Diabetes combination benefits

Health authorities recently notified individual pharmaceutical companies of the suspension of financial impact analysis

The original company expressed its willingness to voluntarily lower the registered diabetes drug by 5% and virtually none

SGLT-2 inhibitory diabetes medication (from left to right, Forxiga, Jardiance, Xigduo, Jardiance Duo)

As health authorities officially announced the suspension of financial impact analysis on drugs subject to expanding the scope of use, discussions on expanding the benefit standard for diabetes solvents are likely to be postponed up to three years later.

 

According to the industry, the HIRA recently stopped evaluating financial impact analysis reports submitted by individual pharmaceutical companies based on a request to temporarily suspend economic impact analysis on drugs subject to the expansion of the scope of use of insurance drugs by the Ministry of Health and Welfare.

 

The plan to expand the salary standard has a structure in which the HIRA Drug Standards Department listens to related academic societies and internal opinions and confirms the contents.

 

After that, the Ministry of Drug Safety and Standards reports this to the Ministry of Health and Welfare, and the Ministry of Health and Welfare will review whether to lower the drug price based on additional financial needs to the HIRA drug price calculation government.

 

However, the expansion of the standard for diabetes solvents has been conducted by first requesting opinions from pharmaceutical companies and self-reviewing them over the past year, and notified of the request to temporarily revise the financial impact analysis review in mid-December 2022.

 

The industry is taking this as an exception because a financial impact review is an essential administrative requirement for drugs that expand their salary standards.

 

This is because some pharmaceutical companies' confirmation of the HIRA has been set to proceed with the voluntary cut conducted in November, not the financial impact analysis.

 

The future outlook following the aftermath cannot rule out the possibility that the expansion of the combined benefit standard will go to a zero source base if sufficient financial savings due to voluntary cuts are not reflected.

 

In addition, there seems to be room to review the combined benefits once again from 2025 when SGLT-2 and DPP-4 diabetes treatment generic enter in earnest.

 

Considering that the additional finances required for this combined benefit are a banding width of 30 to 50 billion won, the most efficient way to realize this without any separate financial requirements may be to voluntarily cut 5% of the existing drug costs, mainly from the original company.

 

It is not easy to enforce such a method in the face of the patent of the original diabetes treatment, and it is believed that few foreign subsidiaries have submitted such doctors to the Ministry of Health and Welfare so far.

 

Therefore, it is analyzed that the health authorities are more likely to use the compensated amount by waiting for the expiration of the original drug patent within one to three years rather than spending additional finances to expand the combined benefits of diabetes drugs.

 

If the original drug price is reduced by 30% due to ex officio adjustment, the budget will be reduced by about 30 billion to 50 billion, which is interpreted as an intention to turn it into a share of combined benefits.

 

The expansion of salary standards for the combination of diabetes treatment SGLT-2 inhibitor drugs and DPP-4 inhibitor drugs was expected to be applied by the end of this year as it was discussed in 2022 after the diabetes association requested it to the health authorities in 2016.

 

Since then, the HIRA has conducted a financial impact analysis in June by reviewing the pay standards for three-drug therapy such as metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, and SGLT-2+sulfonylurea or insulin combination therapy.