Suggested remit To appraise the clinical and cost effectiveness of lumasiran within its marketing authorisation for treating primary hyperoxaluria type 1.
 
Status Awaiting development
Decision None selected
Process STA 2018
ID number 3765

Provisional Schedule

Expected publication 26 September 2022

Project Team

Project lead Celia Mayers

Email enquiries

Stakeholders

Companies sponsors • Alnylam (lumasiran)
Others • Department of Health and Social Care
  • Metabolic Kidney Stones Unit, Royal Free Hospital
  • NHS England
Patient carer groups • Metabolic Support UK
Professional groups • British Association of Paediatric Nephrology
  • Royal College of Physicians
  • UK Kidney Association
Comparator companies • Tor Generics (pyridoxine- Vitamin B6) (confidentiality agreement not signed, not participating)
  • Wockhardt UK (pyridoxine- Vitamin B6) (confidentiality agreement not signed, not participating)
General commentators • All Wales Therapeutics 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
  • Scottish Medicines Consortium
  • Welsh Government
  • Welsh Health Specialised Services Committee

Timeline

Key events during the development of the guidance:

Date Update
16 June 2022 The company has informed NICE that they will not be able to provide a complete response to the evaluation consultation document (ECD) in time for this topic to be discussed at the committee meeting on 11 August 2022. As such, the date for the second evaluation committee meeting is now to be confirmed.
20 May 2022 - 13 June 2022 Draft guidance
03 November 2021 Invitation to participate
11 June 2021 Please note that following on from a request received from the company, the timelines for this evaluation have been revised and it is now anticipated to begin in early November 2021 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately mid-January 2022. 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 submission.
15 January 2021 Please note that following on from a request received from the company, the timelines for this evaluation have been revised and it is now anticipated to begin in mid-May 2021 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately early July 2021. Publication of this topic is expected to be in mid-March 2022. 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 submission.
24 July 2020 (14:00) Scoping workshop (Manchester)
05 June 2020 - 03 July 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators

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