Suspension
 
Status Suspended
Process STA pre-2018
ID number 1066

Project Team

Project lead Kate Moore

Email enquiries

Consultees

Companies sponsors Merck Sharpe & Dohme (pembrolizumab)
Others Department for Health and Social Care
  NHS England
  Welsh Government
Professional groups Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists

Commentators

Comparator companies Accord Healthcare (CAU not returned, not participating)
  Allergan (CAU not returned, not participating)
  Bristol-Myers Squibb (nivolumab)
  Celgene (CAU not returned, not participating)
  Concordia International (CAU not returned, not participating)
  Dr. Reddy’s Laboratories (CAU not returned, not participating)
  Hameln Pharmaceuticals (CAU not returned, not participating)
  Hospira UK (CAU not returned, not participating)
  Medac GmbH (CAU not returned, not participating)
  Nordic Pharma (CAU not returned, not participating)
  Orion Pharma (CAU not returned, not participating)
  Pfizer (CAU not returned, not participating)
  Rosemont Pharmaceuticals (CAU not returned, not participating)
  Sandoz (CAU not returned, not participating)
  Sanofi (CAU not returned, not participating)
  Seacross Pharmaceuticals (CAU not returned, not participating)
General commentators British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  All Wales Therapeutics and Toxicology Centre
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
01 March 2018 The company who produce pembrolizumab, Merck Sharp & Dohme, have requested a suspension of the submission until after CHMP opinion is received. NICE has considered this request and has agreed to suspend the appraisal. Therefore, the evidence submission deadline (5pm on 28 February 2018) has also been suspended and the committee meeting on 12 June 2018 has been cancelled. We will provide a further update on the scheduling of this appraisal in due course.
01 March 2018 Suspended, Suspension
03 January 2018 Invitation to participate
07 December 2017 In progress, In progress
18 August 2017 Suspended, Following on from advice received from the company, the timelines for this appraisal are to be confirmed as a pivotal study relevant to this proposed indication has failed to meet its primary endpoint for overall survival. Therefore, NICE has decided to suspend this appraisal from its work programme.
18 August 2017 As you will be aware, the Department of Health has asked NICE to carry out a Single Technology Appraisal of pembrolizumab for treating recurrent or metastatic squamous cell carcinoma of the head and neck after platinum-based chemotherapy. Following on from advice received from the company, the timelines for this appraisal are to be confirmed as a pivotal study relevant to this proposed indication has failed to meet its primary endpoint for overall survival. Therefore, NICE has decided to suspend this appraisal from its work programme. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties if the situation changes
03 July 2017 - 31 July 2017 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
22 July 2016 Referral
22 July 2016 In progress, Topic referred

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