The government expects the ‘Measures to Improve Patient Access and Reinforce Reimbursement Management for High-Priced Severe Disease Treatments’ that gained industry attention for increasing the
scope of use of the pharmacoeconomic evaluation exemption system (PE exemption system) will be applied to drugs that apply for reimbursement in January.

In other words, the government plans to confirm and apply final revisions in December. The revisions to the Health Insurance Review and Assessment Service’s guidelines are currently complete and are being reflected in the National Health Insurance Service’s detailed standards for negotiations (negotiation guidelines). After the process is complete, it will be possible to extend the application of the PE exemption system to pediatric new drugs that apply for reimbursement in January.

In the case of the 200 set as the ‘small number of patients’ standard, the government reaffirmed its position that extending PE exemption to drugs for adults deviates from the purpose and priority of reimbursement while emphasizing the flexibility of the Drug Reimbursement Evaluation Committee review as it had responded at the last NA audit.

Chang-Hyun Oh, Director of the Pharmaceutical Benefits Division replied so at the QA session on pending issues at a recent meeting with the multinational pharmaceutical company press on the 29th. Also, Oh drew the line and said that it was different from the government’s intentions regarding the market’s prediction that the measures will be immediately applied from November upon notice.

The following is the QA script between the press corp and Director Oh.

▶After the administrative notice, HIRA has not yet publicly announced the expansion of the PE exemption system to pediatric drugs. Were there any problems in the implementation process?
“We are currently changing the NHIS negotiation guidelines. The Measures to Improve Patient Access and Reinforce Reimbursement Management for High-Priced Severe Disease Treatments does not only include expanding PE exemptions to pediatric drugs. It also includes the expedited listing of severe disease treatments and expanding the scope of reference countries to A9 which is set for December 11. These revisions have to be made collectively (none of them have been publicly announced yet). We will be able to confirm and revise the plan in December.

▶The pharma and bio industry expected the measures to be implemented immediately upon notice this month (in November) and awaited HIRA’s public notification. But at the current pace, the system will be applied next year at the earliest. Is this a delay or a deferment?
“Since other revisions that need to be implemented also need to be reviewed and unilaterally implemented, the measure will be applicable to drugs that apply for reimbursement from January. Since the government had not announced that it will be implemented from November, it is not a delay."

▶The industry is still strongly voicing the need to extend the PE exemptions to drugs used in adults.”
“A clause ‘drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option, and demonstrates improvement in quality of life or is otherwise approved by the committee’ has been added to HIRA’s guidelines. At the same time, ‘when the drug’s main indication is for pediatric patients’ condition has been added to NHIS’s reimbursement standard procedure improvement plan. As these two are being applied together, reimbursement will be extended to drugs whose main indication is for ‘pediatric’ patients among drugs used for both children and adults. Therefore, the extension will be applied to pediatric patients. There have been many requests for expanding the reimbursement benefit to drugs that affect adult patients. We can review it, but our current priority is in benefiting pediatric patients rather than adults.”

▶The NA and others have pointed out how the extension had rather raised the threshold for PE exemptions and reimbursement. What is the government’s opinion on this?
"I have already explained the reason why the ‘small number of patients’ clause had been included at the past NA audit. The restriction was set to clarify that PE exemptions are applied when the drugs have difficulty producing evidence. DREC had answered to the National Assembly that it will deliberate reimbursements in consideration of the severity of the disease for drugs that affect a small number of patients. The same is true for the 200 range that had been set. Considering the severity of the disease, even if the number of patients exceeds 200, the drug can be considered and reviewed as a drug that affects a small number of patients. I believe DREC will make a reasonable decision."