Presentation (CTI)

OBJECTIVES: Bispecific antibodies (bsAbs) emerged as a novel therapeutic class, in particular to treat hematological malignancies. These drugs provide an innovative mechanism of action simultaneously targeting two different antigens. Several bsAbs improved the clinical outcome of hematological diseases, particularly in relapsed or refractory (RR) settings and received the marketing authorization.This study aims to assess the value of bsAbs defined by the HTA bodies of three European countries after approval by EMA for hematological malignancies.
METHODS: We identified bsAbs approved by EMA up to December 2024. The added therapeutic value (ATV) was obtained from the official HTA documents of the Haute Autorité de santé (HAS), the Federal Joint Committee or Gemeinsamer Bundesausschuss (G-BA), and the Italian Medicines Agency (AIFA).
RESULTS: We identified eight bsAbs for hematological diseases, mosunetuzumab, glofitamab, epcoritamab, and odronextamab for lymphoma, teclistamab, elranatamab, and talquetamab for multiple myeloma and blinatumomab for acute lymphoblastic B-cell leukemia (B-ALL). No regulatory agency recognized a maximum/important ATV for bsAbs, except for blinatumomab as part of the consolidation therapy in pediatric patients with high-risk B-ALL.The HAS claimed that the ATV was absent for glofitamab, epcoritamab, teclistamab, elranatamab, talquetamab, and absent/minor/moderate for blinatumomab; no ATV was assigned to mosunetuzumab. The AIFA claimed that the ATV was absent for glofitamab, epcoritamab, and absent/low/moderate/important for blinatumomab. Finally, the G-BA claimed that the ATV was absent for epcoritamab, teclistamab, and elranatamab, non-quantifiable for mosunetuzumab, glofitamab, talquetamab, and absent/non-quantifiable/important for blinatumomab.
CONCLUSIONS: ATV is crucial for defining the place in therapy of drugs at the national level, and patients’ access. The present study shows the alignment of the three agencies in assessing the value of bsAbs approved for hematological malignancies, with a lack of recognition of ATV for most of the indications. Further analysis will be carried out to assess the reasons and the consequences in terms of access.