Suggested remit: To appraise the clinical and cost effectiveness of esketamine within its marketing authorisation for the treatment of major depressive disorder.
 
Status In progress
Technology type Medicine
Decision Selected
Process STA 2018
ID number 1414

Provisional Schedule

Appeal 27 July 2022

Project Team

Project lead Celia Mayers

Email enquiries

External Assessment Group Kleijnen Systematic Reviews Ltd

Stakeholders

Companies sponsors Janssen (esketamine)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups SANE
Professional groups British Association for Psychopharmacology
  Royal College of Psychiatrists
  Royal College of Physicians
Comparator companies Accord Healthcare (amitriptyline, citalopram, duloxetine, escitalopram, imipramine, lofepramine, mirtazapine, fluoxetine, paroxetine, quetiapine, sertraline and venlafaxine) (Confidentiality agreement not signed, not participating)
  Amneal Pharma Europe (duloxetine, paroxetine) (Confidentiality agreement not signed, not participating)
  Arristo Pharma (quetiapine) (Confidentiality agreement not signed, not participating)
  AstraZeneca (quetiapine) (Confidentiality agreement not signed, not participating)
  Aurobindo Pharma (citalopram, duloxetine, escitalopram, fluoxetine, mirtazapine, paroxetine, quetiapine, sertraline and venlafaxine) (Confidentiality agreement not signed, not participating)
  Chiesi (venlafaxine) (Confidentiality agreement not signed, not participating)
  Consilient Health (duloxetine, escitalopram, quetiapine and venlafaxine) (Confidentiality agreement not signed, not participating)
  Creo Pharma (lofepramine and trazodone)
  Dexcel Pharma (venlafaxine) (Confidentiality agreement not signed, not participating)
  Dr Reddys Labs (duloxetine, fluoxetine and sertraline) (Confidentiality agreement not signed, not participating)
  Fontus heath (quetiapine) (Confidentiality agreement not signed, not participating)
  GlaxoSmithKline (paroxetine) (Confidentiality agreement not signed, not participating)
  HBS Healthcare (duloxetine) (Confidentiality agreement not signed, not participating)
  King Pharmaceuticals (nortriptyline) (Confidentiality agreement not signed, not participating)
  Kyowa Kirin (phenelzine) (Confidentiality agreement not signed, not participating)
  Lilly UK (duloxetine and fluoxetine) (Confidentiality agreement not signed, not participating)
  Lundbeck (citalopram, escitalopram, vortioxetine)
  Lupin (sertraline) (Confidentiality agreement not signed, not participating)
  Marlborough (doxepin) (Confidentiality agreement not signed, not participating)
  Merck Sharp & Dohme (mirtazapine) (Confidentiality agreement not signed, not participating)
  Mylan (citalopram, clomipramine, escitalopram, fluoxetine, fluvoxamine, lofepramine, mianserin, mirtazapine, paroxetine, quetiapine, trazodone and venlafaxine) (Confidentiality agreement not signed, not participating)
  Par Laboratories Europe (fluoxetine) (Confidentiality agreement not signed, not participating)
  Pfizer (reboxetine, sertraline and venlafaxine) (Confidentiality agreement not signed, not participating)
  Rivopharm (citalopram, trazodone) (Confidentiality agreement not signed, not participating)
  Sandoz (citalopram, paroxetine and quetiapine) (Confidentiality agreement not signed, not participating)
  Servier (agomelatine) (Confidentiality agreement not signed, not participating)
  Sun Pharmaceuticals (sertraline and venlafaxine) (Confidentiality agreement not signed, not participating)
  Teva UK (amitriptyline, citalopram, clomipramine, fluoxetine, fluvoxamine, imipramine, lofepramine, mianserin, mirtazapine, paroxetine, sertraline, trazodone and venlafaxine) (Confidentiality agreement not signed, not participating)
  Wockhardt (amitriptyline, fluoxetine, fluvoxamine, mirtazapine and venlafaxine) (Confidentiality agreement not signed, not participating)
  Zentiva (citalopram, duloxetine, escitalopram, quetiapine, trazodone and trimipramine) (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
27 May 2022 - 14 June 2022 Final draft guidance: 2
07 April 2022 Committee meeting: 4
01 April 2021 The appraisal committee met to discuss this this topic on 11 February 2021. Following this meeting, the company requested additional time to consider options with NICE. Therefore, the outcome of the Appraisal Committee Meeting will not be released at this time. An update will be provided in due course.
11 February 2021 Committee meeting: 3
27 August 2020 - 25 September 2020 Draft guidance: 2
05 August 2020 Committee meeting: 2
30 June 2020 In progress. Esketamine for treatment-resistant depression has now been rescheduled into the work programme and is due to be discussed at committee on Wednesday 5 August 2020.
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.
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.
28 January 2020 - 18 February 2020 Draft guidance
04 February 2020 The company (Janssen) has informed NICE that they intend to submit additional information in response to the ACD. Therefore, additional time will be needed by NICE to consider this information. The appraisal committee meeting will be rescheduled into the work programme and the updated appraisal committee meeting date will be communicated in due course. Please note that the ACD consultation date remains unchanged.
07 January 2020 Committee meeting
01 May 2019 Invitation to participate
01 May 2019 In progress. Invitation to Participate
17 September 2018 (14:00) Scoping workshop (London)
25 July 2018 - 22 August 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators

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