Submission of α-GPC clinical reevaluation plan is imminent

It is an issue such as clinical method, cost, and participating companies

Pharmaceutical companies are preparing in earnest with two months ahead of the deadline for submitting data for the clinical reevaluation plan of Choline alfoscerate.

 

They are contemplating the indications for clinical trials and clinical work.

 

The method of paying the cost of clinical trials and the process of selecting participating companies will not be easy.

 

According to industry sources on the 19th, the MFDS announced in June that it would conduct a clinical reevaluation of Choline alfoscerate.

 

The MFDS requested that 134 companies submit the results of domestic clinical trials for 255 items.

 

In case of conducting a clinical trial, it was instructed to submit a clinical trial protocol by December 23rd.

 

Accordingly, companies that hold Choline alfoscerate are busy preparing clinical trial plans.

 

According to the existing clinical re-evaluation practice, it is highly likely that companies with large sales will take the lead in conducting clinical trials and other companies will participate in a way that shares the cost.

 

Companies such as Chong Kun Dang and Daewoong Bio have started to set up a full-fledged clinical trial plan.

 

It is said that these companies will soon meet with the MFDS representative to discuss clinical trial design, etc.

 

Choline alfoscerate is a drug that has three indications: ▲Secondary symptoms due to cerebrovascular defects and degenerative or degenerative cerebral temperamental syndrome ▲Emotional and behavioral changes, and ▲senile pseudodepression.

 

In principle, clinical trials for each indication should be conducted and data proving efficacy should be submitted.

 

However, pharmaceutical companies are also considering how to set targets and conduct clinical trials by slightly changing existing indications.

 

The MOHW acknowledged that it is effective against 'secondary symptoms due to cerebrovascular defects and degenerative or degenerative cerebral stromal syndrome' of patients diagnosed with dementia, and determined the positive list system for patients diagnosed with dementia and other patients.

 

The method of separating and conducting clinical trials was also being considered.

 

A method of separately conducting clinical trials by dividing the indication area for each pharmaceutical company could also be promoted.

 

Another brain function improvement agent 'Acetyl-L-Carnitine' was also divided by company and clinical reevaluation was conducted.

 

Acetyl-L-Carnitine, generic for Dong-A ST's Nicetile, has been approved for use in 'primary degenerative diseases' or 'secondary degenerative diseases caused by cerebrovascular disease'.

 

When The MFDS ordered a clinical re-evaluation in 2013, Dong-A ST took the lead in conducting a “primary degenerative disease” clinical trial.

 

Hanmi was in charge of the clinical trial for "secondary degenerative diseases caused by cerebrovascular disease." In July last year, Acetyl-L-Carnitine was removed from the indication for a “primary a degenerative disease” because the clinical results conducted by Dong-A ST did not meet the efficacy.

 

Hanmi is still undergoing clinical trials.

 

When the clinical trial design and clinical method of Choline alfoscerate are determined, the recruitment process for participating companies is expected to proceed.

 

At this time, it is also an issue of how each company will bear the cost of clinical trials.

 

If each company decides to pay the same clinical cost, companies with small sales volume of Choline alfoscerate will have to consider participating in reevaluation.

 

If the submission of clinical reevaluation data is abandoned, the authorization will be revoked.

 

The risk of redemption due to the price-volume agreement is also a burden for pharmaceutical companies.

 

Recently, some pharmaceutical companies with Choline alfoscerate agreed to adjust drug prices according to the price-volume agreement negotiation system.

 

The agreement stipulated that when a clinical trial is conducted for the renewal of the MFDS's product license and re-evaluation of drugs, the relevant facts should be notified to the NHIS.

 

If the approval is withdrawn as a result of reevaluation, etc., the pharmaceutical company has a clause that requires the NHIS to return the full amount of the bill from the date the MFDS makes the clinical trial to the date of the removal of the list.

 

If a pharmaceutical company has agreed to reduce the drug price of Choline alfoscerate according to the price-volume agreement negotiation system, and withdrawal from the market as a result of a re-evaluation later, all sales sold so far must be returned to the NHIS.

 

If pharmaceutical companies fail to demonstrate the efficacy of Choline alfoscerate in clinical trials, approval may be revoked in the worst case.

 

At this time, for products that have undergone the price-volume agreement negotiation system, all prescription amounts must be returned from negotiation to cancellation of the license.

 

For example, if Choline alfoscerate with an annual prescription amount of ₩10 billion is canceled due to a clinical trial failure 5 years after the price-volume agreement negotiation system, ₩50 billion will be required.

 

Drug price agreement based on the Price-Volume agreement Pharmaceutical companies are inevitably burdened with clinical reevaluation.

 

An industry official said that there are a lot of homework from setting up clinical design to recruiting participating companies with about two months left until the submission of the clinical reevaluation plan.

 

He said, "With the burden of uncertainty about the revaluation results, a lot of pain between pharmaceutical companies is inevitable."