[Reporter’s View] Reimb for SLGT-2i combo still in discussi

When will a conclusion ever be made?

The agenda has been in the last stages of review for 5 months.

 

At this pace, discussions on expanding reimbursement of SGLT-2 inhibitors as combination therapy may again be passed on to the next year.

 

The discussion on expanding reimbursement of SGLT-2 inhibitors as combination therapy has remained stagnant for a long time.

 

After no progress being made for over 3 years, the industry saw hope in listing their fixed-dose combinations with the Health Insurance Reimbursement and Assessment Service’s diabetes expert committee agreeing on integrating and recognizing reimbursement for the combined use of DPP-4 inhibitors and SGLT-2 class drugs and three-drug combination therapies.

 

However, the year has changed since then, and no news of reimbursing of SGLT-2 inhibitor combos, which are under formal review by HIRA, has been released until now.

 

HIRA had announced that the agenda was "in the final stages of determining reimbursement standards" in June, but now it is November.

 

Moreover, SGLT-2 inhibitors are now under further pressure with the imminent expiry of their post-marketing surveillance term.

 

Most of the SGLT-2 inhibitor drugs are required to submit PMS results by 2023-2024.

 

This means the companies have only 1 to 2 years until the deadline.

 

For PMS, companies need to secure and register hundreds to thousands of patients in their study.

 

However, due to the characteristic of Korea’s antidiabetic drug market, non-reimbursed drugs cannot attract and make prescriptions.

 

Unless the reimbursement issue is resolved, it would be virtually impossible for companies to fulfill the number of patients for PMS as required by the Ministry of Food and Drug Safety.

 

A conclusion has to be made one way or another.

 

The academic society has found consensus and submitted its opinion statement recommending reimbursement to be expanded to combination therapy, and the MFDS had changed the labeling category for SGLT-2 inhibitors from by ingredient to ▲monotherapy or ▲combined therapy.

 

The baton is now in HIRA’s hands, and the institution must now cross the finish line.

 

Also, an institutional arrangement should also be made.

 

SGLT-2 inhibitor combinations are also prescription drugs, and there is no harm in playing caution.

 

Although the government had taken too long, such a cautious stance was also necessary.

 

If the class effect of SGLT-2 inhibitors is to be recognized, guidelines on 'the amount of time required to obtain sufficient prescription experience or the amount of prescription' should also be soon prepared.