Prolia’s drug price cut 30% before the entry of biosimilars

Its price has been reduced to KRW 154,700 due to PVA price cut

Underwent 4th PVA negotiations... sales continued to rise since its launch

Prolia, the No.

 

1 product in the domestic osteoporosis treatment market, has had its upper insurance price limit adjusted this month through price-volume agreement (PVA) negotiations.

 

The drug underwent 4 PVA negotiations in total, which led to a price drop of nearly 30% from the initial price it received in October 2017 upon reimbursement.

 

According to industry sources on the 2nd, the upper limit for Prolia Prefilled Syringe (denosumab, Amgen Korea) was lowered from KRW 156,100 to KRW 154,700 from the 1st of this month under ‘Type B’ PVA negotiations with the National Health Insurance Service.

 

The rate of reduction this time was -0.9% Type B negotiations are applied when the expected claims amount of a drug that has been previously adjusted through Type A negotiations or has not been adjusted for 4 years since its initial date of listing or price adjustment increased by 60% or more compared to the previous year, or increased by 10% or more but the total amount exceeds KRW 5 billion.

 

This is the 4th time Prolia’s insurance price ceiling has already been adjusted through PVA negotiations.

 

In December 2020, the cap was reduced by 6.5% due to an increase in expected claims amount of over 30%, which qualifies the drug for ‘Type A’ PVA negotiations.

 

In August 2022, the price was reduced by 5.0% under Type A negotiations.

 

And in August 2023, the cap was adjusted by 3.7%, also through Type A negotiations.

 

Prolia’s sales have been on the rise ever since it was applied reimbursement benefit in October 2017.

 

In particular, since April 2019, when reimbursement coverage was expanded to first-line therapies, its sales have grown to exceed KRW 100 billion in annual sales.

 

The synergies of Amgen and Chong Kun Dang’s copromotion have also contributed to the steep rise.

 

According to IQVIA, Prolia posted sales of KRW 47.3 billion in 2019, KRW 75.1 billion in 2020, KRW 92.1 billion in 2021, KRW 115.7 billion in 2022, and then KRW 151.1 billion in 2023.

 

Sales in 2023 increased by 219% compared to 2019.

 

The steep rise in performance has inevitably led the company to receive PVA negotiations 3 years in a row.

 

In May, Prolia received reimbursement extensions in Korea.

 

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.

 

At the time, Amgen had voluntarily reduced the price ceiling of its drug upon the reimbursement extension.

 

That voluntary reduction likely reduced the reduction rate during this year’s PVA negotiations.

 

Even so, the price is already down -28.3% compared to the price at the time of the October 2017 reimbursement (KRW 215,678).

 

This is a further reduction in price than the 20% ex officio reduction an original drug would receive the first year a biosimilar is listed.

 

Prolia's patent is scheduled to expire next March.

 

Celltrion and other biotechs are preparing to receive approval for its biosimilars.

 

Therefore, the price of Prolia is expected to drop further once a biosimilar enters the market.

 

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

 

Its use in the field will continue to increase in the future due to its high compliance that is provided by its longer dosing interval of every 6 months, and has clinical results that have proven its effect even after 10 years of treatment,” said an industry official.