33% price gap with pitavastatin + ezetimibe follow-on drugs

Will be newly listed at a calculated price that is 21% lower than the currently-listed lowest price

Calculated rate 53.55%→45…not meeting standard requirements 85%→80

Price gap will be widened before 2030 reevaluation of upper limit prices

Follow-on drugs of the pitavastatin and ezetimibe combination received calculated prices more than 30% lower than the existing highest price for the same formulation, reflecting the immediate impact of the drug pricing system reform.

With the re-evaluation of upper limit prices for previously listed drugs not yet implemented, the price gap has widened further as newly listed products receive lower calculated prices.

According to industry sources on the 29th, Dong-A ST's "PitaEZ Tab" 1/10mg (pitavastatin calcium/ezetimibe) will be listed for reimbursement next month at 734 won.

Compared to the existing highest price of 1,093 won for the same pitavastatin·ezetimibe 1/10mg formulation, it is 359 won (32.8%) lower. Even compared to the lowest price of 929 won for the same formulation, it is 195 won (21.0%) cheaper.

As the base calculation rate was adjusted downward from 53.55% to 45%, the starting point for drug pricing calculations has changed. Even for follow-on drugs that meet all standard requirements, pricing starts about 16% lower than before.

Furthermore, as the calculation ratio for products not meeting standard requirements was tightened from 85% to 80%, drug prices dropped even further for outsourced bioequivalence (BE) studies.

Until this month, the calculation rate for a product meeting only one standard requirement was 85% of 53.55%, resulting in a calculated price of roughly 45.52%.

Starting next month, 80% will be applied to the 45% calculation rate, bringing the final calculation rate down to 36%.Even a simple numerical comparison shows a difference of about 9.5 percentage points.

PitaEZ Tab reflects both the lowered calculation rate and the tightened calculation ratio for standard requirements. Because it met only one standard requirement, its drug price was calculated at 80% of the lowered 45% calculation rate.

Dongkwang Pharmaceutical's 'Pz Tab' 1/10mg, much like PitaEZ Tab, is a product for which BE testing was outsourced to Daewon Pharm. Last August, because it failed to meet one standard requirement, it was listed for reimbursement at 929 won, the lowest price for the same formulation at the time.

PitaEZ Tab also failed to meet one standard requirement, but as both the calculation rate and the standard requirement calculation ratio were tightened, it received a price 195 won lower than the previous lowest price.

Re-evaluation of Previously Listed Drugs from 2030... Large Price Gap to Persist for at Least 4 Years

Because the pitavastatin 1mg + ezetimibe 10mg combination is a second-tier product for the re-evaluation of previously listed drugs, its drug price reduction will begin in 2030.

Starting at 51%, the price will be reduced by 2 percentage points each year, reaching 45% by 2036.

In other words, the 33% price gap between newly listed follow-on drugs and the highest price of the same formulation will only begin to narrow after at least four years. It will take up to 10 years for prices to fall to a comparable level.

This also means the calculated price barrier for new generic listings has risen accordingly. Although there is only a two-month difference in listing times, the aftermath of the drug pricing system reform has manifested as a price gap of at least 21%.

The low-dose pitavastatin + ezetimibe combination market has seen full-scale competition beginning this year. Last April, Ilsung Is, Daewoong Pharmaceutical, Ildong Pharmaceutical, and Hanlim Pharm were the first to list their products for reimbursement.

JW Pharmaceutical, the leader in the pitavastatin + ezetimibe market, listed a low-dose product in June to defend against follow-on pharmaceutical companies' low-dose market-penetration strategies.

Subsequently, Ahn-Gook Pharm's Pevarozet, Boryung's Lzerozet, Daewon Pharm's Tavalozet, Bukwang Pharmaceutical's Erozet Tab, Ahn-Gook Newpharm's Newpharm Pitaeze Tab, and Dongkwang Pharm's Pz Tab successfully entered the reimbursement list one after another.

JW Pharmaceutical's low-dose Livalozet had been receiving the highest price of 1,093 won, but through a voluntary price reduction, its price will drop to 1,042 won starting next month.