The benefit discussion for Steglatro was excluded

In the combined benefit criteria with TZD

The HIRA discusses SGLT2 3 treatment benefit standards, analyzing financial impact

This is because the combined effectiveness of clinical trials has not been verified

While the HIRA is discussing the standard for combination therapy benefits for SGLT-2-suppressing diabetes treatments, only Steglatro (MSD Korea) has been excluded from the combination of TZD affiliates, drawing attention.

 

While the combination of DPP-4 inhibitors between families is recognized, the combination between TZD families is differentiated by component.

 

Kim Ae-ryeon, head of the HIRA Pharmaceutical Management Office, said at a briefing with the Korea Special Press Association on the 14th that she is conducting a financial impact analysis after reviewing the benefit criteria for Metformin + SGLT-2 inhibitor + DPP-4 inhibitor and Metformin + SGLT-2 inhibitor.

 

The HIRA plans to review the pharmaceutical company's financial impact analysis, academic societies, and expert opinions, and then review the Drug Reimbursment Evaluation Committee within the processing deadline to complete the standard change and drug price evaluation.

 

As a result, standards are expected to be prepared at least within this year.

 

However, MSD's Ertugliflozin was excluded from the discussion in the combination of Metformin+SGLT-2+TZD among the three-drug therapy.

 

It is different from the fact that Metformin+SGLT-2+DPP-43 drugs recognized combination between series regardless of ingredients.

 

An official from the HIRA explained, "It reflected the approval of the MFDS." The efficacy set by the MFDS for SGLT-2 drugs only broadly define monotherapy and combination therapy for adult type 2 diabetes patients, but did not present specific ingredients.

 

This is a simplification of the MFDS' permission to prepare a combined benefit standard for diabetes treatments.

 

However, unlike other SGLT-2 inhibitors, only Steglatro does not have the results of combined clinical trials with the TZD family in the information for experts in the permit.

 

However, clinical trial information with DPP4 inhibition such as Sitagliptin is provided.

 

In the end, drugs that have not been verified for combined effect through clinical trials are believed to have been excluded from the discussion on standards.

 

Metformin+SGLT2+DPP43 drug therapy seems to be possible because all of the SGLT-2 drugs (Forxiga, Jardiance, Suglat, and Steglatro) on the market in Korea have proven their efficacy through DPP-4 combined clinical trials.

 

Steglatro has the lowest domestic market share compared to other SGLT-2 drugs.

 

Another weakness is that it is excluded from the three-drug treatment benefit standard between TZD in the situation of chasing competitors.