AstraZeneca’s Tagrisso, targeted therapy for lung cancer, has won recognition as the first-line standard treatment for epidermal growth factor receptor (EGFR)-mutated lung cancer in the U.K., Taiwan, and Australia.

The latest development has drawn attention to whether the Korean authorities would allow the national health insurance benefit for Tagrisso, observers said.

The U.K. National Institute for Health and Care Excellence (NICE) on Friday recommended the use of Tagrisso (ingredient: osimertinib) as the primary therapy for EGFR- and T790-mutated non-small cell lung cancer (NSCLC) through the Cancer Drug Fund. The NICE is to confirm it finally on Oct. 14.

Developed by AstraZeneca, Tagrisso is a third-generation EGFR tyrosine kinase inhibitor (TKI). The drug is reimbursable for the second-line treatment in EGRF positive progressive or metastatic NSCLC in Korea.

Tagrisso showed superior efficacy to conventional EGFR TKIs in EGFR-mutated lung cancer patients with T790-mutation tumors or brain metastasis. AstraZeneca has successfully expanded the indication of Tagrisso to first-line therapy around the world, including Korea.

The phase-3 FLAURA study demonstrated that Tagrisso extended progression-free survival (PFS) by 8.7 months and overall survival (OS) by 6.8 months, compared to the existing treatment.

Among NSCLC drugs, Tagrisso is the only primary therapy that proved improvement in three-year or longer OS in a clinical trial, according to AstraZeneca. Based on this trial data, the U.S. National Comprehensive Cancer Network (NCCN) recommends Tagrisso at the highest recommendation level (category 1) in EGFR mutation-positive NSCLC.

In Korea, however, Tagrisso has repeatedly failed to win reimbursement since it expanded indication to the first-line therapy in December 2018.

In May 2019, a user filed an online petition on Cheong Wa Dae’s website, demanding the state health insurance benefit.

The petition came after the Health Insurance Review and Assessment Service (HIRA)’s Cancer Drug Reimbursement Committee ruled that Tagrisso as the first-line treatment was inapt for reimbursement on April 29. The committee has virtually delayed the review until it gets updated data on Tagrisso.

Tagrisso won reimbursement in Taiwan in April, in Australia in July, and in the U.K. recently.

The U.K. is one of the seven countries that the Korean health authorities refer to when reviewing drug reimbursement.

Industry officials here are watching whether the NICE’s recommendation of Tagrisso reimbursement would prompt the local authorities to resume the lung cancer drug's review.