IMD Vildagle to receive reimbursed price of KRW 403

MOHW to apply changes on reimbursement and maximum price from Apr. 1

29 items drops license, Boryung’s Pacitol pricing drop by 21% from April next year

Hanmi Pharmaceutical’s dipeptidyl peptidase-4 (DPP-4) inhibiting diabetic treatment Vildagle 50 mg tablet (vildagliptin hydrochloride) would receive health insurance reimbursement from next month.

 

The treatment is an incrementally modified drug (IMD) of Galvus tablet (vildagliptin) that evaded the original’s patent, and it would be listed at a price range of 400 won per tablet.

 

The reimbursed price of Boryung Pharmaceutical’s Pacitol injection (paricalcitol) would be dropped by over 21 percent when its premium pricing period ends in March last year.

 

According to the pharmaceutical industry on Mar.

 

18, Korea’s Ministry of Health and Welfare (MOHW) is in process of amending the ‘List of Reimbursed Drugs and Maximum Price’ with the said changes.

 

The revision would come in effect from Apr.

 

1.

 

◆ Drug listed with maximum price of target product profile (TPP): Hanmi Pharmaceutical’s Vildagle 50 mg tablet would receive reimbursement from next month.

 

Unlike the original Galvus, the IMD has hydrochloride base other than the active ingredient vildagliptin, which was the key to evade the patent.

 

And apparently the IMD has one less indication than the original of ‘using combination therapy when blood sugar level is uncontrollable with sulfonylureas, metformin or thiazolidinediones monotherapy.’ As the drug is on condition to submit evidential data, the ministry is predicted to price the drug at 403 won, or at 90 percent of the TPP.

 

In case the TPP or same-substance drug is not on the list of reimbursed drug, the drugs to submit evidential data but approved as an IMD or as a new formulation would be priced at 90 percent of the TPP.

 

◆ License-withdrawn items: From next month, total 29 items would be unlisted for reimbursement with their companies voluntarily withdrawing the item license.

 

According to the Pharmaceutical Affairs Act, MOHW is to immediately remove reimbursement on a listed drug which the license is voluntarily returning by its company to Ministry of Food and Drug Safety due to an internal issue.

 

Pharmaceutical companies choose to terminate license on an items as a survival strategy, or for sales or marketability issues.

 

Some of them include Leucokain injection by CJ HealthCare, Montelu V tablet by LG Chem, Solifenocil tablet by Mothers Pharm and Daviroad tablet by GC Pharma.

 

◆ Pricing reduction after pricing benefit period: The pricing reduction rate for first generics, currently priced with weighted pricing benefit for a year, has been calculated.

 

One of the big names is Boryung Pharmaceutical’s Pacitol injection (paricalcitol).

 

Its price would be adjusted to 53.55 percent of the first-in-class, and it would maintain the price of 15,309 won for one year, until Mar.

 

31 next year, with the pricing benefit for the Innovative Pharmaceutical Company added.

 

However, the government sustains the pricing benefit until the number of same-substance generic makers is three or less.

 

From Apr.

 

1 next year, the drug would be priced at 12,056 won with 21.2 percent drop.

 

The pricing benefit on DHP Korea’s Bromonac eye drops (bromfenac sodium hydrate) would also be stripped off from Dec.

 

31, and its price would be reduced from the beginning of next year.

 

The drug receives weighted pricing of 59.5 percent of the original’s price for a year from the point when the first generic is listed.

 

The pricing benefit would be maintained until the number of same-substance generic makers is three or less.

 

After the pricing benefit period, the eye drop’s price would fall from 1,829 won to 1,646 won by 10 percent.

 

Eight other drugs’ pricing would be lowered by 10 percent when the benefit period expires.

 

These drugs receive pricing benefit of 59.5 percent of the maximum price for a year from the point when the first generic is listed.

 

The benefit would last until the number of same-substance generic makers becomes four or more.

 

The pricing benefit on KMS Pharm’s Elqueenxaban would be dropped from May 31, and the benefits on Union Korea’s Union Rasagiline, Korea Prime Pharm’s Rasat, Korea Pharma’s Pharma Rasagiline, Celltrion’s Cellpaline would be expired from Jan.

 

31 next year.

 

From then on, their pricing would be reduced by 10 percent.