Billing for α-GPC is managed

The HIRA and the MFDS responded in writing to Rep. Nam In-soon of the National Assembly

Monitoring of clinical reevaluation pharmaceutical companies thoroughly

The HIRA plans to consider the need to manage claims by selecting Choline alfoscerate, which is under controversy over reducing adaptation certificates, as the "selection focused item." The MFDS plans to periodically monitor pharmaceutical companies that have been clinically reassessed, block unnecessary clinical extensions, and take administrative action against pharmaceutical companies that have failed to reassess.

 

On the 24th, the HIRA and the MFDS responded to Nam In-soon's criticism of the Democratic Party of Korea about Choline alfoscerate.

 

She ordered the HIRA to review and implement follow-up measures to prevent Choline alfoscerate from prescribing drugs based on reduced benefit due to the lack of proven efficacy and effectiveness of other than dementia.

 

The HIRA said it will collect opinions from the public and medical circles and decide whether to select and manage Choline alfoscerate as a selective target after deliberation and resolution process of the central screening coordinator committee.

 

It is a proactive screening system that selects items that need to improve medical trends, such as increased medical expenses, screening problems, and social issues, and makes intensive screening after prior notice to induce improvement in autonomous medical trends of medical institutions.

 

The HIRA will make efforts to make sure that Choline alfoscerate is not prescribed for other than dementia in front-line medical institutions.

 

In addition, the HIRA said it is currently monitoring claims, amounts, and actual number of employees after the suspension of execution of Choline alfoscerate's benefit standard notice.

 

"We will continue to monitor Choline alfoscerate's claims and come up with follow-up measures with related agencies," The HIRA said.

 

"We will continue to re-evaluate the benefit adequacy of the system to streamline spending structure for health insurance fiscal sustainability of health insurance." She ordered the MFDS to block pharmaceutical companies from indiscriminately extending the clinical re-evaluation period of Choline alfoscerate and start managing pharmaceutical companies that have not submitted clinical plans.

 

The MFDS said it will monitor the progress of clinical re-evaluation periodically and speed up the process of changing or canceling permits if it is deemed ineffective or insufficient.

 

The MFDS said 11 items from eight companies that did not participate in the clinical re-evaluation are being subject to secondary administrative measures under the Pharmaceous Affairs law.

 

The first disposal will be suspended for two months, the second disposal will be suspended for six months, and the third disposal will be revoked.

 

The MFDS announced on the 10th that it had previously notified the procedure of changing permission to delete "emotional and behavioral changes, senile caustic depression," which is not included in the scope of clinical re-evaluation.

 

The intention is that there is a need for management only for "secondary symptoms and metamorphic or degenerative cerebral substrate syndrome caused by cerebrovascular deficits" where clinical re-evaluation has been decided.

 

The MFDS said, "To reevaluate the validity quickly, we adjusted and approved the clinical trial period after consulting experts based on the progress of clinical trials of similar adaptive items and data on insurance claims by the HIRA." The MFDS replied, "We will closely review the re-evaluation process and take administrative action against non-submitted pharmaceutical companies."