Multinational drugmakers are demanding Seoul’s quicker approval for insurance benefits of cancer and rare drugs for the sake of patients while ignoring the existing system to expedite the process, a government official said.

Korea’s “Drug Approval-Drug Price Evaluation Linkage System” allows pharmaceutical companies to apply for reimbursements to the Health Insurance Review and Assessment Service (HIRA) based on the medicine’s safety and efficacy, before obtaining the nod from the Ministry of Food and Drug Safety (MFDS).

As the processes of the ministry’s license approval and HIRA’s evaluation for reimbursement can be carried out simultaneously, the drugmaker can shorten the period of a product release. To make use of the system, drugmakers must present reliable evidence for the right drug pricing.

However, Kwak Myung-sub, director of pharmaceutical benefits division at the Ministry of Health and Welfare, said multinational drug companies were not using the linkage system for anti-cancer and rare medicines.

“The system allows drug approval and reimbursement request simultaneously, but multinational drugmakers are strategically avoiding it. They are seeking the MFDS’ nod first and requesting reimbursements later intentionally,” Kwak recently told reporters. “The companies are blaming the HIRA and the health and welfare ministry as if the authorities are not quickly reviewing drugs for reimbursements.”

According to the health and welfare ministry, no company has applied for simultaneous drug approval and reimbursement review on an anti-cancer remedy or an orphan drug since the linkage system began in September 2014.

Some firms intentionally supplement data to delay the review period or strategically cancel drug assessment requests.

Drug companies also tend to weigh timings of reimbursements to win a higher drug price and adjust indications in consideration of the drug’s competition against rivals, the ministry said.

Although multinational drugmakers claim their drug prices in Korea are lower than those of the Organization for Economic Cooperation and Development and seven advanced nations (the U.S., Japan, the U.K., Germany, France, Switzerland, and Italy), they do not have clear evidence to support their argument, according to the ministry.

In 2016, the Korean Research-based Pharma Industry Association (KRPIA) said in a report that local drug prices were at 45 percent level of the average of those of the OECD.

However, Korea’s drug pricing is different from dual pricing systems of other countries, which makes it difficult to identify actual drug prices, the ministry said.

Choi Sang-eun, a professor at Korea University’s College of Pharmacy, said in a recent report that it was impossible to learn the actual prices of expensive drugs such as anticancer treatments. The report was commissioned by the HIRA last year to compare domestic prices of the drugs with those overseas.

hwz@docdocdoc.co.kr

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