Manufacturers of choline alfoscerate, a dementia drug, are reportedly preparing to file an administrative lawsuit against the government for limiting the national health insurance benefit for the medication from September.

The Ministry of Health and Welfare on Wednesday put a public notice about details on the renewed standards and methods of applying insurance benefits to choline alfoscerate drugs, following the reassessment of the drug’s reimbursement.

The government announced earlier that it would allow insurance benefits for the drug only for the secondary symptoms caused by cerebrovascular defects and degenerative organic brain syndromes such as poor memory, direction sensation disorder, lack of motivation, and decreased concentration.

However, the medicine will not get the insurance benefit for symptoms, including emotional and behavioral changes, anxiety, irritability, indifference by people around, and masked depression of the elderly. In this case, choline alfoscerate will get a “selected reimbursement” where the patient pays 80 percent of the cost.

The Ministry of Food and Drug Safety requested choline alfoscerate sellers to submit clinical trial plans by the end of the year.

To keep the prescription drug status of choline alfoscerate, the drugmakers must submit plans to prove the drug’s effectiveness in clinical trials. The issue here is “how to set variables for the evaluation of efficacy.”

Italfarmaco, the original developer of choline alfoscerate, evaluated the drug’s efficacy in combination with donepezil, another dementia treatment adjuvant, in the ASCOMALVA study. The combined effect is the reason why the drug’s efficacy became controversial, prompting the authorities to order the drugmakers to reevaluate it in new clinical trials.

Last year, critics said the government was squandering the funds of the Health Insurance Review and Assessment Service by allowing choline alfoscerate to be used for a too wide scope of dementia treatment. The regulator also deleted donepezil’s indication for vascular dementia.

To receive full insurance benefits for choline alfoscerate, local pharmaceutical firms should conduct trials to prove that the drug can improve symptoms including reduced memory, direction sensation disorder due to lack of motivation, and decreased concentration.

The food and drug safety ministry has allowed drug companies to jointly conduct tests, as clinical trials require a massive capital.

Whether drugmakers could maintain the 350 billion won annual sales of choline alfoscerate will hinge on their plans of the drug reevaluation through clinical trials, observers said.

kym@docdocdoc.co.kr

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