The first Technology Appraisal Committee meeting for this appraisal was held on 10 May 2018. That meeting was held before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had considered the use of nivolumab with ipilimumab intended for the treatment of untreated metastatic renal cell carcinoma. The meeting was therefore held in private. This is described in our Cancer Drugs Fund process addendum. On 27 July 2018, the CHMP adopted a negative opinion, recommending the refusal of the marketing authorisation for Opdivo with Yervoy (nivolumab with ipilimumab) in this indication. Following an update from the company, a re-examination of this opinion will be sought. This appraisal will therefore be re-scheduled and a further update will be issued in due course.
 
Status Suspended
Process TAG
ID number 1182

Project Team

Project lead Jeremy Powell

Email enquiries

Consultees

Companies sponsors Bristol-Myers Squibb (nivolumab and ipilimumab)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Kidney Cancer Support Network
  Kidney Cancer UK
  Kidney Research UK
  Association of Cancer Physicians
  British Uro-Oncology Group
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists

Commentators

Associated public health groups Public Health England
  Public Health Wales
Comparator companies Novartis Pharmaceuticals (interleukin-2, pazopanib)
  Pfizer (sunitinib)
  Roche Products (interferon-alfa 2a)
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
14 August 2018 Suspended, The first Technology Appraisal Committee meeting for this appraisal was held on 10 May 2018. That meeting was held before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had considered the use of nivolumab with ipilimumab intended for the treatment of untreated metastatic renal cell carcinoma. The meeting was therefore held in private. This is described in our Cancer Drugs Fund process addendum. On 27 July 2018, the CHMP adopted a negative opinion, recommending the refusal of the marketing authorisation for Opdivo with Yervoy (nivolumab with ipilimumab) in this indication. Following an update from the company, a re-examination of this opinion will be sought. This appraisal will therefore be re-scheduled and a further update will be issued in due course.
10 May 2018 Committee meeting: 1
05 December 2017 Invitation to participate
05 December 2017 In progress, Appraisal started.
21 April 2017 Referral
29 March 2017 Draft scope documents

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