AstraZeneca Korea reapplies for Lynparza reimbursement in prostate cancer

AstraZeneca Korea has recently reapplied for health insurance coverage for its PARP inhibitor Lynparza (olaparib) for the prostate cancer indication.

Korea Biomedical Review has learned that AstraZeneca Korea submitted a reimbursement application for Lynparza to the Health Insurance Review and Assessment Service (HIRA) on April 18. The company has applied for insurance coverage for both indications, which are supported by two phase 3 clinical trials: the PROfound and PROpel studies.

Lynparza is licensed in Korea for two indications in prostate cancer. The first is for “the treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed after prior treatment with a novel hormonal therapy,” based on the PROfound trial. The second is for “combination therapy with abiraterone and prednisolone in adult patients who have not received prior chemotherapy after diagnosis of mCRPC,” based on the PROpel trial.

In 2022, AstraZeneca Korea applied for reimbursement for the treatment of BRCA-mutated mCRPC and passed the Cancer Disease Review Committee’s review with approval to set the reimbursement threshold. However, subsequent discussions on risk-sharing arrangements (RSAs) did not pass the Pharmaceutical Reimbursement Evaluation Committee (PREC) stage.

In clinical practice, there is a strong call for the reimbursement of Lynparza in the treatment of prostate cancer patients. Jeong Chang-wook, professor of urology at Seoul National University Hospital, told Korea Biomedical Review that insurance coverage for Lynparza would enable timely treatment and maximize its effectiveness.

“Lynparza is known to have excellent therapeutic efficacy in patients with BRCA mutations, but its high cost has limited patient access,” said Jeong. “Most patients consider Lynparza only after they have exhausted other drugs, at which point their condition has deteriorated significantly, reducing its efficacy and increasing side effects, such as anemia.”

“This limitation is even more pronounced in the first-line treatment of mCRPC,” he added. “There are data showing that the combination of abiraterone (Zytiga) and a PARP inhibitor is beneficial, but non-reimbursement has limited its use in clinical practice. If reimbursement becomes a reality, a significant number of patients could benefit.”

In a subanalysis of mCRPC patients with BRCA1/2 mutations in the PROfound study, Lynparza significantly improved radiologic progression-free survival (rPFS) to a median of 9.8 months compared to 3 months in the control arm for patients who had progressed after prior abiraterone or enzalutamide (Xtandi) (HR 0.22, 95% CI 0.15–0.32; p<0.0001). Overall survival (OS) was also improved, with a median of 20.1 months compared to 14.4 months in the control group (HR 0.63, 95% CI 0.42–0.95).

In the PROpel study, the combination of Lynparza and abiraterone was evaluated in mCRPC patients who had not received prior chemotherapy. The combination reduced the risk of disease progression or death by 34 percent compared to abiraterone monotherapy (HR 0.66; 95% CI 0.54–0.81; p<0.0001), with rPFS reaching 24.8 months in the combination arm—8.2 months longer than the 16.6 months observed with abiraterone alone.

However, hurdles remain before Lynparza can be reimbursed for prostate cancer. While the drug is approved in Korea for several cancers—including ovarian, breast, pancreatic, and endometrial—it currently has insurance coverage only for ovarian cancer.

Pharmaceutical industry officials have consistently pointed out that drugs with multiple indications, such as Lynparza, are used differently across cancer types, making it difficult to assess their full value under the current pricing methodology.

This underscores the need for an indication-specific pricing system that considers the unique characteristics of each cancer type.

Regarding the reimbursement application, AstraZeneca Korea stated, “We will do our best to bring new hope to prostate cancer patients in Korea.”