Suggested remit: To appraise the clinical and cost effectiveness of pralsetinib within its marketing authorisation for treating RET fusion-positive advanced non-small-cell lung cancer.
Status In progress
Decision Selected
Process STA 2018
ID number 3875

Provisional Schedule

Expected publication 23 June 2022

Project Team

Project lead Kate Moore

Email enquiries


Companies sponsors Roche (pralsetinib)
Others Department of Health and Social care
  NHS England
  Welsh Government
Patient carer groups Roy Castle Lung Cancer Foundation
Professional groups Association of Cancer Physicians
  British Thoracic Oncology Group
  British Thoracic Society
  Royal College of Pathologists
  Royal College of Physicians
Comparator companies Accord Healthcare - not participating
  Actavis UK - not participating
  Aspire Pharma - not participating
  Boehringer Ingelheim - not participating
  Bristol-Myers Squibb Pharmaceuticals - not participating
  Celgene - not participating
  Consilient Health Ltd - not participating
  Dr Reddy’s Laboratories - not participating
  Eli Lilly (selpercatinib, pemetrexed)
  Fresenius Kabi - not participating
  Fresenius Kabi Oncology - not participating
  Hospira UK - not participating
  Medac GmbH - not participating
  Merck Sharp & Dohme (pembrolizumab)
  Organon Pharma (UK) - not participating
  Pfizer (bevacizumab, carboplatin, cisplatin, docetaxel, gemcitabine, paclitaxel)
  Pierre Fabre - not participating
  Roche (atezolizumab, bevacizumab)
  Sandoz - not participating
  Sanofi - not participating
  Seacross pharmaceuticals - not participating
  Sun Pharma - not participating
  Teva UK - not participating
General commentators All Wales Therapeutic and Toxicology Centre
  British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare Products Regulatory Agency
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research


Key events during the development of the guidance:

Date Update
07 April 2022 Committee meeting: 2
03 March 2022 - 24 March 2022 Draft guidance
10 February 2022 Committee meeting: 1
19 November 2021 We have been able to reschedule this appraisal with the first committee meeting discussion now being held on 10 February 2022.
11 May 2021 The company, Roche, has been in contact with NICE to request a delay to the submission deadline for this appraisal, due to regulatory feedback. Therefore, the appraisal committee meeting discussion on 15 December 2021 has been cancelled. We will confirm the new timelines and update stakeholders when we have more information.
26 April 2021 Invitation to participate
09 February 2021 - 09 March 2021 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
18 February 2021 In progress. DHSC referral received

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