New criteria set for unstable supply and demand drugs

New criteria set for adjustment evaluation applications of drugs with unstable supply and demand… preliminary management of high-priced anticancer drugs is strengthened

Will also evaluate applications for price increases of national essential drugs that use homegrown ingredients

Head of the drug post-management department will attend the Cancer Disease Deliberation Committee meeting…for preemptive response

The Health Insurance Review and Assessment Service has decided to clarify the criteria for evaluating adjustment applications for drugs with unstable supply and demand and strengthen preliminary management of high-priced anticancer drugs.

 

HIRA announced so on the 9th while issuing a prenotification of the “Partial Amendments to the Evaluation Criteria and Procedures for Whether a Drug is Eligible for Medical Benefits” and the “Partial Amendments to the Operating Regulations of the Severe Disease Deliberation Committee.” The deadline for submitting opinions on the criteria is the 15th.

 

First, in the prenotification of the “Partial Amendments to the Evaluation Criteria and Procedures for Whether a Drug is Eligible for Medical Benefits,” drugs with unstable supply and demand were newly added as evaluation criteria for adjustment applications.

 

“In order to support the stabilization of drug supply in the context of health security, HIRA has established criteria for the evaluation of adjustment applications to be eligible for negotiations in cases where there is a request for cooperation from central administrative agencies regarding the supply of drugs due to an infectious disease crisis or an urgent shortage of supply, and in cases where an increase in drug price is necessary due to diversification of raw material supply as a national essential medicine.” Accordingly, the following items will be added to the evaluation criteria for adjustment applications: ▲ if there is a request for cooperation from central administrative agencies related to the supply of drugs due to an infectious disease crisis or urgent shortage of supply ▲ if a national essential medicine has diversified its supply of raw materials.

 

The amendment to the regulation is a follow-up to the government's “Plan to Reflect the Innovative Value of New Drugs and Improve the Drug Price System for Health Security.” In particular, the evaluation criteria for adjustment applications to grant drug pricing premiums for national essential medicines that use domestically produced raw materials seems to have been established.

 

The price of drugs with unstable supply and demand is already being raised through adjustment applications upon the council's recommendation.

 

The amendment to the Operating Regulations of the Serious (Cancer) Disease Deliberation Committee also added a provision for the Head of the department in charge of drug post-management to attend the CDDC meeting.

 

On this, HIRA explained, “The recent increase in the number of new drugs that are expensive and have great uncertainty in terms of efficacy has increased the importance of performance management after reimbursement and expansion.

 

Therefore, the amendment was made to strengthen the practicality of drug management by allowing the head of the department that collects and evaluates the actual effectiveness of drugs to participate in the deliberation stage.” HIRA has recently been promoting the introduction of post-management of high-priced drugs through RWD.

 

It has also established a drug performance evaluation division under the Health Insurance Review and Assessment Policy Research Institute.

 

Prior to the full-scale implementation of the system, it is understood that the amendment was made to preemptively prepare a post-management plan by having the heads of relevant departments participate in the cancer review, the first gateway to the review of anticancer drugs.