Suggested remit: To appraise the clinical and cost effectiveness of fezolinetant within its marketing authorisation for treating vasomotor symptoms associated with the menopause.
- Status:
- In progress
- Technology type:
- Medicine
- Decision:
- Selected
- Reason for decision:
- Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
- Process:
- STA Standard
- ID number:
- 5071
Project Team
- Project lead
- Leena Issa
Email enquiries
If you have any queries please email [email protected]
- External Assessment Group:
- Centre for Reviews and Dissemination and Centre for Health Economics, University of York
Stakeholders
- Companies sponsors
- Astellas Pharma (fezolinetant)
- Others
- Department of Health and Social Care
- NHS England
- Patient carer groups
- Menopause and Cancer
- Professional groups
- British Menopause Society
- Royal College of Physicians
- Society for Endocrinology
- UK Clinical Pharmacy Association
- Associated public health groups
- None
- Comparator companies
- HRT
- Bayer (oestrogen) (confidentiality agreement signed, participating)
- Gedeon Richter UK (oestrogen) (confidentiality agreement signed, participating)
- ADVANZ Pharma (tibolone) (confidentiality agreement not signed, not participating)
- Artisto Pharma (tibolone) (confidentiality agreement not signed, not participating)
- Besins Healthcare (UK) (combined oestrogen/progesterone) (confidentiality agreement not signed, not participating)
- Merus Labs Luxco II S.à R.L. (oestrogen) (confidentiality agreement not signed, not participating)
- Mylan (oestrogen, combined oestrogen and progesterone) (confidentiality agreement not signed, not participating)
- Novartis (oestrogen) (confidentiality agreement not signed, not participating)
- Novo Nordisk (combined oestrogen and progesterone) (confidentiality agreement not signed, not participating)
- Orion (oestrogen, combined oestrogen and progesterone) (confidentiality agreement not signed, not participating)
- Organon Phama UK (tibolone) (confidentiality agreement not signed, not participating)
- Pfizer (oestrogen, combined oestrogen and progesterone) (confidentiality agreement not signed, not participating)
- Strides Pharma UK (tibolone) (confidentiality agreement not signed, not participating)
- Theramex UK (oestrogen, progesterone, combined oestrogen and progesterone) (confidentiality agreement not signed, not participating)
- Anti-depressants (SSRIs, SNRIs)
- A. Menarini Farmaceutica Internazionale SRL (dapoxetine) (confidentiality agreement not signed, not participating)
- Accord Healthcare (citalopram, escitalopram, fluoxetine, paroxetine, sertraline) (confidentiality agreement not signed, not participating)
- Accord UK (citalopram, fluoxetine, paroxetine) (confidentiality agreement not signed, not participating)
- ADVANZ Pharma (citalopram, fluoxetine, venlafaxine) (confidentiality agreement not signed, not participating)
- Amarox (citalopram, duloxetine) (confidentiality agreement not signed, not participating)
- Amdipharm (citalopram, venlafaxine) (confidentiality agreement not signed, not participating)
- Aspire Pharma (duloxetine, venlafaxine) (confidentiality agreement not signed, not participating)
- Aurobindo Pharma-Milpharm (citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline, venlafaxine) (confidentiality agreement not signed, not participating)
- Bristol Laboratories (venlafaxine) (confidentiality agreement not signed, not participating)
- Brown & Burk UK (escitalopram, fluoxetine) (confidentiality agreement not signed, not participating)
- Cipla EU (fluoxetine) (confidentiality agreement not signed, not participating)
- Dexcel Pharma (venlafaxine) (confidentiality agreement not signed, not participating)
- Dr Reddy’s Laboratory (duloxetine, fluoxetine, sertraline) (confidentiality agreement not signed, not participating)
- Eli Lilly and Company (duloxetine) (confidentiality agreement not signed, not participating)
- Endo Ventures (fluoxetine) (confidentiality agreement not signed, not participating)
- Fannin UK (fluoxetine) (confidentiality agreement not signed, not participating)
- Flamingo Pharma (fluoxetine, sertraline) (confidentiality agreement not signed, not participating)
- GlaxoSmithKline (paroxetine) (confidentiality agreement not signed, not participating)
- Glenmark Pharmaceuticals Europe (escitalopram) (confidentiality agreement not signed, not participating)
- Krka UK (venlafaxine) (confidentiality agreement not signed, not participating)
- Lundbeck (citalopram, escitalopram, vortioxetine) (confidentiality agreement not signed, not participating)
- Lupin Healthcare (sertraline) (confidentiality agreement not signed, not participating)
- Martindale Pharma, an Ethypharm Group Company (venlafaxine) (confidentiality agreement not signed, not participating)
- Morningside Healthcare (paroxetine, venlafaxine) (confidentiality agreement not signed, not participating)
- Mylan (dapoxetine, fluvoxamine, fluoxetine, sertraline) (confidentiality agreement not signed, not participating)
- Neuraxpharm UK (duloxetine) (confidentiality agreement not signed, not participating)
- Pinewoord Healthcare (fluoxetine) (confidentiality agreement not signed, not participating)
- Ranbaxy Ltd (Sun Pharma) (sertraline, venlafaxine) (confidentiality agreement not signed, not participating)
- Rivopharm UK (citalopram) (confidentiality agreement not signed, not participating)
- Rosemont Pharmaceuticals (fluoxetine, venlafaxine) (confidentiality agreement not signed, not participating)
- Sandoz (citalopram, paroxetine) (confidentiality agreement not signed, not participating)
- Thame Laboratories (citalopram) (confidentiality agreement not signed, not participating)
- Tillomed Laboratories (venlafaxine) (confidentiality agreement not signed, not participating)
- Viatris (sertraline, venlafaxine) (confidentiality agreement not signed, not participating)
- Zentiva (citalopram, sertraline) (confidentiality agreement not signed, not participating)
- Zentiva (duloxetine) (confidentiality agreement not signed, not participating)
- Clonidine
- Sandoz (confidentiality agreement not signed, not participating)
- Syri (confidentiality agreement not signed, not participating)
- Anti-convulsants
- ADVANZ Pharma (pregabalin) (confidentiality agreement not signed, not participating)
- Amarox (gabapentin, pregabalin) (confidentiality agreement not signed, not participating)
- Aristo Pharma (pregabalin) (confidentiality agreement not signed, not participating)
- Aspire Pharma (pregabalin) (confidentiality agreement not signed, not participating)
- Aurobindo Pharma - Milpharm (gabapentin, pregabalin) (confidentiality agreement not signed, not participating)
- Brown & Burk UK (gabapentin, pregabalin) (confidentiality agreement not signed, not participating)
- Colonis Pharma (gabapentin) (confidentiality agreement not signed, not participating)
- Dr Reddy’s Laboratories (UK) (pregabalin) (confidentiality agreement not signed, not participating)
- Glenmark Pharmaceuticals Europe (gabapentin) (confidentiality agreement not signed, not participating)
- MSN Laboratories Europe (pregabalin) (confidentiality agreement not signed, not participating)
- Mylan (pregabalin) (confidentiality agreement not signed, not participating)
- Neuraxpharm UK (pregabalin) (confidentiality agreement not signed, not participating)
- Northumbria Pharma (pregabalin) (confidentiality agreement not signed, not participating)
- Ranbaxy (UK) Limited a Sun Pharmaceutical Company (pregabalin) (confidentiality agreement not signed, not participating)
- Rivopharm UK (gabapentin) (confidentiality agreement not signed, not participating)
- Rosemont Pharmaceuticals Limited (gabapentin, pregabalin) (confidentiality agreement not signed, not participating)
- Sandoz Limited (pregabalin) (confidentiality agreement not signed, not participating)
- Strides Pharma UK (gabapentin) (confidentiality agreement not signed, not participating)
- Thame Laboratories (gabapentin) (confidentiality agreement not signed, not participating)
- Tillomed Laboratories (gabapentin, pregabalin) (confidentiality agreement not signed, not participating)
- Viatris (gabapentin, pregabalin) (confidentiality agreement not signed, not participating)
- Wockhardt UK (pregabalin) (confidentiality agreement not signed, not participating)
- Zentiva (pregabalin) (confidentiality agreement not signed, not participating)
- General commentators
- All Wales Therapeutics and Toxicology Centre
- British National Formulary
- Department of Health - Northern Ireland
- Healthcare Improvement Scotland
- Medicines and Healthcare products Regulatory Agency
- NHS Wales Joint Commissioning Committee
- Scottish Medicines Consortium
- Welsh Government
- Relevant research groups
- Nottingham Clinical Trials Unit
Timeline
Key events during the development of the guidance:
Date | Update |
---|---|
30 April 2025 | Following the release of the Draft Guidance for this appraisal, the company requested additional time to respond. NICE has agreed to an extension and as a result the date for the second committee meeting is to be confirmed. |
03 April 2025 - 28 April 2025 | Draft guidance |
11 March 2025 | Committee meeting: 1 |
11 March 2025 | Declaration of interests |
30 July 2024 | Invitation to participate |
20 June 2024 | Draft scope documents |
12 October 2023 | Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in late July 2024. 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 submission. |
24 July 2023 | Stakeholder workshop |
25 May 2023 - 23 June 2023 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 5071 |
25 May 2023 | In progress. Scoping commencing |
25 November 2022 | As you will be aware, the Department for Health & Social Care has asked NICE to conduct an appraisal of Fezolinetant for untreated vasomotor symptoms associated with the menopause. Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in early December 2023. 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 submission. |
07 June 2022 | Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
For further information on our processes and methods, please see our CHTE processes and methods manual