The Ministry of Food and Drug Safety said it would discuss whether to re-assess the clinical usefulness of choline alfoscerate, a drug for cognitive impairment, at the meeting of the Central Pharmaceutical Affairs Council on Friday.

“We will open the council’s meeting on Friday to see whether it is necessary to re-evaluate choline alfoscerate and how we would do it,” the ministry said in a briefing Tuesday.

Last Friday, the Health Insurance Review and Assessment Service (HIRA) said it would limit the insurance benefit for choline alfoscerate after reviewing the drug’s reimbursement. HIRA said although the drug had a strong social demand for indications outside dementia-related symptoms, its clinical usefulness was uncertain.

Thus, HIRA said, the government would maintain the insurance benefit only for secondary symptoms from cerebrovascular defects and degenerative organic brain syndrome.

As for indications for emotional and behavioral changes and masked depression of the elderly, choline alfoscerate will get a selected reimbursement where the patient pays 80 percent of the medical cost, the agency added.

HIRA’s decision led drugmakers to criticize the ministry for having failed to release the drug review result for over six months after receiving related data from the companies.

Mindful of the criticism, a ministry official said the ministry was proceeding with the drug review schedule separately from the HIRA decision.

“We have requested manufacturers to submit additional data. We received experts’ advice and went through an internal review to include the agenda in the upcoming meeting of the central pharmaceutical affairs council,” the official said.

The ministry would decide whether to conduct a “special re-assessment” on choline alfoscerate depending on the council’s ruling. However, as the council is an advisory group, it does not make the final call, he added.

If the council judges that the ministry needs to go ahead with the special re-assessment on the dementia drug, the regulator would have to review the validness of the drug’s authorized indication. In that case, the repercussions would be significant.

The ministry’s special re-evaluation would be focused on the drug’s clinical usefulness only, the ministry official said.

If the ministry concludes that choline alfoscerate was ineffective on the two indications for emotional and behavioral changes and masked depression of the elderly, it may nullify the drug’s license. Then, the drug will not be able to receive the limited insurance benefit, either.

“We will announce whether we will re-evaluate choline alfoscerate as soon as possible,” the official said.