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

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
10 July 2020 The release of the final appraisal document (FAD) for this topic has been suspended. This is because the company (Merck Sharp & Dohme) is proposing an updated value proposition for pembrolizumab and additional evidence about the clinical use of pembrolizumab monotherapy and combination therapy. This means that the basis for the decision-making is likely to change. Further details regarding the next steps (such as an appraisal committee meeting) and timings of this topic will be available in due course.
02 June 2020 Committee meeting: 2
09 April 2020 Topic update: this appraisal has not been defined as therapeutically critical (please follow the link titled rapid guidelines and evidence summaries within the yellow banner at the top of the page for information on recent changes to the way we work). The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide updates as and when this information becomes clear.
15 January 2020 - 05 February 2020 Appraisal consultation
21 January 2020 The company, Merck Sharp & Dohme, has informed NICE that they intend to submit additional information in response to the Appraisal Consultation Document. Therefore, additional time will be needed by NICE to consider this information. The appraisal committee meeting will be rescheduled into the work programme and the updated appraisal committee meeting date will be communicated in due course.
08 January 2020 Topic title changed from 'Pembrolizumab for treating recurrent or metastatic squamous cell head and neck cancer', to 'Pembrolizumab for untreated metastatic or unresectable recurrent squamous cell head and neck cancer'.
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