Solriamfetol within its marketing authorisation for treating excessive waketime sleepiness caused by narcolepsy
Topic update: this appraisal has not been defined as therapeutically critical. 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 an update when this information is available.
 
Status Schedule affected by COVID-19
Process STA 2018
ID number 1602

Project Team

Project lead Gemma Barnacle

Email enquiries

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

Consultees

Companies sponsors Jazz Pharmaceuticals (solriamfetol)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Professional groups Association of British Neurologists
  British Thoracic Society
  Royal College of Physicians
  Royal Society of Medicine – Sleep medicine section

Commentators

Comparator companies Accord-UK (methylphenidate) (confidentiality agreement not signed, not participating)
  Aurobindo Pharma - Milpharm (modafinil) (confidentiality agreement not signed, not participating)
  BioProjet (pitolisant hydrochloride) (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)
  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
07 July 2020 Committee meeting
05 May 2020 Schedule affected by COVID-19. Topic update: this appraisal has not been defined as therapeutically critical. 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 an update when this information is available.
02 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.
28 October 2019 Please note that the company have requested additional time in order to facilitate a suitably comprehensive and robust evidence submission. NICE have agreed to this and the new deadline for submissions is expected to be early-January 2020.
08 August 2019 Invitation to participate

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