The patient's life comes first

Lee Eun-young, secretary general of Korea Leukmia patients organization, said

On March 5, the MFDS approved Kymriah(Tisagenlecleucel), the world's first treatment for CAR-T, as the first advanced bio-medicine under the Advanced Regenerative Bio Act.

 

Targets are patients with B-cell acute lymphocytic leukemia and submicrobial giant B-cell lymphoma under the age of 25 who are recurrent and nonresponsive.

 

Kymriah was already licensed in August 2017 by the U.S.

 

FDA and in March 2019 by the Ministry of Health, Labor and Welfare of Japan, where there was no further treatment due to recurrence or non-compliance, resulting in treatment for late-stage blood cancer patients.

 

Emily Whitehead, who was diagnosed with acute lymphocytic leukemia at the age of five and failed to treat it, has been living in good health since joining the first clinical trial of the CAR-T drug Kymriah in 2012.

 

However, in Korea, there was news of Eun-chan who recently died while preparing for Kymriah treatment.

 

Emily Whitehead's experience is touching around the world, but we are facing sad news that we are not being treated in time.

 

Eun-chan's mother left a wish on her blog, saying, "It will be a lifelong regret that Eun-chan was not able to receive CAR-T treatment, but I hope that other patients in similar cases will not lose their lives like Eun-chan." Kymriah has been given only once in a lifetime, or "one shot," to allow for near-cure treatment and long-term survival.

 

Therefore, if the existing treatment does not work, or if patients with multiple recurrences of blood cancer can rely on it for the last time.In acute lymphocytic leukemia, 82% and lymphoma 39.1% show Complete Response Rate.

 

The effectiveness of treatment above a certain level can be verified.

 

When Kymriah was licensed in Korea, not only were it already licensed in more than 30 countries, but there are also many countries that have health insurance registered, including Japan.

 

What if Kymriah's domestic approval had progressed a little faster?

 

In Korea, it would have been a medical environment where CAR-T treatment could be done as quickly as in Japan, and health insurance coverage would have been carried out as quickly as in Japan.

 

If that were the case, Eun-chan might have been able to receive Kymriah treatment by now.

 

A sad situation like Eun-chan should not be allowed to happen again.

 

Korea also needs a system that can quickly register new drugs directly related to life without alternatives and has more than a certain level of therapeutic effect like Kymriah.

 

The scope of the "new drug directly related to life" should be set through social discussions, and the MFDS should set a "temporary drug price" at the same time as the approval and apply health insurance to save the patient's life first The HIRA's Cancer Drugs Benefit Advisory Committee and Pharmacological Benefit Advice Committee, the NHIS negotiations, will be carried out quickly to ensure that the "final drug price" is finalized.

 

Afterwards, the government shall actively engage in the introduction of a new drug health insurance rapid registration system directly related to life by post-settlement.

 

The reason why pharmaceutical companies developed new drugs is to save people's lives, and the reason why the government creates and operates a health insurance system is to prevent patients from losing their lives because they have no treatment costs.

 

Pharmaceutical companies and governments should put priority on patients' lives over profits and health insurance finances.

 

Novartis Korea should actively cooperate with the government to quickly provide health insurance benefits by preparing a socially acceptable rational CAR-T treatment Kymriah financial sharing plan.