Controversy over Rutatera's exclusion from disaster expenses

Korea alliance of patients organization, purchased through the KOEDC, eligible for disaster medical expenses

The NHIS, "Clinical drugs cannot be supported before marketing authorization"

It has been pointed out that the NHIS is causing economic damage to patients by not applying disaster medical expenses to anticancer drugs for the treatment of rare tumors, which has greatly increased the cost of medication due to the COVID-19 pandemic.

 

The NHIS announced that it was unable to apply disaster medical expenses for the reason that Rutatera, a neuroendocrine tumor treatment drug, was not permitted to be marketed in Korea.

 

The association criticized it as an unreasonable and underfounded measure.

 

The reason for this controversy is that the cost of a single dose of the treatment is about ₩26 million, and the cost is estimated at about ₩104 million when the treatment cycle is 4 times.

 

On the 20th, the Korea alliance of patients organization issued a statement and urged that the NHIS should support Rutatera's disaster medical expenses.

 

Rutatera obtained a commercial license from the US Food and Drug Administration (FDA) on January 26, 2018.

 

The MFDS designated this drug as an emergency drug on November 28, last year.

 

However, it has not yet been officially approved, but the MFDS is designating it as a orphan drug in December of last year, according to a request for marketing permission from Novartis Korea.

 

As a result, domestic patients receive this drug from overseas through the KOEDC.

 

The controversy over the disaster medical expenses started with the rejection of the request by the NHIS for Rutatera's disaster medical expenses, patient A with a neuroendocrine tumor in Korea, purchased from the KOEDC.

 

It is known that the NHIS rejected Mr.

 

A's application because Rutatera was not officially approved and is still in clinical trials.

 

Particularly, patients who are burdened with the cost of administering Rutatera 1 cycle (4 injections) of more than ₩104 million receive overseas expeditions to Malaysia for administration of Lutetium that are similar to Rutatera.

 

The situation in which expedition treatment was difficult with the COVID-19 Pandemic also contributed to the controversy over the rejection of disaster medical expenses.

 

With expedition treatment, the cost of administering Lutetium is reduced to about ₩32 million to ₩40 million per cycle, but The Korea alliance of patients organization's position is that patients have to take risks such as medical accidents and serious safety accidents, and even COVID-19 outbreak has made it difficult.

 

As a result, the Korea alliance of patients organization strongly emphasized the need for Rutatera to support disaster medical expenses.

 

The opinion that the decision of the NHIS is different from that of the disaster medical expenses support project and contrary to the purpose of enacting the law.

 

The Korea alliance of patients organization pointed out that patient A was planning to do so after receiving an answer from the staff of the Siheung branch of the NHIS that the drug cost of Rutatera, which was purchased at the KOEDC, can be supported as disaster medical expenses from ₩20 million to ₩30 million a year, but the NHIS took a position that the drug cannot be applied because it is in clinical trials.

 

The organization said that this is different from the contents of the disaster medical expenses business and does not comply with the law, and the government-issued booklet includes medicines purchased from the KOEDC as targets for support.

 

The association stressed that Rutatera is currently completing phase II clinical trials in Korea and is in the process of reviewing permits, and the NHIS needs to reconsider its complaints about rejection.

 

Meanwhile, this statement was jointly presented by the Korean Association of Neuroendocrine Tumor (KANT) along with the Korea alliance of patients organization.