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PTJA13 – Publication of Project Plan.

PTJA13 – Publication of Project Plan.

PTJA13 – Satralizumab is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive – the project plan is now available.

Due to unexpected changes to the timelines of the EU regulatory procedure of satralizumab, the finalization of this assessment falls outside of the EUnetHTA Joint Action 3 timeframe. Due to this, the authoring team was unable to continue the assessment.

Although the assessment will not be continued by EUnetHTA, the CHMP has adopted a positive opinion for staralizumab which is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive, and its marketing authorization is pending a decision by the European Commission. Therefore, satralizumab will be assessed through national HTA procedures in due time.

The authoring team of PTJA13 has finalized the project plan, outlining EUnetHTA’s PICO proposal which has been adapted following the CHMP opinion, and would have been considered for this assessment should it have continued. Please see below the project plan provided by the Joint Assessment Authoring Team.

PTJA13 – Final Project Plan

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