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UK's NICE Backs Tagrisso for First-, Second-Line EGFR-Positive Lung Cancer

NEW YORK – The UK's National Institute for Health and Care Excellence on Friday published a draft decision saying that it would recommend osimertinib (AstraZeneca's Tagrisso) for routine use in the National Health Service for first-line treatment of advanced, EGFR mutation-positive non-small-cell lung cancer patients, and second-line treatment of locally advanced or metastatic, EGFR mutation-positive NSCLC patients who have the T790m resistance mutation.

The proposed positive recommendation is a reversal from NICE's initial negative recommendation in January 2020. At that time, NICE determined that osimertinib did not meet its end-of-life criteria for life-extending treatments, and that the drug's cost-effectiveness estimates exceeded what NICE considers an acceptable use of NHS resources.

Now, NICE has inked an updated commercial agreement with AstraZeneca that includes a discounted price for osimertinib. Based on this new price, NICE has determined that the cost-effectiveness estimates for the drug are within the acceptable range.

The estimated price of osimertinib is £5,770 ($7,385) for a month's supply. NICE did not disclose the discounted price but noted that its new commercial agreement with AstraZeneca includes a patient access program. Previously, patients in the UK with the T790m mutation could receive osimertinib as second-line treatment through the Cancer Drugs Fund, which is another pathway by which National Health Service patients can get access to treatments that don't meet NICE's cost-effectiveness threshold based on current evidence.

In the US, osimertinib, a third-generation EGFR-targeting TKI, first received market approval in 2015 in the second-line setting, followed by a first-line approval in 2018. The first-line approval was based on a randomized clinical trial that demonstrated osimertinib's benefit over first-generation TKIs, including erlotinib (Genentech/Astellas Oncology's Tarceva) and gefitinib (AstraZeneca's Iressa).

Meanwhile, in the UK, afatinib (Boehringer Ingelheim's Gilotrif) is the most-prescribed first-line treatment for EGFR-positive NSCLC patients. NICE's evidence review committee conducted an indirect comparison of afatinib and osimertinib and determined that the progression-free survival benefit was comparable between the two agents.

"Osimertinib is a significant new treatment for up to 1,800 people with lung cancer — allowing them to spend more precious time with their loved ones without suffering from distressing side-effects," John Stewart, the NHS's director of specialized commissioning said in a statement. "And [this] is why the NHS has worked closely with NICE and AstraZeneca to reach a deal that not only benefits patients but is also a fair price for taxpayers."