[Reporter’s Notebook] The new drug is here, but not for everyone: Korea’s tight grip on innovation access
A few days ago, I interviewed two thoracic surgery specialists -- one based in Austria, the other in Korea -- to discuss perioperative immunotherapy for early-stage non-small cell lung cancer (NSCLC). The Austrian professor casually remarked, “We use Keytruda (ingredient: pembrolizumab) in the perioperative setting for early-stage lung cancer as it is fully reimbursed by the government.”
The Korean professor let out a restrained sigh. “I envy you. In Korea, we can’t use it unless the patient pays out of pocket,” he said. “There’s no insurance coverage yet for that indication.”
The estimated out-of-pocket cost for Keytruda when used in a non-reimbursed setting in Korea is roughly 5 million won ($3,393) per month.
That brief exchange reveals a persistent problem in Korea’s healthcare system -- life-saving treatments may be approved, available, and effective -- but often remain out of reach due to delayed or overly narrow reimbursement policies. For many Korean physicians, this gap between scientific advancement and insurance reality is becoming a daily frustration.
Another case is Roche’s Evrysdi (ingredient: risdiplam), an oral therapy for spinal muscular atrophy (SMA). Approved by Korean regulators in 2020, it wasn’t until mid-2023 that insurance reimbursement was granted.
Even now, the conditions remain strict. During a dual interview with a professor from Japan and another from Korea, the contrast between the two nations was evident.
In Korea, patients must undergo regular assessments, and if they don’t show measurable improvement, coverage can be withdrawn.
Under the current system, SMA patients treated with Evrysdi are required to undergo standardized motor-function evaluations roughly every four months, and these results directly determine whether insurance support continues.
But clinicians point out that the evaluation framework does not adequately account for temporary changes unrelated to the drug’s effectiveness.
If a patient has recently been hospitalized for an infection, undergone surgery, experienced an injury, or simply shows fluctuating physical condition on the day of testing, their motor score can drop -- and the system may still interpret this decline as treatment failure.
As a result, even patients who are clinically benefiting from therapy remain vulnerable to losing coverage due to short-term events that have little to do with the drug itself.
In Japan, by contrast, reimbursement was granted much earlier and across a broader age range, while continuation decisions rely more on clinical judgment of the attending physician than administrative thresholds.
Novartis’ Kymriah (ingredient: tisagenlecleucel), a CAR-T therapy for blood cancers, was a landmark listing when Korea approved reimbursement in 2022 under a performance-based agreement. Yet many hospitals still hesitate to use it -- not because of the science, but because of the financial risk.
In Korea, doctors must secure prior approval, meet narrow eligibility definitions, and report post-treatment outcomes. If anything falls outside the criteria, the hospital may face full claim denial, even after the drug has been administered. In some cases, institutions have been left with liabilities exceeding 300 million won.
In contrast, when I interviewed Korean professors last year during the American Society of Hematology (ASH) 2024 Congress, they said they were taken aback after hearing their U.S. counterpart explain that he had never been denied reimbursement when using Kymriah.
A quiet frustration shared across interviews
Throughout various interviews, one sentiment kept resurfacing: a growing sense among Korean physicians that the system doesn’t trust them.
“There’s this assumption that if we’re not closely monitored, we’ll prescribe irresponsibly,” a medical oncologist said. “But we’re not talking about over-the-counter painkillers. These are serious therapies used by experts. The distrust is demoralizing.”
Another oncologist was blunter.
“If the government trusts us to diagnose and treat advanced cancer, why can’t they trust us to decide when an approved, globally used therapy should be applied? Instead, we spend time filling out justification forms, calculating survival curves, and waiting months -- while the patient’s cancer grows,” he said.
This erosion of professional autonomy, they argue, not only delays care but discourages use of innovative treatments altogether.
No one disputes that Korea must be prudent in managing its healthcare budget. But the current model, doctors warn, has created a system so focused on economic control that it sidelines medical judgment.
Many calls for a middle path -- one that ensures financial accountability while empowering clinicians. Faster temporary reimbursement mechanisms, post-listing outcome monitoring, and more realistic trust in physicians’ expertise are among the proposals circulating.
Korea’s health system remains one of the most comprehensive in Asia. But for cutting-edge treatments, being comprehensive is no longer enough, being responsive matters too.