Reimbursed Dupixent requires prior prescription record

MOHW announces revised NHI Reimbursement Listing Criteria and Method

For reimbursement, patient needs to show EASI score over 23 before administration

Patients to document daily administration log, healthcare institute to oversee

The reimbursement criteria for patients taking now listed Sanofi Aventis Korea’s severe atopic dermatitis treatment Dupixent Pre-filled syringe 300 mg (dupilumab) were officially disclosed.

 

Reimbursement on the treatment is granted for an adult patient age over 18 with chronic and severe atopic dermatitis symptoms continuing over three years, who has a record of topical treatment and systemic immunosuppressive therapy within six months.

 

And when the patient has to resume treatment after a hiatus with a medical reason would also be granted with reimbursement under certain circumstances.

 

Korea’s Ministry of Health and Welfare (MOHW) recently announced partially revised ‘National Health Insurance Reimbursement Listing Criteria and Method’ reflecting the details of the newly listed atopic dermatitis treatment.

 

Dupixent is a first non-anticancer or rare disease treatment in Korea to have signed the risk sharing agreement (RSA) with the government.

 

However, patients requesting for National Health Insurance reimbursement on the treatment have to qualify for a list of conditions.

 

◆ Patient condition = According to the announcement, the treatment is listed for treating chronic severe atopic dermatitis patient over the age of 18 with symptoms continuing over three years.

 

Also, the adult patient should have symptoms unable to be managed after four-week topical treatment (corticosteroids or calcineurin inhibitor) as first-line treatment, and not showing more than 50 percent decrease of Eczema Area Severity Index (EASI) score after three-month systemic immunosuppressant therapy (cyclosporine or methotrexate), and have EASI score over 23 before administrating the treatment.

 

Also, the patient has to have a record to receiving topical treatment and systemic immunosuppressant therapy within past six months.

 

◆ Reimbursement evaluation = Reimbursement is granted for six months more after 14 weeks of administration and the patient showing more than 75 percent decrease of EASI score at week 16.

 

From then on, reimbursement would be granted continuously when the result of initial evaluation response is maintained in EASI evaluation every six months.

 

By principle, the reimbursement is limited to in-patient prescription only, and an outpatient prescription for a patient discharged from hospital covers four-week of dose of the treatment at most.

 

However, for patients demonstrating stable disease activity and no adverse reaction at week 24 after the initial administration, their outpatient prescription can cover up to eight to 12 weeks of dose.

 

To confirm a patient’s self-injection record during the administration period, the patient has to document ‘daily administration log’ and their healthcare institute has to confirm and oversee the daily log.

 

A doctor specializing in atopic dermatitis related department like a department of dermatology or allergy has to prescribe the treatment, and objective data of the prescribed patient and their response assessment result of multiple dose administration (past treatment record, EASI evaluation result, photos of patient body with symptoms) should be handed in.

 

◆ Reimbursement when resuming treatment after hiatus = Patients needs to pass a certain condition to receive reimbursement again when resuming the treatment after a hiatus for medical reason.

 

Patients, who had a hiatus before the first response assessment at week 16, may receive reimbursement for resumed treatment if the patient qualifies for the initial administration standard (EASI score over 23).

 

On the other hand, two conditions apply for a treatment-resuming patient, who took hiatus after the initial response assessment followed by multiple dose treatment.

 

Resuming after a hiatus shorter than three months would be considered continuous administration.

 

But a patient would have pass the initial administration standard (EASI score over 23) to receive the reimbursement again if the hiatus was longer than three months.

 

MOHW plans to collect public opinion until Jan 30, and to finalize the revision on Jan 31.

 

Contact Pharmaceutical Management Department of Health Insurance Review and Assessment Service (HIRA) for inquiries on the details of the announcement.