Yuhan provides Leclaza with 6 million won per month for free

Yuhan Corporation runs a EAP until the first treatment benefits apply

There was no fair competition problem even in the second treatment

When the benefit is applied, EAP is terminated, and patients must pay for it

Leclaza

Regarding Yuhan's providing free medicines to patients until the first treatment of Leclaza is covered by insurance, Yuhan said, "It is not an act of inducing patients and there is no problem under the Fair Trade Act." On the 10th, Yuhan held a press conference for permission for the first treatment of Leclaza at the Plaza Hotel in Seoul.

 

On this day, CEO Cho Wook-je announced the free supply of Leclaza through the Expanded Access Program.

 

Yuhan Corporation launches large-scale 'EAP' for the first time as a domestic pharmaceutical company EAP is a humanitarian system that provides treatment opportunities by supplying new drugs free of charge to patients who do not have adequate treatment.

 

Usually, instead of patients participating in clinical trials, new drugs are administered more rapidly.

 

According to Article 34 of the Pharmaceutical Affairs Act, 'drugs for clinical trials shall not be used for purposes other than clinical trials.

 

However, if the approval of the Minister of the Ministry of Food and Drug Safety falls under each of the following subparagraphs, the relevant drug may be used for purposes other than clinical trials.' At this time, the exceptions are limited to 'patients with life-threatening serious diseases such as terminal cancer or acquired immunodeficiency syndrome' or 'emergency patients prescribed by Prime Minister Ordinance, such as life is in jeopardy or there is no alternative treatment method'.

 

Based on this clause, Yuhan Corporation's plan is to supply Leclaza's first-line clinical trial drug to patients.

 

If the clinical trial for the first treatment of Leclaza is conducted in the form of a researcher's clinical trial, Leclaza will be supplied to the participating patients.

 

Yuhan had already operated EAP in the same way until Leclaza was approved as a second-line treatment and reimbursement was applied.

 

In the pharmaceutical industry, Leclaza's EAP operation is seen as the first attempt among domestic pharmaceutical companies.

 

This is because it is the first drug developed by a domestic company for an expensive and life-threatening treatment such as cancer.

 

Cho Wook-je, CEO of Yuhan Corporation, said, "Because the drug is so expensive, there are many people who find it difficult to use Leclaza due to economic conditions.

 

We will provide it free of charge through EAP until Leclaza is officially covered by reimbursement." The scale will be determined upon request from medical staff treating lung cancer on site.” "Tagrisso and Leclaza both use EAP as non-reimbursed drugs, and there is no problem with fair competition" Some criticize Yuhan's plan to use Leclaza for sympathy, saying that it violates fair competition.

 

It is criticized that, as in the case of Novartis Glivec in the past, support for drug prices through EAP can be seen as an act of luring patients.

 

Regarding this, Yuhan Corporation said, “It is different from the Glivec case,” and drew a line, saying, “We operated the same program until the benefit was applied after the second treatment was approved, but there was no problem.”

Gleevec

In 2013, Novartis stopped subsidizing the cost of Glivec, a leukemia treatment.

 

Until just before that, Novartis subsidized 5% of the drug cost for patients taking Glivec.

 

Since 95% of the cost of leukemia treatment was supported by health insurance finances, patients took Glivec virtually free.

 

In June 2013, when the release of a large number of generic products was announced ahead of the expiration of the Glivec patent, Novartis decided to stop supporting the drug price.

 

It is based on the judgment that supporting the price of Glivec even though a generic with the same ingredients has been released can be considered an act of attracting patients and can constitute an unfair trade act under the Fair Trade Act.

 

If the competitive drug Tagrisso is covered, it is likely to be seen as an act of attracting patients, but since both drugs are not covered by insurance as the first-line treatment, there is no problem under the Fair Trade Act.

 

An official from Yuhan Corporation said, "We understand that supporting the cost of medicines with the benefit applied is against fair competition.

 

The case of Gleevec falls under this category." Once the reimbursement is decided, the free provision ends immediately.

 

At this time, the patient has to pay all of his or her own expenses.” The official said, "The monthly cost of Leclaza alone is about 6 million won.

 

According to the PFS results, if the drug is administered continuously for 20 months, the amount that the patient will have to bear will exceed 120 million won." It is purely a decision for the patient.

 

From the company or doctor's point of view, there is nothing to take 10 won." "There will be more participants than in the second treatment...

 

Lexraza is provided without size restrictions" Yuhan expects that the number of patients participating in EAP related to the first treatment will increase compared to the second treatment.

 

According to Yuhan Corporation, around 10 patients participated in EAP after Leclaza's second-line treatment was approved and until insurance coverage was applied.

 

It is explained that the number of participants was not large because the process from approval to reimbursement was fast and the procedure for participating in EAP was complicated.

 

The key is when the primary treatment benefit is applied.

 

The longer it takes for coverage of Leclaza to expand as a first-line treatment, the more patients are expected to participate in the compassionate use program.

 

Yuhan plans to provide Leclaza in any size, no matter how long it takes to get paid.

 

An official from Yuhan Corporation said, "It is impossible to estimate how many patients will participate in the program.

 

Therefore, it is currently unknown how much the related budget will be.

 

However, we expect more patients to participate than in the second treatment." AstraZeneca, which has a competitive drug, seems to refrain from the official response.

 

However, AstraZeneca Korea explained that it is not considering a separate legal response against Yuhan Corporation.

 

An official from AstraZeneca Korea said, “We are doing our best to increase the accessibility of patients who use Tagrisso in Korea,” and “We are reviewing ways to work for patients.”