreed that the appraisal can be referred back to the appraisal committee. The appeal stage of this appraisal topic has been suspended. This will allow the company to submit, and the appraisal committee to consider, the new evidence. We are withdrawing the FAD, it will not be published on our web site and its content remains confidential.
10 February 2016 Committee meeting: 2
16 December 2015 - 19 January 2016 Appraisal consultation
09 October 2015 Consultation documents published

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