Drug pricing adjustment guidelines to be established soon

Due to the rise in drugs being applied price hikes

NHIS completes final expert advisory meeting… will release results within the year

With the rise of drugs that show unstable supply and the consequent rise in drugs requesting pricing adjustments, the National Health Insurance Service plans to establish a guideline for smooth pricing adjustment negotiations and disclose it soon.

 

The NHIS recently completed expert consultations and is currently revising the final draft.

 

According to industry sources on the 13th, the NHIS had started establishing a guideline for the pricing adjustment negotiations to simplify materials requiring submissions and ensure accurate cost analysis.

 

Also, the authorities had collected opinions from the industry after establishing a consultative body with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association.

 

Since October, the body has started to consult with experts to establish a guideline.

 

Currently, the NHIS completed expert consultations, and final preparations to release the final draft are said to be in progress.

 

An NHIS official explained, “We plan to release the pricing adjustment negotiation guidelines before the end of the year.

 

Final work is currently in progress.” Due to the rise in the number of drugs with unstable supply and demand requesting pricing adjustments, the need for a clear pricing adjustment negotiation guideline has been increasing.

 

Moreover, the drug subject to negotiations has also increased with the NHIS’s expansion of drugs subject to adjustment applications in 2021.

 

Previously, only drugs that did not have alternative drugs or were necessary for medical treatment were able to apply for pricing adjustments, but from 2021, drugs with an administration cost lower than their alternatives and are necessary for medical treatment and drugs that only one other company owns a drug with the same administration route and ingredient can also apply for pricing adjustments.

 

Recently, resolving the supply and demand instability has emerged as a government task, and drugs subject to pricing adjustment are being interpreted broadly.

 

Starting with acetaminophen at the end of last year, prices of magnesium hydroxide and pseudoephedrine were also increased through pricing adjustment negotiations, and the application for the pricing adjustment of budesonide passed the Drug Reimbursement Review Committee, and will soon begin full-scale negotiations.

 

The adjustment negotiations aim to facilitate a stable supply of drugs by conserving drug costs.

 

However, there was much criticism around the large amount of data submissions required, as most of the data required aligns with those required for the Drug Shortage Prevention Program.

 

In addition, there was an opinion that an accurate cost analysis is needed by setting a fixed ratio for the general management cost and profit.

 

NHIS plans to comprehensively collect these opinions and reflect them in the guidelines.

 

Once the guidelines are created, it is expected to simplify the required data submissions, clarify cost analysis, and facilitate smoother drug pricing negotiations.

 

However, drugs with an unstable supply and demand that are currently undergoing drug negotiations undergo rapid negotiations within a month through prior consultation between the public and private sectors under the condition of increasing their supply, so attention is being paid to whether these will also be able to reach an agreement within the set guidelines.