Presentation (CTI)

OBJECTIVES: To compare and analyse the reimbursement of bispecifics and CAR-T therapies for haematological malignancies in Germany, France, and the UK
METHODS: 109 unique HTA assessments published by the HAS in France, G-BA in Germany, and NICE in the UK for all CAR-T therapies and bispecific antibodies approved for haematological malignancies were assessed. They were analysed to understand the key payer objections related to the comparator arm, the primary endpoint, PROs, and indirect treatment comparisons (ITCs) included in the submissions, along with the HTA outcomes.
RESULTS: HTA assessments for 11 drugs (5 bispecific antibodies and 6 CAR-Ts) were reviewed across France, Germany, and the UK. In the UK, 58% of the assessments involving CAR-Ts were reimbursed across various indications, compared to 100% in Germany and 100% in France. This was consistent with the reimbursement rates for bispecifics, which were 71% in the UK, 100% in Germany, and 87% in France. The majority of payer objections related to the lack of a comparator arm, making the evaluation of efficacy challenging. Payers also highlighted the absence of mature OS data. On the safety front, the incidence of CRS was one of the key issues highlighted. Although many submissions included ITCs, the lack of a relevant patient population and differences in study design limited their use. Other challenges identified by payers included the lack of assessable data on QoL due to the absence of a control group and the monitoring requirements related to the administration of CAR-Ts.
CONCLUSIONS: CAR-Ts and bispecifics have transformed the treatment paradigm for various haematological malignancies. However, there is no substantial difference in the HTA outcomes for bispecifics compared to CAR-Ts. Understanding and comparing these payer challenges is essential to inform the design of future clinical trials and to guide the strategic planning for evidence generation for these therapies.