Enhertu passed the cancer dz review board after a retrial

Submit supplementary data at the beginning of this month

After a retrial in the first half of last year, the anticancer drug Enhertu, which passed the Cancer Disease Review Committee, met another hurdle: passing the Pharmaceutical Reimbursement Evaluation Committee.

 

Enhertu, which succeeded in setting reimbursement standards at the end of the review committee's reexamination in May, was not presented to the Pharmaceutical Reimbursement Evaluation Committee, which was held three times afterward.

 

According to the industry on the 11th, Enhertu's Daiichi Sankyo submitted data to HIRA a day late, which requested PE supplementary data earlier this month.

 

Currently, Enhertu is in PE, and it is expected to be submitted to the committee by taking steps such as the RSA sub-committee.

 

The PE data was submitted on the 5th and is currently awaiting deliberation.

 

Accordingly, it is expected that Enhertu's submission to the Pharmaceutical Reimbursement Evaluation Committee will be decided according to the deliberation results.

 

Currently, it is difficult to estimate when the drug benefit evaluation committee will be presented.

 

Enhertu, which applied for reimbursement in November last year, began reviewing patients' prompt reimbursement.

 

In February, through a national consent petition, 50,000 people agreed to the demand for the benefit, and it was referred to the National Assembly.

 

It is indicated for the treatment of patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2-based therapies.

 

It is also indicated for the treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received two or more therapies, including anti-HER2 therapy.

 

The petitioner for Enhertu reimbursement strongly requested health insurance approval, saying that Enhertu is called the last hope for breast cancer patients and that it is difficult to use because it is an expensive drug that costs about 5 million won per injection.

 

The HIRA reviewed the reimbursement standards for Enhertu for the first time in March.

 

However, in the case of gastric cancer indications, the cancer disease review committee decided to re-deliberate without reaching a conclusion due to the weak evidence and the high price of the applied drug.

 

Still, it was not that the salary standard setting failed, but that it was re-examined, so I was able to continue my hopes.

 

Afterward, Daiichi Sankyo submitted supplementary data and managed to set the salary standard at the cancer screening meeting held in May.

 

In order for the reimbursement to be applied, there are still procedures, such as passing through the Drug Evaluation Committee and then negotiating with NHIS.

 

In many cases, it took a long time to pass the drug evaluation committee after the reimbursement standard was established.

 

In the case of Keytruda, an immuno-oncology drug, it was presented to the Drug Evaluation Committee within six months.

 

Accordingly, there is an opinion that the reimbursement review process for anti-cancer drugs, which must pass through two consecutive committees, should be improved to expedite reimbursement.

 

However, the HIRA draws a line against this argument, saying that the cancer disease review committee, which sets reimbursement standards, and the drug evaluation committee, which determines the adequacy of reimbursement, have distinctly different functions.

 

However, given that Enhertu's petition for expedited reimbursement is a drug that has been referred to the National Assembly, there is a prospect that it will not take long for Enhertu to be presented to the Drug Evaluation Committee.

 

The rare re-discussion by the Cancer Disease Review Committee is an interpretation that the insurance authorities are also conscious of the speed of reimbursement.

 

Daiichi Sankyo also said, "We are actively discussing with the government authorities for the prompt reimbursement of Enhertu, putting the patient's wishes first." Attention is focusing on whether Enhertu, which is facing the drug evaluation committee, will quickly go through the reimbursement process as patients wish.