Sixty-six manufacturers of choline alfoscerate, a dementia drug, filed an appeal to the Health Insurance Review and Assessment Service (HIRA), protesting the agency’s recent decision to limit the national health insurance benefit for the medication.

According to the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), the 66 sellers of choline alfoscerate released the appeal statement on Wednesday.

The Korea Pharmaceutical and Bio-Pharma Manufacturers Association said 66 pharmaceutical companies protested the government’s decision to limit the national health insurance benefit for choline alfoscerate. (KPBMA)

“After winning approval and the renewed license from the Ministry of Food and Drug Safety, choline alfoscerate has been prescribed for over 20 years,” the statement said. “We decided to request HIRA to re-evaluate the validity of reimbursement for choline alfoscerate.”

On June 11, HIRA held a meeting of the Health Insurance Drug Reimbursement Committee and decided that choline alfoscerate would receive the national health insurance benefit only for severe and general dementia. For other indications, choline alfoscerate will get a “selected reimbursement” where the patient pays 80 percent of the cost, instead of the current 30 percent, HIRA said.

However, the decision brought an instant backlash from the 66 pharmaceutical firms. According to the companies, limited reimbursement would raise patients’ out-of-the-pocket costs. Also, HIRA did not distinguish the severity of dementia when making the decision, and undermined the basis for re-assessment of the drug’s efficacy and safety, the companies said.

HIRA’s ruling to ask patients to pay 80 percent of the drug cost for all the other indications except for dementia shows that the agency did not reflect social demand in the re-evaluation of choline alfoscerate, the firms said.

“Increasing individuals’ out-of-the-pocket expense rate from 30 percent to 80 percent contradicts the government’s healthcare policy that aims to lower patients’ medical expenses and improve access to healthcare,” the companies said in the statement.

The rate hike would mainly force the economically vulnerable elderly group to discontinue their medication, they claimed.

The appeal's filing is expected to prolong the conflict between the drug authorities and the pharmaceutical industry.

However, some criticized the drugmakers for demanding excessive reimbursement without verifying the drug’s usefulness.

Lee Dong-geun, secretary-general of the Association of Pharmacists for Healthy Society (APHS), said the selective reimbursement is to differentiate reimbursement rates by considering the cost-effectiveness of a drug.

Thus, the reimbursement for choline alfoscerate has reflected “excessive social needs” so far because the drug’s usefulness has never been verified, he added.

kch@docdocdoc.co.kr

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