AD drug Dupixent’s fails 1st negotiations for RSA renewal

Reimbursement extensions are difficult due to the expected increase in claims amount… expect to reach an agreement in the following negotiations

The first round of negotiations to renew the risk-sharing agreement (RSA) contract for the severe atopic dermatitis treatment ‘Dupixent (dupilumab, Sanofi)’ has fallen through.

 

The company and the National Health Insurance Service plan to discuss Dupixent’s RSA renewal through additional negotiations.

 

According to the industry on the 11th, the first round of negotiations for Dupixent's RSA renewal fell through.

 

Dupixent was listed for reimbursement through the RSA in 2020.

 

Three types of RSA - refund type for initial treatment, refund type, and expenditure cap type, were applied for reimbursement.

 

At the time, the Ministry of Health and Welfare explained, "The pharmaceutical company signed an agreement to refund a part of the amount administered for a certain period of time, and then refund a certain percentage of the drug claims amount to the NHIS while limiting the total expenditure amount." Accordingly, the first biological drug used to treat severe atopic dermatitis was listed with reimbursement in Korea.

 

At the time of the initial reimbursement listing, its subjects were limited to adult patients with moderate-to-severe atopic dermatitis who are not adequately controlled with topical treatments or for whom these treatments are not recommended.

 

However, starting in April of this year, a new reimbursement category was added to reimburse the drug for the treatment of severe atopic dermatitis in children and adolescents aged 6 to 17.

 

Dupixent’s sales rose vividly after the reimbursement listing.

 

Based on IQVIA, it posted sales of KRW 72.2billion in 2021, and KRW 105.2 billion in 2022, As the treatment of pediatrics and adolescent are now also covered and the company is seeking to expand coverage to include severe asthma and atopic dermatitis in infants and toddlers, the amount of health insurance claims are likely to only increase further.

 

Therefore, price cuts and refund rate adjustments are inevitable during RSA contract renewal.

 

With the RSA term expiring by the end of this year, the NHIS and Sanofi were unable to reach an agreement in the first round of negotiations that began at the end of July.

 

However, as additional negotiations are legally granted, it is expected that an agreement will be reached before the end of the RSA term.

 

So far, no final breakdown has occurred during RSA contract renewal negotiations.

 

If the RSA contract is not renewed, the drug will be converted to non-reimbursed status.