Gov't opposes to suspending reimb·ingredient prescribing

of drugs in shortage

MOHW says, "It may aggravate patient·pharmacy chaos, and it is a matter of agreement between the gov't and the medical community"

In response to the request to restrict reimbursement of Imotun Cap…"The drug has proven usefulness, requires careful consideration"

The government has opposed the proposed measure, which aims to minimize the chaos in prescription·dispensing by suspending insurance reimbursement or blocking prescription code of drugs when substitute drugs are available.

 

Suspending reimbursement of drugs covered by insurance is a temporary measure implemented in the case of administrative meaures from the Ministry of Food and Drug Safety (MFDS), such as canceling marketing authorization.

 

The government rationale is that suspending reimbursement due to drug shortages would only confuse patients and pharmacies.

 

At the time of the separation of prescribing and dispensing of drugs, the government also opposed to the measure to allow active ingredient prescribing of drugs in shortages.

 

The rationale for the opposition was that it violated the agreement between the government and the medical community.

 

On October 15th, the Ministry of Health and Welfare (MOHW) announced this in response to written parliamentary questions submitted by Rep Seo Youngseok and Rep.

 

Nam In-soon of the Democratic Party of Korea.

 

Rep.

 

Seo asked MOHW's opinion about suspending insurance reimbursement or blocking the prescription code of drugs when substitute drugs are available.

 

To resolve the issue of drug shortages, Rep.

 

Nam proposed the need to legalize the DUR notification, limit the number of days of prescription, temporarily suspend issuing reimbursement, and implement active ingredient prescription.

 

The MOHW explained that they are reviewing drug pricing adjustments after receiving applications from pharmaceutical companies when the drug shortages consultative body requests that it is necessary to increase the supply by adjusting the ceiling price.

 

The MOHW also answered that suspending reimbursement of drugs in shortages and implementing active ingredient prescription requires careful consideration.

 

"Suspension of reimbursement is a limited measure when the MFDS' approval of the product is revoked," the MOHW stated.

 

"Suspension of reimbursement for drugs in shortages may cause confusion in the field, such as patients and pharmacies, so careful consideration is required." "Currently, the drugs that have been reported to be out of supply are being directed to DUR.

 

In addition, the DUR notification on additional drugs in shortages should be prioritized by establishing standards for drugs in shortages," the MOHW stated, adding, "We believe that limiting the number of prescription days for drugs in shortage is necessary in exceptional cases where it is difficult to increase production, such as a shortage of raw materials.

 

It is necessary to prepare a relevant legal basis." Regarding the active ingredient prescribing for drugs that are in shortage, the MOHW stated, "It is necessary to be cautious by changing the agreement at the time of the separation." Regarding the MOHW's measures against the shortage of Imotun supply at clinical sites such as pharmacies, the MOHW staged that they would consider utilizing substitute drugs.

 

In response to Rep.

 

Suh's point that special measures such as restricting Imotun's salary are necessary, the MOHW expressed their position on careful consideration.

 

The MOHW explained, "Imotun Cap is produced by receiving the supply of Avocado-Soya Unsaponifiables raw materials from France," adding, "As it is a herbal ingredient, the production of raw materials is constant.

 

Therefore, there will be a small increase in supply in 2023 compared to 2022, but there will be a limit to sufficient supply." "The drug in question was discussed at a meeting between the public-private consultative body for drug shortages and the medical community," the MOHW added.

 

"It was discussed as an adjunctive treatment for osteoarthritis, and it was discussed as a drug that is difficult to respond to first considering the possibility of using other drugs with similar effects.

 

We will consider the use of alternative drugs in the future." "Imotun Cap was recognized for its clinical usefulness in the 2022 re-evaluation after the conditional reimbursement was maintained in the 2021 reimbursement appropriateness re-evaluation," the MOHW added.

 

"The reimbursement restriction should be reviewed carefully considering the overall social needs.

 

The supply of the drug has been maintained by 160,000 capsules annually, and it does not fall under the reason for the reimbursement restriction due to the recognition of usefulness."