The government will extend reimbursement for osteoporosis drugs, including Prolia (denosumab, Amgen). In particular, along with the reimbursement extension, the government has allowed switching between osteoporosis drugs.

According to industry sources on the 20th, the Ministry of Health and Welfare recently issued an administrative notice of the ‘Details on the Standards and Methods for Applying Medical Benefits’ that outlined the contents above. Without special objections, the standards are expected to be in force from May.

The main point of the amendment was to extend the reimbursement standard for major osteoporosis drugs used in the field.

Specifically, the Ministry of Health and Welfare has decided to expand the criteria to allow borderline patients who have reached the T-score treatment goal to continue to receiving reimbursement for osteoporosis drugs.

Patients who have been recognized as eligible for reimbursement for a T-score of -2.5 or less (T-score≤-2.5) when measuring bone mineral density using Dual-Energy X-ray Absorptiometry (DXA) of the central bone, will be eligible for an additional year of reimbursement if their T-score improves during treatment to a T-score greater than -2.5 but less than or equal to -2.0.

If the T-score remains greater than -2.5 but less than or equal to -2.0 thereafter, reimbursement will be allowed for another year.

In the additionally approved period, patients will be allowed to switch between raloxifene, bazedoxifene, bisphosphonate, and denosumab.

The patients may also switch to zoledronic acid injections.

The MOHW explained, "After referring to textbooks, guidelines, clinical papers, and academic society (expert) opinions, we decided to extend reimbursement to allow patients diagnosed with a T-score of -2.5 or less via DEXA to continue using the treatment if their T-score improves to -2.5 but less than or equal to -2.0."

Meanwhile, the government's reimbursement extension for osteoporosis drugs sheds light on Prolia, which currently dominates the osteoporosis prescription drug market. Since this year, the MOHW has been scrutinizing osteoporosis drugs, known as selective focus review, due to the sharp rise in their claims.

In essence, the government’s focus is on Prolia, among osteoporosis drugs. According to the drug research institution IQVIA, Prolia generated KRW 151.1 billion in prescription sales last year after posting KRW115.7 billion in 2022 in Korea.

As a single product, it is second only to Keytruda (pembrolizumab), an immuno-oncology drug with unrivaled sales, in the domestic prescription market. The single drug’s sales in the domestic prescription market are comparable to those of mid-sized pharmaceutical companies

Despite the government's scrutiny, Prolia's growth is expected to continue with the osteoporosis drug's reimbursement expansion and switching.

An industry insider who requested anonymity said, "Last year, the top three items in terms of sales were Keytruda, Prolia, and Lipitor, and the sales of each exceeded the total sales of all mid-sized domestic pharmaceutical companies. Given the level of influence a single item can have on market trends, we need to consider reclassifying the threshold for blockbusters to drugs that post more than KRW 50 billion in annual sales.”