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New HTA Decisions in France
June 2020
Drug name
GLIVEC® (imatinib)
Company
Novartis Pharma SAS
Decision date
06/11/2019
Therapeutic area
Cancer
Therapeutic sub area
Cancer: general and other
Therapeutic area 2
Blood and immune system conditions
Therapeutic sub area 2
Blood and immune system conditions: general and other
Official notice date
25/11/2019
Reimbursement %
65
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
GLIVEC® is indicated for: - the treatment of adult patients and children with Philadelphia chromosome (bcr-abl) positive (Ph +) newly diagnosed chronic myelogenous leukemia (CML) when bone marrow transplantation cannot be considered a first-line treatment; - the treatment of adult patients and children with Ph + CML in chronic phase after failure of treatment with interferon alpha, or accelerated phase or blast crisis; - the treatment of adult patients and children with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph + ALL) in combination with chemotherapy; - the treatment of adult patients with relapsed or refractory Ph + ALL in monotherapy; - the treatment of adult patients with myelodysplastic/myeloproliferative syndromes (MDS/MPS) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements; - the treatment of adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) associated with FIP1L1-PDGFRα rearrangement; - the treatment of adult patients with unresectable and/or metastatic Kit (CD117) positive gastrointestinal stromal tumours (GISTs); - the adjuvant treatment of adult patients with a significant risk of relapse after resection of Kit (CD117) positive gastrointestinal stromal tumor GIST; - the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP or Darier-Ferrand disease) and adult patients with relapsed and/or metastatic DFSP not undergoing surgical treatment
Decision Type
New technology assessment
Summary
The committee considered the actual benefit of GLIVEC® to be 'important' in the indications of the Marketing Authorisation. It was concluded that GLIVEC® 100 mg film-coated tablets does not provide any improvement in the medical service rendered (ASMR V) compared to the presentations already listed. The committee proposed 65% reimbursement.