Reason for request
Favourable opinion for reimbursement in paediatric patients with newly diagnosed Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL).
What therapeutic improvement?
No clinical added value.
Role in the care pathway?
The current care pathway in the first-line treatment of acute lymphoblastic leukaemia in paediatric patients is based on the combination of imatinib (GLIVEC) with multi-agent chemotherapy following an induction, consolidation, maintenance regimen. Depending on the situations (in particular Ph+ ALL at high risk of relapse) and in the event of a compatible HLA donor, allogeneic hematopoietic stem cell transplantation (HSCT) may be envisaged after first remission is obtained.
Role of the medicinal product in the care pathway
SPRYCEL (dasatinib), in the form of film-coated tablets or powder for oral suspension, is an alternative to GLIVEC (imatinib), as a film-coated tablet, in the treatment of paediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy. The Committee highlights the benefit of having access to a powder for oral suspension form and reiterates that the two oral forms (tablets and powder) are not bioequivalent. The recommendations relative to dosage (see SPC) must be followed when switching from one form to the other.
 See complete indications on page 3 of the opinion
The clinical benefit of SPRYCEL is substantial in the indication for paediatric patients with newly diagnosed Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.
Clinical Added Value
|no clinical added value||
SPRYCEL (dasatinib) in combination with chemotherapy provides no clinical added value (CAV V) in the care pathway for the treatment of paediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy.