Started a demand survey for drugs participating in the pilot

Submit by the 4th of the following month

In earnest from the second half

Due to the burden of simultaneous data submission, there are likely to be fewer participating drugs.

 

The government started a demand survey for drugs to participate in the parallel trial project of 'Permission Evaluation Negotiation', which is being pursued rapid reimbursement.

 

The project was planned to drastically shorten the registration period by simultaneously proceeding with benefit evaluation and negotiations from the MFDS approval application stage.

 

According to the industry on the 30th, the Ministry of Health and Welfare is conducting a drug demand survey to participate in a parallel pilot project in 2023, including application for permission, evaluation of benefits, and negotiation of drug prices, as part of a plan to improve access to treatment for expensive severe diseases and strengthen reimbursement management.

 

Candidate drugs are scheduled to apply for approval from the Ministry of Food and Drug Safety in 2023 and are drugs aimed at treating diseases that threaten survival (life expectancy is less than one year) or rare diseases.

 

If there is no existing treatment or if there is a clinically significant improvement in efficacy, etc.

 

compared to existing treatment, participation is possible.

 

The data to be submitted are related to approval: ▲the expected date of application for domestic approval, ▲effectiveness and effect among items of application for domestic approval (scheduled) , ▲countries approved in foreign countries and items permitted, ▲consistency between items approved in foreign countries and items scheduled for application for domestic approval.

 

Regarding disease information of approved indications, ▲ disease severity, life expectancy, survival rate, progress, etc.

 

▲ existing treatment methods, and treatment performance data for the disease.

 

Regarding clinical usefulness, ▲a clinical trial summary of the therapeutic confirmatory trial (or related evidence source), ▲the expected number of patients, ▲A8 listing status and listing price, ▲benefits evaluation result in excluding countries, ▲cost when applying for decision Effectiveness application track expected data (PE, medication cost comparison, etc.) can be submitted.

 

The data will be used as basic data for selecting drugs for pilot projects.

 

Applications must be submitted to KPBMA by April 4th.

 

The government plans to promote the pilot project in earnest from the second half of the year.

 

On the 28th, Yoo Mi-young, head of the Pharmaceutical Management Office of the HIRA, said at a meeting with the Korea Special Press Association, “We are currently discussing the target selection and related procedures with the relevant departments of the Ministry of Food and Drug Safety to promote the pilot project.” Explained.

 

It is expected that there will be not many drugs to participate in the pilot project.

 

Since the evaluation methods and conditions of the three agencies - MFDS, HIRA, and NHIS - are different, related pharmaceutical companies are also burdened with preparing data at the same time.

 

It is interpreted that the first step was to investigate demand before starting the pilot project in earnest in the second half of the year.