Favourable opinion for reimbursement “as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase”.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of ENRYLAZE (recombinant crisantaspase) 10 mg/0.5 mL solution for injection/infusion is substantial in the MA indication.
Clinical Added Value
no clinical added value
Considering:
the poor methodological quality of the purely descriptive and non-comparative study, preventing any formal conclusion from being reached with respect to the results;
the results observed in this study, which suggest a partial maintenance of NSAA 48 hours post-dose ≥ 0.1 IU/mL (on a pharmacodynamic endpoint);
the safety profile deemed to be acceptable and similar to that known for native crisantaspase;
justification of the absence of a comparative study by the situation of persistent supply tensions for native crisantaspase between 2016 and 2023;
the partially met medical need;
the Committee deems that ENRYLAZE (recombinant crisantaspase) 10 mg/0.5 mL solution for injection/infusion provides no clinical added value (CAV V) compared to the clinically relevant comparator (CRISANTASPASE PORTON BIOPHARMA (formerly ERWINASE) (L-asparaginase from Erwinia)).
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