'Photos' to be excluded from files for negotiated drugs

Risk-Sharing Agreement (RSA) drug list to be disclosed

The National Health Insurance Service (NHIS) is gathering industry opinions…product photos→Manufacturing Instruction Record

"There are drugs without manufacturing records after the photo being submitted…reimbursement will be retracted for some products"

The NHIS is pursuing changes to disclose names of RSA drugs and their RSA types…refund rate to be disclose to future applicants

"Some companies submitted product photos and test certificates, but their production records were not found the following year.

 

This must not happen." The National Health Insurance Service (NHIS) made this statement during a recent drug price consultation session with pharmaceutical industry stakeholders, announcing future institutional changes.

 

According to industry sources on November 18, the NHIS is gathering opinions on changes to the documentation required for negotiated drugs and the scope of disclosure for Risk-Sharing Agreement (RSA) drugs, until November 21.

 

The main point of the changes to the negotiated drug documentation is to replace product photos with the Manufacturing Instruction Record.

 

The goal is to prevent instances such as the submission of a semi-finished product test certificate or the forgery of a finished product test certificate when no finished product inventory is actually available for shipment.

 

Consequently, product photos will not be required unless requested.

 

The primary objective is to substitute these with the Manufacturing Instruction Record to secure credibility.

 

The NHIS plans to conduct an internal review in December and apply these changes starting with the main negotiations for negotiated drugs in January next year.

 

The NHIS is also pursuing the disclosure of information regarding RSA drugs.

 

The NHIS is also seeking opinions on the scope of information to be disclosed, including the drug name and type, within the same deadline.

 

Some in the National Assembly have argued that related information must be disclosed to ensure the transparent operation of the RSA system.

 

The NHIS is seeking opinions on two options: Option 1, which discloses only the drug name, and Option 2, which discloses both the drug name and the RSA type.

 

The NHIS is also gathering general opinions on the overall disclosure of RSA drug information.

 

The NHIS plans to disclose drug name and the contractually set refund rate to subsequent reimbursement applicants.

 

An NHIS official previously stated, "We believe it is right to disclose the refund rate information for RSA drugs.

 

We will ensure that this information is provided upon request when a reimbursement application is submitted to HIRA.

 

However, the requesting applicant must sign a non-disclosure agreement."