Suggested remit: To evaluate the benefits and costs of palovarotene within its marketing authorisation for preventing heterotopic ossification associated with fibrodysplasia ossificans progressiva for national commissioning by NHS England.
The company have advised that the European Medicines Agency Committee for Medicinal Products (CHMP) have issued a negative opinion for Palovarotene to reduce the formation of heterotopic ossification associated with fibrodysplasia ossificans progressiva. Therefore, NICE has decided to suspend this evaluation from its work program until further information is available. As this evaluation has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes.
 
Status Suspended
Technology type Medicine
Decision Selected
Process HST
ID number 3739

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Timeline

Key events during the development of the guidance:

Date Update
21 March 2023 Suspended. The company have advised that the European Medicines Agency Committee for Medicinal Products (CHMP) have issued a negative opinion for Palovarotene to reduce the formation of heterotopic ossification associated with fibrodysplasia ossificans progressiva. Therefore, NICE has decided to suspend this evaluation from its work program until further information is available. As this evaluation has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes.
04 August 2022 Invitation to participate
14 March 2022 (14:00) Scoping workshop
18 January 2022 - 15 February 2022 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators

For further information on our processes and methods, please see our CHTE processes and methods manual