Suggested remit - To appraise the clinical and cost effectiveness of pitolisant hydrochloride within its marketing authorisation for treating excessive daytime sleepiness caused by obstructive sleep apnoea.
 
Status In progress
Process STA 2018
ID number 1065

Provisional Schedule

Committee meeting 13 April 2021

Project Team

Project lead Gavin Kenny

Email enquiries

Evidence Review Group / Assessment Group Kleijnen Systematic Reviews Ltd

Consultees

Companies sponsors Lincoln Medical
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 Ltd (methylphenidate) (confidentiality agreement not signed, not participating)
  Aurobindo Pharma - Milpharm Ltd. (modafinil) (confidentiality agreement not signed, not participating)
  Flynn Pharma Ltd (dexamphetamine, methylphenidate) (confidentiality agreement not signed, not participating)
  Generics UK T/A Mylan (methylphenidate) (confidentiality agreement not signed, not participating)
  Janssen-Cilag Ltd (methylphenidate) (confidentiality agreement not signed, not participating)
  Jazz Pharmaceuticals (solriamfetol)
  Martindale Pharma (dexamphetamine) (confidentiality agreement not signed, not participating)
  Novartis Pharmaceuticals UK Ltd (methylphenidate) (confidentiality agreement not signed, not participating)
  Sandoz Limited (methylphenidate) (confidentiality agreement not signed, not participating)
  Shire Pharmaceuticals Limited (methylphenidate) (confidentiality agreement not signed, not participating)
  Teva Pharma B.V (modafinil) (confidentiality agreement not signed, not participating)
  UCB Pharma Limited (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
24 June 2020 Topic update: this appraisal was due to pause at ERG report delivery, however the topic will now continue on the original timelines and no longer pause at this point.
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.
05 March 2020 Invitation to participate
09 December 2019 In progress. Referred: 19/03/2019
09 December 2019 The Department for Health and Social Care has asked NICE to conduct an appraisal of Pitolisant hydrochloride for treating excessive daytime 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. We now anticipate that the appraisal will begin during early-March 2020 when we will write to you about how you can get involved.
20 September 2018 - 18 October 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