Suggested remit: To appraise the clinical and cost effectiveness of evinacumab within its marketing authorisation for treating homozygous familial hypercholesterolaemia in people aged 12 years and over.
Status
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In progress
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Technology type
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Medicine
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Decision
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Awaiting decision
|
Process |
STA Standard
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ID number |
2704
|
Project Team
Project lead |
Celia Mayers |
Email enquiries
External Assessment Group |
BMJ Technology Assessment Group (BMJ-TAG), BMJ |
Stakeholders
Companies sponsors |
Ultragenyx (Evinacumab) |
Others |
Department of Health and Social Care |
|
NHS England |
Patient carer groups |
Gene People |
|
HEART UK |
Professional groups |
Royal College of Physicians |
Assessment group |
National Institute for Health Research |
Associated public health groups |
None |
Comparator companies |
Amgen (evolocumab) – confidentiality agreement not signed, not participating |
|
Amryt Pharmaceuticals DAC (lomitapide) – confidentiality agreement not signed, not participating |
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Aurobindo Pharma – Milpharm (ezetimibe) – confidentiality agreement not signed, not participating |
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Daiichi Sankyo UK (ezetimibe) – confidentiality agreement not signed, not participating |
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Glenmark Pharmaceuticals Europe (ezetimibe) – confidentiality agreement not signed, not participating |
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Organon Pharma UK (ezetimibe) – confidentiality agreement not signed, not participating |
|
Sandoz (ezetimibe) – confidentiality agreement not signed, not participating |
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Zentiva (ezetimibe) – confidentiality agreement not signed, not participating |
General commentators |
All Wales Therapeutics and Toxicology Centre |
|
British National Formulary |
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Department of Health, Social Services and Public Safety for Northern Ireland |
|
Healthcare Improvement Scotland |
|
Scottish Medicines Consortium |
|
Welsh Health Specialised Services Committee |
Date
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Update
|
08 April 2024
|
NICE previously paused the publication of final draft guidance recommending evinacumab for the treatment of homozygous familial hypercholesterolaemia in people aged 12 and older [ID2704]. NICE has now decided to withdraw the final draft guidance for evinacumab. This is because there is some uncertainty about the dose of lomitapide (the comparator for evinacumab in adults) used in the cost effectiveness analysis of evinacumab, and this raises some uncertainty about the cost effectiveness of evinacumab.
Commencing on 8 April 2024, NICE will hold a 28-day stakeholder engagement in which stakeholders are requested to provide information on the dose and efficacy of lomitapide in clinical practice. NICE will then hold a committee meeting to consider the dose of lomitapide and its impact on the cost effectiveness of evinacumab. |
29 January 2024
|
NICE has received a non-appeal request for change on the final draft guidance (FDG) for this appraisal. While the appraisal team consider the request, publication of the final guidance is paused. Final guidance will not publish as planned on 7 February 2024. |
14 November 2023
|
Committee meeting |
17 March 2023
|
Invitation to participate |
01 March 2023
|
Topic selection |
11 January 2023 - 08 February 2023
|
Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 2704 |
11 January 2023
|
In progress. Scoping commencing |
14 December 2020
|
The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of evinacumab for treating homozygous familial hypercholesterolaemia in people aged 12 and over.
Please note that following on from advice received from the company, further information regarding the timelines for this appraisal will be available in due course.
In the meantime, NICE will continue to monitor the situation and will provide an update as and when the situation changes.
|
14 September 2020 (14:00)
|
Scoping workshop |
16 July 2020 - 13 August 2020
|
Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
For further information on our processes and methods, please see our CHTE processes and methods manual