The domestic diabetes treatment market will likely undergo fierce competition as new SGLT-2 inhibitors, including the generic products of patent-expired Forxiga (dapagliflozin), new drug enavogliflozin, and other combo drugs will hit the market next month.
The Ministry of Health and Welfare has put three enavogliflozin products – Daewoong’s Envlo, Daewoong Bio’s Benavo, and HanAll Biopharma’s Eaglex – on its reimbursement list starting this month.
Enavogliflozin is the first sodium-glucose cotransporter 2 inhibitor. Envlo received approval from the Ministry of Food and Drug Safety to be used for type-2 diabetes alone or as a combination therapy on Nov. 30. Benavo and Eaglex were approved a week later.
According to revised reimbursement standards, enavogliflozin can receive insurance benefits only when used as a two-drug therapy with metformin.
Other SGLT-2 inhibitors, such as dapagliflozin, ipragliflozin, empagliflozin, and ertugliflozin, can be used with metformin and sulphonal urea (SU) as a two-drug therapy.
Starting this month, the insurance authorities also reimburse the three-drug therapy of metformin + SGLT-2 inhibitor + thiazolidinedione (TZD). However, they excluded ertugliflozin and enavogliflozin from reimbursement. They also did not recognize reimbursement for the combined use of enavogliflozin and insulin injections.
The revised standards also recognized reimbursement for four compound products of dapagliflozin and SU-family’s glimepiride. They are Jinyang’s Dapagreen G, Hutecs Korea’s Gluxiga, KyungDong’s Dapamepi, and Mother’s Pharm’s Xig Double M.
Usually, type-2 diabetes treatments receive reimbursement by adding combination drugs when they fail to control hemoglobin A1C (HbA1C) based on metformin. Accordingly, SGLT-2 inhibitor combo drugs use the combination with metformin most frequently. Currently, combinations of the original drug Forxiga with Jardiance (empagliflozin), such as Xigduo and Jardiance Duo, are used widely.
However, patients who are forbidden to use metformin or cannot use it due to side effects can use two-drug therapies, including SU-class drugs, with insurance benefits from the start. With the reimbursement registration of four more compounds, including Dapagreen G, type-2 diabetes patients who cannot start treatment with metformin can also begin treatment by taking one pill a day.
Also, the revised standards recognized five compounds of SGLT-2 inhibitors and DPP (dipeptidyl peptidase)-4 inhibitors – LG Chem’s ZemiDapa (dapagliflozin/gemigliptin), Chong Kun Dang’s Exiglu S (dapagliflozin/sitagliptin), AstraZeneca’s Qtern (dapagliflozin/saxagliptin), Behringer Ingelheim’s Esglito (empagliflozin/linagliptin), and MSD’s Stegluzan (ertugliflozin/sitagliptin).
However, they can get reimbursement only when used in combination with metformin. In other words, reimbursement is available only for the combination of metformin + SGLT-2 inhibitor + DPP-4 inhibitor from this month.