Benefit redemption of α-GPC will be promoted soon

by the NHIS

Negotiations are possible for 60 days in accordance with the NHIS

The consortium of Daewoong and Chong Kun Dang is recruiting companies to participate in joint clinical trials by the 9th

As the clinical re-evaluation of Choline alfoscerate is imminent, the NHIS' benefit redemption contract is expected to be pursued sooner or later.

 

The consortium of Daewoong and Chong Kun Dang On the 1st of the month, an online briefing session for clinical reevaluation was held, and it was announced that it would recruit pharmaceutical companies to participate in the joint clinical trial of Choline alfoscerate by the 9th.

 

The consortiums divided into degenerative and vascular in the case of mild cognitive impairment, and each investing a clinical cost of ₩9.5 billion for 54 months.

 

It has a plan to invest about ₩10 billion in 60 months by adopting a method.

 

Korea United Pharm recruited pharmaceutical companies to participate in the joint clinical trial of mild cognitive impairment until the 4th.

 

As pharmaceutical companies participating in the clinical re-evaluation of Daewoong Bio and Chong Kun Dang's consortium group and United Group are confirmed within this week, the MOHW is also expected to proceed with the redemption of benefits according to the results of clinical re-evaluation.

 

The MOHW has been reviewing a generic negotiation plan that states,'If the clinical trial fails, the entire health insurance prescription amount from the date the MFDS to conduct the clinical trial will be returned to the NHIS'.

 

According to the Rules on the Standards for medical Benefits by the NHIS, If the Minister of Health and Welfare acknowledges that it is necessary for the stable supply of drugs that have already been notified of medical care benefits and the upper limit, it applies to the chairman of the NHIS.

 

Negotiations may be ordered with drug manufacturers, consignment manufacturers, and importers on matters referred to in Article 11-2 (7) 4.

 

In this case, the procedures in Article 11 (7) to (9) shall be applied mutatis mutandis.

 

In the case of Choline alfoscerate, it is highly likely that the MOHW will issue a collective negotiation order to the NHIS during this week as the clinical usefulness re-evaluation can be included in the'etc.' in the phrase'stable supply, etc.' If the MOHW issues a negotiation order within this week, the NHIS will be able to proceed with a generic medical care benefit contract that includes reimbursement of benefits for pharmaceutical companies that have submitted a clinical re-evaluation plan as early as next week.

 

In preparation for the failure of a clinical trial, if the approval is canceled after reevaluation or the criteria for benefits are changed, the contract will contain details such as the full refund of the benefits or the recovery of the benefits of the deleted indication.

 

If a pharmaceutical company participating in clinical reevaluation does not comply with the NHIS' contract, it will take the procedure to delete benefits.

 

It is stated that the procedures in Article 11, Paragraph 7 to Paragraph 9 of the Medical Benefit Standards are applied mutatis mutandis to items subject to clinical re-evaluation such as Choline alfoscerate, and thus there is a possibility of the deletion of benefits if the Minister of Welfare does not comply with the negotiation order.

 

The NHIS predicts that if it signs a contract related to reimbursement of benefits along with clinical reevaluation of Choline alfoscerate, it can protect health insurance finances of more than ₩300 billion per year.