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New HTA Decisions in England
November 2018
Drug name
MYLOTARG® (gemtuzumab ozogamicin)
Company
Pfizer
Decision date
14/11/2018
Therapeutic area
Cancer
Therapeutic sub area
Blood and bone marrow cancers
Decision
Recommended with restrictions
Indication
Untreated de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia, in people 15 years and over
Decision Detail
The patient starts induction therapy when either the cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (that is, because the test was unsuccessful) or when their cytogenetic test results are not yet available The patient starts consolidation therapy when their cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (because the test was unsuccessful) The company provides gemtuzumab ozogamicin according to the commercial arrangement
Summary
Results from the ALFA-0701 trial demonstrated that gemtuzumab ozogamicin plus daunorubicin and cytarabine increased median event-free survival and relapse-free survival compared to daunorubicin and cytarabine alone. Median overall survival also showed an increase from 21.8 months to 27.5 months. The committee concluded that patients are more likely to live longer without the disease relapsing or symptoms returning. The most plausible cost-effectiveness estimates for gemtuzumab ozogamicin compared with daunorubicin and cytarabine in patients whose disease has been favourable , intermediate or unknown cytogenetics fall within the range NICE considers an acceptable use of NHS resources. Gemtuzumab ozogamicin can therefore be recommended in this patient population.