Amendment to cascading drug price revision revealed

The MOHW, announced ‘a partial revision of the Criteria for Decision or Adjustment on Drugs’

Calculation standards come into effect in the second half, target object and standard reform are from next year

A cut off point system of the same formulations, as previously announced

Finally came the result.

 

The reinstatement of the cascading drug price system was revised and revised to change the generic insurance price according to whether or not it had its own bioequivalence test.

 

As is known, there is a difference in the price of IMDs and generics.

 

Revisions were included to keep the addition in recognition of the effort and innovation.

 

However, in the case of listed drugs, the application sentence linking permit and drug prices after three years of preparation period is missing from the readministrative notice.

 

This was confirmed that there would be no change as a result of the planned re-evaluation process (3 years) to be carried out through a re-evaluation procedure separately announced according to the 'Criteria for Decision or Adjustment on Drugs'.

 

The Ministry of Health and Welfare announced ‘a partial revision of the Criteria for Decision or Adjustment on Drugs’ today (Jan 28) morning and looked up opinion in the industry.

 

When the first notice amendment was issued on July 2 last year, the government decided to revise the notice in early September and enter into full-scale implementation this year.

 

However, due to the high impact of drug price reform, some additions were inevitable due to continued protests and protests.

 

◆Standard to estimate the drug price (including eye drops)= Looking at the contents, the first relevant revision notice and the basic framework of July 2 last year are the same.

 

The revised bill for the price standard system, which cuts the generic price by 15% according to its own and co-prosperity into 'stairs' and limits the same number of generics as the so-called 'cut line', was also included in the revised proposal.

 

In detail, a new set of criteria for applying differential prices (submission of biometric data or evidence of clinical trials and the use of registered ingredients) has been established.

 

The cascading reorganization will change the price of the drug depending on the criteria, provided that the same formulations are listed under 19 products.

 

53.55% if all are met, 45.52% if only one is met, and 38.69% if there is no requirement.

 

In the case of 'A cut off point system', when more than 20 products of the same formulations are listed, it is calculated automatically 85% of the lower amount between the lower price of the upper limit of the same system and the amount calculated as 38.69%.

 

Eye drops are also multi-use or single-use eye drops.

 

However, if the applied product is a single-use or multi-use product, the calculation criteria will be pushed forward.

 

Eye drops are also multi-use or single-use eye drops.

 

However, if the applied product is a single-use or multi-use product, the calculation criteria will be pushed forward.

 

If revised, it will take effect on July 1st.

 

◆Reorganization of Addition System= The industry's current focus is on this reform.

 

The reorganization plan includes all the contents of the first draft made last year, including the comprehensive maintenance of synthetic and biologic drugs, and the extension of the period of addition.

 

Looking specifically at the addition of IMDs, the IMD maintains the addition until the IMD or the individual single or complex constituting the product and the same route of administration, ingredient, and formulation are listed.

 

This includes IMD complexes.

 

Just this has a condition.

 

Excludes two or more listed companies that have the same dosage, route, ingredient, and formulation as the individual single compound and compound listed in the combination.

 

Also, products added after the addition period has passed cannot be added.

 

In addition, the addition requirements for both synthetic (chemical) and biologics are the same as those published last year.

 

The addition period and the number of companies that have been set for each standard have been unified and maintained.

 

Specifically, the period for adding synthetic and biopharmaceuticals is one year, and if the number of companies is three or less, the period for adding and maintaining all of them is up to two years.

 

However, if the pharmaceutical company wants to extend the addition period, the government prepared a system to adjust the addition rate and extend the addition period within the two-year limit through the review of the Pharmaceutical Benefits Advisory Committee.

 

The government plans to implement this addition system by January 17, next year after receiving opinions.