Yuhan Corporation has been planning for free of charge since March when it expanded the first-line treatment indication of Lexraza (Lazertinib) for Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-small Cell Lung Cancer (NSCLC). The introduction of the Early Access Program (EAP) was formalized.
It was decided to introduce EAP and supply Recraza free of charge for researcher-led clinical trials until the first treatment health insurance reimbursement decision is made. From July, patients who participate in clinical trials by researchers will receive Rexraza free of charge until reimbursement is applied.
Yuhan Corporation’s Lecraza approval and salary application log.
According to the pharmaceutical industry on the 12th, a total of 24 clinical trials are currently underway using Rexraza at domestic clinical sites.
Among them, the case where EAP is applied is a researcher-led clinical trial targeting primary lung cancer treatment, excluding secondary treatment covered by health insurance. The EAP will proceed from the date of approval of each hospital’s Institutional Review Board (IRB) until the time when Lexraza’s reimbursement standard is expanded.
A typical researcher-led clinical trial would be the ‘ABLATE study’.
The study is a study comparing the effects and safety of Lexraza and ‘Rexraza + radiation therapy’ in patients with ‘simultaneous minor metastatic EGFR mutation non-small cell lung cancer’.
Recently, 68 patients have been recruited, and full-scale analysis is scheduled to begin.
Professor Lim Seon-min (Department of Oncology) of Yonsei Cancer Hospital, who is conducting the research, said, “With the application of EAP, there is no burden on the patient for the drug. Patients with less than 5,” he said. “Since the target was patients who could receive radiation therapy, the target was patients who did not have a large variation, and this is a study comparing the effects of Lexraza and ‘Lexraza + radiation treatment’ as the first treatment.”
He said, “Even if you are treated with Lexraza, the disease may progress due to resistance at any moment. It was designed with the hope that it could be sufficiently delayed.” “This is a study to see if radiation therapy can be more effective than that. It is a researcher-led clinical trial following the first-line treatment of Rexraza, and it is being conducted as a multicenter study in consultation with the Anticancer Therapy Research Association.”
Giving back to society and accumulating clinical information at the same time, ‘two rabbits’
If so, what is the background behind Yuhan’s decision to supply for free?
The first reason is that, as it was developed as a ‘domestic new drug’ after harvest, the company intends to reduce the burden of patients’ medical expenses even before the health insurance benefit is expanded in terms of corporate social contribution. Cho Wook-je, president of Yuhan Corporation, also emphasized that he had decided to introduce EAP in the sense of ‘giving back to society’, but if you look deeply, you can see that he is implementing the management philosophy of the late Dr. Il-il Il-il, the founder.
If the patient takes Lexraza without health insurance coverage, the treatment cost to be borne by the patient is 70 million won per year, and about 120 million won for up to 20.6 months of progression-free survival (PFS) confirmed by clinical results. It means that Yuhan Corp.’s social contribution will ease the burden of patients even at least for the cost until the health insurance benefit is expanded.
Yuhan Corporation R&D President Kim Yeol-hong (oncology) said, “When adding a second treatment indication, the reimbursement was determined quickly, so the EAP application period was relatively short.” Cases are not easy to access. It means that through the application of EAP at the company level, we will increase patient accessibility even before the application of reimbursement.”
He said, “It is to supply after writing a patient consent form while conducting clinical trials by researchers.” Since it is a supply, there is no reason to make a separate budget,” he explained.
The industry is appraising that the decision was possible because it was Yuhan Corporation, and evaluated that it would have been impossible for a general owner pharmaceutical company.
The interim results of MARIPOSA’s phase 3 clinical trial, which confirms the first-line combination therapy effect of Lexraza and Librivant, are expected to be announced at ESMO 2023.
The second reason is to secure various data through real-world data in that extensive evidence is essential as it claims to be a global new drug.
In addition to the interim announcement of the MARIPOSA phase 3 clinical trial, which confirms the first-line combination therapy effect of Lexraza and Librivant (amivantamab) in collaboration with Janssen, a global pharmaceutical company, various clinical trial results from the first treatment are added. It is solved with the intention to do it.
For reference, the midterm presentation of MARIPOSA phase 3 clinical trial, which is evaluated as a critical turning point in the global market as well as the use of Lexraza as the first treatment, is scheduled to be announced at the European Society of Oncology (ESMO 2023) held in Madrid, Spain in October. expected to be fully operational.
Moreover, as President Yoon Seok-yeol showed his will to develop a new domestic drug as a pledge during his candidacy, it is analyzed that the accumulation of various clinical trial results through the application of EAP served as an essential factor at the time when Lexraza had to show the results of entering the global market as a domestic new drug.
Lastly, there is also a strategy to not give up the primary treatment market to Tagrisso, a competitor. As the clinical benefits were confirmed through the LASER301 study, the strategy is to provide more opportunities to various doctors and to receive proper evaluation afterwards. In particular, there is a plan to target the lung cancer treatment market of the respiratory department of a local university hospital.
The industry is analyzing that the free supply was decided for various reasons. On the 10th, Yuhan Corporation CEO Cho Wook-je expressed his will to break through head-on, showing confidence, saying, “I don’t care too much” and “If you can do it yourself, do it.”
An executive at a domestic pharmaceutical company, who requested anonymity, said, “We are looking at various strategies and tactics. The important thing is that, as a domestic new drug, it is essential to accumulate various clinical information in a situation where Rexraza is currently about to enter the global market.” It seems that EAP was planned from the beginning to keep pace with the government’s policy stance by securing clinical evidence of
2023-07-11 20:40:00
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