Nicergoline for dementia listed at 50% of the highest-priced

Over 20 products were listed for reimbursement in three months since March

37 products are covered by insurance…Highest price at KRW 424 and lowest price at KRW 221

Sermion, the original drug containing the ingredient nicergoline.

Before March this year, there were only two products containing the active ingredient nicergoline available.

 

However, the number quickly increased, resulting in nearly a 50% difference between the highest and lowest prices.

 

The prices of the listed products are getting cheaper with a stepwise pricing system applied.

 

This reflects that more products are being listed for reimbursement listing.

 

According to industry sources on September 1st, Korea Pharma's Pharma Nicergoline Tab 30mg was listed for reimbursement with a ceiling price of KRW 221 per tablet.

 

Because there are already over 20 existing drugs in the same class, it was priced at around 85% of the prices of those, which is the lowest price.

 

The price KRW 221 is nearly 50% of the highest price, KRW 424.

 

Just last year, no one predicted that such many products containing nicergoline would be listed for reimbursement.

 

In February, the products containing nicergoline 30mg were the original Il Dong's Sermion Tab 30 mg and Hanmi Pharm's Nicegoline Tab 30mg.

 

After three pharmaceutical companies released their products in March, 20 products became available by March.

 

The products listed since June have applied a stepwise pricing system, and the price is set at 85% of the lower price between the lowest price for the same medicine and the price calculated at 38.69% of the original drug price.

 

Consequently, Hutecs Korea Pharmaceutical's Sarminon Tab 30mg, initially priced at 38.69% of the original price, was calculated at around 85%, now KRW 260 per tablet.

 

Therefore, Pharma Nicergoline Tab 30mg's price was set at KRW 221, 85% of the lowest priced Sarminon Tab 30mg.

 

The ceiling price will become even lower for products that will be listed and priced at 85% of the lowest price.

 

Since 20 products became available in just under three months, latecomer products will, in turn, experience a price burden.

 

Nearly 37 Nicergoline Tab 30mg are listed for reimbursement until now.

 

The number of products containing the active ingredient nicergoline approvals by year (unit:#, source: the Ministry of Food and Drug Safety (MFDS), excluding products set for import or API).

The products containing nicergoline is used for the first-line treatment of dementia symptoms, including memory impairment, concentration difficulties, judgment issues, and lack of initiative, related to primary degenerative vascular dementia and complex dementia.

 

Korean pharmaceutical companies have jumped into this market this year because previously listed preventative drugs for dementia have failed to show efficacy and are being withdrawn.

 

First, products containing acetyl-L-carnitine and oxiracetam were removed from the market after clinical trial reassessment failed.

 

Clinical trial reassessment for the active ingredient choline alfoscerate is also underway, but the results are not promising.

 

During the reimbursement reassessment review, it was decided that choline alfoscerate cannot be covered by reimbursement when used for mild cognitive disorder, an earlier stage of dementia.

 

However, pharmaceutical companies have filed a lawsuit to seek nullification of reimbursement reduction for choline alfoscerate and received cancellation of the administration order, thus maintaining the reimbursement criteria.

 

However, after losing the appeal court, pharmaceutical companies will likely face sales reductions.

 

The annual prescription sales of choline alfoscerate amount to KRW 622.6 billion (based on UBIST).

 

The market impact is expected to be substantial when reimbursement coverage for the mild cognitive impairment indication is no longer available because such use amounts to 80% of the sales.

 

In countermeasures, pharmaceutical companies quickly released products containing nicergoline.

 

The first product to be launched in South Korea was in 1978.

 

The safety of the drug has been confirmed since it was launched 46 years ago.

 

However, the National Health Insurance Service (NHIS) may attempt to reassess reimbursements.

 

Even if that is the case, pharmaceutical companies can use products containing nicergoline as quick cards to fill the sales gap for drugs that provide cognitive benefits.

 

An employee of a Korean pharmaceutical company said, "Nicergoline is categorized as an alpha-blocker and is effective in increasing blood flow in the brain and peripheral nervous system through vasodilation,' and added, "Because it is commonly used as a preventative measure for senile dementia or cognitive dementia, it is the most suitable drug to replace cognitive enhancers."