Forxiga withdraws from the Korean mkt despite reimbursement

Leaving patients in Korea unable to receive benefits from the reimbursement extension

Generic versions do not have the same indication…Jardiance enjoys a reflective benefit

The SGLT-2 inhibitor ‘Forxiga Tab,’ which its company plans to withdraw from the Korean market in the first half of the year, will now be reimbursed for chronic heart failure.

 

However, the withdrawal of the drug from the market has put a damper on the reimbursement expansion.

 

Even if it is reimbursed from next month, there will inevitably be a gap in the use of the treatment when stocks run out due to the discontinuation of its supply.

 

Therefore, patients with heart failure in Korea are at risk of losing access to the treatment option of Forxiga despite the coverage expansion.

 

The Ministry of Health and Welfare announced in a preliminary notice of revisions to the drug reimbursement standards that it will expand reimbursement for SGLT-2 inhibitors such as Forxiga and Jardiance to chronic heart failure from the 1st of next month.

 

With the revision, Forxiga and Jardiance will be reimbursed for patients with chronic heart failure and a left ventricular ejection fraction of 40% or less who are receiving a stable dose of standard therapy.

 

Here, standard therapy is defined as an ACE inhibitor or angiotensin Ⅱ receptor blocker (ARB) or sacubitril-valsartan in combination with a beta-blocker or aldosterone antagonist.

 

Forxiga and Jardiance can also be used in combination with other standard therapies for heart failure.

 

As a result, the treatment scope of Forxiga, which had mainly been used to treat patients with diabetes, was been extended to chronic heart failure.

 

However, the reimbursement extension was overshadowed by the company's withdrawal from the domestic market in the first half of this year.

 

AstraZeneca announced late last year that it would be withdrawing Forxiga from the domestic market in the first half of this year.

 

Given the upcoming domestic supply disruption, patients with heart failure may be hesitant to use Foxiga even with the reimbursement extension.

 

The patients will have to discontinue use of Forxiga the day the remaining stock runs out, On this, AstraZeneca Korea said, "We are in multi-faceted discussions with the health authorities on how to continue treatment for patients with chronic heart failure and chronic kidney disease who are using Forxiga.

 

We currently have secured sufficient quantities for domestic supply for the year.” The problem is, other than Forxigna, none of the same-ingredient generics that have been released since April last year own the chronic heart failure indication.

 

Upon Forxiga’s market withdrawal, generic versions of the same drug would have to be used, but this is difficult because the generic versions are not authorized or reimbursed for the chronic heart failure indication.

 

This is because Forxiga’s patent for chronic heart failure does not expire until March 2040.

 

Due to this, the reimbursement extension granted for SGLT-2 inhibitors is likely to benefit Boehringer Ingelheim Korea's Jardiance.

 

Jardiance has yet to launch a generic, and other SGLT-2 inhibitor generic drugs do not have a chronic heart failure indication.

 

Therefore, whether the health insurance authorities will find a way to maintain the use of dapagliflozin, Forxiga’s main ingredient, available for chronic heart failure, remains to be seen.