GSK Korea's inhalation-type triple combination asthma medicines Trelegy 100 Ellipta (fluticasone furoate/umeclidinium/vilanterol) and Trelegy200 Ellipta will get health insurance benefits starting this month.

According to a notice by the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service, Trelegy 100 and 200 Ellipta have been approved for the maintenance therapy of adult (18 years of age or older) asthma patients who have experienced at least one severe exacerbation within 12 months despite the combination maintenance therapy of moderate or high-dose inhaled corticosteroids and long-acting inhaled beta-2 agonists, and vilanterol triphenate + fluticasone furoate inhalation, which are the same as the same drug, by meeting the respective notifications. If a patient is concurrently taking umeclidinium inhalation and wishes to switch to this medication by the labeling for this medication, coverage will be authorized, GSK Korea said on Monday.

Trelegy Ellipta is a triple therapy treatment, a metered-dose inhalation administered once daily at the same time. Trelegy Ellipta combines an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-agonist (LABA) to reduce inflammation and dilate bronchioles in people with asthma. The company added that Trelegy Ellipta has a longer duration of action compared to existing treatments, allowing patients to take fewer doses.

In particular, Trelegy 100 Ellipta was approved for health insurance coverage as a maintenance therapy for COPD (chronic obstructive pulmonary disease) in June 2021, which has now been expanded to include asthma.

Asthma is a chronic, allergic, inflammatory disease of the airways characterized by airway hyper-responsiveness and reversible airway obstruction. When certain allergens are inhaled, the bronchial tubes become inflamed, swollen, and constricted, causing severe narrowing of the bronchi, resulting in varying degrees of wheezing, shortness of breath, chest tightness, and cough. Some 30-50 percent of patients with moderate/severe asthma experience difficulty controlling their symptoms despite ICS/LABA inhaler therapy, suggesting a need for step-up therapy, in which patients move up a level of medication based on their symptoms after a two-drug regimen.

The Trelegy 100 and Trelegy 200 Ellipta asthma reimbursement is based on U.S. real-world evidence (RWE) data from 890 adult asthma patients aged 18 years and older who initiated asthma treatment with Trelegy Ellipta between September 2016 and March 2020.

In addition, the primary efficacy endpoint of the CAPTAIN study, a phase 3 clinical trial of 2,436 adults 18 years and older with asthma who were uncontrolled on ICS/LABA maintenance therapy, Trelegy Ellipt significantly improved lung function. Compared to Relvar Ellipta (fluticasone furoate/vilanterol), Trelegy Elliptas improved lung function by 110 mL (95 percent CI: 66-153) and 92 mL (95 percent CI: 49-135) more at week 24 for both Trelegy100 and Trelegy 200 Ellipta doses.

The improved lung function in the Trelegy Ellipta group was also consistent for both Trelegy 100 and Trelegy 200 Ellipta doses, as measured by the change in FEV1 (forced expiratory volume in one second) from baseline three hours after dosing.

"Asthma is a chronic respiratory disease that requires lifelong management, and it is important that patients who experience asthma exacerbations receive appropriate treatment," said Professor Chung Jae-won of the Inje University Ilsan Paik Hospital. "Major guidelines recommend triple therapy with an ICS/LABA plus LAMA as the optimal treatment for patients with severe asthma whose symptoms are not controlled by a two-drug ICS/LABA regimen before starting oral corticosteroid therapy."

Lee Dong-hoon, executive vice president of GSK Korea's General Medicine Division, said, "Trelegy Ellipta, an ICS/LAMA/LABA triple combination, has demonstrated an excellent therapeutic effectiveness and safety profile in clinical studies, including improved lung function and asthma symptom control in patients with asthma, making the three-drug once-daily regimen an effective treatment option for asthma as well as COPD. We expect this coverage to provide treatment benefits and convenience for asthma patients in Korea who have difficulty controlling their symptoms."