Ofev will be reimbursed next month

Ildong·Yungjin's pirfenidone will join the competition

Ofev will be reimbursed for chronic interstitial lung disease (ILD)

Ofev's indication is different from its competitor pirfenidone

Creates opportunities for Ildong·Yungjin to strengthen their ILD lineups

Product photo of Ofev

Ofev Soft Cap (nintedanib esylate, Boehringer Ingelheim Korea) , which was approved in South Korea in 2016, will be listed for reimbursement next month, creating an opportunity for follow-on drugs.

 

It took a long time to secure reimbursement, and with its compound patent already expired, generic manufacturers have obtained marketing authorization and are now awaiting reimbursement.

 

Generic manufacturers plan to apply for reimbursement immediately upon Ofev’s listing to receive the same reimbursement price and commence market sales soon.

 

Some generic companies are even securing distribution channels by launching non-reimbursed versions before the reimbursement takes effect.

 

According to industry sources on the 28th, Ofev soft cap will be reimbursed from next month at KRW 26,220 for the 150 mg and KRW 20,960 for 100 mg.

 

After Ofev was approved in South Korea in October 2016, the drug applied for reimbursement in October 2020 but was deemed non-reimbursable, and the company re-applied for reimbursement in March of last year.

 

Ofev has secured three indications.

 

At the time of its domestic approval in October 2016, it was indicated for idiopathic pulmonary fibrosis (IPF), in February 2020, for systemic sclerosis-associated ILD, and in June 2020, for chronic fibrosing ILD with a progressive phenotype (PPF).

 

The current reimbursement criteria cover only ILD with a PPF.

 

The Health Insurance Review & Assessment Service (HIRA) determined that reimbursement for IPF was not appropriate, as the company did not submit separate cost-effectiveness evidence.

 

In the case of IPF, Ildong Pharmaceutical's Pirespa Tab (pirfenidone) established a dominant position when they were reimbursed under a risk-sharing agreement (RSA) starting in October 2015.

 

Subsequently, generic pirfenidone formulations entered the market, and Pirespa Tab's RSA ended in October 2017.

 

Currently, pirfenidone formulations from Ildong Pharmaceutical, Yungjin Pharmaceutical, Kolon Pharma, and Korea United Pharm are listed for reimbursement.

 

When Pirespa entered the RSA, it was difficult for follow-on products in the same indication to be included in the scheme, making reimbursement listing for Ofev challenging.

 

After securing Ofev's three indications in 2020, the company was reportedly focused on obtaining reimbursement for PPF, a segment with no market competition.

 

The Drug Reimbursement Evaluation Committee (DREC) recognized clinical utility, citing the significant improvement in the annual decline rate of forced vital capacity (FVC) compared with placebo and judging that the cost-effectiveness ratio fell within an acceptable range, deeming reimbursement appropriate.

 

Reimbursement also includes patients with systemic sclerosis-associated interstitial lung disease who exhibited delayed lung function decline.

 

It is estimated that approximately 329 patients will be eligible for Ofev reimbursement in Korea.

 

With reimbursement, annual out-of-pocket drug costs are expected to amount to KRW 5.74 million, significantly reducing the financial burden.

 

Under non-reimbursed status, costs amounted to approximately KRW 19.14 million.

 

However, the imminent entry of generic versions poses a threat to Ofev.

 

Ofev's compound patent expired on January 25 of this year.

 

As a result, generic manufacturers have either already launched their products or are preparing to do so following approval.

 

The currently approved generics are Daewoong Pharmaceutical's Opevia Tab, Yungjin Pharm's Nintebro Tab, and Ildong's Cuinnta Tab.

 

With Ofev being listed as an innovator drug, these generics are now more likely to receive reimbursement within three months of their listing applications.

 

If they apply for reimbursement in May, they could be covered as early as August.

 

The fact that the compound patent has expired and that nintedanib is designated as an orphan drug allows it to receive the same top reimbursement price as the original, creating opportunities for the generics.

 

In particular, companies that have already established a foothold in the pulmonary fibrosis market with pirfenidone formulations can expect synergies by maintaining their existing customer base while expanding their product line.

 

Pirfenidone and nintedanib have different reimbursed indications.

 

Last year, pirfenidone formulations posted sales of KRW 34 billion for Ildong's Pirespa (according to UBIST) and KRW 4.9 billion for Yungjin's Fybro.

 

Yungjin began marketing immediately after the patent expired, while Ildong recently started non-reimbursed marketing.

 

Ildong held a symposium on the launch of Cuinnta Tab on the 26th–27th at the Gravity Chosun Seoul Pangyo Hotel, attended by approximately 80 respiratory medicine specialists from across the country.