The alternative drug pricing system will be improved

Promotion of the highest price for alternative drugs

Positive review of first-in-class refund system and dual pricing system

Up to 110% of the highest price for herbal medicines and alternative medicines with improved clinical usefulness is added

It is expected that the specific direction of the public-private consultative body for rational drug price calculation of domestically developed innovative new drugs will be set, and system improvements will be promoted from May at the earliest.

 

According to the industry, the public-private consultative body for improving the drug pricing system, composed of officials from the Ministry of Health and Welfare, KPBMA, and KRPIA, has held five rounds of discussions since last December and is expected to give positive incentives to new drugs.

 

The drug price system improvement classification plan that the health authorities and the industry have formed a consensus on ▲innovative value for new drugs, ▲recognition of appropriate value for natural medicines (formerly new natural medicines), ▲derived system improvement for raw material self-sufficiency, and ▲stabilization of pharmaceutical supply maintenance of the period of accrual of the amount, etc.

 

This proposal is a point of convergence in the larger framework, and the specific calculation method needs to be narrowed down through a general meeting of the public-private consultative body around the middle of this month.

 

The most noteworthy part is the method of assigning value to new drugs and IMDs, and it is expected to be able to receive up to 10% higher drug prices than existing ones.

 

If the alternative drug was reduced to 53.55% due to patent expiration, an additional 86.8% (100% 53.55%) is requested.

 

IMD is expected to be recognized for up to 110% of development target products, including drugs for which the Ministry of Food and Drug Safety has approved data submission, as well as new usage and dosage.

 

It is also eye-catching to prepare measures to strengthen its status as the originator of oriental medicine and to promote herbal medicine and herbal preparations.

 

In the case of herbal medicines with improved clinical usefulness, it is likely to apply an additional 110% of the highest price of alternative medicines.

 

For drugs using domestically produced drug substances, the additional period will be extended from 1 year to 5 years, and an exception to the follow-up management system will be applied.

 

It is expected that the system will be improved so that if the number of companies for administration routes and products of the same dosage form is two or less, the addition of already-listed products will be maintained until there are three or more.