Dupixent receives the green light for reimb extensions

to severe AD and asthma in infants and toddlers

Experts at the expert advisory meeting determined that reimbursement extensions to infants and young children are justifiable

Prepared a plan to expand reimbursement standards for asthma as well...Will begin cost-effectiveness review

The insurance authorities showed a positive stance on expanding coverage of Dupixent (dupilumab, Sanofi), which is available for patients with severe atopic dermatitis from 6 years of age, to critically ill infants and toddlers from 6 months to 5 years of age.

 

Depending on the cost-effective review results, the reimbursement process may gain momentum in the future.

 

In addition, it appears that the authorities are also reviewing reimbursing the drug for another indication, asthma.

 

The Health Insurance Review and Assessment Service recently revealed so in response to a written inquiry they received at the NA audit.

 

Last April, Sanofi applied HIRA to expand reimbursement so that infants and young children with symptomatic atopic dermatitis from 6 months to 5 years of age can also receive reimbursement for the drug.”.

 

Dupixent obtained the relevant indication from the Ministry of Food and Drug Safety on November 3 last year.

 

The indication was approved based on the results of a Phase III clinical trial (LIBERTY AD PRESCHOOL) that was conducted on atopic dermatitis patients aged 6 months to 5 years of age, which confirmed a significant improvement in AD lesions compared to the placebo group.

 

HIRA subsequently held an expert advisory meeting and reported the review plan to the Ministry of Health and Welfare to secure the feasibility of expanding Duppixent’s reimbursement to infants and toddlers.

 

A full-scale cost-effectiveness evaluation will be conducted accordingly.

 

Regarding the application of reimbursement for the asthma indication, the agenda is also expected to enter the cost-effectiveness evaluation stage soon.

 

It is said that the reimbursement standards were set after two expert advisory meetings held to prepare the reimbursement standards.

 

Dupixent is indicated for severe eosinophilic asthma and oral corticosteroid-dependent severe asthma in adults (aged 18 and older) and adolescents (aged 12 to 17).

 

At the expert advisory committee that took place last July, the members decided that the reimbursement standards should be set, but undergo additional expert advice on the unification of terminology and detailed standards with other drugs in the process of being listed for reimbursement for the same indication.

 

Additional expert advice and opinion collection were conducted thereafter.

 

Based on this, if a reimbursement standard plan is prepared and reported to the Ministry of Health and Welfare, a cost-effectiveness evaluation for the indication will also begin, similar to the case of AD in infants and toddlers.

 

As Cinqair Inj and Nucala Inj, which are biological asthma drugs, have recently succeeded in being reimbursed, the possibility of Dupixent's successful reimbursement expansion has also been increasing.

 

Of course, it takes a considerable amount of time to evaluate cost-effectiveness and it is not easy to pass, so it is currently impossible to predict when the reimbursement expansion will take place.

 

Nevertheless, as the feasibility of expanding the salary standard has been recognized, it is expected that the reimbursement process can accelerate if pharmaceutical companies are willing to present appropriate cost-sharing plans.

 

In addition to the reimbursement extension, Dupixent is also in the process of renewing its risk-sharing contract.

 

After the first round of RSA renewal negotiations broke down, it seems highly likely that a contract renewal will be agreed upon in the second round of negotiations.

 

Attention is being paid to whether Dupixent's Sanofi will be able to kill two birds with one stone, by expanding reimbursement and renewing the risk-sharing agreement, remains to be seen.

 

Based on IQVIA, Dupixent posted sales of KRW 105.2 billion in 2022.

 

As claims are expected to increase further this year due to reimbursement extension to children and adolescents, there is a possibility that the pharmaceutical company's share of the burden will increase with the renewal of the risk-sharing system.