Trodelvy approved for reimbursement with the ICER value

Incremental Cost-Effectiveness Ratio (ICER) value has been applied, the first case in KOR gains attention

provides benefits compared to standard therapies used as a second-line or later treatment for patients with metastatic TNBC

Assessed as bringing a paradigm shift to previous treatments limited to chemotherapy

As Trodelvy (sacituzumab govitecan), the first antibody-drug conjugates (ADC) for treating Triple-Negative Breast Cancer (TNBC) available in South Korea, becomes reimbursed, a paradigm shift in the treatment is expected.

 

Experts assess that the metastatic TNBC treatment, which has been challenging due to a high risk of metastasis and relapse and relied on chemotherapy, has undergone a transition.

 

There is a high demand for Trodelvy, as demonstrated by two previous National Petitions with over 50,000.

 

In the future, the survival benefit is expected to rise.

 

Trodelvy can be reimbursed by the national health insurance from June for the treatment of Triple-Negative Breast Cancer (TNBC).

 

A paradigm shift in TNBC treatment is expected.

On June 11, Gilead Sciences Korea hosted a session to celebrate reimbursement approval of Trodelvy, and the company shared the latest updates on TNBC treatment and the significance of reimbursement.

 

TNBC is a type of breast cancer that is negative for three receptors: two types of hormone receptors and the HER2 receptor.

 

TNBC has unmet needs because there is no receptor that treatment can target, and treatment options have been limited to cytotoxic anticancer agents.

 

Trodelvy is known to bind Trop-2 protein, releasing the medicine inside tumor cells.

 

It minimally affects healthy cells, and it can destroy not only tumor cells but also the tumor microenvironment (TME).

 

Besides cytotoxic anticancer agents, Trodelvy is the only treatment approved by the Ministry of Food and Drug Safety (MFDS) as a second-line treatment for patients with metastatic TNBC, regardless of existing genetic mutations or biomarkers.

 

When MFDS granted approval in May 2023, Trodelvy presented a cost burden of KRW 10 million per cycle.

 

It was approved for national health insurance reimbursement in June, thereby expanding patient accessibility.

 

Specifically, Trodelvy can be reimbursed for treating locally advanced or metastatic TNBC as a third-line or later treatment.

 

If recurrence occurs during or within one year of completing neoadjuvant or adjuvant chemotherapy, previous treatments are considered as first-line treatment, allowing for reimbursement of Trodelvy in the second-line setting as well.

 

Trodelvy was categorized as having innovativeness.

 

It gained attention for becoming the first case to clear the DREC review, with its price being measured based on its an Incremental Cost-Effectiveness Ratio (ICER) values.

 

Dr.

 

Joohyuk Sohn, a Professor at Yonsei Cancer Hospital's Department of Oncology, who presented during the meeting, assessed that reimbursement approval of Trodelvy will bring a new shift in the treatment of TNBC.

 

Dr.

 

Joohyuk Sohn, a Professor at Yonsei Cancer Hospital

Dr.

 

Sohn explained, "While there has been remarkable progress with the emergence of various new drugs for breast cancer, treatment options for TNBC have remained limited.

 

It has been challenging to treat due to its faster and more aggressive progression compared to other types of breast cancer." Additionally, Trodelvy, with efficacy confirmed through the Phase 3 ASCENT study and now reimbursed, is considered a potential new game changer.

 

Dr.

 

Sohn stated, "The final analysis results of the ASCENT study showed that the overall survival (OS) of the Trodelvy treatment group, including patients with brain metastases, was 11.8 months, approximately twice as long as the single-agent chemotherapy group (6.9 months), and it reduced the risk of death by 49%." The breast cancer guidelines of the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) foremost recommend Trodelvy as a second-line treatment for metastatic triple-negative breast cancer.

 

Dr.

 

Sohn emphasized, "For patients who were hesitant to receive treatment because Trodevly was not reimbursable, despite the clear clinically confirmed treatment benefits, the reimbursement listing of Trodelvy will bring survival benefits." "When new drug efficacy is proven, rapid reimbursement approval is needed to expand patient access" In particular, Dr.

 

Sohn suggested that if a new drug's efficacy is sufficient, a rapid reimbursement approval is necessary.

 

Dr.

 

Sohn stressed, "Regarding (new drug) accessibility, it takes too long, usually 3 to 4 years, and I think it's problematic that we consider it a good thing when it takes only 2 years," and added, "While reimbursement listings can be delayed due to health insurance finances.

 

If the research data is not accurate, it can also be delayed.

 

However, if the benefit in OS is proven, rapidly expanded reimbursement is necessary." Meanwhile, Trodelvy is recently expected to expand its indication as a first-line treatment for TNBC through combination therapy with the immunotherapy Keytruda.

 

In the interim analysis results of the Phase 3 'ASCENT-04/KEYNOTE-D19' clinical trial, presented at the recent American Society of Clinical Oncology (ASCO 2025) Annual Meeting, the median progression-free survival (mPFS) for the Keytruda-Trodelvy group was 11.2 months, showing a significant improvement over the control group's chemotherapy+Keytruda at 7.8 months.

 

The duration of response (DOR) for the Trodelvy-Keytruda treatment group was 16.5 months, while chemotherapy+Keytruda was limited to 9.2 months.

 

The OS data were yet incomplete, but a positive trend was observed with Trodelvy plus Keytruda.