Pricing negotiations for Bayer’s Nubeqa fall through

Due to intensified market competition following the launch of multiple Xtandi generics

"We made every effort to improve patient access but failed… have no plans to reapply."

Bayer Korea's prostate cancer therapy Nubeqa (darolutamide) has failed to reach a pricing agreement with the National Health Insurance Service (NHIS) and is unlikely to pursue another attempt at securing reimbursement in Korea.

The reimbursement environment has become increasingly competitive due to the expiration of the patent for Nubeqa’s competitor Xtandi (enzalutamide), and the following mass launch of its generics last month.

The entry of lower-priced Xtandi generics alongside Erleada and Xtandi has made reimbursement price negotiations for Nubeqa even more challenging.

According to industry sources on the 10th, Nubeqa, which received a positive reimbursement recommendation from the Drub Reimbursement Evaluation Committee (DREC) in March for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), ultimately failed to reach a final agreement with the NHIS on pricing.

A Bayer representative said, "We made every effort to improve patient access to Nubeqa, but were ultimately unable to reach an agreement." The company added that, considering the current market environment in Korea, it has no plans to resubmit the reimbursement application.

At the March DREC meeting, Nubeqa was deemed eligible for reimbursement if the drug is priced below the committee's assessed value for use ▲in combination with androgen deprivation therapy (ADT) or ▲with docetaxel plus ADT for the treatment of patients with mHSPC.

The major competitors in the mHSPC market are Erleada (apalutamide) and Xtandi. As a later entrant, Nubeqa has been closely chasing the two established therapies.

Although Nubeqa cleared the Cancer Drug Deliberation Committee (CDDC) in December last year and the DREC in March this year, negotiations reportedly stalled over details of the Risk Sharing Agreement (RSA), including the reimbursement rate.

Erleada has continued to expand its market presence, generating KRW 53.3 billion in prescription sales last year, up 71% from the previous year. The product is also seeking reimbursement expansion for high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).

Although its reimbursement expansion failed after price negotiations in February, the company has indicated that it intends to resubmit the application.

Xtandi recorded KRW 38 billion in prescription sales last year, a 26% increase year over year. However, with 9 companies having launched generic versions, the competitive landscape is expected to undergo a significant transformation.