Suggested remit: To appraise the clinical and cost effectiveness of leniolisib within its marketing authorisation for untreated activated phosphoinositide 3-kinase delta syndrome in people 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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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
|
Process |
HST Standard
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ID number |
6130
|
Provisional Schedule
Committee meeting: 2 |
11 December 2024 |
Expected publication |
05 March 2025 |
Project Team
Email enquiries
External Assessment Group |
Newcastle NIHR TAR Team, Newcastle University |
Stakeholders
Companies sponsors |
Pharming Group N.V (leniolisib) |
Others |
Cambridge University Hospitals, NHS Foundation Trust |
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Department of Health and Social Care |
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NHS England |
Patient carer groups |
Gene People |
|
Immunodeficiency UK |
Professional groups |
British Society for Immunology |
|
Royal College of Physicians |
Comparator companies |
None |
General commentators |
All Wales Therapeutics and Toxicology Centre |
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British National Formulary |
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Department of Health, Social Services and Public Safety for 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 |
Date
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Update
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31 October 2024 - 21 November 2024
|
Evaluation consultation |
10 October 2024
|
Committee meeting |
11 January 2024
|
Please note that following on from advice received from the company this evaluation has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the evaluation will recommence during late May 2024 when the deadline for submissions is expected. |
19 September 2023
|
Topic selection |
19 September 2023
|
Topic selection. Following a challenge from the company, the topic routing was re-considered by the Topic Selection Oversight Panel (TSOP) in July 2023. The panel concluded that the topic be routed to the Highly Specialised Technologies (HST) work programme. Please see project documents for further details. |
31 August 2023
|
Invitation to participate |
06 June 2023
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The topic was discussed at the Topic Selection Oversight Panel (TSOP) in March 2023. The panel concluded that the topic was suitable for a Technology Appraisal (TA) evaluation. The company have challenged the routing decision and the timelines for the evaluation are to be confirmed. |
12 January 2023 (14:00)
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Scoping workshop |
08 November 2022 - 06 December 2022
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Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
13 October 2022
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In progress |
16 May 2022
|
Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
For further information on how we select topics for development, please see our page about topic selection