Enhertu lands in general hospitals in KOR after reimb

Passes drug committees of ‘Bit 5’ hospitals in Korea, including SMC and SNUH

Listed rapidly after passing DREC review in February

Hospitals in Korea are busy preparing a prescription environment for the reimbursed Enhertu.

 

According to industry sources, Daiichi Sankyo and AstraZeneca Korea’s antibody-drug conjugate (ADC) for HER2-positive breast cancer, Enhertu (trastuzumab deruxtecan) has passed the drug committee (DC) review of 46 medical institutions in Korea, including the ‘Big 5’ tertiary hospitals in Korea - Samsung Medical Center, Seoul National University Hospital, Seoul St.Mary’s Hospital, Asan Medical Center, and Sinchon Severance Hospital.

 

After receiving approval for Enhertu in Korea in September 2022, the companies submitted a reimbursement application for the drug in December of the same year, and the agenda passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in February.

 

The same month, the company began negotiating drug prices with the National Health Insurance Service and concluded the negotiations at an unprecedented speed and was listed on the reimbursement list this month (April).

 

With 50,000 people signing the petition and the government being questioned on the reimbursement progress repeatedly by the National Assembly, both the government and the company would have had to carry a significant burden during reimbursement discussions.

 

When considering the limited scope of freedom the company has with regard to the drug price, the fact that Enhertu’s reimbursement passed the DREC review this time implies that the government has set the ICER threshold at least KRW 50 million.

 

With the listing, Enhertu is reimbursed for patients with HER2-positive unresectable or metastatic breast cancer that has failed treatment with both trastuzumab and taxanes (including recurrence while receiving adjuvant therapy after surgery or within 6 months of completion of therapy).

 

Also, patients with locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who failed two or more prior therapies, including trastuzumab +(fluorouracil or capecitabine) +cisplatin; or have HER2 overexpressive (IHC 3+, or 'IHC 2+ and FISH positive or SISH positive') metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; and have an ECOG performance status (PS) of 0 or 1, are eligible to receive reimbursement.

 

Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy.

 

The interim analysis results that were updated in 2022 showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1.

 

The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1.

 

Also, in terms of overall survival (OS), the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1