PTJA10 – Crizanlizumab for the prevention of vaso-occlusive crises in sickle cell disease patients aged 16 years and older – Final assessment now available

This is the pharmaceutical Joint Assessment PTJA10 – Crizanlizumab for the prevention of vaso-occlusive crises in sickle cell disease patients aged 16 years and older. In October, 2020, the European Commission granted conditional marketing authorisation for Adakveo® (crizanlizumab) for the prevention of vaso-occlusive crises in sickle cell disease patients aged 16 years and older. Publication of this PTJA10 was postponed by 5 weeks due to the unavailability of the EPAR. This Joint Assessment aims to compare the clinical effectiveness and safety of crizanlizumab in the target patient populations with relevant comparators according to the national requirements of EUnetHTA partners.

Below is the documentation provided by the Joint Assessment Authoring Team (Project Plan, Assessment Report and responses to the Factual Accuracy Check performed by Novartis); and the Core Submission Dossier prepared by Novartis, the Marketing Authorisation Holder of crizanlizumab.

For any questions regarding the assessment, please contact WP4_Pharmaceuticals@zinl.nl

PTJA10 – Final Project Plan

PTJA10 – Final Assessment Report

PTJA10 – MAH Core Submission Dossier

PTJA10 – Plain Language Summary

PTJA10 – External Comments – Factual accuracy Check MAH