To appraise the clinical and cost effectiveness of pembrolizumab within its marketing authorisation for untreated recurrent or metastatic squamous cell carcinoma of the head and neck.
 
Status In progress
Process STA 2018
ID number 1140

Provisional Schedule

Expected publication 12 February 2020

Project Team

Project lead Gemma Barnacle

Email enquiries

Evidence Review Group / Assessment Group Liverpool Reviews and Implementation Group, University of Liverpool

Consultees

Companies sponsors Merck Sharpe & Dohme
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups The Swallows - Head and Neck Cancer Support Group
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists

Commentators

Comparator companies Accord Healthcare (carboplatin, cisplatin, fluorouracil)
  Almirall (fluorouracil) (Confidentiality agreement not signed, not participating)
  Consilient Health (fluororacil) (Confidentiality agreement not signed, not participating)
  Hospira UK (carboplatin, cisplatin, fluorouracil) (Confidentiality agreement not signed, not participating)
  Medac GmbH (fluorouracil) (Confidentiality agreement not signed, not participating)
  Merck (cetuximab) (Confidentiality agreement not signed, not participating)
  Sandoz (cisplatin) (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
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
21 March 2019 Invitation to participate
18 January 2019 In progress, Following on from advice received from the company this appraisal has now been rescheduled into the work programme. For information, the appraisal is anticipated to begin during mid- March 2019.
03 September 2018 Suspended, As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of pembrolizumab for untreated recurrent or metastatic squamous cell carcinoma of the head and neck. Following on from advice received from the company, the timelines for this appraisal are currently to be confirmed and therefore the appraisal is suspended. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties as and when the situation changes
09 February 2018 As you will be aware, the Department of Health has asked NICE to conduct an appraisal of pembrolizumab for untreated, recurrent or metastatic squamous cell carcinoma of the head and neck. Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during early October 2018 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately early December 2018
14 September 2017 As you will be aware, the Department of Health has asked NICE to carry out a Single Technology Appraisal of pembrolizumab for untreated recurrent or metastatic squamous cell carcinoma of the head and neck. Following on from advice received from the company, the timelines for this appraisal are currently to be confirmed. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties when the situation changes.
28 June 2017 - 26 July 2017 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
01 March 2017 Referral
01 March 2017 In progress, Topic referred

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