[Reporter's View] Dilemma of off-label prescribing

For patients who have used all cancer treatment options, the only remaining path is often clinical trials. This is because a system has become rigid, so that even if a treatment with expected efficacy exists, institutional constraints prevent it from being prescribed.

Theoretically, off-label prescribing is permitted. In South Korea.

To use an off-label drug, a hospital's Institutional Review Board (IRB) must first deliberate on the case, after which the Health Insurance Review and Assessment Service (HIRA) determines whether to approve. However, critics point out that IRBs are limited to specific hospitals, and because deliberation standards are applied at a very high level, significant hurdles remain before actual approval is secured.

Furthermore, the problem is that this pre-approval system and the list of available treatments operate differently across hospitals. Even under identical patient conditions, a prescription may be possible at one specific hospital but impossible at another.

Consequently, the decision to treat depends not on the patient’s clinical status but on the medical institution's decision. Patients must search for a hospital that can provide treatment, rather than choosing the treatment itself.

As a result, it is difficult for patients even to know under what circumstances treatment is possible or to what extent it is allowed. This structure, in which treatment availability varies by hospital and situation despite the same disease and conditions, causes significant confusion.

This issue is even more pronounced among patient groups outside approved indications. It is not uncommon for patients with the same biomarker to be excluded from treatment simply because they do not fall within the authorized indication. In a system where off-label use is effectively blocked, the options available to these patients become extremely limited.

Within this framework, the only option left for patients is to participate in clinical trials. However, clinical trials are not a realistic option for everyone. Participation conditions are stringent, and accessibility varies widely by region and institution. Most importantly, for patients who might be missing their treatment window, a clinical trial is less a choice and more a last resort.

Under these circumstances, the discussion on expanding off-label prescribing is emerging as an alternative rather than simply an option. Instead of dismissing this as a risky or unrealistic approach, it is necessary to consider it as a solution to guaranteeing treatment opportunities within a limited fiscal environment. At the very least, restructuring is required to ensure that the system does not block treatment opportunities.

This is not a regulatory issue, but it is a minimum requirement to reduce confusion caused by a lack of standards and to provide patients with a predictable treatment environment. If the structure where clinical trials are the only remaining option persists, fair treatment opportunities can hardly be guaranteed.