'Nubeqa' reimb progress…changes to prostate cancer trt strategies

Bayer is set to negotiate with the National Health Insurance Service…3 indications, including combination therapies

Patent expiration of 'Xtandi' approaches and delays in 'Erleada' reimbursement process…volatility↑

Prostate cancer treatment 'Nubeqa' 

The prostate cancer treatment 'Nubeqa' is under reviews for final insurance reimbursement hurdle.

As the competing drug 'Erleada' faced setbacks in price negotiations and the patent expiration of Xtandi approaches, a total shift in the competitive landscape among Androgen Receptor Pathway Inhibitors (ARPI) is expected.

According to industry sources, Bayer Korea is set to enter price negotiations with the National Health Insurance Service for Nubeqa (darolutamide). 

Nubeqa passed the Drug Benefit Evaluation Committee earlier this month, advancing to the final stage of coverage.

The indications that passed the reimbursement evaluation include ▲high-risk non-metastatic castration-resistant prostate cancer ▲hormone-sensitive metastatic prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) ▲mHSPC in combination with docetaxel and ADT.

Among these, the hormone-sensitive combination therapies were approved as suitable for reimbursement on the condition that a price below the evaluated amount be accepted.

Once reimbursement discussions are finalized, Nubeqa will be available for practical clinical use in both triplet and doublet therapies. The strength of this drug lies in its differentiated treatment strategies, depending on whether docetaxel is co-administered, allowing for customized treatment tailored to the patient's condition.

Doctors evaluate that this will expand treatment options, as triplet therapy (Nubeqa+ADT+docetaxel) can be used for patients who require aggressive early treatment. In contrast, doublet therapy (Nubeqa+ADT) can be considered for elderly patients or those with high chemotherapy burdens due to comorbidities.

Clinical evidence for Nubeqa continues to accumulate, with the ARANOTE study targeting mHSPC patients showing that the Nubeqa + ADT doublet therapy significantly improved outcomes, reducing the risk of radiological progression or death by 46% compared to placebo.

It also delayed the time to progression and PSA progression, showing consistent results across secondary endpoints. A post-monitoring analysis confirmed delay in time to deterioration of quality-of-life and pain progression.

Furthermore, the ARASENS study showed that the triplet combination of Nubeqa + ADT + docetaxel significantly improved overall survival, reducing the risk of death by 32.5%.

Competition among ARPIs intensifies…the market is closely watching variables such as reimbursement and patents

Currently, the prostate cancer treatment landscape is centered on androgen receptor inhibitors.

Major treatment options include Janssen's 'Zytiga (abiraterone),' 'Erleada (apalutamide),' and 'Xtandi (enzalutamide)' serving as major options alongside Nubeqa.

However, several variables surround the market environment. Competing drug Erleada reportedly failed to reach an agreement during recent price negotiations with the National Health Insurance Service on expanding reimbursement for its high-risk non-metastatic indication.

Prostate cancer treatment 'Xtandi'

Analysis suggests that the adjustment of the Risk-Sharing Agreements (RSA) rate following the expansion of the target population is a key point of contention.

Furthermore, the patent for Xtandi, which has led the market, is set to expire in major countries, starting with the U.S., in 2027. 

As Xtandi is a blockbuster with annual sales of approximately $6 billion, the possibility of structural market changes due to generic entry is being discussed in the mid- to long-term.

Ultimately, Nubeqa's reimbursement progress, beyond a new listing, is evaluated as a variable that will influence the overall competitive landscape.

As treatment options with clinical use as both doublet and triplet combination strategies are made available, depending on reimbursement status, the paradigm of prostate cancer treatment in Korea is increasingly likely to be restructured toward more patient-centered care.