Will Enhertu pass PE evaluations for reimb in KOR?

passed CDDC review after redeliberations

Gov-company unable to reach agreement after submitting pharmacoeconomic evaluation data in July

Recently submitted supplementary materials again… Expects to pass the PE evaluation subcommittee in October

Due to delays in the review of the economic feasibility of the anticancer drug Enhertu (trastuzumab deruxtecan), the industry is seeing delays in its reimbursement agenda being submitted for deliberation to the Drug Reimbursement Evaluation Committee.

 

The agenda had previously passed the Cancer Disease Deliberation Committee review after redeliberation in May.

 

The company expects to receive positive results at the Pharmacoeconomic Evaluation Subcommittee meeting in October.

 

According to industry sources on the 12th, Daiichi Sankyo recently submitted supplementary pharmacoeconomic evaluation data to HIRA for its Enhertu and expects to pass HIRA deliberations in October.

 

Enhertu passed the CDDC review after redeliberations in May.

 

The committee determined Entertu reimbursable 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 an anti-HER2-based regimen (third-line or higher treatment) As a result, the agenda was supposed to be submitted for deliberation by the Drug Reimbursement Evaluation Committee.

 

However, it seems that the company and the government are having difficulty reaching a consensus in the pharmacoeconomic evaluation process.

 

Daiichi Sankyo submitted the PE evaluation data in July, but was unable to reach an agreement with HIRA.

 

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

 

Currently, the Pharmacoeconomic Evaluation Subcommittee is evaluating the cost-effectiveness of Enhertu compared to Kadcyla.

 

However, as Enhertu demonstrated an extension in progression-free survival (mPFS) by more than 22 months compared to existing drugs, and the increase in the administration period that followed, there have been limitations in proving the cost-effectiveness of the drug using the current economic evaluation method.

 

Even so, Daiichi Sankyo has accepted most of the deliberation results from the last Pharmacoeconomic Evaluation Subcommittee’s deliberation in order to quickly receive reimbursement.

 

The company had requested redeliberation on some aspects that are difficult to accept.

 

Daiichi Sankyo recently submitted the supplementary materials and is expecting positive results at the Pharmacoeconomic Evaluation Subcommittee meeting that will be held in October.

 

In the paper, ‘Analysis of Socioeconomic Indirect Cost of Premature Death in Patients with HER2-positive Metastatic Breast Cancer (MBC) using Nationwide Claims Data’ that was recently published on Yakhak Hoeji on August 31, research teams of Sungkyunkwan University’s School of Pharmacy and Samsung Medical Center showed that socioeconomic benefits were greater with the administration of Enhertu.

 

The research teams identified the claims data of 2,212 patients with HER2-positive MBC who were prescribed trastuzumab-emtansine as a second-or-higher-line of treatment from January 2007 to May 2021 using nationwide insurance claims data to estimate the progression-free survival (mPFS) and the resulting socioeconomic benefits.

 

As a result, the mPFS of trastuzumab-emtansine ranged from 7.1 months (age 65 or older) to 12.5 months (age 30s), and the mPFS of trastuzumab-deruxtecan (Enhertu) was more than three times longer for all ages, ranging from 23.4 months (age 65 or older) to a maximum of 41.1 months (age 30).

 

Accordingly, the socioeconomic benefits brought about by the extended PFS with the use of trastuzumab-deruxtecan (Enhertu) compared to existing drugs were estimated to amount to KRW 261.4 billion, which is averages to KRW 118 million per patient.

 

An official from Daiichi Sankyo Korea said, "We hope that the authorities will review Enhertu’s reimbursement more flexibly, in consideration of the various aspects such as social losses of breast cancer and the extension of patients' lives that can be expected through Enhertu treatment under the framework of Korea’s current pharmacoeconomic evaluation system.