#Tragedy struck Mr. A all of a sudden. He visited a hospital thinking it would not matter much but was told he had acute myeloid leukemia. Treatments began immediately but saw little progress. His doctor said standard remedies seemed to have little effects and recommended him to seek other treatments.
Mr. A underwent the next-generation sequencing, had its results analyzed by “Watson for Genomics,” and found mutations called the “FLT3 nonframeshift.” IBM’s artificial intelligence-based diagnostic software recommended Sofafenib as an appropriate treatment. Doctors agreed, too.
Mr. A was overjoyed at the news but fell into despair soon. His doctor said he could not prescribe Sofafenib for acute myeloid leukemia, as it was approved as a liver cancer drug.
Mr. A offered to pay 100 percent of the drug price but was turned down. The doctor said he would apply to the government to approve him to prescribe it for leukemia. Mr. A felt embarrassed and dismayed with the situation itself.
It is but one episode among many that have occurred since a local university hospital began treatments with Watson. There have been many cases in which cancer patients found treatments with Watson diagnosis but failed to get prescription for the drug in Korea.
The university hospital introduced Watson to provide custom-made treatments for cancer patients. However, the hospital staffs say they have become keenly aware of the Korean healthcare system’s limitations bound by the inflexible rules of the Health Insurance Review and Assessment Service (HIRA), which critics often describe as the “HIRA quackery.” Medical workers had experienced similar problems even before the introduction of Watson, but are doing now far more frequently after its application.
Watson for Oncology offers treatments according to patients’ conditions after analyzing a vast amount of latest bibliography and theses. Its offering is divided into the three categories of “Recommended,” “For Consideration,” and “Not Recommended.” There have been criticisms, however, treatments recommended by Watson could not be applied to clinical situations, as they did not comply with HIRA’s criteria for insurance benefits.
The same is true with Watson for Genomics. Watson for Genomics analyzes cancer patients’ data earned by NGS test and finds out mutations in two to three minutes, and suggests appropriate treatments.
However, the latest treatments found out by Watson for Genomics often failed to be applied in Korea in part because they don’t meet criteria for insurance payments and because there are too many limitations for them to be used without insurance benefits.
In July last year, the government introduced the past-facto approval system for off-label anti-tumor therapies to increase access to cancer treatments. Anticancer drugs should be used within the extent of the approved range by the Ministry of Food and Drug Safety, in principle. If doctors and patients want to use the drugs beyond the authorized scope, they need to win HIRA’s approval in advance, in what is called the prior approval system. The government recently introduced the post-approval system, giving another means of using.
Medical workers in the field still complain about its restrictive nature, however. They point out that HIRA, more often than not, disapproves prior or post-approvals to make off-label prescriptions based on clinical judgments. If patients fail to get prior or post approvals, they cannot use anticancer therapies, even 100 percent at their expense.
The more new treatments medical workers find using Watson, the more frustrated they are in the face of “institutional walls.”
Some patients buy anticancer treatments recommended by Watson through overseas travels. They buy the drugs in China and ask doctors here to let them know how to take the medicines.
“We have come to offer the latest treatments for patients thanks to Watson for Oncology, Watson for Genomic and NGS tests,” a hemato-oncology professor at a university hospital here. “The problem is we cannot put into practice Watson-recommended treatments, however.”
The professor said he applied for prior or post approvals by attaching evidentiary data presented by Watson when recommending treatments, but are more often turned down by HIRA than not. “Whenever our applications are rejected, I feel as if the prescription right in Korea rests with HIRA, not doctors,” he said.
Another hemato-oncology professor at a different university hospital that has adopted Watson said the government is taking the lead in depriving patients of opportunities to receive best treatments.
“Patients in Korea find it difficult to enjoy the benefits of the newest treatments and remedies because doctors have to treat them according to payment criteria suggested by HIRA,” he said. “There is the onrush of new treatments as data on genomic mutations are accumulated, but Korean patients are being denied even the opportunities to get such treatments.”
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