To evaluate the benefits and costs of maralixibat within its marketing authorisation for treating type 2 progressive familial intrahepatic cholestasis for national commissioning by NHS England.
As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Highly Specialised Technology of maralixibat for treating type 2 progressive familial intrahepatic cholestasis. For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application from the European Medicines Agency for this indication at this time. Therefore, NICE has decided to suspend this evaluation from its current work programme. As this evaluation has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
 
Status Suspended
Process HST
ID number 3818

Project Team

Project lead Michelle Adhemar

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
29 October 2021 Suspended. As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Highly Specialised Technology of maralixibat for treating type 2 progressive familial intrahepatic cholestasis. For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application from the European Medicines Agency for this indication at this time. Therefore, NICE has decided to suspend this evaluation from its current work programme. As this evaluation has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
01 March 2021 (14:00) Scoping workshop
08 January 2021 - 05 February 2021 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
08 January 2021 Draft scope documents

For further information on how we develop guidance, please see our page about NICE highly specialised technologies guidance