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New HTA Decisions in England
August 2020
Drug name
ROZLYTREK® (entrectinib)
Decision date
Therapeutic area
Therapeutic sub area
Lung cancer
Entrectinib is recommended, within its marketing authorisation, as an option for treating ROS1-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had ROS1 inhibitors.
Decision Detail
It is recommended only if the company provides entrectinib according to the commercial arrangement. There is a simple discount patient access scheme for entrectinib.
During the technical engagement stage it was agreed that the STARTRK 2 ROS1-positive NSCLC population was the relevant population for this appraisal. STARTRK 2 is an ongoing single-arm, multicentre basket trial (that is, a trial that included patients who had different types of cancer but the same gene mutation). Most (73%) people had previous therapy for advanced disease and everyone had the licensed entrectinib dose. The primary efficacy endpoints in STARTRK 2 were objective response rate and duration of response. The survival data are immature (not yet complete). The results cannot be reported because they are confidential. The updated pooled analyses (n=94; May 2019 enrolment data cut-off), reported an overall response rate of 73.4% (95% confidence interval [CI] 63.3 to 82.0). The median progression-free survival for entrectinib was 16.8 months (95% CI 12.0 to 21.4). The committee considered that the STARTRK 2 subgroup was representative of NHS clinical practice. It noted that only a small number of people with ROS1-positive NSCLC were included in the basket trial and that the results were immature. However, the committee agreed that entrectinib produced a high overall response rate and slowed disease progression. Two indirect comparisons of entrectinib, using evidence from a different kind of NSCLC, show that it is clinically effective compared with pemetrexed and platinum chemotherapy. But because the evidence is from a different population, this is uncertain. The decision-making ICERs used by the committee, which took account of all available confidential discounts including discounts for comparators and follow-up treatments, were higher. But these still remained within the range NICE normally considers an acceptable use of NHS resources for end-of-life treatments. Despite the immaturity and uncertainty with the data, the committee was persuaded that the highest ICER for entrectinib compared with PEM+PLAT was likely to be below £50,000 per QALY gained. The committee concluded that entrectinib can be considered cost effective. Therefore it can be recommended for routine commissioning as an option for treating ROS1-positive advanced NSCLC.