Will Lixiana follow-ons take over the market?

1-year since TAVIs were approved for reimb in Korea

Major domestic companies apply for approval of their generics... targets the NOAC market

Affected by KHRS’s guidelines... the impact of reimbursement to be in full swing this year

Activity in related markets has been rising due to the aftermath of the reimbursement approval for Transcatheter Aortic Valve Implantation (TAVI) that had been made last year.

 

Pharmaceutical companies have been increasingly conducting activities to target the Non-vitamin K antagonist oral anticoagulant (NOAC) market.

 

다이이찌산쿄 릭시아나 제품사진.

According to industry sources on the 17th, a series of marketing authorizations have been granted for follow-on drugs of Daiichi Sankyo’s NOAC drug ‘Lixiana (edoxaban)’ recently.

 

More specifically, 6 incrementally modified drugs with different salt formations than the original, the 15mg and 30mg formulations of Hutecs Korea Pharmaceuticals’ ‘Enxiana,’ Handok’s ‘Megaxaban,’ and Genu Pharma’s ‘Genupharma Edoxaban’ were approved on the 12th.

 

However, the prospects are that it would be difficult to launch a product within a short period of time as more than 3 years remain until the patent that the companies were unable to avoid, Lixiana’s substance patent, expires.

 

Meanwhile, the NOAC market, which is being led by Lixiana, has been pointed to as a representative prescription drug market that is showing rapid growth.

 

According to the market research institution UBIST, Lixiana’s prescription sales amounted to KRW 89 billion last year, up 4.9% from the KRW 84.8 billion of the previous year.

 

Lixiana is currently being jointly marketed by Daiichi Sankyo Korea and Daewoong Pharmaceutical in Korea.

 

The NOAC market is expected to continue to grow further as TAVI procedures are being conducted in earnest in the field with its reimbursement.

 

Since May last year, the Ministry of Health and Welfare has converted the coverage status of TAVI procedures for severe aortic stenosis patients over the age of 80 to provide full reimbursement.

 

Following full reimbursement, the Korean Heart Rhythm Society published a revised 'NOAC Use Guideline' in the second half of last year and presented specific criteria for NOAC use in various situations.

 

In particular, as the guideline specified that 'the basis for the use of NOAC on TAVI patients was established,’ the revision heralded expanded NOAC use.

 

Therefore, in line with the growing NOAC prescription market, the domestic pharmaceutical companies' efforts to enter their generics into the market are expected to continue to increase in the future.

 

An official from a domestic pharmaceutical company who requested anonymity, predicted, "The launch of a low-dose 15mg formulation of Lixiana had a direct impact on sales growth last year.

 

The full reimbursement of the TAVI procedure would also further impact Lixiana’s growth.” The official added, “Also, new prescriptions for NOACs are expected to increase significantly in the future as we are into the 1-year point of TAVI’s reimbursement.

 

For the same reason, I believe domestic pharmaceutical companies will also actively work to release their generics as well.”