30-day negotiation window for essential medicines

Expanded RSA types for high-price medicines

NHIS has started collecting public opinions on revisions…aim to promote the new drug's innovative value

The National Health Insurance Service (NHIS) has started revising guidelines related to the government's initiative to improve the drug pricing system to 'reflect on the new drug innovative value.' First, the NHIS announced to introduce Risk Sharing Agreement (RSA) types and has reduced the time required to negotiate pricing adjustments for national essential medicines.

 

The NHIS has recently drafted a revision to the guidelines for drug price negotiations and detailed matters for RSA drug price negotiations, collecting public opinions.

 

The deadline for submitting opinions is December 4.

 

Regarding revision to the guidelines for drug price negotiations, the NHIS established a basis for shortening the time required for drug price negotiation and pre-negotiating the national essential medicines.

 

In detail, the NHIS decided that the negotiating period for drugs evaluated at the Drug Reimbursement Evaluation Committee (DREC) to require assistance from the central administrative agency for drug supply issues, such as crisis for infectious diseases or emergency drug shortages, will be 60 days instead of 30 days.

 

Also, pre-negotiation is possible, and the pre-negotiation application will be the same as a submitted document to the Health Insurance Review and Assessment Service (HIRA).

 

For detailed matters for RSA drug price negotiations, the NHIS announced introducing an early-stage treatment cost refund type and an achievement-based refund type.

 

The early-stage treatment cost refund type is for applicants seeking refunds from NHIS for a portion of the initial administration cost.

 

Also, the achievement-based refund type is for applicants requesting refunds of a portion of the total claim amount of the drug from NHIS when an individual does not meet the predetermined treatment effects after a follow-up·monitoring for a specified time.

 

Recently, these two types have been applied to high-priced drugs.

 

With the newly added types, contract additions·changes will be permitted during negotiations, and post-management procedures will be officially incorporated.

 

Additionally, the current revision will simplify the procedure required at RSA termination.

 

Previously, the NHIS requested an evaluation of the RSA-approved drug's clinical usefulness and cost-effectiveness before the contract termination.

 

The current revision will skip the drug procedure under the third contract for RSA.

 

Also, the NHIS will request confirmation from the HIRA director related to changes to RSA drugs, including substitute drugs or reimbursement criteria.

 

"The revision has been established to bring improvements to the drug pricing system to reflect on new drug innovative value and to ensure healthcare security," the NHIS explained regarding the current revision.

 

"To promote innovative new drug value and incentivize innovative growth, the NHIS aims to support sustainable, innovative systems for the pharmaceutical and biotech industry.

 

This includes ensuring stable drug supplies by setting reasonable drug prices for essential pharmaceuticals required by patient treatments and establishing a foundation for essential healthcare." The current revision is a follow-up to the 'Specific evaluation criteria of new drugs and medicines in consideration for negotiation,' which was established by the HIRA in August, and the 'Pharmaceutical Approval and Adjustment Criteria,' which was announced in October.

 

The government plans to promote new drugs' innovative value and to improve the drug pricing system to ensure healthcare safety by favoring the national essential medicine.

 

The government will expand the number of pharmaceuticals for RSA and provide benefits for the drug pricing of the national essential medicines that use domestic raw materials.

 

An NHIS employee explained, "We plan to implement the revised draft by hearing public opinions alongside the announced draft by the Ministry of Health and Welfare (MOHW).