To appraise the clinical and cost effectiveness of pembrolizumab within its marketing authorisation for untreated PD-L1 positive non-small-cell lung cancer with at least 1% tumour proportion score

Following on from information provided to NICE by the company in November 2018, the appraisal of Pembrolizumab for untreated PD-L1 positive non-small-cell lung cancer with at least 1% tumour proportion score [ID1247] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.

Status:
Discontinued
Technology type:
Medicine
Decision:
Selected
Process:
TA
ID number:
1247

Email enquiries

If you have any queries please email scheduling@nice.org.uk

Stakeholders

Companies sponsors
Merck Sharp & Dohme (pembrolizumab)
Others
Department of Health and Social Care
 
NHS England
 
NHS North East Hampshire and Farnham CCG
 
NHS Swale CCG
 
Welsh Government
Patient carer groups
Black Health Agency
 
British Lung Foundation
 
Cancer Black Care
 
Cancer Equality
 
HAWC
 
Helen Rollason Cancer Charity
 
Independent Cancer Patients Voice
 
Macmillan Cancer Support
 
Maggie’s Centres
 
Marie Curie
 
Muslim Council of Britain
 
Roy Castle Lung Cancer Foundation
 
South Asian Health Foundation
 
Specialised Healthcare Alliance
 
Tenovus Cancer Care
 
UK Lung Cancer Coalition
Professional groups
Association of Anaesthetists
 
Association of Cancer Physicians
 
Association of Respiratory Nurse Specialists
 
Association of Surgeons of Great Britain and Ireland
 
British Geriatrics Society
 
British Institute of Radiology
 
British Psychosocial Oncology Society
 
British Thoracic Oncology Group
 
British Thoracic Society
 
Cancer Research UK
 
National Lung Cancer Forum for Nurses
 
Primary Care Respiratory Society UK
 
Royal College of Anaesthetists
 
Royal College of General Practitioners
 
Royal College of Nursing
 
Royal College of Pathologists
 
Royal College of Physicians
 
Royal College of Radiologists
 
Royal Pharmaceutical Society
 
Royal Society of Medicine
 
Society and College of Radiographers
 
UK Clinical Pharmacy Association
 
UK Health Forum
 
UK Oncology Nursing Society
Associated public health groups
Public Health England
 
Public Health Wales
Comparator companies
Accord Healthcare (cisplatin, carboplatin, docetaxel, gemcitabine, paclitaxel)
 
Actavis UK (docetaxel, gemcitabine, paclitaxel, vinorelbine, pemetrexed)
 
Celgene (paclitaxel)
 
Dr Reddy’s Laboratories (docetaxel, pemetrexed)
 
Hospira UK (cisplatin, carboplatin, docetaxel, gemcitabine, paclitaxel)
 
Lilly UK (gemcitabine, pemetrexed)
 
Medac GmbH (docetaxel, paclitaxel, vinorelbine)
 
Pierre Fabre (vinorelbine)
 
Sun Pharma (gemcitabine)
 
Sandoz (cisplatin)
 
Sanofi (docetaxel)
 
Seacross pharmaceuticals (docetaxel)
General commentators
All Wales Therapeutic and Toxicology Centre
 
Allied Health Professionals Federation
 
Board of Community Health Councils in Wales
 
British National Formulary
 
Care Quality Commission
 
Department of Health, Social Services and Public Safety for Northern Ireland
 
Healthcare Improvement Scotland
 
Medicines and Healthcare Products Regulatory Agency
 
National Association of Primary Care
 
National Pharmacy Association
 
NHS Alliance
 
NHS Confederation
 
Scottish Medicines Consortium
 
Welsh Health Specialised Services Committee
Relevant research groups
Cochrane Lung Cancer Group
 
Institute of Cancer Research
 
MRC Clinical Trials Unit
 
National Cancer Research Institute
 
National Cancer Research Network
 
National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
31 October 2022 Following on from information provided to NICE by the company in November 2018, the appraisal of Pembrolizumab for untreated PD-L1 positive non-small-cell lung cancer with at least 1% tumour proportion score [ID1247] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
31 October 2022 Discontinued. Following on from information provided to NICE by the company in November 2018, the appraisal of Pembrolizumab for untreated PD-L1 positive non-small-cell lung cancer with at least 1% tumour proportion score [ID1247] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
23 June 2020 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of Pembrolizumab for untreated PD-L1 positive non-small-cell lung cancer with at least 1% tumour proportion score. For information, the company have advised that the Committee for Medicinal Products for Human Use have not recommended an indication expansion based on the clinical trial KEYNOTE-042 at this time and therefore company will not be pursuing a licence extension with the European Medicines Agency. Therefore this appraisal will remain suspended from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
24 October 2018 Invitation to participate
24 October 2018 Suspended. This appraisal has formally started in line with the anticipated regulatory timelines. However, the company that markets pembrolizumab has informed us that they will not provide an evidence submission for this appraisal. NICE is therefore suspending this appraisal with immediate effect.
24 July 2018 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 PD-L1 positive non-small-cell lung cancer with at least 1% tumour proportion score. Please note that the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in mid October 2018.
17 November 2017 - 15 December 2017 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
17 November 2017 In progress. In progress

For further information on our processes and methods, please see our CHTE processes and methods manual