From drug approval to follow-up management

The NHIS opens a new drug price management office from January 1st

The NHIS established drug price management from January 1 of this year, and began step-by-step management for stable supply of drugs and drug cost management.

 

Along with the establishment of the Drug Price Management Office, the TF of the Drug Management Department was established, and an improvement plan to apply various research services conducted so far to the field is prepared.

 

The full-cycle management plan for released by the NHIS is divided into steps such as item permission, reimbursement registration, distribution and supply, and follow-up management.

 

First of all, the drug product approval stage is under the responsibility of the MFDS, but the NHIS began negotiations on previously listed drugs in connection with the clinical re-evaluation of the MFDS from last December.

 

According to the order of the MOHW, it is underway for 230 items of 130 drugs subject to clinical reevaluation, except for Choline alfoscerate 122 items extended until April 12, Ateroid by Alvogen Korea, Mesocan 50mg by Chodang, and Aju Vesseldue-F Soft Cap decided to withdraw the item during the negotiation process.

 

As a result of negotiating payback in conjunction with clinical reevaluation for the first time, 47% of clinical reevaluation items are withdrawn or negotiated, and the remaining 53% are negotiating.

 

The NHIS said, "The MFDS will proceed with a contract to recover drug costs for drugs that are not effective through monitoring the results of the review of drug safety and effectiveness." In the reimbursement registration stage, the drug price negotiation rules were revised after the Lipiodol status in 2019, which contained the obligation to supply drugs, and from October last year, a negotiation procedure was introduced for all drugs, and contracts for mandatory provisions such as supply and quality management were signed.

 

The drug price negotiation management system was reorganized to reinforce management such as negotiations following the introduction of the comprehensive evaluation system and to negotiate registered drugs in connection with the reevaluation of the drug price addition by the MOHW.

 

The MOHW plans to link the drug price re-evaluation project, negotiate previously listed drugs, make rational evaluation of high-priced rare disease treatments, and prepare management plans.

 

In order to manage the distribution and supply stages, the Research Service for Improving the Drug Supply and Purchasing System was completed in 2018-2019, and the specific implementation plan will be in charge of the full cycle TF.

 

Follow-up management after drug registration is the last step in the full-cycle management.

 

In particular, ultra-high-priced drugs such as Kymriah, which take more than ₩500 million for a single administration, are challenging to pay.

 

The NHIS is contemplating a new payment plan for ultra-high-priced drugs in preparation for this.

 

The NHIS plans to develop an efficient drug expenditure plan by developing a financial demand prediction model based on the analysis of the drug expenditure structure and analyzing the financial expenditure according to the characteristics of diseases and drugs (patent expiration, etc.).

 

The NHIS Drug Price Management Office, Part 4, 1TF