[Reporter's view] Controversy over α-GPC

Negotiations on the return of benefits of the 'Choline alfoscerate' legislation, which was the subject of the revaluation project of the listed drugs, have been concluded.

 

However, the controversy over the return rate has not ended.

 

The NHIS negotiated with 58 pharmaceutical companies that owned 123 Choline alfoscerate on August 10.

 

It announced that it has agreed with 44 pharmaceutical companies on a 20% return rate.

 

Chong Kun Dang, which had been conducting PVA in the third quarter of this year, also finished negotiations.

 

There are about 10 pharmaceutical companies that have not agreed.

 

Negotiations on the repatriation of Choline alfoscerate lasted about eight months from December 14 to August 10.

 

In the process, the timing of recovery was changed from "the day of submission of a clinical trial to the MFDS" to "the day when the MFDS approved the clinical trial," and the amount of recovery also fell from "full 100%" to "20%." The controversy erupted when three pharmaceutical companies that had already signed a 100% return rate in PVA negotiations before the benefit revaluation Choline alfoscerate filed complaints with the Anti-Corruption and Civil Rights Commission for equity reasons.

 

Negotiation about Choline alfoscerate is the first conditional recovery negotiation in conjunction with the MFDS' clinical reassessment.

 

However, all the NHIS negotiations in accordance with the safety and validity verification and quality control requirements have a redemption clause related to revaluation.

 

This is a revised guideline after the 2019 Lipiodol crisis.

 

In the second quarter of last year's PVA negotiations, Arlico, Hana and Kyongbo agreed that if the authorization for revaluation is dropped, the pharmaceutical company should return the full claim from the date of clinical testing to the NHIS.

 

Anti‑Corruption and Civil Rights Commission has conveyed to health authorities that the NHIS and the three pharmaceutical companies should maintain a contract following a clinical trial revaluation, but set a 100% return rate equal to 20%.

 

Anti‑Corruption and Civil Rights Commission's recommendations are not compulsory.

 

However, it is unlikely to raise the rate again, as the rate of return of Choline alfoscerate, which is undergoing simultaneous re-evaluation and clinical re-evaluation, has been agreed to 20% with an eight-month negotiation process.

 

The NHIS should set out what guidelines to maintain in future drug price negotiations in accordance with AAnti‑Corruption and Civil Rights Commission's recommendations.

 

Through revaluation, it is necessary to clarify whether there is a possibility of maintaining the existing "health insurance claim in full" or changing it to 20% agreed with pharmaceutical companies.