Reimb for the petitioned ADC drug Enhertu unclear

Remains pending at the DREC stage after passing CDDC review in May

Reimbursement discussions for the anticancer drug ‘Enhertu’ that received 50,000 consents in a national petition are making slow progress.

 

Daiichi Sankyo Korea’s HER2-directed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan), which finally passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review after redeliberation in May, remains pending, undeliberated at the 4 subsequent Drug Reimbursement Evaluation Committee meetings.

 

The next DREC meeting will be held on September 7th, but whether Enhertu will be deliberated then remains unknown.

 

The drug is currently receiving review at the pharmacoeconomic evaluations subcommittee level, but no conclusion has yet been reached on the drug’s cost-effectiveness.

 

However, with the review nearing the 150-day deadline at HIRA’s level, how the discussion will progress is gaining much attention.

 

For reimbursement, 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.

 

However, due to the significant efficacy of Enhertu that was demonstrated through a Phase III trial, which had not been small compared to other existing treatments, the government is having difficulty calculating an appropriate drug price.

 

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 OS, the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1 Also, in the DESTINY-Breast01 trial, Enhertu demonstrated continued anticancer effect in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens that include T-DM1, trastuzumab, and pertuzumab.

 

Results showed that Enhertu met its main efficacy outcome with a confirmed objective response rate (ORR) of 60.9% % (95% CI, 53.4-68.0) and an mPFS of 16.4 months.

 

Enhertu was approved by the Ministry of Food and Drug Safety in September last year based on the DESTINY-Breast01 and DESTINY-Gastric01 trials.

 

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.

 

Also, in December, based on the DESTINY-Breast03 trial, the drug’s indication was expanded to treat patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.