Kymriah is expected to be able to register insurance benefit

as early as April

Breakdowns and deadlines may be extended

Kymriah, an ultra-high-priced one-shot treatment, is expected to be covered by insurance benefits as early as April.

 

According to related industries, Novartis Korea's CAR-T new drug Kymriah officially began drug price negotiations with NHIS in the last week of the same month after passing the Drug Benefit Evaluation Committee of the HIRA on January 13.

 

Considering that the drug price negotiation deadline is 60 days, the negotiations should be completed at the end of March.

 

If so, the Health Insurance Policy Committee, the final decision body for drug benefits, is usually held at the beginning of each month, and if Kymriah's price negotiations are concluded in March, it will be possible to register them in April.

 

Pharmaceutical price negotiations themselves may break down, and the possibility cannot be ruled out that discussions will not end within the negotiation deadline.

 

Recently, more and more cases are extending the deadline for negotiations.

 

Since Kymriah is ultra-high-priced, it is not expected that it will be smooth to find an agreement between the government and pharmaceutical companies.

 

Kymriah's indications are ▲Diffuse Large-B-Cell Lympoma (DLBCL) adult patient treatment after two or more systemic treatments and ▲ post-transplantation recurrence or secondary recurrence in children and young adult patients under the age of 25 and subsequent B-Acute Lymphoblastic leukemia (B-ALL).

 

There is a difference in standards for Kymriah's two indications.

 

B-ALL applies only to Expenditure Cap, but in the case of DLBLC, a performance-based type was added.

 

This means that pharmaceutical companies share part of the drug price according to treatment performance for all DLBCL patients.

 

The problem is that unlike conventional drugs that are mass-produced, the manufacturing cost is astronomically high due to the nature of Kymriah, which produces one batch of cells extracted from patients, and the cost burden of pharmaceutical companies increases in the event of a patient with an Expenditure Cap or higher.

 

Novartis Korea's efforts are essential to the goal of conclusion of drug price negotiations, but it remains to be seen whether this will lead to achievement.

 

About 200 DLBCL and B-ALL patients who have refused or recurred to existing treatment are in critical condition, with only six months of life expectancy due to no alternative treatment options or no standard treatment until Kymriah is approved.

 

The median survival period of DLBCL patients who failed secondary treatment in Korea is around 4.73 months, and about 70% of patients who failed secondary treatment repeatedly perform rescue chemotherapy.