General BESPONSA project information

Project name

Real-world evidence of Besponsa in Belgium in acute lymphoblastic leukemia patients according to the prevailing reimbursement criteria

Project abbreviation

BESPONSA

Project code

HDBP0211

Primary organization that oversees implementation of project

• Pfizer N.V.S.A

Partner organization participating in project

• Not applicable

Organization that commissioned this project

• National Institute for Health and Disability Insurance (RIZIV-INAMI)

Organization providing monetary or material support

• Pfizer N.V.S.A

Brief project description

Real-world data are needed in the frame of a managed entry agreement (MEA) between Pfizer and the RIZIV-INAMI for Besponsa (inotuzumab ozogamicine), a drug used in the treatment of a type of leukemia (relapsed/refractory B-cell acute lymphoblastic leukemia, R/R ALL). The collected data will be used to demonstrate health outcome and resource use in the frame of managed entry agreement with RIZIV/INAMI (art 112 convention).

A convention for a temporary reimbursement has been concluded between Pfizer N.V.S.A and RIZIV-INAMI for the specialty Besponsa, Pfizer opted to collect real-world data using the healthdata.be platform.

• Legislation regarding MEA , described in Art. 112 Royal Decree of February 1^st 2018
• Besponsa reimbursement criteria in paragraph 9830100, 9830200 and 9830300 of the ministerial decree of August 19^th 2019

The convention started on the 1^st of August 2019 and expired 31^st of March 2021. At that time new agreements have been negotiated between Pfizer and RIZIV-INAMI. Pfizer got an extension for a period till 30/04/2026. Pfizer has to report to the “Commissie Tegemoetkoming Geneesmiddelen/ la Commission de Remboursement des Médicaments” (CTG/CRM) of RIZIV-INAMI by 30th October 2025.