Severe atopic drug Dupixent listed, first benefit from RSA

Price of ₩710,000 was approved at Health Affairs Face-up Meeting, effective on the 1st of next month

Put the 'cap' on the required finances with the initial treatment refund type and the total amount limit type

Sanofi Aventis' treatment for severe atopic dermatitis, Dupixent PFS 300mg (Dupilumab), will be listed next month after all of its reimbursment hurdles.

 

Although it was not an anticancer drug or a rare disease treatment agent, there was a difficulty in expanding the RSA, but the government and the health authorities were able to follow this track as they decided to expand the RSA disease.

 

The MFDS held a Health Insurance Policy Deliberation Committee this afternoon, saying Dupixent's reimbursement was resolved.

 

Dupixent was the first to be listed due to the expansion of RSA diseases.

 

According to the resolution, the drug is listed on the first day of next month as an RSA with a combination of initial treatment refund type, refund type and total limit type.

 

The reimubrsed price is ₩710,000 per syringe.

 

The RSA initial treatment reimbursement type included in this drug contract is the reimbursement by the pharmaceutical company to the NHIS for the initial period of time.

 

In addition, the refund type refers to the pharmaceutical company refunding a certain percentage of the drug bill to the NHIS, and the total limit contract is the mechanism by which a pharmaceutical company refunds a certain percentage of the amount to the NHIS if the actual amount exceeds the pre-set annual expected cap.

 

Dupixent entered the domestic market in earnest with the approval of the MFDS on March 30 last year.

 

Following the application for insurance registration on Feb 22 this year, the Pharmaceutical Benefits Evaluation Committee (Pharmaceutical Committee) was determined to be eligible for RSA on July 25.

 

Later, on October 10, Formulary approval was recognized.

 

The drug price negotiations with the NHIS were held from Oct 22 to Dec 17.

 

At the time of deliberation, the textbook and clinical guidelines indicated clinical usefulness in severe atopic patients who were not adequately controlled or recommended by local or systemic immunosuppressants.

 

Indeed, the cost of one-day administration is more expensive than alternative drugs, but the cost-effectiveness is considered to be acceptable through additional RSA and economic evaluation.

 

Looking at the prices of major seven countries (A7) referring to the prices, they are listed in the United States, Italy, the United Kingdom, France, Germany, and Japan, and the A7 foreign drug prices (adjusted average price) are set at ₩ 971,661 per syringe.

 

Meanwhile, the annual fiscal expenditures (estimated billings) presented during the drug price negotiations with the NHIS are about ₩76.2 billion.