Drug briefing on Enhertu's NSCLC reimb has been requested

The company applied for reimbursement of two additional indications at the end of last year…company's share of the financial burden would be a determining factor

To present Enhertu's efficacy through a drug briefing session…two-way communication

Product photo of Enhertu

It has been reported that Daiichi Sankyo, which is aiming for Enhertu (trastuzumab deruxtecan)'s expanded reimbursement for HER2-mutant non-small cell lung cancer (NSCLC), will hold a drug briefing session with the Health Insurance Review & Assessment Service (HIRA).

 

In April 2024, Enhertu was added to the reimbursement listing in South Korea as a treatment for HER2-positive metastatic breast cancer and gastric cancer.

 

It has garnered attention as the drug received benefits for exceeding the incremental cost-effectiveness ratio (ICER) value, an index for economic evaluation.

 

According to industry sources on March 17, Daiichi Sankyo recently requested a drug briefing regarding Enhertu's HER2-mutant NSCLC treatment.

 

Enhertu, an antibody-drug conjugate (ADC) jointly developed by Daiichi Sankyo and AstraZeneca, was approved by the U.S.

 

Food and Drug Administration (FDA) in 2019.

 

In December 2024, Daiichi Sankyo applied for insurance reimbursement of the ADC Enhertu's two additional indications.

 

The company had applied for Enhertu's indication to treat ▲Patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have previously undergone systemic therapy in the metastatic setting or relapsed within 6 months of completing adjuvant chemotherapy and hormone receptor-positive (HR+) patients who have received or are unsuitable for endocrine therapy ▲Patients with unresectable or metastatic NSCLC with activated HER2 (ERBB2) mutations who have previously received systemic therapy, including platinum-based chemotherapy.

 

Enhertu was added to the reimbursement listing as a treatment for HER2-positive metastatic breast cancer and gastric cancer in April of last year.

 

The ceiling price of the drug was KRW 1.43 million per vial.

 

The Ministry of Health and Welfare (MOHW) explained that after the reimbursement of Enhertu, "Patients with HER2-positive metastatic breast cancer who spent approximately KRW 83 million annually for administration cost will now only pay KRW 4.17 million with the health insurance coverage." It has been reported that the health authority offered benefits for Enhertu's inclusion in the reimbursement list, considering the ICER value.

 

Enhertu reportedly generated sales of approximately KRW 20 billion last year.

 

Analysis suggests that if the reimbursement is applied to NSCLC with many patients, reimbursement claim amount will increase.

 

As a result, whether the reimbursement will be expanded will depend on pharmaceutical company's share of financial burden.

 

However, expanded reimbursement of Enhertu is expected to provide significant therapeutic benefits for patients, given that Enhertu has demonstrated clear efficacy.

 

Enhertu demonstrated an anti-tumor response for the second-line treatment of HER2-mutant metastatic NSCLC through the DESTINY-Lung02 study.

 

The clinical results demonstrated that Enhertu had Blinded Independent Central Review (BICR)-assessed confirmed ORR of 49%, complete response (CR) of 1%, and partial response (PR) of 48%.

 

Daiichi Sankyo is expected to present these efficacy data to persuade reviewers at the HIRA.

 

The drug briefing session was introduced in 2010 to enhance transparency and objectivity in evaluations by facilitating the mutual exchange of information about new drugs between pharmaceutical companies and evaluators.

 

These sessions are typically held within 1-2 months after a drug evaluation application is submitted.

 

If additional data are requested, the session is scheduled once the supplementary materials are reviewed.

 

Attendees include HIRA personnel and related deputy directors responsible for setting the standards and reimbursement evaluations for new drugs.

 

Daiichi Sankyo previously utilized a drug briefing session during the initial listing of Enhertu, which reportedly positively impacted its reimbursement approval, leading them to apply for another session.

 

"Drug briefing sessions provide accurate drug information and, through two-way communication, allow for sharing any supplemental details, which can help expedite the reimbursement review process," said an industry employee.