Ilaris·Latuda newly reimb…Dupixent’s reimb extended

Dupixent’s extended scope of reimbursement will cover infants and young children

MOHW preannounces revision of the Drug Reimbursement Standards...expected to take effect on Aug. 1

New insurance reimbursement standards will be established for Novartis Korea’s Novartis' Ilaris (canakinumab), which is used to treat hereditary recurrent fever syndrome, and Bukwang Pharmaceutical’s imported drug Latuda (lurasidone HCI), which is used to treat schizophrenia and bipolar I depression.

 

Also, the scope of reimbursement for Sanofi's severe atopic dermatitis treatment Dupixent (dupilumab) will be extended to cover infants and children 6 months to 5 years of age.

 

On the 19th, the Ministry of Health and Welfare made a preannouncement of an administrative notice on the 'Partial Amendment to the Details on the Standards and Methods for Applying Medical Care Benefits’ and implemented the new standards starting on August 1st.

 

◆Ilaris Inj=Among its indications, the drug’s indications for Cryopyrin-Associated Periodic Syndromes  (CAPS), Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), and Familial Mediterranean Fever (FMF) were deemed eligible for reimbursement.

 

Otherwise, it is non-covered and the patient is responsible for the full cost of the drug.

 

For CAPS, pediatric and adult patients 2 years of age and older with a confirmed NLRP3 gene mutation are eligible for reimbursement.

 

Patients must meet both criteria for reimbursement: confirmed moderate-to-severe disease activity, and C-reactive protein (CRP) or serum amyloid A protein (SAA) >10 mg/L.

 

In addition, the patient has to satisfy one of the following conditions: patients with Familial Cold Autoinflammatory Syndrome (FCAS)/Familial Cold Urticaria (FCU), Muckle-Wells Syndromes (MWS), who are unable to perform activities of daily living; or have a confirmed diagnosis of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)/ Chronic Infantile Neurologic, Cutaneous, and Articular Syndrome (CINCA).

 

In TRAPS, children and adults 2 years of age and older with a confirmed TNFRSF1A gene mutation will be eligible.

 

The patient needs to meet both of the following criteria: confirmed moderate-to-severe disease activity and a C-reactive protein (CRP) or serum amyloid A protein (SAA) level of 10 mg/L or greater.

 

IN FMF, children and adults 2 years of age and older with a confirmed MEFV gene mutation are eligible.

 

These patients also need to satisfy all of the following three conditions for reimbursement: confirmation of moderate-to-severe disease activity; C-reactive protein (CRP) or serum amyloid A protein (SAA) of 10 mg/L or higher; and inadequate response to colchicine after 3 months of treatment, or inability to receive colchicine due to contraindications or side effects.

 

◆Latuda Tab= A new reimbursement standard will be set for oral lurasidone HCI 20mg.

 

In principle, it is reimbursable when administered within the scope of its indication.

 

When used for depression in individuals 24 years of age or younger, careful consideration should be given to whether the clinical benefit outweighs the risk, as indicated by the labeling (warnings, adverse reactions, general precautions, etc.) ◆Dupixent Inj=THe reimbursed indications for Dupilumab Prefilled Inj 300 mg will be extended.

 

Currently available in children 6 to 11 years of age, its reimbursement will be extended to cover patients with chronic severe atopic dermatitis 6 months to 5 years of age.

 

Patients must meet both of the following conditions for reimbursement: the condition has not been adequately controlled with first-line topical therapy (moderate-or-stronger corticosteroids or calcineurin inhibitors) for at least 4 weeks or is unable to use such due to side effects; EASI 21 or higher prior to initiation of treatment.