Demand for ADC Enhertu rise despite nonreimbursement

Cumulative sales exceed KRW 10 bil

Daiichi Sankyo released the drug without reimbursement earlier this year… Cumulative sales until the Q3 reach KRW 13.8 billion

Remains non-listed after passing CDDC review…NA calls for its reimb listing

Cumulative sales of Daiichi Sankyo’s HER2-positive breast cancer treatment ‘Enhertu (trastuzumab-deruxtecan)’ have exceeded KRW 10 billion even without reimbursement.

 

According to the market research institution IQVIA on the 27th, Enhertu's cumulative sales were KRW 13.8 billion by Q3 this year.

 

Sales steadily increased from KRW 2.2 billion in Q1, to KRW 5.2 billion in Q2, then to 6.4 billion in Q3 this year.

 

In other words, the drug has posted cumulative sales of more than KRW 10 billion without insurance reimbursement.

 

The non-reimbursed administration cost of Enhertu is known to be around KRW 7 million for each cycle that consists of 3 doses.

 

For patients who participate in the company's Patient Assistant Program (PAP), the price drops to the high KRW 5 million range, which still poses quite a burden to the patient.

 

Sales show that quite a few patients are in need of the drug.

 

Voices calling for Enhertu's reimbursement were even raised during the National Assembly audit.

 

At the NA audit on the National Health Insurance Service and Health Insurance Review and Assessment Service, Rep.

 

Ki-Yoon Kang of the People Power Party, said, “I do not understand why Enhertu, which is undergoing pharmacoeconomic evaluations, cannot be reimbursed even though its global clinical trials are complete.

 

Please review its reimbursement so no patients are left to die due to a lack of treatment.” Enhertu is a treatment for HER2-positive breast cancer.

 

It is an antibody-drug conjugate (ADC) that has recently attracted attention and was approved by the Ministry of Food and Drug Safety in September last year.

 

It is indicated for ▲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 an anti-HER2-based regimen.

 

It further expanded indications in December and can be used in patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

 

However, it has been making less progress in receiving insurance reimbursement.

 

Although the agenda had passed HIRA’s Cancer Disease Deliberation Committee review after redeliberation in May, it remains pending without being presented for review at the Drug Reimbursement Evaluation Committee level.

 

The company had recently submitted supplementary pharmacoeconomic evaluation data to HIRA and is again awaiting DREC review.

 

However, the company and the government are having difficulty reaching a consensus regarding Enhertu’s pharmacoeconomic evaluation results.

 

The industry analysis is that Enhertu's superior effect is hindering economic evaluations.

 

For pharmacoeconomic evaluations, Enhertu’s cost-effectiveness is being compared to that of Kadcyla.

 

Enhertu demonstrated an extension in median progression-free survival (mPFS) by more than 22 months compared to existing drugs.

 

The prolonged survival leads to an increased administration period.

 

However, the current economic evaluation system is known to have difficulty reflecting this.

 

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

 

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

 

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 a mPFS of 16.4 months.