[Reporter’s View] Still no news on SGLT-2 combo reimb.

Still no news nor progress has been made on the discussions regarding reimbursement of combination therapies using SGLT-2 inhibitors.

 

After a long three years, the Health Insurance Review and Assessment Service called for a diabetes expert meeting to discuss expanding reimbursement of SGLTL-2 inhibitors in September last year.

 

At the meeting, the experts saw consensus on integrating and accepting the ‘class effect’ of DPP-4 and SGLT-2 inhibitor combinations as well as three-drug combinations for reimbursement.

 

Such results had sparked hope that the non-reimbursed combination drugs would also be finally listed for reimbursement.

 

But that was the last spark of hope.

 

The year has passed and April has come with no news on the reimbursement of SGLT-2 combos that is now subject to formal review by the Health Insurance Review and Assessment Service.

 

Recognizing the expected efficacy of drugs with the same mechanism of action is an issue that requires consideration.

 

However, with the interests of various experts and pharmaceutical companies clashing, and the opinions of the experts divided, the issue was dealt with case-by-case.

 

However, consistency was the issue for the reimbursement deliberation of SGLT-2 inhibitors.

 

The authorities recognized the class effect of some drugs are recognized regardless of their indication and applied the same reimbursement standard, while other cases of reimbursement for some classes differ by each drug.

 

In 2013, the diabetes society played a leading role in discussing the reimbursement extension of DPP-4 inhibitors and TZD class combos and claimed the need and justification for the extension.

 

The society emphasized the importance of clinical experience and expert judgment over fiscal impact, and the government accepted the expert’s decision based on disease characteristics and drug use experience.

 

What has changed since then?

 

The academic society changed its position on the reimbursement of SGLT-2 inhibitors in 2018 and pushed back the plans for the proposed improvement.

 

Many drugs were expected to be affected by the plan, not only SGLT-2 inhibitors such as ‘Jardiance (empagliflozin),’ ‘Forxiga (empagliflozin),’ ‘Suglat (ipragliflozin),’ ‘Steglatro (ertugliflozin)’ but DPP-4 inhibitors such as ‘Januvia (sitagliptin),’ ‘Galvus (vildagliptin),’ ‘Trajenta (linagliptin),’ ‘Zemiblo (gemigliptin)’ were affected.

 

However, the amendments that were made thereon were encouraging.

 

The society had reached a consensus and submitted an opinion that reimbursement should be extended to combination therapies, which was accepted by the Ministry of Food and Drug Safety.

 

The MFDS then announced it would ‘simplify’ the diabetes treatment indications in August of the same year, from listing the ingredients to ▲monotherapy or ▲combination therapy, adding momentum.

 

The various movements made had borne fruit.

 

And then the baton was handed over to the government.

 

The SGLT-2 inhibitors are now also subject to PMS.

 

Most of the drugs are required to submit their PMS results between 2023-2024.

 

In other words, the companies only have around a year or two left.

 

For the PMS study, hundreds to thousands of patients need to be recruited and registered.

 

However, due to the characteristic of the diabetes market, it is hard to secure a stable proportion of prescriptions for a non-reimbursed drug.

 

Unless the reimbursement issue is resolved, the companies will not be able to recruit the necessary amount of patients required by the MFDS.

 

Now is the time to conclude this issue once and for all, and decide on extending reimbursement for SGLF-2 inhibitors.