Daewoong’s P-CAB Fexuclue completes first PVA

Completes first price-volume agreement negotiations with NHIS since receiving reimbursement

Attention to whether the same reimbursement system will be applied as its competitor, K-CAB... Last year's prescriptions amounted to KRW 78.8 billion.

Daewoong Pharmaceutical's new drug for gastroesophageal reflux disease, ‘Fexuclue,' has agreed to complete negotiations through the price-volume agreement system with the National Health Insurance Service for the first time since its reimbursement listing.

 

Before negotiations, Daewoong Pharmaceutical was known to have wanted to apply the reimbursement system rather than a price cut, so the outcome of the negotiations is drawing attention.

 

According to industry sources on the 16th, Daewoong Pharmaceutical's ‘Fexuclue Tab 10, 40mg’ and Daewoong Bio's ‘We Cab Tab 10, 40 mg.’ which contain identical ingredients, have completed price-volume agreement negotiations.

 

The PVA system allows the NHIS and pharmaceutical companies to negotiate and reduce the maximum insurance price of drugs with increased usage by up to 12.5% this year.

 

The aim is to save Korea’s national health insurance finances.

 

The type of negotiation applied to Fexuclue this time is Type A, which is carried out when the amount of claims in the same product group with the expected claims amount agreed with the NHIS increases by 30% of the expected claims amount.

 

Fexuclue, which was listed for reimbursement in July 2022, recorded a prescription volume of KRW 12.9 billion in the first year of its release based on UBIST and then grew exponentially to record a prescription volume of KRW 78.8 billion last year (2024).

 

In particular, the analysis shows that the product’s growth accelerated after signing a copromotion agreement with Chong Kun Dang in April last year In response, the NHIS selected Fexuclue as a drug subject to PVA monitoring in the fourth quarter of last year, and negotiations began in early December of that year upon the Ministry of Health and Welfare’s order.

 

Before negotiations, it was reported that Daewoong Pharmaceutical wanted to apply the  refund-type agreement like its competitor ‘K-CAB (HK Inno.N).’ The refund-type agreement is a system that maintains the maximum insurance price of a drug while returning the difference to the National Health Insurance Service.

 

When exporting the drug overseas, this can be advantageous as the drug’s listed price is higher than the actual price.

 

Currently, K-CAB is the only product that has signed a refund-type PVA system.

 

In 2015, Boryung’s hypertension drug Kanarb entered into a refund-type agreement, but in 2018, it chose to lower the maximum insurance price instead of extending the contract.

 

On the other hand, K-CAB entered into a refund-type agreement in 2021 and extended the agreement at the end of last year.

 

As a result, its ceiling price of KRW 1,300 per tablet was maintained when it was first listed in 2019.

 

Fexuclue is listed at KRW 939, which is 70% of the price of K-CAB.

 

If the ceiling price is lowered through the PVA, the gap between K-CAB and Fexuclue will widen further.

 

However, the relatively low price of the drug may be advantageous in sales competition between products, so it is interesting to see what kind of agreement Daewoong and the NHIS have reached.

 

P-CAB (potassium-competitive acid blocker) class drugs like Fexuclue are characterized by a longer duration of efficacy due to their longer half-life than PPIs, making them effective for controlling nighttime acid secretion.

 

It is easy to take because it only needs to be taken once a day, regardless of meal intake, and its market size has been rapidly increasing.

 

Currently, in addition to K-CAB and Fexuclue, ‘Ja Q Bo (Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical),’ a new domestic drug with the same mechanism of action (P-CAB), has also been listed for reimbursement, making it a three-way competition.