Oxiracetam’s next...ordeal of brain function enhancers

Companies lose suit filed to lift the reimbursement restriction for choline alfoscerate in the ₩500 billion market

Prescription and dispensing of acetyl-L-carnitine banned after failing clinical reevaluations

Oxiracetam to receive clinical reevaluations at the end of the year and reimbursement reevaluations next year

Korean Drug Co.’s

It’s a time of ordeal for brain function enhancers.

 

In addition to choline alfoscerate, whose scope of use has been reduced through reimbursement reevaluations, acetyl-L-carnitine failed to demonstrate its efficacy during clinical reevaluations.

 

As a result, acetyl-L-carnitine is expected to completely disappear from the prescription market.

 

Oxiracetam, which accounts for the third-largest share of the brain function enhancer market, is set to receive clinical reevaluations and reimbursement reevaluations soon.

 

If oxiracetam also takes a blow, industry officials predict that the brain function enhancer market itself will greatly retract.

 

On the 5th, the Ministry of Food and Drug Safety announced that it will suspend prescriptions and dispensing of acetyl-L-carnitine as the drug failed to demonstrate its efficacy in ‘secondary degenerative diseases caused by cerebrovascular disease’ during clinical reevaluations.

 

In other words, acetyl-L-carnitine was unable to prove its efficacy in the indication.

 

Acetyl-L-carnitine had previously been unable to demonstrate its efficacy for 'primary degenerative diseases' during clinical reevaluations.

 

Being unable to demonstrate efficacy for both of its indications, the ingredient is set to be removed from the reimbursement list.

 

Acetyl-L-carnitine had been subject to reimbursement reevaluations next year, however, if it is removed from the reimbursement list, the ingredient will naturally be excluded from reevaluations as well.

 

The average annual claims amount of acetyl-L-carnitine over the last 3 years was ₩58.1 billion, the second-best grossing ingredient in the brain function enhancer market next to choline alfoscerate, which boasts a market size of ₩500 billion.

 

The problem is that the next-in-place brain function enhancer is also up for reevaluations soon.

 

The drug up for the next reevaluation is oxiracetam, which is represented in Korea by Korean Drug Co.’s Neuromed tablet.

 

Clinical reevaluation reports for oxiracetam are also due for submission by the end of this year.

 

Like other ingredients, oxiracetam’s indication for improving Alzheimer-type dementia had also been deleted due to the inability to demonstrate its efficacy, and a clinical reevaluation is being conducted to verify its efficacy for the remaining indication, for the 'improvement of vascular cognitive disorder symptoms.’ If the year-end reports submitted are unable to verify the drug’s efficacy in the remaining indication, the prescription and dispensing of oxiracetam will likely be discontinued, just like in acetyl-L-carnitine's case.

 

However, another great obstacle remains even after verifying the clinical efficacy as oxiracetam is also subject to reimbursement reevaluations next year.

 

Oxiracetam’s 3-year average claims amount is ₩23.3 billion, less than that of choline alfoscerate or acetyl-L-carnitine.

 

But as Neuromed raised ₩11.5 billion in prescriptions last year, the amount earned in terms of each item is by no means small.

 

If oxiracetam also suffers a blow from that reevaluation, all the main brain function enhancers will be reduced reimbursement or removed from the reimbursement list, thereby contracting the total market.

 

Brain function enhancers have been widely used to prevent dementia in elderly patients and have well served as a cash cow for domestic pharmaceutical companies.

 

Reimbursement for choline alfoscerate was maintained through the reimbursement reevaluations that were conducted to verify the drug’s efficacy in dementia in 2020.

 

However, the patient coinsurance rate for the main indication in improving cognitive disorders rose from 30% to 80%, and was applied selective reimbursement.

 

Despite this, the previous reimbursement rate is being applied because some of the affected companies appealed the decision, and filed for a stay of execution of the reimbursement reduction disposition.

 

However, Chong Kun Dang and the other companies lost the suit that they filed to cancel the reimbursement reduction, and the stay of execution will be lifted soon.

 

Also, the fact that the companies must demonstrate their drug’s efficacy through clinical reassessments by 2025 will add a significant burden on the companies.