Multi-indication anti-cancer drugs, 'Tevimbra' offers alternative

Approval·reimbursement hurdles are now set high…'clinical equivalence+rational' pricing model garners attention

Increased choices within the same efficacy profile…reduced financial burden through competition is expected

Product photo of 'Tevimbra (tislelizumab)' 

As advanced oncology treatments surge, discussions are in full swing to bridge the gap between the financial burden and improved patient access.

The government recently presented the enhancement of coverage for rare cancers as a core task through the 5th Comprehensive Cancer Control Plan (2026–2030), and the need to re-examine the overall financial structure of oncology reimbursement is gaining attention.

Related to this, the Korean Society of Medical Oncology has also emphasized the need to expand the scope of reimbursement for rare cancer treatments, calling for a balance between coverage expansion and fiscal sustainability.

The background to these policy discussions is the rapid expansion of approved uses for multi-indication oncology drugs, such as immune checkpoint inhibitors, antibody-drug conjugates, and bispecific antibodies, which could accelerate the pace of expenditure growth.

The recent regulatory and expanded reimbursement of the immunotherapy 'Tevimbra (tislelizumab)' is garnering significant attention. It is being interpreted as a case study demonstrating how realistic alternatives can be implemented amidst spending on multi-indication oncology drugs is skyrocketing.

Tevimbra entered the Korean market in April last year, becoming the first immunotherapy to successfully secure reimbursement for the first-line treatment of esophageal cancer in combination with chemotherapy. Within just two months, it expanded its approved indications to a total of five, including esophageal cancer, gastric cancer, and first- and second-line treatment of non-small cell lung cancer.

In December of the same year, an unusual record for Tevimbra was set when all five of these indications passed the Cancer Drug Review Committee in a single session. After that, it secured additional indications in perioperative adjuvant therapy for non-small cell lung cancer, extensive-stage small-cell lung cancer, and nasopharyngeal cancer. This drug's scope was expanded from major to rare cancers with limited existing treatment options in a short period. However, the expanded reimbursement for major indications remains ongoing.

Despite concerns in the medical community that regulatory and reimbursement hurdles are rising, Tevimbra's rapid achievement is raising expectations, largely due to a strategy that combines proven clinical equivalence with a rational pricing model. 

By demonstrating clinical utility equivalent to first-in-class agents while offering a pricing structure that reduces the financial burden relative to competitors, the drug has navigated the approval and reimbursement processes swiftly. Experts evaluate Tevimbra as a symbolic case that tests the consistency of the reimbursement review process.

Both clinicians and National Health Insurance subscribers are also welcoming Tevimbra as an expansion of treatment options. Clinicians appreciate the increased choices within the same efficacy profile, allowing for prescriptions tailored to patient characteristics. At the same time, payers view the situation positively as price competition between drugs with equivalent clinical effects can lead to significant cost savings.

Providing options for rare cancers like nasopharyngeal cancer, or for areas like perioperative non-small cell lung cancer and esophageal cancer where reimbursed treatment options were previously lacking, aligns with the government's goal of expanding reimbursement coverage.

In a situation where the reimbursement system is becoming restricted due to spending being concentrated on specific immunotherapies, a drug that successfully enters the reimbursement list by presenting a new price structure based on clinical similarity is expected to set a favorable precedent.

Professor Ji-Youn Han of the Hematology-Oncology Department at the National Cancer Center said, "Tevimbra demonstrated an efficacy and safety profile equivalent to that of existing immunotherapies across various studies. In certain patient subgroups, it has shown clear relative advantages." 

Professor Han added, "As clinical evidence for Tevimbra grows, it is an option that can broaden the scope of treatment selection and improve clinical benefits and access. We hope for rapid reimbursement expansion so that patients can receive benefits."