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New HTA Decisions in England
October 2020
Drug name
TAGRISSO® (osimertinib)
Decision date
Therapeutic area
Therapeutic sub area
Lung cancer
Osimertinib is recommended, within its marketing authorisation, as an option for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults.
Decision Detail
It is recommended only if the company provides osimertinib according to the commercial arrangement. The company has a commercial arrangement, including a patient access scheme, which makes osimertinib available to the NHS with a discount.
The clinical evidence for osimertinib was presented in the randomised controlled trial FLAURA, comparing the efficacy and safety of osimertinib with standard care (erlotinib or gefitinib) for people with locally advanced or metastatic EGFR mutation-positive NSCLC. Interim analysis showed that progression-free survival was statistically significantly longer with osimertinib than with erlotinib or gefitinib. Interim results showed that osimertinib extended overall survival compared with standard care but overall survival benefit was difficult to establish because the data were very immature. There is some uncertainty about the comparison of osimertinib with afatinib, which may be more effective than erlotinib and gefitinib, because there is no direct evidence comparing them. Because of a new commercial arrangement, the cost-effectiveness estimates for osimertinib are within what NICE considers an acceptable use of NHS resources (the exact ICERs cannot be reported here because they are commercial in confidence).