Forxiga Generics: April's Reimbursement End Spurs Price Adjustment 'Round Two'

The additional reimbursement period for the SGLT-2 inhibitor diabetes treatment 'Forxiga (active ingredient Dapagliflozin)' ends on April 7th. However, products with maintained upper limits under the additional reimbursement criteria raise questions about potential effects on prescription competition following adjusted drug prices. The Ministry of Health and Welfare (MOHW) decision to include generic versions of Forxiga, effective April 8th, comes after the expiration of its patent last year. This inclusion encompasses generic versions of the original drug, dapagliflozin propanediol, and its salt-modified generics.

The calculated upper limits for dapagliflozin 10mg, set at $0.39 for the salt-modified initial inclusion product, will see adjustments post-reimbursement expiration. Similarly, the assessed amounts for 5mg formulations will also undergo changes. Temporary additional reimbursements for simultaneous entry of original and generic drugs are in place. However, with the expiration of the one-year period, single-drug formulations will see the cessation of additional reimbursements on April 7th, leading to decreased upper limits for both 10mg and 5mg formulations. Despite this, the possibility of maintaining drug prices for certain items remains if the number of companies producing the same product remains limited.

It is expected that the upper limits for salt-modified formulations such as Chong Kun Dang's Exiglu-S tablets (Dapagliflozin), Samjin Pharmaceutical's Dapazin tablets 10mg (Dapagliflozin), Hanmi Pharmaceutical's Dapalon tablets (Dapagliflozin Bis L-proline), Boryung's Trudapa tablets 10mg (Dapagliflozin Bis L-proline), Kyung Dong Pharmaceutical's Dapazin tablets 10mg (Dapagliflozin Bis L-proline), Daewon Pharmaceutical's Dapaone tablets (Dapagliflozin Citrate), Dong-A ST's Dapapro tablets (Dapagliflozin formate), will be maintained.

Generic versions of Forxiga have garnered approximately $22.2 million in outpatient prescription sales over nine months, comprising around 30% of the original drug's sales. Notably, Boryung's Trudapa emerges as a leading competitor in this segment. Moreover, leading companies like Boryung, Chong Kun Dang, Hanmi Pharmaceutical, Daewon Pharmaceutical, and Dong-A ST largely maintain upper limits under the additional reimbursement criteria. The widening gap in drug prices is expected to significantly influence prescription competition moving forward.