Imfinzi reimb discussions at a standstill in Korea

Warning lights lit up access to a new treatment for bile duct cancer

Remains non-reimbursed 3 years after approval…patients are becoming increasingly anxious

MOHW’s fast-track listing policy to the test in the aftermath of the MFN policy

Concerns are mounting over multinational pharmaceutical companies’ market strategies as U.S.

 

President Donald Trump’s Most-Favored-Nation (MFN) drug pricing policy moves toward implementation.

 

If enforced, U.S.

 

drug prices would be pegged to the lowest levels among major advanced markets — raising the risk that Korea’s comparatively low prices could be used as reference points, escalating fears of a “Korea-passing” scenario.

 

In fact, the ripple effects of the MFN policy are becoming concrete as major multinational pharmaceutical companies like Pfizer and AstraZeneca engage in negotiations.

 

Domestic drug prices for major new drugs are only about one-fourth of their U.S.

 

counterparts.

 

Consequently, concerns are mounting that multinational pharmaceutical companies may avoid the Korean market or reduce supply, inevitably leading to reduced access to new drugs.

 

During the recent NA audit, Rep.

 

Jia Han of the People Power Party warned, “If the MFN policy is implemented, Korea could be excluded from new drug introductions.

 

Patients with severe illnesses could be particularly harmed.” Bile duct cancer coverage gap remains unfilled for 10 years… Urgent need for ‘Imfinzi’ listing raised

Imfinzi

This trend is especially critical for bile duct cancer patients, who have extremely limited treatment options.

 

Bile duct cancer is difficult to diagnose early, with over half of patients diagnosed at metastatic stages.

 

The 5-year survival rate for patients diagnosed with distant metastasis is only 4.1%.

 

In 2022, the immune checkpoint inhibitor ‘Imfinzi (durvalumab)’ was approved in combination with chemotherapy as first-line treatment for bile duct cancer, offering the possibility of long-term survival.

 

In clinical trials, Imfinzi demonstrated improved 3-year long-term survival rates compared to the control group, with even more pronounced effects observed in Korean patient cohorts.

 

However, despite being approved over 3 years ago, reimbursement has yet to be granted.

 

Imfinzi received a “redeliberation” verdict from the Drug Reimbursement Evaluation Committee (DREC) in September, but subsequent discussions have stalled, deepening patient anxiety.

 

Notably, no new drugs for bile duct cancer have been reimbursed in the past decade.

 

This stands in stark contrast to the expansion of reimbursement for immune-oncology drugs in other cancers like lung and breast cancer.

 

Professor Changhoon Yoo of the Department of Medical Oncology at Asan Medical Center in Seoul emphasized, "Biliary tract cancer has a very poor prognosis and limited treatment options.

 

While Imfinzi improves survival rates and quality of life, its non-reimbursed status places a heavy financial burden on patients.

 

Patients need rapid access to this global standard of care.“ ” Strengthening compensation for innovative drugs"...

 

attention rises on November DREC review results Experts unanimously agree that a flexible drug pricing evaluation system that reflects disease characteristics and societal needs is necessary for covering innovative treatments like Imfinzi.

 

In the UK, considering Imfinzi was the first approved immunotherapy for primary biliary cancer as a first-line treatment, the ICER (Incremental Cost-Effectiveness Ratio) threshold was applied flexibly to determine its National Health Service coverage.

 

The longer discussions drag on, the more unlikely reimbursement becomes due to the aftermath of MFN-driven global pricing effects.

 

AstraZeneca Korea said it “remains committed to improving access and fulfilling all required procedures for Imfinzi’s reimbursement.” At the recent NA audit, Minister of Health and Welfare Eun-kyeong Jeong acknowledged MFN-related access risks and pledged to “improve compensation for innovative new drugs and improve patient access through expedited listing.” Consequently, attention is focused on whether discussions regarding Imfinzi's reimbursement will resume at the upcoming DREC meeting on November 6.

 

The industry is watching closely to see if this committee meeting could mark a new turning point in treatment for bile duct cancer patients.