The Health Insurance Review and Assessment Service (HIRA) announced reimbursement criteria for the Nucala Autoinjector (mepolizumab) for patients with severe eosinophilic asthma, effective from May 1.
GSK Korea’s self-injectable Nucala Autoinjector won reimbursement for severe eosinophilic asthma, allowing eligible patients aged 12 or older to receive long-term prescriptions for at-home treatment. (Credit: GSK Korea)
The revised criteria reimburse Nucala Autoinjector for patients aged 12 or older with severe eosinophilic asthma whose disease remains uncontrolled despite treatment with high-dose inhaled corticosteroids and long-acting beta2 agonists (ICS-LABA), or long-acting muscarinic antagonists (LAMA).
Patients are eligible if their blood eosinophil count was 300 cells per microliter or higher within one year before starting treatment and they had four or more exacerbations requiring systemic corticosteroids within the same period, or if they had received continuous oral corticosteroids for six months before treatment.
Patients become eligible if they present with a blood eosinophil count of 400 cells per microliter or higher within 1 year before treatment and have three or more exacerbations requiring systemic corticosteroids during the same period.
Because the Nucala Autoinjector enables self-injection, patients must keep a medication diary to confirm their treatment period, while medical institutions manage the records. For long-term prescriptions, physicians may write one prescription for eight to 12 weeks for discharged or outpatient patients, with both in-hospital and outside prescriptions permitted.
Patients who show stable disease activity and no adverse effects six months after the first dose may receive prescriptions reimbursed for up to 24 weeks.
The Nucala Autoinjector lets patients administer the drug at home. In a usability study, 102 of 103 patients self-administered the treatment successfully, achieving a 99 percent success rate. The company found that most patients preferred the autoinjector and considered it convenient.
Clinical data showed that the autoinjector matched the pharmacokinetic and safety profile of the lyophilized formulation. In the usability study, 96 percent of patients found the autoinjector easy, convenient, and expressed high confidence in self-administration.
"Reimbursement for Nucala Autoinjector, the self-injection formulation of Nucala, one of the major treatments for severe eosinophilic asthma, enables us to provide more patients with treatment convenience through self-administration at home," said Lee Dong-hoon, business unit head of the general medicine and specialty business unit at GSK Korea. "With the addition of long-term prescription criteria through this reimbursement, we aim to create a treatment environment that allows patients to continue both daily life and therapy."
Lee Han-soo
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