Korea’s national health insurance program is expanding coverage across autoimmune diseases, oncology, and inflammation with four major drug additions set to take effect June 1.
The update adds UCB’s Bimzelx, Gilead’s Trodelvy, AbbVie’s Rinvoq, and Celltrion’s biosimilar to Roche’s Actemra to the reimbursement list.
Bimzelx: Korea's first IL-17A/F inhibitor enters psoriasis coverage
Bimzelx (bimekizumab) enters the psoriasis market as the country’s first reimbursed interleukin (IL)-17A and IL-17F dual inhibitor.
Approved in August 2024 for adults with chronic plaque psoriasis lasting at least six months, the drug requires patients to have skin involvement on 10 percent or more of their body and a PASI (psoriasis area and severity index) score of at least 10.
Coverage is priced at 801,332 won ($583.13) and continues only if patients show at least a 75 percent PASI reduction after 16 weeks, with biannual reassessments required to maintain access. Patients must first have failed treatment with methotrexate, cyclosporine, or phototherapy.
Since March 1, Korea also permits reimbursement for therapy switches between biologics and JAK inhibitors -- such as Humira (adalimumab), Stelara (ustekinumab), Cosentyx (secukinumab), or oral agents like Otezla (apremilast) -- when treatment is discontinued due to lack of efficacy, safety concerns, or poor adherence.
Each switch must be backed by a physician’s note, and the new therapy must be continued for at least six months to retain coverage.
Rinvoq: Psoriatic arthritis joins Korea's coverage list
While previously approved for psoriatic arthritis, Rinvoq (upadacitinib) had been excluded from coverage until now.
The revision caps a wave of recent access wins for AbbVie, which earlier this week marked the one-year anniversary of Rinvoq’s reimbursement in ulcerative colitis and Crohn’s disease with a nationwide symposium.
At the event, Professor Yoon Hyuk of gastroenterology at Seoul National University Bundang Hospital emphasized that patients who “start treatment with Rinvoq, not those who switch from biologics," see higher remission and endoscopic response rates. He added that "to maximize mucosal healing, it is critical to prioritize effective options like Rinvoq from the beginning," according to AbbVie's Monday release.
In rheumatoid arthritis, reimbursement is still contingent on failure of at least six months of disease-modifying antirheumatic drugs (DMARDs), including three months of methotrexate unless contraindicated.
Exemptions apply for patients 65 and older or those with cancer or cardiovascular comorbidities who fail tumor necrosis factor (TNF) inhibitors.
Disease activity must drop by 1.2 points or more on the disease activity score (DAS28) scale after six months to extend coverage. Further switches across JAKs, IL-6 inhibitors, T-cell modulators, and TNF blockers are allowed -- but only after a minimum treatment period.
Trodelvy: Gilead breaks through with Korea's first ICER-based cancer listing
Trodelvy (sacituzumab govitecan), Gilead’s antibody-drug conjugate for metastatic triple-negative breast cancer, finally won reimbursement at 1,052,300 won ($765.11) per vial after more than a year of gridlock.
The listing follows two public petitions backed by over 100,000 signatures and marks Korea’s first application of its flexible incremental cost-effectiveness ratio (ICER) model for an oncology drug.
Coverage is limited to patients who have received at least two prior systemic therapies, one of which must have targeted metastatic disease.
Avtozma: Celltrion's Actemra biosimilar hits market at 30% discount
Rounding out the update is Celltrion’s Avtozma, a subcutaneous (SC) biosimilar to Roche’s tocilizumab used for autoimmune diseases, reimbursed at 245,938 won ($178.76), approximately 30 percent lower than the price of branded Actemra.
Celltrion received approval earlier this year for both the SC and intravenous (IV) forms of Avtozma, positioning it as the first company in Korea to match the full formulation range of the originator. However, the IV version has not yet been listed for reimbursement.
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