How will be negotiated generic drug prices?

The NHIS, pharmaceutical industry meeting scheduled for 31st will be replaced in writing

Pharmaceutical associations, possible to communicate opinions on drug prices such as small and medium-sized pharmaceutical companies

The details of the amendments to various systems that change the framework for drug coverage have been unveiled at once.

 

The MOHW and the HIRA announced on the 23rd, 'Partial Amendments to the Rules for Pharmaceutical Reimbursement Listing Standard and Methods (Draft)', 'Criteria for Decision or Adjustment on Drugs', 'Partially revised detailed evaluation criteria for drugs to be negotiated, such as new drugs', and plan to conduct an opinion inquiry for 80 days until June 11th.

 

Some of the amendments to the legislative and administrative notices and advance notices are follow-up measures to supplement the drug price policy this year, which the government reported to the subcommittee on the Health Insurance Policy Deliberative Committee in December last year.

 

In particular, the rules regarding the standard of medical care allowances are that generic drugs that are registered through the drug price calculation method instead of drug price negotiations have also been required to undergo drug price negotiations for 60 days.

 

As of yet, the status of the 'Determination and Adjustment of Pharmaceuticals' and 'Detailed Operation Guidelines' have not yet been issued from the NHIS.

 

The amendments to the rules that have been published so far ▲ complement the principles of the decision on medical care benefits, the detailed principles of the decision on the medical care benefits, and the introduction of a priority system between drugs (draft 1, Article 2) ▲ Introduce regulations to reject the application for a decision in case of attempting to register by avoiding drug price cuts (Article 10-2)▲ Unification procedure of drug registration decision (Article 11-2) ▲ When adjustment is necessary due to changes in permits, it is admitted that adjustment is necessary in consideration of other foreign drug permits, insurance listing status, and clinical evidence (Article 13).

 

In the case of the NHIS, it is underway to put some flesh on the bones of this system, and the establishment of a standard contract for concrete generic drug price negotiations and the establishment of a statistical and computational management system for negotiations.

 

Initially, the NHIS planned to release such information and gather opinions related to the drug price policy through regular meetings of the pharmaceutical industry scheduled for the coming 31st, but decided to replace the face-to-face meetings in writing due to the spread of COVID-19.

 

The NHIS first consulted with pharmaceutical companies such as the KPBMA, the KRPIA, and the KOBIA for opinions on the proposed rule amendment by the Ministry of Health and Welfare and plan to receive opinions on general drug negotiations from domestic pharmaceutical companies such as small and medium-sized pharmaceutical companies.