Stivarga renews RSA and Azilect lowers pricing by 30%

Betmiga expands indication and lowers pricing by 5.9%

MOHW to reflect changes on List of Reimbursed Drugs and Maximum Reimbursed Price

By renewing an expiring risk sharing agreement (RSA) with National Health Insurance Service (NHIS), Bayer Korea has decided to lower the maximum reimbursed price for metastatic colorectal cancer and gastrointestinal stromal tumor (GIST) treatment Stivarga 40 mg tablet (regorafenib) by 7 percent.

 

And the health regulator has authorized pricing reduction on idiopathic Parkinson’s disease treatment Azilect tablet (rasagiline msylate) by 30 percent.

 

Korea’s Ministry of Health and Welfare (MOHW) plans to reflect the changes on the List of Reimbursed Drugs and Maximum Reimbursed Price.

 

Although most of the changes would come in effect from Mar.

 

1, some changes would be enforced from different dates due to individual issues.

 

◆ RSA-renewed drug: Bayer’s Stivarga has successfully renewed soon-to-be expiring RSA with NHIS on the 40 mg tablet, indicated to treat metastatic colorectal cancer, GIST, and hepatocellular carcinoma (HCC).

 

Stivarga 40 mg tablet took the refund type RSA track from June 1, 2016, and received reimbursement in Korea.

 

The original RSA, typically lasting for four years, was expected to expire on coming May 31.

 

The current reimbursed price is at 36,608 won, and the company has agreed to lower it by 7 percent to 34,045 won after renewing the negotiation.

 

The lowered pricing would be applied from June 1, when the renewed agreement comes in effect.

 

Accordingly, Korea now has three RSA-renewed drugs including Stivarga.

 

Merck’s metastatic colorectal cancer treatment Erbitux (cetuximab) and Astellas Pharma’s metastatic prostate cancer treatment Xtandi (enzalutamide) have also renewed their agreements.

 

◆ Pricing reduction by increased volume: The maximum reimbursed pricea for Betmiga (migabegron) 50 mg and 25 mg tablets would be lowered as they are now subject for Price-volume Agreement (PVA) negotiated with NHIS.

 

The government manages post-marketing pricing with PVA for drugs exceeding initially estimated volume and claimed amount.

 

Under the PVA system, their prices are renegotiated and brought down.

 

The tablet took the Type Na (나) PVA for the negotiation.

 

Type Ga (가) PVA applies to a new drug listed with pricing negotiation, but had claimed volume over 30 percent higher than the estimated volume.

 

For the agreement, the item has to have same company name, administration method, substance, and formulation as when it was first listed.

 

The Type Na PVA, applied to Betmiga, is for new drug either price adjusted by Type Ga or four years passed since listing date, and accumulated claimed volume surpassed the estimation by 30 percent.

 

It also applies when a drug’s accumulated claimed volume in a year is surged by 60 percent from the previous year, or is increased by 10 percent but the increased amount is over 5 billion won.

 

The negotiated pricing each lowered the original prices by 5.9 percent.

 

The maximum prices of 50 mg tablet and 20 mg tablet was dropped from 757 won to 712 won, and from 505 won to 475 won, respectively.

 

.The new pricing would take in effect from Mar

 

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.Meanwhile, another drug’s pricing would be lowered early due to expanded indication

 

.Based on analysis of estimated additional claimed volume and the increase rate, Takeda Pharmaceuticals Korea has agreed to reduce the pricing of Adcetris (brentuximab)

 

.Coming in effect from March, the current price of 3,262,400 won would be reduced by 3.6 percent to 3,144,953 won

 

.◆ Government-authorized changes: Due to generic’s reimbursement listing, total ten originals or drugs with same administration method, ingredients and formulation as an original would have their maximum price brought down by the government from Mar

 

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.When a first generic is listed for reimbursement, the government applies so-called ‘half-price,’ or 53.55 percent of the original’s price, on the generic

 

.But it applies weighted pricing of 70 percent of the original’s for the first year from the point of listing

 

.And the weighted pricing is sustained, even after a year, when there are less than three companies supplying items in the same class

 

.The pricing is kept until the number of companies reaches over four

 

.The prices of Lundbeck Korea’s Azilect 1 mg tablet and 0.5 mg tablet would fall by 30 percent from 3,501 won and 2,348 won to 2,451 won and 1,643 won, respectively

 

.And the price of Lily Korea’s osteoporosis treatment Forsteo (teriparatide) has also dropped by 30 percent from 326,358 won to 228,451 won

 

.Dong-A ST’s osteoporosis treatment Teribone SC injection 56.5 μg (teriparatide acetate) would be priced 22.2 percent lower from 73,287 to 57,001 won

 

.Except for Forsteo, other drugs’ weighted pricing would be eliminated from next Feb

 

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.The ‘half-price’ would be applied from then on

 

.◆ Raised maximum price and voluntarily-reduced drug pricing: Prices of seven items, designated as radiopharmaceuticals, would be significantly raised from Mar

 

.1 to secure consistent supply in Korean market

 

.The government either accepts raised maximum pricing of radiopharmaceuticals and National Essential Drugs, or compensates for the raised pricing by negotiating with NHIS

 

.The price of Korea Atomic Energy Research Institute’s Kaeri MIBG (1311) injection (2-iodobenzyguanidine (1311)) would be raised slight or exponentially by 0.4 percent of 120.6 percent, depending on the dose

 

.Some other items are voluntarily lowering their prices to better compete in the market

 

.The following six items are the case; Dong Kook Pharmaceutical’s antidepressant Dulcerin capsule (duloxetine hydrocholoride) in two doses, Dong Wha Pharm’s severe hand eczema treatment alitno soft capsule (alitretinoin) in two doses, Pharmbio Korea’s chronic pancreatitis quick symptom reliever Foichol 100 mg tablet (camostat mesilate), Hanmi Pharmaceutical’s HIV-1 infection and chronic hepatitis B virus treatment Tefovir tablet (tenofovir disoproxil phosphate)

 

.Dulcerin 30 mg and 60 mg capsules’ would be lowered by 4 percent and 6.7 percent, respectively

 

.Hanmi Pharmaceutical’s Tefovir tablet price would be lowered by 17.5 percent from 2,910 won to 2,400 won

 

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