Forxiga, has the largest number of clinical trials

Competitiveness increased with the SGLT-2 benefit expansion

Demonstrate original strengths like Lipitor

With the expansion of SGLT-2 inhibitor coverage, which began in April, combination prescriptions of various diabetes drugs and SGLT-2 drugs are expected to increase.

 

However, as the clinical basis for each drug is a prerequisite for the expansion of this benefit, there are differences in detailed application depending on the presence or absence of clinical trials.

 

Expectations are growing that AstraZeneca's Forxiga, which has the most clinical trials among SGLT-2 inhibitors, will rise further.

 

Kim Jong-hwa, Director of Insurance, Korean Diabetes Association

Kim Jong-Hwa, head of the Department of Endocrinology at Bucheon Sejong Hospital (insurance director of the Korean Diabetes Association), said, “Forxiga is the first SGLT-2 inhibitor in Korea and has the most related clinical studies among drugs in the same class, so it will become the same as Lipitor in the statin class.

 

expected".

 

From April 1, the Ministry of Health and Welfare applied the expansion of the combination benefit for diabetes treatment SGLT-2 inhibitors.

 

According to the notice, the reimbursement of two-drug combination therapy with sulfonylurea (SU), which was limited to some drugs, has been expanded to all SGLT-2 inhibitors.

 

▲Metformin + SU + SGLT-2, ▲Metformin + DPP-4 + SGLT-2, and ▲Metformin + Thiazolidinedione (TZD) + SGLT-2 can be used as reimbursements for the three-drug regimen.

 

Daewoong Pharmaceutical's Envlo, which has no evidence in the SU+SGLT-2 inhibitor dual therapy, is not covered by insurance coverage.

 

This is because Envlo has not proven its effectiveness through clinical trials in combination with the SU series.

 

Even in the metformin + TZD + SGLT-2 triple therapy, MSD's Steglatro and Envlo, which have no clinical evidence, are not covered by reimbursement.

 

The drugs that can be used in the two-drug regimen that is not included in this reimbursement are also limited.

 

In the DPP-4+SGLT-2 two-drug regimen, only Forxiga and Steglatro can be used together with Januvia at the full cost of the first type patient.

 

Among various exceptions, the drug that can be used most widely is, of course, Forxiga.

 

As explained by Director Kim, Forxiga has proven its efficacy and safety in combination with monotherapy and other diabetes drugs through a total of 15 clinical trials.

 

Clinical trials included not only metformin, but also various combination therapies such as sulfonylurea, insulin, DPP-4 inhibitor, TZD, sulfonylurea + metformin, and DPP-4 + metformin.

 

This is the background of the increased utilization of Forxiga.

 

By demonstrating the effect of protecting heart disease and heart function along with blood sugar control, Forxiga had a significant impact on changing the treatment guidelines to prioritize SGLT-2 inhibitors in patients with comorbidities such as cardiovascular disease.

 

“The obesity rate of type 2 diabetic patients in Korea is getting higher and the number of patients with heart failure is also increasing,” said Kim.

 

shows good compatibility with DPP-4 inhibitors and TZD, so a good effect can be produced if the combination therapy is used appropriately." Director Kim expected that Forxiga would become the same as Lipitor, a statin drug used to treat hyperlipidemia, as it accumulated long-term prescription experience and clinical data.

 

Lipitor is an old drug that has been released in Korea for 25 years as a treatment for hyperlipidemia containing atorvastatin.

 

Although more than 100 generics have been launched on the market since the patent expired, Lipitor still boasts an annual prescription of about 200 billion won.

 

Forxiga also faces a full-fledged generic competition system this year.

 

About 150 dapagliflozin products (including complex drugs) registered for a benefit that was released last month are reached.

 

From the standpoint of Forsh, the expansion of the combination benefit widened the utilization and at the same time had to defend against the offensive of generics.

 

It is expected that the strengths of the original product will be maintained even in the generic competition.

 

He believed that it was necessary to pay attention to the side effects of SGLT-2 that would arise from the surge in generics.

 

"If using SGLT-2 inhibitors indiscriminately in diabetic patients, they can be poisonous.

 

We need to clearly determine which patients need SGLT-2 inhibitor prescription so that it can be used for appropriate patients," he urged.