Kyowa Kirin has completed the reimbursement negotiation with the Korean government for Crysvita, a hypophosphatemic rickets treatment, in just 30 days.

As a result, the drug will likely become the first treatment to benefit from Korea’s new accelerated reimbursement process, which expedites the review period for reimbursement negotiations from the conventional 60 days to 30 days.

According to industry watchers, Crysvita is expected to receive reimbursement from May 1.

The Ministry of Health and Welfare (MOHW) had previously announced that it would shorten the reimbursement negotiation period to improve patient access to risk-sharing drugs exempt from economic evaluation.

When looking at Korea’s new drug approval schedule, after a pharmaceutical company applies for a reimbursement determination, it takes 120 days for the review committee to evaluate clinical efficacy, cost-effectiveness, and benefit appropriateness.

Afterward, if the MOHW approves the drug for reimbursement negotiation, it took 60 days to negotiate with the National Health Insurance Service (NHIS), and another 30 days to deliberate with the Health Insurance Policy Review Committee and unveil the drug price.

The MOHW’s plan is to shorten the negotiation period with the NHIS from 60 days to 30 days by conducting preliminary negotiations at the drug review committee stage to have enough time to coordinate opinions.

Hypophosphatemic rickets comes with severe leg bending, which is characterized by signs around the age of two and is usually detected after the disease has progressed significantly.

Missed treatment can lead to side effects such as limb deformity, short stature, increased risk of fractures, kidney calcification, elevated parathyroid levels, and in severe cases, inability to walk.

While Crysvita is not used for a life-threatening condition, it is associated with quality of life and became the first drug to receive accelerated reimbursement.