Suggested remit: To appraise the clinical and cost effectiveness of idebenone within its marketing authorisation for treating visual impairment in Leber’s hereditary optic neuropathy (LHON) in people aged 12 years and over.
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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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Selected
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Reason for decision
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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
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Further information
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The topic was re-considered for guidance development by the Topic Selection Oversight Panel in January 2023. The panel concluded that Idebenone meets the selection and eligibility criteria for medicines and has been selected for evaluation. A scoping consultation will take place in May 2023, to develop the draft scope and determine the final routing.
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| Process |
STA Standard
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| ID number |
547
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Provisional Schedule
| Committee meeting: 2 |
11 February 2025 |
| Expected publication |
23 April 2025 |
Project Team
Email enquiries
| External Assessment Group |
BMJ Technology Assessment Group (BMJ-TAG), BMJ |
Stakeholders
| Companies sponsors |
Chiesi |
| Others |
Department of Health and Social Care |
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NHS England |
| Patient carer groups |
LHON Society |
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Metabolic Support UK |
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The Lily Foundation |
| Professional groups |
Royal College of Ophthalmologists |
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Royal College of Physicians |
| General commentators |
All Wales Therapeutics and Toxicology Centre |
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British National Formulary |
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Department of Health - Northern Ireland |
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Healthcare Improvement Scotland |
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Medicines and Healthcare products Regulatory Agency |
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Scottish Medicines Consortium |
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Welsh Government |
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Welsh Health Specialised Services Committee |
| Relevant research groups |
National Institute for Health Research |
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Date
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Update
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20 September 2024
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The second appraisal committee meeting discussion has been scheduled for 11 February 2025. |
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24 April 2024 - 16 May 2024
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Draft guidance: 1 |
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08 May 2024
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Following the committee meeting on 3 April 2024, we issued draft guidance for consultation. The company, Chiesi Limited, has asked to provide additional evidence to address the committee’s requests as part of their response to the consultation.
To allow time for the additional evidence to be submitted by the company and to be critiqued by the External Academic Group, this will no longer be discussed at the committee meeting on 4 June 2024. The second committee meeting discussion will be rearranged, and we will update all stakeholders with the new date in due course.
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03 April 2024
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Committee meeting: 1 |
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07 September 2023
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Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
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07 September 2023
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Topic selection |
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07 September 2023
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In progress |
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23 August 2023
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Invitation to participate |
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23 August 2023
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The topic routing was considered by the Topic Selection Oversight Panel (TSOP) in July 2023. The panel concluded that the topic should be routed to the Technology Appraisal (TA) work programme. Please see project documents for further details |
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22 August 2023
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Topic selection |
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17 May 2023 - 15 June 2023
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Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
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17 May 2023
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In progress. Scoping commenced |
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20 February 2023
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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