Delayed insurance coverage for pulmonary fibrosis drug Ofev sparks calls for reimbursement reform

Pulmonary fibrosis is a rare disease that causes the lungs to harden and leads to shortness of breath. However, the approval of insurance coverage for Ofev (nintedanib), a critical treatment for pulmonary fibrosis patients, has been delayed. Experts note that this delay exacerbates the financial burden on health insurance systems, as frequent acute exacerbations of pneumonia—a common and severe complication of pulmonary fibrosis—continue to strain resources. Ofev, used to treat idiopathic pulmonary fibrosis (characterized by lung scarring with no known cause) and progressive pulmonary fibrosis (where scarring worsens over time), was introduced in Korea in 2016 but remains non-reimbursable.

"Among rare diseases, idiopathic pulmonary fibrosis has the largest impact on disease burden because it results in the highest number of deaths," said Song Jin-woo, a professor of respiratory medicine at Asan Medical Center. 

He made these remarks during a discussion on improving access to orphan drugs, hosted by Rep. Seo Young-seok of the Democratic Party of Korea and the Korean Organization for Rare Diseases. "This condition incurs the highest healthcare costs among rare diseases, as patients often experience acute exacerbations, such as pneumonia, leading to rapid deterioration," he explained, highlighting the medical challenges.

The costs associated with hospitalizations due to acute exacerbations of pulmonary fibrosis make up the majority of healthcare expenses for these patients, according to Song.

By proactively controlling the progression of lung fibrosis with medications before the disease worsens, the nation could significantly lower the overall mortality rate of pulmonary fibrosis patients, he noted.

“This approach could also substantially reduce healthcare costs by preventing disease progression, which leads to death or costly acute exacerbations.”

Song also said that the number of pulmonary fibrosis patients in Korea was growing rapidly. 

“Korea has a very high prevalence of advanced idiopathic pulmonary fibrosis compared to other countries. The biggest reason for the high prevalence is that it is a disease that affects older adults,” he said. ”The disease occurs in people over 50 years old, and it is not uncommon, especially in men over 60 years old, with a prevalence of as low as 1 in 1,500 and as high as 1 in 500. Especially in Korea, where the population is aging, this group of patients is expected to increase.” 

Currently, two drugs—pirfenidone and nintedanib—are used to treat idiopathic pulmonary fibrosis. However, pirfenidone, which is covered by insurance, often causes digestive system issues and photosensitivity, leading about half of patients to stop treatment within the first year. Meanwhile, nintedanib, though available, is not reimbursed. "When we analyze the data, about half of the patients using pirfenidone for a year cannot tolerate it and discontinue treatment, with side effects being one of the primary reasons for stopping," Song said.

Furthermore, nintedanib is the only available treatment for advanced pulmonary fibrosis, but it has remained non-reimbursed for nearly eight years due to a pricing dispute between health authorities and Boehringer Ingelheim. "Many patients with idiopathic pulmonary fibrosis cannot access the drug because of insurance coverage issues, and those with advanced pulmonary fibrosis are unable to obtain Ofev, despite it being a first-line treatment, due to its high cost," he noted.

Lee Dong-wook, a patient with advanced pulmonary fibrosis who participated in the panel discussion, urged the swift reimbursement of nintedanib, emphasizing that it is a "life-saving drug" for those with pulmonary fibrosis. He highlighted that while nintedanib is covered by insurance in countries such as the U.S., Japan, the U.K., Taiwan, Italy, Switzerland, and Australia, it remains non-reimbursable in Korea. This situation deprives patients with advanced pulmonary fibrosis of access to treatment, even though the drug is available in clinics, he said.

Commenting on the non-reimbursement of nintedanib, a drug licensed in Korea for over eight years, Lee Eun-joo, an official from the Insurance and Pharmaceutical Affairs Division of the Ministry of Health and Welfare, said, "Ofev applied for reimbursement in 2020, but the application was rejected, and it is currently under re-evaluation. We are mindful of the situation in the medical field and will monitor the progress of benefits." She added, "We will also explore policies to address any gaps related to rare diseases and consider ways to reduce the financial burden of using the drug."