Combination of Epidiolex & Clobazam are reimbursed

The HIRA provides guidance on how to administer and evaluate

Starting this month, detailed standards for the health insurance application of "Epidiolex (Cannabidiol)," used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex, have been unveiled.

 

The HIRA recently released 'Question and Answer on Applying Benefit Standards to Epidiolex' and guided details on targets and methods of evaluation.

 

Epidiolex was Emergency Use Medication by the MFDS for the use of "the treatment of Lennox-Gastaut syndrome and seizure related to Dravet syndrome" in patients over the age of two.

 

It was supplied to Korea through the Korea Organ & Essential Drug Center from April 1st.

 

Epidiolex can be reimbursed if ▲ the requirements for not showing a reduction in seizure frequency with other antiepileptic drugs are met or ▲ has a history of administration of antiepileptic drugs before Epidiolex.

 

However, the history of administration of antiepileptic drugs before administration of the drug means "the history of more than five of the 11 antiepileptic drugs prescribed in the detailed recognition criteria for care benefits being administered at sufficient internal medicine capacity." The administration history should be checked by detailed medical records.

 

The requirement for patients who have not shown a decrease in seizure frequency with other antiepileptic drugs refers to "the frequency of seizures did not decrease by more than 50% compared to the time of initial antiepileptic drugs even though more than five of the 11 drugs were administered with sufficient internal medicine." Patients who administer Epidiolex only can be reimbursed in combination with Clobazam.

 

If Clobazam cannot be administered, Epidiolex will be reimbursed if detailed medical records confirm it.

 

The HIRA also detailed the 'methods of assessment for sustainable investment'.

 

It explained that for an additional 3 months after the first 3 months of Epidiolex administration, the seizure frequency should be reduced by more than 50% for the first 3 months of the drug, and for continuous additional administration after the first 6 months of the drug, the seizure frequency should be reduced by 50% or more.

 

In order to evaluate the appropriateness of continued administration of Epidiolex and prevent drug abuse, patients or guardians should fill out the seizure log with frequency of seizures and whether Epidiolex is administered, and medical institutions should manage it.

 

As for patients who have already been administered Epidiolex since April 1st, it is considered to meet the requirements for the benefit ▲if the criteria for detailed recognition of medical benefits at the time of initial administration of the drug, ▲if the 'subject to administration' requirements are met and can be verified through the details of the medical records, and ▲ five or more of the 11 types of antiepileptic drugs can be checked in detail in the medical records, and the necessity and appropriateness of the drug launch are considered to meet the requirements of the benefit unit if confirmed by a specialist.

 

It can be administered continuously if the assessment method for patients three months after Epidiolex administration for non-reimbursement meets Da-1 of the criteria for detailed recognition of medical benefits at the time of initial effectiveness assessment (three months after administration of the drug), or if the seizure frequency is maintained by more than 50% compared to the initial dose of the drug, or if it is confirmed by experts that treatment effects and continuous administration are necessary after the drug is started.