Three makers of SGLT-2 inhibiting antidiabetic drugs said they would seek changes in approval conditions to allow their drugs to be used in combination with DPP-4 inhibitors in November.
The move draws attention to whether the state health insurance review agency will resume the discussion to approve insurance benefits for combo drugs mixing SGLT-2 inhibitors and DPP-4 inhibitors.
AstraZeneca, Boehringer Ingelheim, and MSD said they would apply for approval condition changes for SGLT-2 inhibitors as early as Nov. 3.
In August, the food and drug safety ministry revised the rules to describe combo therapy’s efficacy against type-2 diabetes. With the revision, drugmakers can group medicines by efficacy, rather than listing all the drugs available for combination therapy by product name.
In early this year, the Korean Diabetes Association and the Korean Endocrine Society submitted their opinions to the Health Insurance Review and Assessment Service (HIRA) to request reimbursement for combo treatments among SGLT-2 inhibitors, DPP-4 inhibitors, and thiazolidinedione (TZD). They also argued that HIRA should review combo treatment reimbursement based on drug classes.
To do so, the food and drug safety ministry should first change how it states approval conditions, health experts said, and the ministry accepted their opinion.
Although the ministry’s revision of rules allowed drugmakers to apply for reimbursement for combos of SGLT-2 inhibitors and DPP-4 inhibitors, the discussion for insurance benefits will start only after the ministry grants changes in approval conditions, HIRA said.
“After the ministry changes approval conditions for antidiabetic drugs, we will discuss changing the insurance criteria,” an official at HIRA said.
The comment indicates that the three companies could push for insurance benefits for combo therapy.
An official at MSD said the company would apply for changes in approval conditions on Nov. 3. AstraZeneca and Boehringer Ingelheim also said they would follow suit swiftly.
AstraZeneca owns Forxiga (ingredient: dapagliflozin), the leading product in the 90 billion won SGLT-2 inhibitor market, and Boehringer Ingelheim’s Jardiance (empagliflozin) occupies almost all of the rest market share.
Steglatro (ertugliflozin), the latecomer by MSD, sells only 1.5 billion won per year, almost invisible in the domestic SGLT-2 inhibitor market.
The three drugmakers all own combo therapies of SGLT-2 inhibitor plus DPP-4 inhibitor. In the much larger DPP-4 inhibitor market worth 500 billion won in Korea, MSD has the upper hand.
It is unpredictable which company will become a leader in combination therapy if the government grants reimbursement.