MOHW to reduce pricing in combination drug changing API

MOHW decides to link changes in labeling and pricing of calcium chloride injections

First case of linked labeling and pricing change to be applied on seven items on December reimbursed drug list

HIRA DREC to compile guideline, to be enforced next year

The South Korean government is to reevaluate and reduce the reimbursed pricing on drugs that changed the main active pharmaceutical ingredient (API) due to the change of labeling.

 

Immediately, calcium chloride combination injections are subjected to the new change with the updated list of reimbursed drug effective from Dec.

 

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As it would be the first case of adjusting reimbursed pricing according to the labeling, the government would swiftly set relevant reimbursement standard or guideline.

 

An industry source reported on Dec.

 

16 that the Ministry of Health and Welfare (MOHW) unveiled a plan for drug labeling reevaluation based on the order to change the antibiotic injection labeling.

 

The reevaluation was initially planned as the Ministry of Food and Drug Safety (MFDS) amended the labeling of an antibiotic combination drug with calcium chloride.

 

As the substance is categorized as a disintegrating agent, some raised an issue if it should be considered as an API.

 

MFDS has decided to change the key API as an ‘isotonic agent’ after consulting experts about the substance, particularly its related safety and efficacy evidence (reevaluation included) and the international approval status of the drug.

 

Since then the ministry has been in legal suits with the pharmaceutical companies opposing against the decision.

 

However, the litigation was ruled in favor of the government, and MOHW decided to adjust (reduce) the listed combination drug reflecting the change.

 

The pricing adjustment subject drugs would be deduced from the new list of reimbursed drug and their upper limit pricing effective from Dec.

 

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And Daily Pharm analyzed the list and found seven combination items containing calcium chloride assumed to be affected.

 

The seven items include UK Chemipharm’s Tagonin Kit Injection (teicoplanin), Meta Kit Injection (cefmetazole sodium), Tetan Kit Injection (cefotetan disodium), Thiam Kit Injection (cefotiam hydrochloride), Trison Kit Injection (ceftriaxone sodium hydrate), Trison Kit 2 g Injection, and Vanco Injection (vancomycin hydrochloride).

 

Labeling adjustment carries onto pricing reevaluation could become a norm after stipulating relevant regulation and guideline However, the problem is that the government has no reimbursement standard or guideline related to the case it was a first case of the labeling change carrying onto reimbursed pricing reevaluation.

 

But the first subject drugs can estimate the adjust pricing by referring to the upper limit pricing of similar combination drugs without calcium chloride.

 

Regardless, the government would have to set down a clarified standard or guideline for the reevaluation, as it normally uses a clear standard to adjust upper limit pricing.

 

In fact, MOHW plans to consult the Drug Reimbursement Evaluation Committee (DREC), associated under the Health Insurance Review and Assessment (HIRA), to compile a related standards and guideline.

 

Without much of trouble, the pricing adjustment could be enforced from the next year first quarter.