Will Ofev be reimbursed for idiopathic pulmonary fibrosis in Korea?

Boehringer Ingelheim submits additional real-world data

Unmet needs persist despite PPF listing in May last year

Attention is once again focused on whether reimbursement coverage for Ofev (nintedanib) can be expanded to include idiopathic pulmonary fibrosis (IPF) in Korea. Despite being approved a decade ago, the drug has remained non-reimbursed for this indication.

According to Dailypharm coverage, Boehringer Ingelheim Korea submitted an application in the second half of last year to expand reimbursement coverage for idiopathic pulmonary fibrosis (IPF) following the drug’s successful listing for progressive pulmonary fibrosis in May last year.

This time, the company is reported to have additionally submitted real-world data (RWD) on patients who failed first-line treatment with Pirespa (pirfenidone), including those who discontinued therapy due to adverse events.

Ofev was approved in Korea in October 2016, but reimbursement discussions have been delayed due to disagreements between the government and the manufacturer over pricing. The drug’s patent has since expired domestically, and multiple generic versions have entered the market.

Nevertheless, a significant unmet medical need has persisted even after Ofev’s initial reimbursement listing. At the time, the government deemed reimbursement inadequate for the IPF indication, citing insufficient cost-effectiveness data.

As a result, attention is now turning to whether IPF patients could use Ofev with reimbursement within the year.

Meanwhile, idiopathic pulmonary fibrosis is the leading cause of death among rare diseases in Korea. It is a rare, intractable condition where the interstitial tissue between the alveoli becomes fibrotic and progressively hardens without an identifiable cause. As the lung structure responsible for oxygen exchange is destroyed, chronic cough and shortness of breath occur, ultimately progressing to respiratory failure.

Disease progression is also rapid. While normal adults experience an annual decline in lung function of approximately 10–20 cc, patients with IPF lose 150–250 cc per year, corresponding to roughly 10% of lung function annually.

Acute exacerbations, which occur in about 10% of patients each year, are particularly fatal. When this state occurs, causing the lungs to rapidly deteriorate within weeks, approximately half of the patients die. The risk of developing lung cancer is 5 to 7 times higher than in the general population, and serious comorbidities such as cardiovascular disease, stroke, and depression are also common.