Govn’t to introduce 460,000 courses of oral COVID-19 drugs

by end of April

Paxlovid prescribed a priority…Lagevrio to be used in patients who are restricted use of Paxlovid

Completes making measures to prevent prescriptions to pregnant women, children and adolescents through DUR

GOV to compensate for damages if serious adverse events arise from administration

Ki-il Lee, the first supervisor of the Central Disaster and Safety Countermeasures Headquarters

The government will be introducing 460,000 courses of oral COVID-19 treatments by the end of next month.

 

In principle, Paxlovid will be prescribed first, and Lagevrio, which has recently been approved for emergency use, should be used for patients who are restricted from using Paxlovid, such as users of contraindicated drugs.

 

On the 25th, COVID-19 Central Disaster and Safety Countermeasures Headquarters (Head, Prime Minister Boo-kyum Kim) presided over a meeting in the videoconference room at the Sejong Government Complex with the central government departments, 17 metropolitan governments, and 18 cities and provinces on their COVID-19 vaccine/treatment development status and measures for support.

 

According to Ki-il Lee, the first supervisor of the Central Disaster and Safety Countermeasures Headquarters who spoke at a briefing by the disease control and management authorities, the government has procured a total of 1,400,000 courses oral COVID-19 treatments and is in the process of introducing them sequentially.

 

As of the 24th, 163,000 courses of Paxlovid (from Pfizer) have been introduced to Korea, 114,000 courses of which have been used on patients in Korea.

 

On the criticism that Paxlovid is not being actively prescribed by managing medical institutions even if symptoms appear unless older adults in their 60s directly ask for prescriptions themselves, the authorities said they will check on it.

 

Ki-il Lee said, “We will do our best to make sure that institutions that conduct rapid antigen testings can immediately prescribe the drugs to those aged 60 years or older and the immunocompromised.

 

We have requested this from the presidents of 16 doctors’ associations in 16 cities and provinces.

 

W We will do our best to allow prescriptions to be made as soon as possible." Also, the government is continuing negotiations to rapidly introduce oral COVID-19 treatments.

 

Including the 20,000 courses introduced yesterday, the government is pushing for the early introduction of 460,000 courses of oral COVID-19 treatments by the end of April.

 

On the 24th, the first 20,000 courses of Lagevrio were introduced in advance for use from tomorrow (26th).

 

Lagevrio was granted Emergency Use Approval on the 23rd by the Ministry of Food and Drug Safety after conducting safety/efficacy reviews and expert consultations.

 

In consideration of its EUA indication, the drug will be used ▲within 5 days of symptom onset, ▲on patients over the age of 60 or age of 40 with underlying diseases or immunocompromised ▲who have difficulty using existing treatments.

 

The authorities will allow use of Lagevrio in patients who have difficulty using other treatments due to the use of contraindicating medications, etc., although Paxlovid will be first prescribed in principle.

 

Patients with severe hepatic or renal impairment or patients taking drugs of specific ingredients (28 types (23 types that are approved in Korea)) are restricted from the use of Lagevrio.

 

In addition, pregnant women and patients under the age of 18 are excluded from eligible subjects in consideration of the EUA condition set by the MFDS.

 

The government said it is making every effort to ensure that the new oral COVID-19 treatment, Lagevrio, can be safely used in the field.

 

In order to prevent prescriptions from being made to pregnant women, children, and adolescents and its safe use, the drug was registered in the DUR (Drug Utilization Review) system, and relevant systemic improvement measures were completed, such as adding drug information to the patient management information system.

 

Also, the 'Treatment Use Guide (6th edition)' has been distributed to medical institutions to guide Lagevrio prescriptions in institutions, and pharmacies will be distributing detailed medication guides to those patients who have been prescribed Lagevrio.

 

Meanwhile, the government announced that it would monitor the introduction and use of oral COVID-19 drugs, and will continue to compensate for serious adverse events that arise by applying the drug’s side effect damage relief procedures.

 

The current side effects damage relief measures include a lump-sum death compensation (114 million won), funeral expenses (9.8 million won), disability lump-sum compensation (29 million won to 114 million won), and hospitalization & treatment expenses (up to 20 million won).

 

Medical institutions, pharmacies, patients, etc.

 

can report side effects that occur after the use of drugs to the Korea Institute of Drug Safety and Risk Management (report online at www.drugsafe.or.kr) or receive related consultations.