Reason for request

First listing

Summary of opinion

Favourable opinion for reimbursement in combination with other chemotherapy medicinal products: 

  • with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic stem cell transplantation (HSCT) in haematological diseases in adult and paediatric patients;
  • when high dose chemotherapy with HSCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.

No clinical added value of the new form compared to the forms already listed.


Clinical Benefit

Substantial

The Committee considers that the clinical benefit of TEPADINA (thiotepa) is substantial in the MA indication.


Clinical Added Value

no clinical added value

This medicinal product is a range supplement that does not provide any clinical added value (CAV V) compared to the forms already listed.


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