Amgen Korea, established in November 2015, has become one of the leading biotechnology companies in the local market.
In just several years, the Korean offshoot of the U.S. multinational firm obtained reimbursement for six key new medicines in a short period.
The six therapies are Kyprolis for multiple myeloma, Blincyto for leukemia, Prolia for osteoporosis, Xgeva for bone metastasis treatment in cancer patients, Repatha for coronary artery disease, and Evenity with a dual mechanism of action for osteoporosis.
Korea Biomedical Review has met with Amgen Korea General Manager Noh Sang-kyung to hear about the company’s achievement in the past five years and the next plans.
Question: In just five years, Amgen Korea not only rolled out six innovative drugs but made them all reimbursable. How did the company settle in the Korean market so quickly?
Answer: When I took office as general manager, I had to organize the company from scratch. So, I deeply thought about how to deliver Amgen’s unique value to domestic patients. Considering that Amgen focused on innovative treatments, we formed Regulatory Affairs Department, Medical Affairs Department, and Value Access Department. Regulatory Affairs Department is responsible for domestic approval of innovative products. After the product is released, Medical Affairs Department provides accurate drug information to local healthcare professionals. Besides, the Value Access Department's role is important because poor access hampers 100 percent delivery of the drug’s value even if the drug is the best treatment option.
Each pharmaceutical product its unique features and advantages. However, when there is an unmet medical need in the local treatment market, it is possible to obtain the license and reimbursement. So, it is very important in the drug reimbursement negotiation to show how much the drug can benefit patients with data from an academic perspective.
I supported Value Access employees to analyze a lot of data, organize them, and identify the unmet local demand quickly. They turned this into data to help the government understand the need for reimbursement sufficiently. I just supported competent executives and employees to produce good results.
However, as the government spending on health insurance is limited, it isn't easy to win recognition for the drug’s innovation. It is also challenging to decide a reimbursement rate even if the drug’s benefit for patients is significant.
It is crucial to communicate with the headquarters over the prices discussed during the reimbursement negotiation with the government.
I worked hard with our staff from various departments to deliver Amgen's innovative products to Korean patients at an appropriate price. As a result, all six products were able to receive the permit and health insurance benefits five years after Amgen Korea's launch. I think this is the biggest achievement in improving treatment accessibility for local patients.
Q: Still, it would not have been easy to make all the expensive new drugs reimbursable. How did the company do it?
A: The winning of reimbursement for all the key products launched is a success story to be proud of.
In Korea, a drugmaker cannot obtain a new drug license if it doesn’t have data of a bridging study. To solve this problem, we looked into clinical data in detail and classified patients in various data analysis ways. This was to obtain orphan drug approval for a small number of patients who needed the treatment. After that, we could continue to expand indications with the permit.
The headquarters was concerned about this attempt, but it was an achievement made by Korean employees who make all efforts to persuade the headquarters.
Since then, after seeing the success stories of Amgen Korea, Amgen China, with similar difficulties, benchmarked our strategy and obtained the nod.
I feel proud that our employees' creative efforts have set a good precedent. I think Amgen Korea has made many successful cases so far because our executives and employees did their best in their field of work.
Q: During the reimbursement negotiations with the government, how did you feel about the Korean drug pricing policy?
A: China and Canada have already announced that they will officially refer to Korea's drug prices, and the U.S. has also announced that they will refer to all OECD countries' drug prices, including Korea’s. Although I haven't felt a sense of crisis yet, I expect that the process of discussing drug prices with the headquarters will become more difficult.
When calculated in proportion to GDP, Korean drug prices are among the lowest in the world. If Korean drug prices affect U.S. drug prices, it is necessary to think deeply about the difficulties in the future. I believe this is a common concern for Amgen Korea and most multinational pharmaceutical companies operating in Korea.
I think it is good to set the drug pricing system by indication, which can measure the value and price of a new drug by different types of cancer and therapy. Such a method can help more patients get benefits and, ultimately, prolong their lives. I always think positively about various considerations helpful to expand patients’ drug accessibility. I hope that the government could review this actively.
Q: Which reimbursement issues is Amgen Korea focusing on now?
A: We’re focusing on getting insurance benefits for the treatment of osteoporosis, a chronic disease. Patients with chronic diseases do not have immediate health problems even if they don’t get treatment right now. But, if they neglect their disease without appropriate treatment, they will likely suffer serious health problems in the long term.
In particular, osteoporosis patients cannot recover easily once the bone density decreases. Even if exercise or diet can improve, if the bone density is too low, the patient needs a drug administration. A medication can restore bone density, and the patient can prevent deterioration through continuous treatment.
The problem is that once diagnosed with hypertension or diabetes, patients continue to get insurance benefits for their treatment, while osteoporosis patients can’t do so when their bone density improves above a certain level.
If patients stop treatment due to financial problems, the bone density deteriorates, which inevitably leads to a vicious cycle that increases fracture risk. For this reason, continuous osteoporosis treatment is very important.
However, it is unfortunate that patients are exposed to the risk of fractures due to reimbursement limitations.
The government also acknowledges this medically but still limits reimbursement because of the insufficient budget.
The nation needs improvement in the osteoporosis treatment environment, which is limited by irrational and unscientific reimbursement.
Q: A labor union was formed in Amgen Korea, recently. How is the relationship with them?
A: When a trade union is established within a company, we need time to build a relationship between the union and the management. The labor union was set up because the workers were worried about job security as their sales activities were restricted amid the prolonged Covid-19 pandemic.
However, I wonder what it would have been like if our communication with employees had been better. So far, I’ve been communicating with our staff through town hall meetings or meals with each team.
But as the company grew in size and the number of employees increased, I came to think that it may be difficult to convey my opinion and direction to all employees accurately.
I think the workers formed the labor union to express their desire “to have a conversation with the company.” Amgen Korea’s labor union is in line with the direction of the company in many ways. So, the company listens to the opinions of the employees actively and has conversations frequently.
Q: Amgen recently announced a plan for job cuts. Do you expect that the workforce reduction will affect Amgen Korea?
A: The U.S. headquarters recently announced that it would cut jobs in the U.S.
But in early this year, Amgen CEO Bob Bradway said Amgen would keep growing, and a quarter of growth will come from the Asia Pacific in the next 10 years. His remarks showed that the company was willing to increase investment in the Asia Pacific region.
I think the company will invest in Korea, next to China and Japan.
Amgen Korea has been doing its job well. We have made remarkable success stories that Amgen in other countries can refer to in quantitative and qualitative performance.
The U.S. headquarters is well aware of Amgen Korea’s efforts and achievements. Whenever they have a meeting, they often mention Korea.
Every time a good Korean example is introduced to Amgen leaders worldwide, I can feel that our employees’ efforts are recognized globally.
Recently, I got the headquarters’ approval for our plan to hire more workers, and the number of open positions was higher than I had planned. The headquarters must have decided so because they recognize that Amgen Korea produces corresponding results as it recruits more people. I can assure you that Amgen Korea employees do not have to worry about workforce reduction.