Suggested remit - To appraise the clinical and cost effectiveness of solriamfetol within its marketing authorisation for treating excessive daytime sleepiness caused by obstructive sleep apnoea
 
Status In progress
Process STA 2018
ID number 1499

Provisional Schedule

Committee meeting 05 November 2020

Project Team

Project lead Gavin Kenny

Email enquiries

Evidence Review Group / Assessment Group Southampton Health Technology Assessment Centre (SHTAC), University of Southampton

Consultees

Companies sponsors Jazz Pharmaceuticals
Others Department of Health and Social Care
  NHS England
  Welsh Government
Professional groups British Thoracic Society
  Royal College of Physicians
  UK Clinical Pharmacy Association

Commentators

Comparator companies Accord-UK (methylphenidate) (confidentiality agreement not signed, not participating)
  Aurobindo Pharma - Milpharm (modafinil) (confidentiality agreement not signed, not participating)
  Flynn Pharma (dexamphetamine, methylphenidate) (confidentiality agreement not signed, not participating)
  Generics UK T/A Mylan (methylphenidate) (confidentiality agreement not signed, not participating)
  Janssen-Cilag (methylphenidate) (confidentiality agreement not signed, not participating)
  Lincoln Medical (pitolisant) hydrochloride
  Martindale Pharma (dexamphetamine) (confidentiality agreement not signed, not participating)
  Novartis Pharmaceuticals UK (methylphenidate) (confidentiality agreement not signed, not participating)
  Sandoz (methylphenidate) (confidentiality agreement not signed, not participating)
  Shire Pharmaceuticals Limited (methylphenidate) (confidentiality agreement not signed, not participating)
  Teva Pharma (modafinil) (confidentiality agreement not signed, not participating)
  UCB Pharma (sodium oxybate) (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
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee

Timeline

Key events during the development of the guidance:

Date Update
03 April 2020 Topic update: this appraisal has not been defined as therapeutically critical (please follow the link titled rapid guidelines and evidence summaries within the yellow banner at the top of the page for information on recent changes to the way we work). The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide updates as and when this information becomes clear.
06 March 2020 Invitation to participate
10 December 2019 In progress, Referred April 2019
18 October 2019 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of solriamfetol for treating excessive waketime sleepiness caused by obstructive sleep apnoea. Please note that following on from advice received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in early March 2020. 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 evidence submission.
14 January 2019 (14:00) Scoping workshop (Manchester)
16 November 2018 - 14 December 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance