Status In progress
Process STA
ID number 971

Provisional Schedule

Expected publication 22 November 2017

Project Team

Project lead Kate Moore

Email enquiries

Consultees

Companies sponsors Bristol-Myers Squibb
Others Department of Health
  NHS England
  Welsh Government
Patient carer groups Swallows Head & Neck Cancer Support Group
Professional groups Cancer Research UK
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists

Commentators

Comparator companies Accord Healthcare - CA&U not returned, not participating
  Actavis UK - CA&U not returned, not participating
  Dr. Reddy's Laboratories - CA&U not returned, not participating
  Hospira UK
  Medac GmbH - CA&U not returned, not participating
  Pfizer - CA&U not returned, not participating
  Sanofi - CA&U not returned, not participating
  Teva UK - CA&U not returned, 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

Timeline

Key events during the development of the guidance:

Date Update
13 October 2017 - 27 October 2017 Final appraisal determination
30 August 2017 Committee meeting: 4
02 August 2017 Following the committee meeting on 31 May 2017, the company has requested to submit an new value proposition for nivolumab. We will therefore not be issuing a document at this stage. The appraisal committee will consider this additional evidence and continue its deliberations on Wednesday 30 August 2017 in a private (part 2) session.
31 May 2017 Committee meeting: 3
11 April 2017 - 04 May 2017 Appraisal consultation
28 February 2017 Committee meeting: 2
27 January 2017 As the Committee for Medicinal Products for Human Use (at European Medicines Agency) has not yet given its opinion for the technology, we are not in a position to be able to release any documentation. At its discussion in November, the committee recommended that additional evidence be requested from the company to inform its decision-making. We have carefully considered the options for progressing this appraisal, taking a number of issues into account. In this exceptional circumstance, we have requested the additional information from the company, without releasing an appraisal consultation document. This information will be reviewed by the evidence review group (ERG), before being discussed by the committee at its meeting on Tuesday 28 February 2017. As nivolumab does not yet have a regulatory opinion, this discussion will be held in private.
24 November 2016 Committee meeting: 1
05 July 2016 Invitation to participate
01 July 2016 Draft scope documents
08 June 2016 Referral

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