Tezepelumab (1) – Tezspire®

• Clinical trials
  • The randomised, double-blind extension study DESTINATION included patients who had completed either the NAVIGATOR study (N = 827) or the SOURCE study (N = 124).

a) Adolescents aged 12 to 17 with severe asthma that is inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus another medicinal product used for maintenance therapy

• The additional benefit is not proven.
• However, for the vast majority of patients in the low-biomarker populations, it remains unclear whether a trial of LAMA would have constituted an appropriate – and therefore, in accordance with the G-BA’s appropriate comparator therapy – escalation of treatment.
• The appropriate comparator therapy has not been implemented in the low-biomarker populations.
• Consequently, the results of the NAVIGATOR, PATHWAY and DESTINATION studies cannot be taken into account for the benefit assessment.

b) Adults with severe asthma that is inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus an additional medicinal product used for maintenance therapy

• The additional benefit is not proven.
• However, for the vast majority of patients in the low-biomarker populations, it remains unclear whether a trial of LAMA would have constituted an appropriate comparator therapy – and therefore, in accordance with the G-BA’s standard of care, necessary – escalation of treatment.
• The appropriate comparator therapy has not been implemented in the low-biomarker populations.
• Consequently, the results of the NAVIGATOR, PATHWAY and DESTINATION studies cannot be taken into account for the benefit assessment.
• It therefore remains unclear whether treatment with dupilumab represents the appropriate, patient-specific escalation of therapy (taking prior treatment into account) for these patients.
• The appropriate comparator therapy has not been applied in the indirect comparison of tezepelumab versus dupilumab presented here.

Courtesy translation only, please refer to the German original.