Suggested remit - To appraise the clinical and cost effectiveness of KTE-X19 within its marketing authorisation for treating relapsed or refractory mantle cell lymphoma
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Status
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In progress
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| Process |
STA 2018
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| ID number |
1313
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Provisional Schedule
| Committee meeting: 1 |
13 October 2020 |
| Expected publication |
06 January 2021 |
Project Team
| Project lead |
Thomas Feist |
Email enquiries
| Evidence Review Group / Assessment Group |
Centre for Reviews and Dissemination and Centre for Health Economics, University of York |
Consultees
| Companies sponsors |
Kite, a Gilead company |
| Others |
Department of Health and Social Care |
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NHS England |
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Welsh Government |
| Patient carer groups |
Royal College of Physicians |
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Royal College of Radiologists |
| Professional groups |
Leukaemia CARE |
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Lymphoma Action |
Commentators
| General commentators |
All Wales Therapeutics & Toxicology Centre |
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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 Scottish Medicines Consortium |
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Welsh Health Specialised Services Committee |
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Date
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Update
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13 February 2020
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Invitation to participate |
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18 October 2019 - 15 November 2019
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Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
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07 May 2019
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As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of KTE-X19 for treating relapsed or refractory mantle cell lymphoma.
Please note that following on from advice received from the company the timelines for this appraisal have been revised.
We now anticipate that the appraisal will begin during late January 2020 when we will write to you about how you can get involved. |
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14 February 2019
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The National Institute for Health and Clinical Excellence (NICE) has been invited to carry out an appraisal of lymphoma (mantle cell, relapsed, refractory) – KTE-X19 (Axicabtagene ciloleucel in the consultation invitation).
We have recently invited stakeholders to respond to a written consultation on the draft scope and to attend a scoping workshop for this appraisal.
On receiving updated regulatory timing information from the company developing KTE-X19, NICE has agreed that a consultation on the draft scope and holding a scoping workshop at this time would not be appropriate.
In light of this information, NICE will not be progressing with the scoping exercise at this time. Consequently the consultation on the draft scope will be closed and the scoping workshop arranged for Monday 11 March 2019 at 10:00 will be cancelled.
The scoping exercise will be rescheduled to take place in line with anticipated regulatory approval timings. We apologise for any inconvenience this may cause
If you have any comments or concerns please do not hesitate to contact me as the project manager for this appraisal on (0161 870 3148 or via email on michelle.adhemar@nice.org.uk or scopingta@nice.org.uk) |
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24 April 2018
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In progress, Topic referred |
For further information on how we develop guidance, please see our page about NICE technology appraisal guidance