First progress to SGLT2i combo reimb. made in 3 years

Expert committee concludes ‘it is necessary to reimburse SGLT-2 inhibitor triple therapy combinations’

Restriction on TZD class drugs to continue… approval of TZD class drugs will be determined separately for each drug

Patients in Korea have come one step closer to receiving reimbursement extensions to SGLT-2 inhibitor combos.

 

This is the first progress that has been made in three years.

 

According to industry sources, the diabetes expert committee that was convened by the Health Insurance Review and Assessment Service earlier this month concluded in the direction of integrating and allowing reimbursement for DPP-4 inhibitor and SGLT-2 inhibitor class and triple therapy combos.

 

However, regarding TZD class drugs with cardiovascular issues, the committee decided to determine the combined use of each TZD class drug separately.

 

Therefore, prescription restrictions on the use of TZD in combos are expected to continue.

 

HIRA is currently discussing formal procedures, including when to put the agenda up for deliberation to the Pharmaceutical Benefit Assessment Committee.

 

The issue has been ongoing for almost 3 years since 2018 when the government’s proposal to ‘amend the reimbursement standards to approve combined use of drugs by class’ to improve convenience and coverage for the patients.

 

However, the amendment was put on hold due to the lack of efficacy data in some drugs that have no clinical studies conducted, and the academia’s opposition that reimbursement should be only allowed according to each drug’s indication.

 

However, academia had first ignited the discussion on expanding reimbursement for diabetes drug combos as the different indications of drugs in the same class lead to confusion in the field and insurance cuts.

 

The case was no different in 2013 when reimbursement was extended to DPP-4 inhibitor and thiazolidinedione class drug combinations.

 

However, the end results were completely different.

 

However, academia, which had always stressed the importance of clinical experience and expert judgment over indications or fiscal impact, had made a very different decision for the use of SGLT-2 inhibitor combos.

 

As a result, the ‘class effect’ of SGLT-2 inhibitors were the only ones not recognized under the reimbursement standards among all oral diabetes drugs in Korea.

 

However, academia had later submitted a statement recognizing the need for reimbursing SGLT-2 inhibitor combos, under which the MFDS had announced that it will ‘simplify’ the method of listing indications of diabetes treatments from ingredients to just ▲single or ▲combination therapy.

 

And HIRA came to a positive conclusion this time.

 

Currently, four SGLT-2 inhibitors - ‘Forxiga (dapagliflozin),’ ‘Jardiance (empagliflozin),’ ‘Suglat (ipragliflozin),’ and ‘Steglatro (ertugliflozin) – are being sold in Korea.

 

For all 9 DPP-4 inhibitors in the Korean market to establish grounds for combined use according to principle, clinical studies on 36 combinations need to be conducted.

 

In the same sense, 8 clinical studies are required to establish evidence for the combined use of 2 TZDs and 4 SGLT-2 inhibitors.