SGLT2i+DPP4i combos' performance falls short of expectations

in the 1st year of its release...even after being allowed use as combination therapy in Korea

2-drug combination products pour into the market after reimbursement extensions… prescription sales reach KRW 8.8 billion

Only 3 major products reach over KRW 2 billion... Most dapagliflozin+sitagliptin combinations posts sales under KRW 100 million

Too strong a trend of prescribing the existing combinations..." patients show resistance to using new combinations”

A large number of 'SGLT-2 inhibitor (SGLT2i)+DPP-4 inhibitor (DPP4i)' combinations entered the market after Korea’s insurance reimbursement was extended to cover ‘SGLT-2 inhibitor + DPP-4 inhibitor’ combinations, however, their sales performance in the first year is falling short of expectations.

 

Of the major products that have been on the market since May, only 3 generated more than KRW 2 billion in prescriptions by the end of the year.

 

Of the more than 30 dapagliflozin+sitagliptin combination products released since September, most prescriptions sold less than KRW 100 million by the end of the year.

 

In the field, prescribers are noting how the extended reimbursement is applied to the 3 drug combinations of SGLT2i+DPP4i+metformin.

 

Therefore, rather than adding metformin to the newly launched SGTL2i+DPP4i two-drug combination drugs, prescribers have been mainly prescribing the combination by adding a single SGLT2i agent to existing DPP4i+metformin combination drugs.

 

SGLT2i+DPP4i combo mkt size KRW 8.8 bil… Esglito>Zemidapa>Qtern According to the pharmaceutical industry on the 23rd, the outpatient prescription market for SGLT2i+DPP4i combination was KRW 8.8 billion last year.

 

Behringer Ingelheim's Esglito (empagliflozin+linagliptin)’ has shown the highest prescription performance, generating KRW 2.7 billion in prescription sales in the 8 months following its reimbursement listing in May last year.

 

This was followed by LG Chem's Zemidapa (dapagliflozin+Zemiglo) and AstraZeneca's Qtern (dapagliflozin+saxagliptin), each of which recorded KRW 2.1 billion.

 

Qtern is being sold by Ildong Pharmaceutical in Korea.

 

The rest of the combination drugs have all posted less than KRW 1 billion in sales.

 

Chng Kun Dang’s ‘Exiglu-S Tab (dapagliflozin+sitagliptin) posted KRW 600 million, Dong-A ST’s Sugadapa (dapagliflozin+evogliptin) posted KRW 500 million, and AstraZeneca's Sidapvia (dapagliflozin+sitagliptin) for KRW 200 million.

 

Of these, all products other than Sidapvia, have been sold in earnest since their reimbursement listing in May last year.

 

Sidapvia was launched in September last year after the patent expiry of Januvia (sitagliptin).

 

The drug is manufactured and supplied by SK Chemicals in Korea.

 

Other dapagliflozin+sitagliptin combinations launched alongside Sidapvia have accumulated less than KRW 100 million in prescriptions from September until the end of the year.

 

Industry expresses performance is 'below expectations'...Different response from when the 96 companies were approved The market was formed after reimbursement was extended to combination therapy in Korea for diabetes in April last year.

 

At the time, the government extended reimbursement to the SGLT2i+DPP4i+metformin combination.

 

In May, the SGLT2i+DPP4i combination drugs were approved The pharmaceutical industry had initially predicted that demand would rise for combination products, especially those that combined SGLT2i and DPP4i since it was the first time the combined use of SGLT2i and DPP4i was reimbursed in Korea.

 

In fact, the pharmaceutical industry had shown great attention, with 96 companies receiving approval for the 2-drug combo around the period of the reimbursement expansion.

 

In April, the patent for the flagship SGLT2i class drug Forxiga (dapagliflozin) expired.

 

The companies that owned original DPP4i drugs rushed to launch combination products that contained dapagliflozin.

 

In September, the patent for Januvia (sitagliptin), the flagship DPP4i class drug, also expired.

 

The expiration of the patents for the top drugs in each class led to a flurry of launches of dapagliflozin+sitagliptin combinations.

 

But now last year's outpatient prescription performance results are out, and the industry consensus is that the performance of the 2-drug combinations is a disappointment.

 

Even when considering that it was the first year of sales, it was not up to expectations.

 

When taking the dapagliflozin+sitagliptin two-drug combination as an example, 34 companies have launched their product since September, but their combined prescription sales amounted to only KRW 1.4 billion.

 

The average prescription per company is less than KRW 50 million.

 

Combination drugs that used original drugs fared similarly.

 

Taking Esgliteo, the highest-selling drug last year that posted KRW 2.7 billion as an example, its components, the single-agent drugs ‘Jadiance (empagliflozin)’ and ‘Trajenta (linagliptin),’ generated prescription sales of KRW 58.1 billion and KRW 61.3 billion, respectively, last year.

 

"Prescribing the more familiar DPP4i+metformin combination"...New combinations at a crossroads The industry has raised various interpretations on the lower-than-expected performance of the drugs.

 

First of all, one analysis was that the new combination drugs were not well received in the field.

 

The government's diabetes benefit extension was for the three-drug combination of SGLT2i+DPP4i+metformin.

 

The SGLT2i-DPP4i two-drug combination by itself is not covered.

 

As a result, prescribers were left to choose one of three options: SGLT2i+DPP4i combo and metformin, SGLT2i+metformin combo and DPP4i, or SGLT2i and DPP4i and metformin.

 

The problem is that prescribers were relatively more familiar with the SGLT2i+metformin or DPP4i+metformin combinations that were already on the market, compared with the more newly introduced SGLT2i+DPP4i combinations.

 

"To use the newly approved SGLT2i+DPP4i combinations, patients would need to change all of their existing medications, whereas DPP4i+metformin combinations require patients to add a single SGLT2i to their existing medications, so there is less patient resistance," explained one endocrinologist.

 

"Also, the combination drugs are not very competitive price-wise when compared with prescribing each drug separately," he added.

 

In the case of the dapagliflozin plus sitagliptin combination, supply issues with sitagliptin also played a role.

 

In the case of sitagliptin, one contract manufacturer manufactures products for 10 or more companies.

 

The production capacity of the contract manufacturers has reportedly become overwhelmed, manufacturing the ingredients for so many companies.

 

Some companies are also reportedly having difficulty producing products for companies due to difficulty procuring raw materials that need to be imported from India.

 

However, there is also industry opinion that it is too early to tell whether SGLT2i+DPP4i combination products will be successful in the market.

 

As there is still a possibility that the sitagliptin contract manufacturers will be able to stabilize their supply, and as related products are in the early stages of their launch, there remains enough potential for future market expansion.