Pulmonary fibrosis drug 'Ofev' under consideration for reimb

The DREC on January 9 gave a drug appropriateness decision for the second and third indications, while excluding the first indication

Drugs from Yungjin Pharm and Daewoong have been approved as formulation change drugs…following reimbursement approval of Ofev, generic companies are projected to aim for estimated course

As 'Ofev Soft cap (nintedanib),' a treatment for pulmonary fibrosis, has been approved for reimbursement appropriateness, latecomer drugs are projected to enter the market quickly.

 

Following the expiration of Ofev's usage patent, latecomer companies are anticipated to prepare for launching their drugs.

 

According to industry sources on January 16, Daewoong's "Ofevvia tab 150 mg,' containing the same active ingredient as Ofev Soft Cap, was approved by the Ministry of Food and Drug Safety (MFDS).

 

Last month, Yungjin Pharm's 'Nintebro Tab 150mg,' containing the same active ingredient, was approved.

 

These companies aim to join the market early by changing the capsule formation of the original drug to tablets.

 

They have successfully avoided the usage patent not registered as a patent in the MFDS.

 

Therefore, latecomer drugs are projected to launch following the patent expiration of the substance patent, which is set to expire on January 25.

 

However, latecomer companies are concerned that 'Ofev' has not been introduced the reimbursement list after it was approved in South Korea in October 2016.

 

If Ofeb becomes introduced to the list, latecomer drugs that are considered products of development can be introduced to the list in three months after applying for reimbursement through the estimated course.

 

Fortunately, Ofev received the green light from the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA).

 

Both the original company and the generic company desire this outcome.

 

The DREC committee determined Ofev's reimbursement appropriateness for the following indications: ▲ Systemic sclerosis-associated interstitial lung disease (SSc-ILD) ▲Treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype.

 

When the pharmaceutical company accepts the result, Ofev will be considered for the reimbursement list after undergoing drug price negotiations with the National Health Insurance Service (NHIS).

 

Yet, the DREC excluded Ofev's first indication, idiopathic pulmonary fibrosis (IPF), for the reimbursement appropriates decision.

 

IPF is a condition characterized by persistent and irreversible deterioration of lung function, leading to progressive scarring of the lungs and symptoms such as shortness of breath.

 

As the disease progresses, lung function gradually and irreversibly declines.

 

18-32% of patients with IPF are known to progress to 'advanced pulmonary fibrosis,' where the lungs become stiffened, and fibrosis continues.

 

The industry draws attention to whether Ofev's Boehringer Ingelheim will accept the reimbursement appropriateness decision for the rest of the indications, excluding the first indication for IPF.

 

Even if Ofev gets introduced to the reimbursement list without the first indication, it will not pose a problem for latecomer companies.

 

This is because the drug's use for IPF is patented, and IPF usage is not included in the currently approved efficacy and effectiveness.

 

The efficacy and effectiveness of drugs from Yungjin Pharm and Daewoong are ▲Delay of pulmonary function decline in patients with SSc-ILD ▲Treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype, excluding IPF.

 

Analysis suggests that these companies could have avoided the usage patent if IPF is excluded from the efficacy·effectiveness section.

 

Consequently, latecomer companies will likely determine the date to apply for reimbursement following Boehringer Ingelheim's next step.

 

If Boehringer Ingelheim undergoes a negotiation process, companies are projected to aim for reimbursement listing as estimated drugs once the origunal drug is introduced to the list.

 

Analysis indicates that companies must apply for reimbursement after negotiations if the original drug's reimbursement listing fails.

 

Despite the non-reimbursement status in the domestic market, Ofev's sales have steadily increased.

 

Based on IQVIA, Ofev generated KRW 1.8 billion in 2020, KRW 3.3 billion in 2021, KRW 5.6 billion in 2022, and KRW 5.7 billion in 2023.

 

Ofev is projected to generate even higher sales when covered by national health insurance reimbursement.