Checkpoint inhibitors, otherwise known as cancer drugs, have been hailed as a new form of treatment. Both large and small pharmaceutical companies have jumped into developing immunotherapies, deemed one of the most popular treatment categories by consulting firm Evaluate Pharma.
With two blockbuster immunotherapies getting reimbursed in late August, Korean cancer patients have gained greater access to these drugs. However, with reimbursement came some restrictions regarding having the drug prescribed off-label, causing protests by cancer patients.
In light of the controversy of off-label drugs, Korea Biomedical Review interviewed Professor Kang Jin-hyoung of Seoul St. Mary’s Hospital to hear the clinicians’ perspective on cancer treatment, off-label use, and the Korean healthcare system.
Personal call to lung cancer treatment
Professor Kang’s journey as a medical oncologist began almost two decades ago.
“I got a call from my elder sister in 2002 who was living in Canada at the time. She said she had a cough despite antibiotic treatment,” Kang recalled. “I had no idea at the time. We eventually discovered it was lung cancer with one metastasis.”
“At the time, there were no targeting agents or immuno-oncology drugs. I tried treating her with systemic chemotherapy for 10 months. She passed away,” he added.
|Professor Kang Jin-hyoung speaks at the Korean Association for Clinical Oncology (ASCO) on Aug. 25 as the Korean Cancer Study Group chairman in Gyeongju, Korea.|
Kang says that it was from this experience that he decided to devote himself to treating lung cancer. He has since met with and treated lung cancer patients for more than two decades.
Dr. Kang graduated from Catholic Medical University in 1978 and began specializing in internal medicine in 1988. After finishing his mandatory military service, he returned to the hospital for fellowship training, and become an assistant professor at Gangnam St. Mary’s hospital 20 years ago. He has since been promoted to a professor at Seoul St. Mary’s Hospital as a medical oncologist in 2005.
As a doctor and professor at one of the so-called Big-Five hospitals in Korea, he spends his time treating patients, researching, and conducting clinical trials in the field of immuno-oncology.
How effective are cancer therapies?
There has been monumental progress in the field of oncology with immunotherapies rapidly gaining indications for many different types of cancers.
Despite the hype, Kang says that the response rate is roughly around 25 percent.
“Doctors are armed with more weapons against cancer,” he said. “But we have found in the past decade or so, that tumor cells are quite resistant, and they often find a survival pathway.”
The real issue is the 70 to 80 percent who do not respond to checkpoint response inhibitors, he said, adding that these drugs affect many different types of organs. In some people, the T-cell is over-activated, which affects various organs including the thyroid, lung, skin, and colon, just to name a few.
Coupled with resistance from cancer cells are the calls from cancer patients to let the drugs be prescribed off-label. In this regard, Kang believes prescription should be evidence-based, like most doctors in the country.
“Some critics are protesting the government’s off-label use policy. I understand their stance because they are in an emergency,” Kang said. “But I believe targeted checkpoint inhibitors should be administered to patients when clinical trials confirm antitumor efficacy,”
“In cases where U.S. FDA has approved the drug but its Korean counterpart, I mean the Ministry of Food and Drug Safety, has not, I believe patients should be able to use the drug with their own money,” he explained. “It makes sense because the drug has proven evidence. But asking for drugs off-label just because everyone else is getting it does not make sense.”
Kang referred to a recent case of a sarcoma patient protesting against the government, calling for off-label use to treat the illness.
“We have no evidence of sarcoma patients benefitting from checkpoint therapies. It doesn’t make sense for patients to ask for them because they heard they are ‘great’ and ‘because everyone else is getting them,’” he explained.
Doctors also face a substantial legal risk in prescribing drugs off-label. Prescribing drugs off-label at a large university hospital in Korea exposes the doctor to the risk of a hefty financial penalty and even a criminal punishment.
This is why Kang advocates treating cancer patients with a multimodality team approach, institutionalized at 70 large hospitals in Korea, where specialists of different fields come together to deal with the patient, especially when trying to treat the patient off-label.
“It’s a very rational idea,” Kang said. “We need to know what side effects arise -- in which patients and at what frequency. We then need to understand how they need to be treated.”
He pointed to Japan as an example, saying that “Opdivo has been on the Japanese market for three or four years now. They have more than 10,000 patients treated with the drug in their database. They say they have the toxicity data. We need to ask, which country is doing it correctly?”
“This is something we need to talk about,” he added.
Korea’s socialist healthcare system
“Our healthcare system is socialist,” Kang said. “I’m no politician. I am just a doctor, but I have 20 to 25 years of experience in the clinical field and experienced firsthand the issues and problems of the insurance system.”
He says the benefits are that it can cover lots of people. However, the system also inadvertently leads to patients gaining a sense of entitlement and rising medical insurance premiums for the rest of the population.
Many patients complain that they have to wait a long time and that hospitality and service quality are poor.
“In my point of view, money has a significant impact on the service and attitude of doctors,” he said. “The new government policy says it will provide coverage for all diseases. Then healthcare should be less expensive, but [on the other hand] the service quality falls below the average.”
He has also, in his clinical experience, confronted cancer patients who have complained about having to pay the standard insurance rate after completing cancer treatment.
Cancer patients have to pay only 5 percent of medical bills during treatment. Once cured, they pay 20 percent of medical fees like the rest of the population.
“I have noticed many cancer patients are not grateful for lower insurance rates,” he said. “Patients are upset because they have to revert to paying 20 percent. They lack the awareness to give back to the community and their workplace.”
Another problem he points out is how long the patient should be under maintenance. As time goes by, the number of patients will accumulate, and the medical expense will rise.
“How are the following generations going to deal with the rising medical fees? How are average employees who are paying their insurance rates going to deal with these rising costs? This is a critical time for discussion,” he added.
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