Revised generic reimbursement regulation to get delayed

NHIS forms Generic Negotiation Management Task Force to set take process

Orphan drug and shortage prevention drug included as subject for the negotiation

Apparently, the postponed action plan on the revised reimbursed generic pricing management, covering all procedures of the listing, would also likely to affect drug pricing negotiation schedule.

 

As the Korea’s Ministry of Health and Welfare (MOHW) is preoccupied with response against COVID-19 outbreak and the main division director’s position still open, the preannouncement of revising ‘Regulation on National Health Insurance Reimbursement Standard’ is getting delayed.

 

The National Health Insurance Service (NHIS), in charge of drug pricing negotiation, has been processing the legislative preannouncement with the government to apply the pricing negotiation terms, previously used on new drug and price-volume linkage system, on generic products as well.

 

A draft of the preannouncement briefly posted on the Ministry of Government Legislation website in February stipulated generic exempted from pricing negotiation for reimbursement listing would be subjected to pricing negotiation track.

 

A pharmaceutical company with generic product has to undertake pre-agreement terms with NHIS on negotiation and agreement compliance when applying for reimbursement to Health Insurance Review and Assessment Service (HIRA).

 

When HIRA completes drug pricing calculation, the applicant company has to negotiate pricing with NHIS for 60 days before the Health Insurance Policy Deliberation Committee (HIPDC) deliberation.

 

The initial plan was to pre-announce the revised regulation and to accept public opinion from February to April, and to start the pricing negation from June.

 

As the negotiation takes at least about 60 days, NHIS had to create a legal foundation before the revised generic pricing system was enforced.

 

However, NHIS’ plan to initiate the generic pricing negotiation by the end of June would be postponed as the legislative preannouncement has not been issued, yet.

 

The NHIS’ key roadmap of the year originally aimed to finish off designing generic negotiation agreement and compliance management task process until coming May with the Generic Negotiation Management Task Force formed under NHIS Health Benefit Strategy Office in January, and also to start drug pricing negotiation and negotiation agreement compliance monitoring in June and July, respectively.