[Reporter's Notebook] Retevmo highlights delays in Korea's rare cancer dr...

The moment this reporter spotted the name Retevmo (selpercatinib) in the list of abstracts selected for the plenary session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, the first reaction was not excitement. It was closer to unease.

ASCO is the world’s largest oncology conference, and its plenary session highlights “practice-changing” studies with the potential to redefine standards of care. The phase 3 LIBRETTO-432 trial, selected for that session, tested Retevmo as adjuvant therapy after surgery in early-stage RET fusion–positive non-small cell lung cancer (NSCLC).

Retevmo may move beyond treating advanced disease, aiming instead to prevent recurrence and improve cure rates in early-stage cancer. Oncology experts recognize the pattern: plenary studies often lead to label expansions, guideline updates and shifts in clinical practice.

But in Korea, patients still lack access to Retevmo -- even for approved metastatic use.

Retevmo was approved by the Ministry of Food and Drug Safety in March 2022 for advanced RET fusion–positive NSCLC, but remains excluded from national health insurance coverage.

Its first review by the Cancer Drug Review Committee (CDRC) failed due to insufficient evidence. A second attempt passed the Pharmaceutical Reimbursement Evaluation Committee but collapsed at the drug price negotiation stage with the National Health Insurance Service.

A third review cleared the CDRC in September last year, but discussions are now stalled at the subcommittee level over cost-effectiveness.

While the process drags on, patients are left to decide whether they can afford to continue treatment -- decisions that directly affect survival.

The monthly cost of Retevmo is estimated at around 8 million won ($5,408). In practice, access is determined less by medical need than by financial capacity.

Of course, reimbursement decisions must be made carefully. The sustainability of the national health insurance system matters. But applying conventional evaluation standards to rare cancer drugs raises a fundamental question.

Rare cancers involve small patient populations, making large-scale clinical evidence difficult to generate. This is an inherent limitation of the disease, not of the therapy.

If authorities continue to delay decisions by citing “insufficient evidence” or the absence of an “appropriate comparator” even after regulatory approval, the cost is borne not in policy terms, but in lost treatment time.

Patients who cannot afford Retevmo are effectively denied therapy, creating a gap between approval and access that becomes a barrier to survival.

The Lee Jae Myung administration has pledged to expand access to treatment for rare and severe diseases. During his campaign, Lee promised to reduce the financial burden on patients and broaden coverage. This year, the government announced plans to shorten evaluation and negotiation timelines from 240 to 100 days and expand patient support.

But policy is measured not by timelines or announcements, but by whether patients can actually receive treatment.

Retevmo illustrates the gap. While global discussions are shifting toward earlier use, Korea remains unable to provide coverage even for approved indications years after authorization.

This is no longer a question of process. It is a test of whether policy can translate into timely access.

It is time for the government to respond.

Kim Yun-mi