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 |
| Process | STA pre-2018 |
| ID number | 1247 |
Project Team
| Project lead | Kate Moore |
Email enquiries
- If you have any queries please email TACommD@nice.org.uk
Consultees
| 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 |
Commentators
| 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 how we develop guidance, please see our page about NICE technology appraisal guidance