Will the COVID-19 drug Paxlovid be reimbursed in H1 2024?

KDCA pushes for its reimbursement as part of Korea’s general healthcare system

After the company applied for the reimbursement in October of the past year, the agenda was not presented to DREC until April this year

Receives 3rd request for supplementary data...reimbursement by June unclear even if the company proceeds with pricing negotiations in May

Whether the reimbursement of the COVID-19 drug Paxlovid (nirmatrelvir and ritonavir, Pfizer), which the government has been working to make part of Korea’s general healthcare system after the end of the COVID-19 pandemic, will be able to be listed within the originally planned date is gaining attention.

 

The Korea Disease Control and Prevention Agency aimed to list the drug within the first half of this year, but in the current situation, it appears that the authorities may miss the target date.

 

According to industry sources on the 15th, the Health Insurance Reimbursement and Assessment Service requested a supplemental response letter for Paxlovid to Pfizer.

 

As a result, Paxlovid was not presented at the Drug Reimbursement Evaluation Committee’s April 4 meeting.

 

At the very least, the DREC will need to recognize the adequacy of the reimbursement in May to list the drug within the first half of the year as targeted.

 

Even if it passes the DREC in May, it will not be easy to list the drug for reimbursement in the first half of the year if the NHIS applies the 60-day negotiation period.

 

Pfizer applied for Paxlovid’s reimbursement to HIRA in October last year.

 

Since then, HIRA has requested Pfizer to submit a supplemental response letter 3 times.

 

As the drug was introduced urgently due to COVID-19, the company seems to have needed some time to prepare the required clinical trial data and pharmacoeconomic evaluation data.

 

Pfizer submitted its first supplemental response in November last year and its second supplemental response in February this year.

 

However, HIRA has requested another supplemental response thereafter.

 

In its 2024 Major Policy Plan Report, the KDCA stated plans to ease the COVID-19 crisis level and adjust the same level of quarantine measures and special support system for COVID-19 as influenza to fully recover to daily life.

 

For this, the agency said it would list COVID-19 drugs in Korea’s health insurance system in the first half of this year to supply the drug through the general healthcare system.

 

However, as the reimbursement of the COVID-19 drug Paxlovid is progressing slower than expected, it is unclear whether the KDCA will meet its targeted plan.

 

The agency plans to stop providing COVID-19 drugs for free from the second half of the year.

 

If the government support is discontinued and patients are required to purchase the drug without reimbursement, its cost of KRW 700,000 for a five-day supply, could bring a serious financial burden.

 

However, if the drug passes DREC in May and the NHIS negotiates quickly in line with the government’s policy, the drug may dramatically be listed for reimbursement in June, making Paxlovid’s coverage with the national health insurance possible within the first half of the year as planned.

 

An industry official said, "Paxlovid’s reimbursement is essential to incorporate COVID-19 into Korea’s daily healthcare system and treat high-risk patients.

 

However, it will be difficult for insurance authorities to recognize the appropriateness of its reimbursement without complete data submission, as they need to uphold the principle of the positive list system."