4th PVA negotiations complete for Prolia

the leading osteoporosis drug in Korea

Dominated the domestic market, posting KRW 41.2 billion in Q1...already the 4th PVA

The government completed price-volume agreement (PVA) negotiations for Prolia Prefilled Syringe (denosumab), the leading product in the domestic osteoporosis treatment market, with Amgen Korea.

 

Whether the drug’s price will be adjusted for the 4th time under the PVA is gaining attention.

 

According to industry sources on the 4th, Amgen Korea and the National Health Insurance Service recently agreed on PVA negotiation terms for Prolia.

 

The current upper insurance price for Prolia is KRW 156,100.

 

Prolia is a biological drug that targets the RANKL protein, which forms osteoclasts that destroy the bone.

 

The drug is co-marketed by Amgen Korea and Chong Kun Dang in Korea.

 

Ever since the drug was granted reimbursement in October 2017, the drug immediately dominated the domestic osteoporosis drug market.

 

In April 2019, the drug was granted extended reimbursement, covering its use as a first-line therapy, which rapidly increased its use.

 

According to IQVIA, Prolia’s domestic sales in Q1 amounted to KRW 41.2 billion, ranking second among all drugs.

 

With sales rising steadily, the company inevitably had to negotiate Prolia’s price under the price-volume agreement system.

 

Prolia's price has already been adjusted 3 times through negotiations.

 

The first was a "Type A" negotiation in December 2020, which resulted in a 6.5% reduction.

 

Type A negotiations are applied when the drug’s expected use amount increases by over 30%.

 

The second was a "Type B" negotiation that was applied in August 2022.

 

Type B negotiations are applied when the expected use amount increased by 60% or more compared to the previous year or increased by 10% or more but the total amount exceeds KRW 5 billion.

 

The third was also a ‘Type B’ negotiation, which resulted in a 3.7% price cut in Prolia’s insurance price ceiling in August last year.

 

If the drug price is adjusted this time, it will be the 4th PVA price reduction.

 

In May, Prolia's insurance price ceiling was lowered from KRW 162,600 to KRW 156,100 due to the reimbursement extension.

 

Prior to the reimbursement extension, patients with a bone mineral density measurement of -2.5 (T-score) or less were eligible for 1 year of benefits, but after the reimbursement extension, patients with a T-score of -2.0 or less and to -.2.5 are eligible for up to 2 years of reimbursement.