Suggested remit: To appraise the clinical and cost effectiveness of belzutifan within its marketing authorisation for untreated tumours caused by von Hippel-Lindau disease.
 
Status In progress
Technology type Medicine
Decision Selected
Reason for decision Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Process STA Standard
ID number 3932

Project Team

Project lead Vonda Murray

Email enquiries

External Assessment Group Kleijnen Systematic Reviews Ltd

Stakeholders

Companies sponsors Merck Sharp & Dohme (belzutifan)
Others Department of Health and Social Care*
  Welsh Government
Patient carer groups VHL UK/Ireland
  UK Kidney Association
  Action Kidney Cancer
Professional groups Association of Cancer Physicians
  Royal College of Physicians
Assessment group Eusa Pharma UK (tivozanib) (confidentiality agreement signed, participating)
  Ipsen (cabozantinib) (confidentiality agreement signed, participating)
  Accord Healthcare (everolimus) (confidentiality agreement not signed, not participating)
  Bristol-Myers Squibb Pharmaceuticals (ipilimumab, nivolumab) (confidentiality agreement not signed, not participating)
  Dr Reddy's Laboratories (everolimus) (confidentiality agreement not signed, not participating)
  Eisai (lenvatinib) (confidentiality agreement not signed, not participating)
  Merck (avelumab) (confidentiality agreement not signed, not participating)
  Merck Sharp & Dohme (pembrolizumab) (confidentiality agreement not signed, not participating)
  Novartis (everolimus, pazopanib) (confidentiality agreement not signed, not participating)
  Pfizer (axitinib, sunitinib) (confidentiality agreement not signed, not participating)
Associated public health groups None
Evidence review group Kleijnen Systematic Reviews
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  NHS England
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
29 November 2023 - 10 January 2024 Draft guidance
08 November 2023 Committee meeting: 1
07 September 2023 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
07 September 2023 Topic selection
07 September 2023 In progress
23 August 2023 The topic routing was re-considered by the Topic Selection Oversight Panel (TSOP) in June 2023. The panel concluded that the topic should remain routed to the Technology Appraisal (TA) work programme. Please see project documents for further details.
13 January 2023 Invitation to participate
23 November 2022 - 14 December 2022 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
13 December 2022 Topic selection
29 November 2022 As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of Belzutifan for treating clear-cell renal carcinoma caused by von Hippel-Lindau disease [ID3932]. Following communications with the company the timelines for this appraisal have been revised. The appraisal is now anticipated to begin during early January 2023 when we will write to you about how you can get involved.
29 December 2021 Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in early July 2022. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission.
10 June 2021 - 08 July 2021 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
26 May 2021 Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin during late September 2021 when we will write to you about how you can get involved. These timelines are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission.
23 November 2020 In progress. DHSC referral received

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