Enhertu, re-discussing with supplementary materials

No conclusions were reached at the meeting held in March

Attention is focusing on whether the reimbursement standards for Enhertu, an anti-cancer drug from Daiichi Sankyo Korea, will be prepared through re-discussion by the Cancer Disease Review Committee.

 

The drug has received more than 50,000 national petitions and is currently accelerating its reimbursement review.

 

However, at the HIRA held last month, it was decided to discuss again without reaching a conclusion on the setting of the salary standard.

 

According to the industry on the 14th, Enhertu's Daiichi Sankyo recently submitted complementary data to HIRA.

 

Previously, at the review committee held on the 22nd of last month, supplementary data was requested on the grounds that the level of evidence for Enhertu's gastric cancer indication was low and that additional supplementation of financial sharing was necessary for the applied drug price.

 

The indications for Enhertu, whose reimbursement criteria were discussed by the review committee, are ▲the treatment of patients with unresectable or metastatic HER2-positive breast cancer who have previously received two or more anti-HER2-based therapies, and ▲two or more therapies including prior anti-HER2 therapies.

 

Treatment of locally advanced or metastatic HER-2-positive gastric or gastroesophageal junction adenocarcinoma.

 

Among the two, the review committee explains that the basis for gastric cancer indication is weak and the price of the applied drug is high, so it is difficult to set the reimbursement standard right away.

 

However, there is still the possibility of prompt reimbursement as the company decided to re-discuss it through supplementary data rather than deciding not to set the standard for reimbursement.

 

As the pharmaceutical company submitted additional supplementary data, attention is focused on whether Enhertu's reimbursement standard will be successful in the next review committee.

 

Cancer screening is scheduled for the 26th of this month.

 

The key is also the price of the drug.

 

It is known that Daiichi Sankyo applied for 2.4 million won per bottle as a salary indicator, which costs about 160 million won per year.

 

It is explained that the key to passing the reimbursement standard is how the insurance authorities and pharmaceutical companies will share the financial burden because the health insurance budget is high.

 

The health authorities seem to have the willingness to pay for this drug.

 

Another positive factor for Enhertu's reimbursement is that the approval review for drugs that have been referred to the National Assembly is speeding up, with more than 50,000 petitions for reimbursement through the National Consent Petition website.

 

Among the drugs referred to the Welfare Committee as a result of a national application, Crysvita, a treatment for pediatric rickets, is expected to be listed as a benefit next month, and Tagrisso, a first-line treatment for non-small cell lung cancer, has passed the review committee.

 

Enhertu is a next-generation ADC (antibody-drug conjugate) drug that selectively acts only on cancer cells to increase treatment effects and minimize side effects.

 

In clinical trials, it showed higher efficacy than existing drugs, raising expectations as a second-line treatment for HER2-positive breast cancer and a third-line treatment for gastric cancer.

 

Enhertu applied for reimbursement to the HIRA in December of last year and launched non-reimbursement in January.