Less than a year after AstraZeneca's lung cancer drug Tagrisso (osimertinib) was granted expanded reimbursement coverage, another round of discussions on its further expansion has begun, drawing attention to its background.

As the expansion request came from the medical community, not pharmaceutical companies, it will be interesting to see if the experts' request will be granted.

#On the 18th, according to the pharmaceutical industry and medical community, the Health Insurance Review and Assessment Service recently held the 8th Cancer Disease Deliberation Committee meeting in 2024 to deliberate on whether to set a reimbursement standard for Tagrisso.

The committee discussed the need to set a reimbursement standard for ‘Tagrisso in combination with pemetrexed and platinum-based chemotherapy’ as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small-cell lung cancer with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation.

In other words, less than a year after the drug’s reimbursement was expanded to its use as a monotherapy, the authorities are reviewing extending its reimbursement as a combination therapy as a first-line treatment for NSCLC.

The review is based on the results of the FLAURA2 study, which compared the efficacy of the Tagrisso+chemotherapy combination therapy with Tagrisso monotherapy. Study results showed that the Tagrisso+chemotherapy combination reduced the risk of disease progression or death by 38% compared to Tagrisso alone.

Median investigator-assessed PFS was 25.5 months, an 8.8-month extension compared to 16.7 months with Tagrisso monotherapy. Median PFS by blinded independent central review (BICR) was 29.4 months, compared with 19.9 months in the Tagrisso monotherapy arm.

This led to a reimbursement discussion, but the outcome was a 'reimbursement standard not established’ decision

However, it is worth noting the background of why CDDC decided to discuss Tagrisso's reimbursement extension.

Usually, a “pharmaceutical company” applies to expand the reimbursement of anticancer drugs, but this time, the Korean Lung Cancer Society applied for the reimbursement expansion upon which the cancer review was held.

The Korean Association For Lung Cancer applied to expand the reimbursement of the Tagrisso+chemotherapy combination, and AstraZeneca supported it. This means that the need to use the Tagrisso+chemotherapy combination has been recognized in clinical practice.

“Pemetrexed plus cisplatin or carboplatin, which is used as combination therapy, is relatively well tolerated by patients,” said Professor Sang-We Kim (Medical Oncology) from Seoul Asan Medical Center. ”It can be relatively difficult because you have to receive chemotherapy for four cycles, but from the fifth cycle, you receive only pemetrexed. Given the positive outcomes, including PFS in the FLAURA2 study, the combination may be a viable first-line treatment option compared to Tagrisso monotherapy.” 

As such, AstraZeneca is expected to further review the data and decide whether to reapply for reimbursement expansions. However, there is a possibility that AstraZeneca may not pursue the reimbursement expansions, given that any additional reimbursement would require further price cuts for Tagrisso.

A HIRA official said, “The regulations allow medical societies to apply for reimbursement of drugs. This is what happened to Tagrisso. There have been many such cases before. However, even if a medical society applies for a reimbursement expansion, it may not be possible to discuss it without the cooperation of the pharmaceutical company because the drug’s cost-effectiveness must be verified.”

“For new drugs that are applied the risk-sharing agreement, it is more often the pharmaceutical company that applies for reimbursement coverage, as they have to prove the drug’s cost-effectiveness. However, it has always been possible for academic societies to apply for reimbursement expansions, like in this case.”