Delay in choline alfoscerate reimbursement reevaluation

No progress since the February DREC meeting, HIRA explains COVID-19 is the reason behind the delay

Industry opinion or expert consultative meeting have not been processed, the procedure would resume after June

Popular brand drugs with choline alfoscerate, Gliatamin and Gliatirin

The sources speculate the Korean pharmaceutical industry’s hot potato, the reimbursement feasibility reevaluation on choline Alfoscerate would be postponed to the latter half of the year.

 

On May 11, pharmaceutical industry sources reported the reimbursement reevaluation on choline alfoscerate has been pressed on since the last year’s National Assembly audit.

 

Answering to Democratic Party Lawmaker Nam In-soon’s criticism on the underwhelming efficacy of choline alfoscerate during the audit session, the Minister of Health and Welfare Park Neung-hoo said, “The reevaluation would be promptly completed by June next year (2020).” From then on, the choline alfoscerate’s efficacy has been questioned increasingly.

 

Ultimately, Health Insurance Review and Assessment Service (HIRA) convened a meeting for Drug Reimbursement Evaluation Committee (DREC) in last February addressing the plan to reevaluate the said substance.

 

Seemingly, the reevaluation plan was close to being set on stone, but the committee meeting did not get to officially discuss over the subject, because it was addressed within ‘reporting agenda,’ not ‘deliberation agenda.’ Regardless, the table has turned as the novel coronavirus started spreading rapidly in Korea from March.

 

As HIRA fully concentrated its capacity on COVID-19 treatment related work, other pharmaceutical affairs have been pushed aside indefinitely.

 

After the February meeting, none of choline alfoscerate reevaluation related vis-à-vis meeting, expert consultation or pan-governmental collaboration have been progressed.

 

Amid the pandemic, HIRA has confirmed ‘completing the reevaluation by June’ is practically impossible.

 

On a phone interview with Daily Pharm, a HIRA official stated, “Due to the COVID-19 pandemic, it is true that [the discussion on the reevaluation] is getting delayed,” and “Since [the DREC meeting in] February, the government agency has not seen any progress on the matter.

 

None of prospective scheduling has been set.” The official explained the agency would be unable to fully conclude the reevaluation within June as the actual time is running out, even if HIRA resumes the discussion immediately.

 

For the reevaluation to rekindle the discussion and to proceed to reimbursement adjustment, the procedure would have to undergo consultation with industry officials, finalize the reevaluation decision, set detailed reimbursement standards, and have the Minister of Health and Welfare to notify the reimbursement standards.

 

The overall procedure would take at least over a month.

 

The pharmaceutical industry also gave a similar outlook.

 

An industry official commented, “Technically, the government’s initial plan to reevaluate the substance in June is unlikely to happen,” and “The practical discussion could resume only in the latter half of the year.” The pharmaceutical industry seems to be relieved by the delayed talks on the reimbursement reevaluation.

 

Prior to the outbreak, the industry officials have continuously requested the government to postpone the listed drug reevaluation.

 

In March, the Federation of Korean Industries (FKI) claimed “The listed drug reevaluation should be postponed for a year.” And in April, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) again urged the government to “defer the listed drug reimbursement reevaluation.” Currently, Ministry of Food and Drug Safety (MFDS) and Ministry of Health and Welfare (MOHW) are respectively deliberating the choline alfoscerate reevaluation discussions.

 

MFDS is contemplating on whether to remove a part of three approved indications during a Special Reevaluation session after the drug renews its item license.

 

With HIRA, MOHW is considering on reducing reimbursement on some of the drug’s indications or switching the reimbursement type to selective reimbursement.

 

As MOHW has constantly expressed negative stance on providing reimbursement on choline alfoscerate, the ministry would highly likely to reduce reimbursement on some of the three approved indications or to turn the reimbursement type into selective benefit.

 

At the moment, choline alfoscerate has been indicated to treat patients showing secondary symptoms of cerebrovascular insufficiency and degenerative brain-organic psychiatric syndrome— impairment of sense of direction, motivation, judgment and concentration due to confusion and degenerated memory, judgment and motivation; changes in emotions and behaviors—emotionally insecure, hypersensitive to stimulation, and indifferent to surrounding; and senile pseudo-depression.