Billions of won in losses if applied retroactively

The prospect of difficulty in negotiating the drug PVA

Controversy over retroactive application of the revised guidelines in April

At worst, legal action is possible

The pharmaceutical industry is complaining about the retroactive application of detailed operation guidelines revised in April at this year's PVA.

 

Although it has already officially proposed excluding retroactive application to the NHIS twice, the NHIS' position is firm.

 

Analysts say that such an issue will be a hurdle to settle the negotiations at a time when the NHIS entered negotiations with the aim of adjusting drug prices in September.

 

In particular, there are pharmaceutical companies that are expected to suffer billions of won in losses from retroactive use, which is expected to take legal action in the worst case scenario.

 

According to the industry on the 20th, the industry officially proposed excluding the retroactive application of detailed operation guidelines in May and June, but the NHIS does not accept it and is negotiating.

 

In the detailed operation guidelines revised in April, the key is to limit PVA exclusion to cases where the main component code is less than 90% of the arithmetic average.

 

Previously, cases where the arithmetic mean was less than that were excluded.

 

As a result, although the arithmetic average price is less than 90%, there are items that have been newly negotiated.

 

For example, in the case of Choline alfoscerate which was mentioned in the revision of the guidelines, Gliatamin soft cap, the No.

 

1 item in sales, is subject to negotiation in accordance with the revised guidelines.

 

The price of the Gliatamin soft cap is 504 won, and the arithmetic average of the main component code is less than 512 won, but the arithmetic average exceeds the 90% (460 won) standard and is included in the target.

 

As of last year's UBIST, Gliatamin's outpatient prescription amount was 110.1 billion won.

 

PVA is supposed to adjust the upper limit from less than 10%, and if the upper limit of Gliatamine falls by only 5%, the company will lose more than 5 billion won.

 

As such losses are formidable, the pharmaceutical industry as a whole is raising its opinion that the revised guidelines should not be applied retroactively in the negotiations.

 

Usually, compared to the previous year's and the previous year's claims, it is an item subject to negotiation if it increases by more than 60% from the previous year's claims, or if it increases by more than 10% and more than 5 billion won.

 

The industry points out that it is impossible to proceed with negotiations based on the previous year's claims as the guidelines have been revised this year.

 

However, the NHIS explained that there is no issue of equity as it has continuously mentioned the guidelines, strengthened the scope of exclusion from negotiations, and applied relaxed standards.

 

The NHIS plans to negotiate with the aim of adjusting the upper limit in September.

 

An official from the NHIS said, "The opinion has been submitted twice, but we plan to proceed with the negotiations as planned." An official from the pharmaceutical industry said, "We mentioned the revised guidelines since last year, but the pharmaceutical industry continued to maintain its opposition until the revision." "If it is applied as a small amount, we plan to watch the results of the negotiations and respond as the damage is great," he said.

 

It is known that both sides are currently reviewing legal principles.

 

If negotiations break down, renegotiation is possible, but if differences are not narrowed in renegotiation, the drug will be excluded from the benefit.

 

In this case, it is highly likely that the pharmaceutical company will solve the problem through lawsuits.