Reassessing the plan for comparing foreign drug prices

Gastrointestinal agents, high blood pressure drugs, and antibiotics will be assessed in the first year

Therapeutic category with the highest number of products will be assessed once every three years

The updated plan until the tenth meeting has been shared, and the government is still gathering opinions

Drugs with the same ingredient products produced by fewer than 3 companies will be excluded

The government will likely reassess foreign drug price comparison by evaluating the therapeutic category with the highest number of products.

 

Consequently, gastrointestinal agents, high blood pressure drugs, and antibiotics will be assessed in the first year.

 

There are over 2000 products in these three therapeutic categories.

 

Furthermore, drugs with the same ingredient products produced by fewer than three companies will likely to be excluded from the assessment.

 

According to industry sources on July 10th, the government is gathering opinions from pharmaceutical companies about the current reassessment plan, which has been shared through ten meetings with the pharmaceutical industry (as of July 5th).

 

The current reassessment plan is not the final one.

 

The issue is still ongoing because it does not include the referencing sources of Germany and Canada.

 

In the first year, according to the reassessment plan, therapeutic categories with the highest number of products, including gastrointestinal agents (2043 products), high blood pressure drugs (2268 products), and antibiotics (2156 products), will be assessed.

 

In the second year, hyperlipidemia drugs, respiratory system medications, central nervous system medications, diabetes drugs, and musculoskeletal disorder medications will be assessed.

 

In the third year, ophthalmology drugs, otolaryngology drugs, dentistry drugs, painkillers, urological and reproductive system medications, anticoagulants, dermatological treatments, anticancer agents, and 17 other therapeutic categories will be assessed.

 

The current plan to reassess foreign drug price comparison (as of July 5th).

 

(Therapeutic category with the highest number of products) In the first year, gastrointestinal agents (2043 products), high blood pressure drugs (2268 products), and antibiotics (2156 products), will be assessed.

 

In the second year, hyperlipidemia drugs, respiratory system medications, central nervous system medications, diabetes drugs, and musculoskeletal disorder medications will be assessed.

 

In the third year, ophthalmology drugs, otolaryngology drugs, dentistry drugs, painkillers, urological and reproductive system medications, anticoagulants, dermatological treatments, anticancer agents, and 17 other therapeutic categories will be assessed.

However, exclusion will be applied to ▲low-priced drugs, orphan drugs, drugs that have been listed as shortage prevention drugs (SPD) ▲Oxygen, nitrogen dioxide, saline solutions, artificial perfusion agents, and radioactive drugs ▲Narcotics ▲Drugs with the same administration, ingredients, and formulation produced by fewer than three companies ▲Products undergone price increases (after January 2020).

 

During the discussion, drugs with the same administration, ingredients, and formulation produced by fewer than three companies were added to the list.

 

A reference price for adjustment is the average price of drugs found in A8 countries.

 

Adjusted mean price will exclude the highest and the lowest prices.

 

Products with a higher drug price than the calculated reference amount will be subjected to a reduction.

 

In cases where fewer than 2 out of 8 countries can be found, the average reduction rate of the most similar product is applied, considering factors such as content, ingredients, formulations, and administration methods.

 

Products with generic prices higher than the standard amount calculated using the highest price within the same product will be reduced.

 

When calculating the average reduction rate, if a negative reduction rate occurs due to lower prices compared to foreign countries, it will be reflected as such in the calculation.

 

For combination therapies, if the assessed amount is lower than the sum of the assessed amounts for monotherapy or combination therapy, the reduction will be limited to the sum of the amounts assessed.

 

The prices of pharmaceuticals that have submitted the required documents will be reduced to the amount assessed for their intended development products.

 

Furthermore, it has been revealed that the current plan included the addition of criteria stating that the calculation of price adjustments referencing foreign drug prices should be based on public prices reimbursed or reimbursed equivalently in the respective country.

 

The pharmaceutical industry's significant opposition to the public reimbursement requirements during the tenth meeting may prompt revisions in the final plan.