Luspatercept (re-assessment, 30 M € limit exceeded: beta-thalassemia with non-transfusion-dependent anemia)



  • Active Substance: Luspatercept
  • Name: Reblozyl®
  • Therapeutic area: Beta-thalassemia with non-transfusion-dependent anemia
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA


Time table:

  • Start: 15.05.2023
  • Publication of assessment: 15.08.2023
  • End of public hearing: 05.09.2023
  • Final decision by G-BA: beginning of November 2023


Comparative therapy:

  • Transfusion therapy with red blood cell concentrates as required in combination with chelation therapy according to the approval, preferably as monotherapy