Will the novel anticancer drug Enhertu be reimb in April?

Starts pricing negotiations with NHIS

MOHW orders pricing negotiation to NHIS… its reimbursement expected before the general election

After going through two Cancer Disease Deliberation Committee meetings and two Drug Reimbursement Evaluation Committee meetings, the anticancer drug ‘Enhertu’ has finally started drug pricing negotiations with the National Health Insurance Service.

 

As the drug has passed drug evaluations after repeated revisions, the negotiations are expected to go smoothly.

 

In particular, it will be interesting to see if the government grants reimbursement within April, as there are analysts who believe that the government is using the scenario of coverage before the parliamentary election.

 

According to the industry on the 28th, the Health and Welfare Ministry recently issued a drug pricing negotiation order to the NHIS for Enhertu, after which the NHIS has begun full-scale negotiations.

 

Enhertu 100mg Inj (fam-trastuzumab deruxtecan-nxki, Daiichi Sankyo Korea) was granted marketing approval in Korea in September 2022.

 

The company applied for reimbursement coverage in December of the same year.

 

In Korea, Enhertu is indicated to treat ▲ unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting and ▲ locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

 

.As a HER2-targeted antibody-drug conjugate (ADC), Enhertu demonstrated clinical efficacy over existing agents

 

.HER2-targeted antibody-drug conjugate (ADC) Enhertu reduced the risk of disease progression or death by nearly 50% compared with conventional chemotherapy, with an mOS of 23.4 months, which was a 6.6-month extension from the 16.8 months in the chemotherapy group

 

.However, this high effect rather posed a hurdle during drug pricing evaluations

 

.Due to the high survival rate, the duration of its use was expected to increase, making it difficult for the drug to pass the economic evaluation threshold

 

.If the ICER value (incremental cost-effectiveness ratio) of a drug, which is used as an indicator for economic evaluation, exceeds the threshold, it makes it difficult for reviewers to recognize the adequacy of the drug’s reimbursement

 

.Due to this, the Cancer Disease Deliberation Committee was held twice last year to set the reimbursement standard for the drug, and the Drug Reimbursement Evaluation Committee meeting, which makes the final judgment on the adequacy of reimbursements appropriateness of drugs, was held twice in January and February this year

 

.Although the ICER value of Enhertu exceeded the threshold of KRW 50 million set for anticancer drugs, the threshold was reportedly lowered to a reasonable level after discussion with the authorities

 

.The company is analyzed to have conceded a lot in terms of drug price

 

.As the drug price and financial sharing have been somewhat clarified during the evaluation process, negotiations are expected to go more smoothly

 

.This raises the possibility that the deal could be finalized earlier than the 60-day negotiation period and listed in April

 

.As there is talk that the government may list Enhertu and promote it as an innovative new drug listing achievement before the general elections, this is expected to speed up the negotiation process

 

.However, there is also an analysis that the MOHW’s negotiation order came later than expected, leaving insufficient physical time to complete negotiations before the Health Insurance Policy Review Committee meeting commences in March.