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New HTA Decisions in England
October 2020
Drug name
TAGRISSO® (osimertinib)
Decision date
Therapeutic area
Therapeutic sub area
Lung cancer
Recommended with restrictions
Osimertinib is recommended as an option for treating epidermal growth factor receptor (EGFR) T790M mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults.
Decision Detail
It is recommended only if: their disease has progressed after first-line treatment with an EGFR tyrosine kinase inhibitor and 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.
This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access agreement for osimertinib for treating EGFR T790M mutation-positive locally advanced or metastatic NSCLC for adults whose disease has progressed after treatment with an EGFR tyrosine kinase inhibitor (NICE technology appraisal guidance 416). As well as new data from the AURA3 trial (an open-label trial that included 419 patients with EGFR T790M mutation-positive NSCLC, whose disease had progressed during first-line EGFR TKI treatment, randomised to either osimertinib or PDC), there were new SACT data from 357 people who had osimertinib in the Cancer Drugs Fund. The committee concluded that the difference in overall survival estimates meant there was uncertainty about the generalisability of the trial data to NHS practice. Population differences could have contributed to the differences in survival results between the trials and the SACT dataset, but this could not be determined. The committee concluded that the most plausible ICER was between £41,799 and £49,649 per QALY gained based on analyses using the company's commercial arrangement. It was lower when the additional commercial information from NHS England was incorporated (commercial in confidence). Osimertinib meets NICE's criteria to be considered a life-extending treatment at the end of life. Although the cost-effectiveness estimates for osimertinib are uncertain, they are likely to be within what NICE considers to be an acceptable use of NHS resources.