Suggested remit: To appraise the clinical and cost effectiveness of elafibranor within its marketing authorisation for treating primary biliary cholangitis.
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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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| Process |
STA Standard
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| ID number |
6331
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Provisional Schedule
| Committee meeting |
03 September 2024 |
Project Team
Email enquiries
| External Assessment Group |
Newcastle NIHR TAR Team, Newcastle University |
Stakeholders
| Companies sponsors |
Ipsen Ltd (Elafibranor) |
| Others |
Department of Health and Social Care |
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NHS England |
| Patient carer groups |
British Liver Trust |
| Professional groups |
British Association for the Study of the Liver |
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PBC Foundation |
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Royal College of Physicians |
| Associated public health groups |
None |
| Comparator companies |
ADVANZ Pharma (Ursodeoxycholic acid, Obeticholic acid) (confidentiality agreement not signed, not participating) |
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Dr. Falk Pharma UK Ltd (Ursodeoxycholic acid) (confidentiality agreement not signed, not participating) |
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Galen Limited (Ursodeoxycholic acid) (confidentiality agreement not signed, not participating) |
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Glenmark Pharmaceuticals Europe Ltd (Ursodeoxycholic acid) (confidentiality agreement not signed, not participating) |
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Norgine Limited (Ursodeoxycholic acid) (confidentiality agreement not signed, not participating) |
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Strides Pharma UK Ltd (Ursodeoxycholic acid) (confidentiality agreement not signed, not participating) |
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Wockhardt UK Ltd (Ursodeoxycholic acid) (confidentiality agreement not signed, not participating) |
| 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 |
None |
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Date
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Update
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02 February 2024
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Invitation to participate |
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22 November 2023 - 20 December 2023
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Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6331 |
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10 October 2023
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In progress. DHSC referral received |
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14 July 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