The original patent's negotiation period will be reduced

to one third

The MOHW reports to the Health Policy Deliberation Committee

Detailed procedures regulations after the spread of the negotiation system

The period of ex officio adjustment drug price negotiations for the original drug that expires patents collectively cut drug prices will be reduced to one-third.

 

It is aimed at improving cases of health insurance financial leaks by abusing the prescribed negotiation period as much as possible when the legal drug price cut rate is set.

 

The MOHW announced that it held a Health Insurance Policy Deliberation Committee this afternoon (25th) and reported on the "improvement of the drug negotiation system." The government is currently negotiating all reimbursed drugs.

 

This is in accordance with the policy to expand the negotiated drugs from the application of new drug insurance to the entire drug from October 2020 to strengthen the quality control and stable supply management of insurance drugs after detecting Valsartan impurities in 2018.

 

For example, in the past, negotiations between the government and companies were conducted to register new drugs, adjust drug prices, and expand the scope of use.

 

However, since the reorganization, negotiations have been underway to adjust the original drug price (100 → 70%) and re-evaluate according to the first generic insurance application.

 

Although the negotiation system has been expanded in this way, the problem of confusion in the operation of the system has been exposed due to insufficient detailed procedural regulations.

 

In the case of supply and quality management contracts, unnecessary overlapping negotiations were held, such as drug price adjustments, and some pharmaceutical companies delayed the negotiation deadline of 60 days to delay the timing of drug prices falling.

 

Some also pointed out that there are no renegotiation and procedural regulations when negotiations break down.

 

It was pointed out that the drug negotiation procedure under the narrow law was unclear about the regulations on follow-up measures, such as exclusion of benefits, in the event of a final breakdown.

 

The improvement plan largely sets ▲ the target to be omitted when negotiating drugs, ▲ to adjust part of the negotiation period of , ▲ to prepare renegotiation procedures in the event of a breakdown of negotiations, and ▲ to clarify that benefits are excluded in the event of a final breakdown of.

 

Specifically, the negotiations will be omitted if there is a contract between the corporation and pharmaceutical companies.

 

In the case of ex officio adjustment negotiations due to the application of a package reduction in drug prices, it will be shortened from the current maximum of 60 days to 20 days.

 

This is a measure designed to reasonably shorten the negotiation period in the case of original ex officio adjustment.

 

When negotiations broke down, renegotiation procedures were also in place.

 

In order to prevent confusion in the clinical field, the government asked to renegotiate the drug characteristics and the progress of negotiations after deliberation by the Drug Benefit Evaluation Committee.

 

In addition, in the case of drugs whose final negotiations have broken down, grounds have been established to exclude benefits.

 

The government has decided to push for the standard rules for medical care benefits and the individuality of notification sometime next month.

 

Considering administrative procedures such as legislative notices, the implementation of the amendment is expected to be possible in the first half of next year.