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
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.
 
Status Suspended
Decision Selected
Process STA pre-2018
ID number 1247

Project Team

Project lead Kate Moore

Email enquiries

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
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