Fasenra's reimb application passes DREC review

the last antibody drug for severe asthma to apply for reimbursement in KOR is applied the RSA track

A monoclonal antibody drug for asthma, like Cinqair and Nucala

Reimbursement adequacy of CSL's Idelvion for Hemophilia B and Brukinsa’s reimbursement extension were all approved

Fasenra, the last of 3 antibody drugs used for severe asthma to apply for reimbursement in Korea, has now passed the Drug Reimbursement Evaluation Committee (DREC) stage, increasing the likelihood of its reimbursement.

 

The drug, like Nucala, is seeking reimbursement through the risk-sharing arrangement (RSA) scheme.

 

The industry is paying attention to Fasenra’s progress because its same-class drug Cinqair has been reimbursed through the general listing process and Fasenra is going through the RSA process Nucala went through.

 

The Health Insurance Review and Assessment Service announced on the 7th that it passed the applications for the reimbursement of new drugs such as Fasenra, Idelvion, and reimbursement extension of Brukinsa at the 3rd 2024 Drug Reimbursement Evaluation Committee.

 

The reimbursement adequacy of Fasenra Prefilled Syringe Inj 30mg (benralizumab, AZ), a treatment for severe eosinophilic asthma, was deemed adequate at the recent DREC meeting.

 

Fasenra had received a non-reimbursement decision at the previous DREC meeting that was held in September last year.

 

Therefore, the company passed HIRA’s review in its second attempt.

 

In particular, Fasenra is receiving attention for the fact that 2 other drugs with the same mechanism of action have already been approved.

 

In October last year, 2 interleukin (IL)-5 antagonists used for severe eosinophilic asthma, like Fasenra, were granted reimbursement.

 

The 2 other drugs are Cinqair (reslizumab, Teva-Handok) and Nucala (mepolizumab, GSK).

 

Cinqair was approved through the regular reimbursement process, and Nucala was approved through the RSA process.

 

This is the first time a drug in the same class has been approved through two different reimbursement schemes.

 

In this sense, DREC’s recognition of Fasenra's reimbursement adequacy is even more unusual.

 

The fact that the company is undergoing the reimbursement process through the RSA track is not exceptional, as latecomers can also apply for RSA since 2020, but no drug has attempted reimbursement listing through the RSA track after a same-class drug was listed through the general track.

 

This is because if a drug in the same class is listed through the general listing process, it is disadvantageous for the latecomer to apply for RSA.

 

However, since one of the drugs -Nucala – was listed through the RSA scheme, it is likely that the company referred to Nucala’s case when applying for Fasenra’s reimbursement through the RSA track.

 

Moreover, as RSA applications were limited to anticancer drugs and rare diseases, Fasenra and Nucala are regarded as exceptions because they are severe chronic diseases.

 

However, the Health Insurance Review and Assessment Service is expected to apply RSA to drugs for severe chronic diseases for which there are no alternatives and which irreversibly cause a significant deterioration in the quality of life, such as systemic pustular psoriasis, interstitial lung disease, hereditary angioedema, and severe asthma.

 

At the meeting, DREC also recognized the reimbursement adequacy of CSL Behring’s ‘Idelvion Inj,’ which is used to treat hemophilia B.

 

As it can extend the dosing cycle by up to 3 weeks, it is expected to be in high demand if it is approved for reimbursement.

 

BeiGene Korea's Brukinsa Cap, which also sought to expand reimbursement, has been deemed adequate for reimbursement in Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL).

 

Burkinsa was first approved reimbursement as a treatment for Waldenström’s macroglobulinemia (WM) in May last year.