Reimb status of Keytruda for breast cancer treatment

HIRA's Drug Reimbursement Evaluation Committee (DREC) decided Keytruda appropriate for reimbursement for second-line treatment

Keytruda used as a first-line treatment remains non-reimbursed…will it pass the CDRC review?

As Keytruda passed the Drug Reimbursement Evaluation Committee (DREC) review after another attempt, it is expected to be reimbursed within the first half of the year.

 

According to the pharmaceutical industry on February 10, the Health Insurance Review and Assessment Service (HIRA) held the 2nd DREC for 2025 and approved reimbursement appropriateness for Gilead Sciences Korea's Trodelvy (sacituzumab govitecan).

 

Product photos of Trodelvy and Keytruda

Trodelvy is an antibody-drug conjugate (ADC) that binds to Trop-2 protein, highly expressed in various cancer types, including breast cancer, and releases medication inside the tumor cells.

 

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

 

Consequently, clinical practices in South Korea can now use the drug as a non-reimbursed treatment for triple-negative breast cancer (TNBC).

 

However, using the drug without reimbursement costs over KRW 10 million per cycle (three weeks).

 

Due to this cost burden, reimbursement is needed to improve patient access and more uses in clinical practices.

 

Furthermore, Trodelvy is the only treatment approved by the MFDS as a second-line treatment for patients with metastatic TNBC, regardless of existing genetic mutation or biomarkers.

 

Patients have high hopes for reimbursement of this medication.

 

In response, the HIRA recognized the necessity of Trodelvy, which was reviewed for reimbursement appropriateness.

 

HIRA stated that Trodelvy is the first case of a new drug being recognized for innovativeness.

 

Last year, HIRA revised the details of the criteria for drugs submitted for negotiations and determined to offer new drugs a benefit from the government based on their ICER value.

 

Innovative drugs are to meet the criteria of ▲If no products or therapy that can be replaced or have therapeutic equivalence ▲Final result index, such as overall survival extension, indicates significant clinical improvements ▲New drugs granted expedited review according to Article 35-4 Clause 2 of the Pharmaceutical Affairs Act or medicine determined to have equivalent value as determined by the committee.

 

HIRA stated, "Trodelvy is the first case for which a revised system aimed at improving patient access to new drugs with innovativeness." Following this decision, Trodelvy is now closer to being reimbursed as the second new ADC drug, following Enhertu.

 

If the company agrees to the drug price negotiations with the National Health Insurance Service (NHIS) without further issue, reimbursement can be applied within the first half of the year.

 

Obtaining reimbursement will positively impact Gilead Sciences, which launched its oncology business division when launching Trodelvy in South Korea, to expand its presence in clinical practices.

 

However, the status of Keytruda (pembrolizumab), used as a first-line treatment in combination with chemotherapy, is concerning as it remains non-reimbursed.

 

Since Trodelvy is used as a second-line treatment, reimbursement approval of Keytruda is essential for use in clinical practices.

 

MSD Korea has also applied for setting reimbursement criteria for Keytruda for up to 17 indications to treat cancers, including TNBC.

 

Now, for metastatic TNBC treatments in clinical practices, chemotherapy, Keytruda or Tecentriq (atezolizumab) is used as first-line treatments, the PARP inhibitor Lynparza (olaparib) is used as a second-line treatment, and Trodevly is used after the second-line treatment.

 

Professor Joohyuk Sohn at Yonsei Cancer Hospital (Department of Oncology) said, "Keytruda is not actually competing against Trodelvy.

 

We hope reimbursement will be provided for drugs benefiting all patients." Sohn added, "Trodelvy extended the progression-free survival (PFS) by five months compared to chemotherapy.

 

Five months is a significant time for patients.

 

And, data indicate that patients who respond well to the treatment can extend up to 10-15 months, so the drug is clinically significant." Meanwhile, HIRA's DREC determined reimbursement appropriateness for Adempas (riociguat, Bayer Korea), a treatment for arterial pulmonary hypertension, in addition to Trodelvy during the second meeting.

 

The committee determined that the plaque psoriasis treatment Bimzelx Autoinjector (bimekizumab, UCB Korea) and Ebglyss Autoinjector inj (lebrikizumab, Lily Korea) would be appropriate for expanded reimbursement scope if the companies accepted the drug price below the evaluated amount.

 

Additionally, the committee determined that Cabometyx tab (cabozantinib, Ipsen Korea), a treatment for renal cell carcinoma (RCC), would be appropriate for expanded reimbursement scope if the company accepted the drug price below the evaluated amount.