It’s only natural a drugmaker that has developed a new innovative therapy goes all out to win its marketing approval and listing as the insurance-covered medication in major markets.
That also explains why the U.S. pharmaceutical company Merck Sharp & Dohme (MSD) is keenly interested in the Korean government’s process to include its new immunotherapeutic anti-cancer drug Keytruda (compound: pembrolizumab) in the list of medications benefitted by health insurance.
|Jan Van Acker, president of MSD Asia-Pacific, expresses his hope that the company’s anti-cancer immunotherapeutic drug Keytruda will receive insurance benefits as soon as possible, during a recent interview with Korea Biomedical Review.|
What sets MSD’s efforts apart from other similar endeavors, however, is they reflect not just company’s but many patients’ wish to get the drug at more affordable prices as early as possible, a top MSD manager says.
“The important thing is to have an environment that you can use for patients who need immunotherapy,” said Jan Van Acker, president of MSD Asia Pacific, in a recent interview with Korea Biomedical Review, adding that the MSD headquarters is also paying close attention to the situation in Korea.
The anti-cancer drug binds to and blocks the programmed cell death protein one located on lymphocytes, allowing the immune system to destroy cancer cells. It has currently become the mainstream of chemotherapy, receiving high expectations and attention from medical staff and patients.
The government is also examining whether to register the insurance benefits of another immunotherapy Nivolumab, developed by Bristol-Myers and marketed as Opdivo. Korean regulators are likely to decide on the insurance benefits for the two drugs as early as the end of June.
“Currently, 18 OECD countries approved Keytruda as a second-line treatment for non-small cell lung cancer (NSCLC), and all of them expressed satisfaction with the results. Cancer patients who receive direct (therapeutic) benefits and doctors who treat them are welcoming it,” the Belgian executive said. “I understand that the Korean government is working to introduce the immunotherapy for cancer as soon as possible, which I hope everyone in Korea can experience a win-win situation.”
Acker said he visits two or three times a year to Korea and has met with officials from Health Insurance Review and Assessment Agency to discuss issues related to Keytruda. He advised in this regard Korea needs a more flexible payment system for innovative new drugs such as anti-cancer drugs.
"I heard that Seoul will not postpone the approval process and that it’s going on rapidly,” he said. “However, other countries have an expedited screening process for drugs that alter the paradigm of treating certain diseases while Korea does not. I believe Korea should have such a system.”
The Belgian executive gave the example of his home country, in which it used to take two or three years to register a new drug 20 years ago, which, however, has been shortened to a year and a half 10 years ago and to a half year now under the fast-track system.
As Korean officials see, however, the main problem is the high price of the immunotherapy, taking several millions of won for one administration. Safety is another concern for them because immunotherapy has been in clinical use for only several years. This is why Seoul tries to retain patients through payment standards and set up a medical institution responsible for controlling adverse effects.
Patients, on the other hand, are demanding that more people benefit from treatment. “We do not care whether some designated specialists or all doctors can prescribe the new therapy as long as it is available for all patients needing it,” Acker said. “But you should not restrict treatment opportunities or accessibility of patients.”
To sum up, Keytruda is currently available as first-line/second-line treatment for non-small cell lung cancer in Korea and U.S., and it is only anticancer drug currently available as a first-line treatment for non-small cell lung cancer.
Also, it is waiting for reimbursement approval as second-line NSCLC treatment in Korea, Acker said.
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