Price nego for reimb of much-petitioned Enhertu complete

at record speed

Reimbursement likely before general elections in April

The long journey of the petitioned anticancer drug ‘Enhertu’ if finally coming to an end.

 

According to Dailypharm’s coverage, Daiichi Sankyo and AstraZeneca Korea recently completed drug pricing negotiations with the National Health Insurance Service (NHIS) for their antibody-drug conjugate (ADC) for HER2-positive breast cancer, Enhertu (trastuzumab deruxtecan) Barring any changes, the drug is expected to be covered from next month (April).

 

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.

 

Although the application passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee after re-deliberations, it took 8 months afterward for the agenda to pass the Drug Reimbursement Evaluation Committee in February.

 

With 50,000 people signing a 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.

 

What is encouraging is the speed with which the negotiations were concluded.

 

Considering how the drug’s pricing negotiations began late last month, the parties had reached an agreement way before the given deadline (60 days).

 

There were certainly challenges that needed to be overcome during negotiations.

 

Even with the extraordinary ICER threshold granted for the drug, the company would have had limitations in accommodating the set standards.

 

In addition to the government and pharmaceutical companies' best efforts, to some extent, the quick progress may also be influenced by the political pressure ahead of general elections.

 

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 Enhertu, which was petitioned by 50,000 people, was presented to the Health Insurance Policy Review Committee this month and will be listed in April.