Log in or register to see all Alerts
New HTA Decisions in France
December 2019
Drug name
VIZIMPRO® (dacomitinib)
Company
Pfizer
Decision date
23/10/2019
Therapeutic area
Cancer
Therapeutic sub area
Lung cancer
Official notice date
25/11/2019
Reimbursement %
100
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
VIZIMPRO® is indicated as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.
Decision Type
New technology assessment
Summary
The committee considered the actual benefit of VIZIMPRO® to be 'important' in the indication of the Marketing Authorisation. Taking into account: - a gain of 5.5 months in progression-free survival demonstrated over gefitinib; - an increase in toxicity, with a higher incidence of grade ≥3 adverse events with VIZIMPRO® (71.4%) than with IRESSA® (47.8%); - lack of demonstration of a gain in overall survival and quality of life; it was concluded that VIZIMPRO® does not provide any improvement in the medical service rendered (ASMR V) in the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. The committee proposed 100% reimbursement.