KDA finally agrees on SGLT2 inhibitor benefits

Korean Diabetes Association delivers an official statement to the government about the coverage

HIRA to further collect opinions from Korean Endocrine Society and MFDS

SGLT-2 inhibitors approved in Korea

The Korean Diabetes Association (KDA) has finally reached an agreement on expanding reimbursement on sodium-glucose transport protein 2 (SGLT2) inhibitor combination therapy.

 

KDA has submitted a statement to the Korean government regarding the needs of expanded coverage on SGLT2 inhibitor plus off-label diabetes treatments, including dipeptidyl peptidase 4 (DPP-4) inhibitor or thiazolidinedione (TZD).

 

The academy has begun fine-tuning their opinions on the reimbursement expansion for the SGLT2 inhibitor combination therapy after the 11th president, Professor Yoon Geon-ho (department of endocrinology at Seoul St.

 

Mary’s Hospital), was appointed in last January.

 

The talks on reimbursed use of the combination therapy actually was started by the medical professionals.

 

Due to the differences in reimbursed indications among same-class drugs, the prescribers have been confused and experienced reduction in expected reimbursement and other inconveniences.

 

Accordingly, the government has started accepting their opinion officially, but the academy itself had internal dispute.

 

Some argued reimbursement expansion should be handled carefully on drugs without clinical evidences, regardless of other reimbursed drugs in the same class.

 

As the closely related academy seemed to be doubtful, the government has halted reimbursement expansion discussion until now.

 

Regarding the issue, Health Insurance Review and Assessment Service (HIRA) official stated, “Based on the statement by KDA, HIRA would further accept and review more opinions submitted by Korean Endocrine Society, other academic societies and Ministry of Food and Drug Safety that grants the approval.” Currently, there are four SGLT2 inhibitors available in Korean market—Forxiga (dapagliflozin), Jardiance (empagliflozin), Suglat (ipragliflozin) and Steglatro (ertugliflozin).

 

Total of 36 clinical studies would have to be conducted for all combinations of therapies, based on nine DDP-4 inhibitors and the four SGLT2 inhibitors commercialized in Korea, to acquire proper data for approval according to the principle.

 

In the same sense, combination therapies with two TZDs and four SGLT2 inhibitors should undergo total eight clinical trials.