Will Enhertu pass the fiscal barrier and be reimb in KOR?

The anticancer drug that the nation petitioned for is receiving reimbursement review

Submitted supplementary data … will soon be presented at the Cancer Disease Review Committee

Proposed the lowest price level in the world... expressed willingness to further share the cost through RSA

The reimbursement progress of the anticancer drug that received 50,000 consents in a national petition is gaining attention.

 

According to industry sources, the reimbursement review data for Enhertu, AstraZeneca and Daiichi Sankyo’s HER2-directed antibody-drug conjugate (ADC), has been supplemented and submitted to the authorities on the 14th.

 

No reimbursement standard had been set for Enhertu at the Cancer Disease Review Committee (CDRC) meeting that was held in March.

 

At the time, there was no disagreement among experts about the clinical usefulness of Enhertu.

 

In other words, the reason why a standard had not been set was considered to be because of its potential financial burden on national health insurance finances.

 

In addition, as the drug was accepted for review at the Petition Review Subcommittee held yesterday (15th), the possibility that the agenda will be deliberated at the Health Insurance Review and Assessment Service’s CDRC meeting that will be held on the 26th is rising.

 

With the reattempt gaining a lot of attention, the pharmaceutical company is also determined to make the cut this time.

 

Daiichi Sankyo was known to have prepared various plans to reduce the financial burden, such as by presenting the drug price of Enhertu at the lowest level in the world and considering applying the risk-sharing agreement (RSA) scheme.

 

A company official said, “The seconds and minutes we waste here may be the matter of life and death for the metastatic breast cancer patients.

 

We will also do our best to save all the time we can to Enhertu's reimbursement to save at least one more patient.” Meanwhile, based on DESTINY-Breast01 and DESTINY-Gastric01 trials, Enhertu was approved by the Ministry of Food and Drug Safety in September for the treatment of ▲unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens (third-line or higher treatment); and ▲locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior therapies including anti-HER2-based regimens.

 

Also, in December last year, its indication was expanded based on the results of the DESTINY-Breast03 trial to be used to treat patients with unresectable or metastatic HER2-positive breast cancer who have received one or more anti-HER2-based regimens.