Reimb. to be expanded for PARP inhibitor Lynparza and Zejula

Both completed drug pricing negotiations at the same time, giving rise to the introduction of first-line maintenance therapy options in ovarian cancer

BRCA-negative patients excluded from coverage… unmet needs remain

The PARP inhibitors ‘Lynparza’ and ‘Zejula’ both crossed the last hurdle in extending their insurance benefits.

 

According to industry sources, AstraZeneca Korea and Takeda Pharmaceuticals Korea have both completed drug pricing negotiations with the National Health Insurance Service (NHIS) to expand their PARP (poly ADP ribose polymerase) inhibitor Lynparza (olaparib) and Zejula (niraparib)’s indications to first-line maintenance treatment in ovarian cancer.

 

Negotiation for the two drugs concluded at the same time because Lynparza’s negotiation period had been extended once.

 

Upon passing the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee meeting this month, the insurance benefit of the two drugs is expected to be extended without difficulty.

 

The approvals are also expected to quickly translate into actual prescriptions.

 

In April, AstraZeneca has already completed the landing procedures for the Lynparza tablet formulation that will be used for the new extended indication in the ‘Big 5’ general hospitals - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St.

 

Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital.

 

Zejula’s formulation does not differ by indication, therefore, its prescription code has already been inserted in most medical institutions.

 

However, the expanded reimbursement coverage will not benefit the BRCA-negative patients that account for 80-90% of the total ovarian cancer population.

 

The Lynparza tablet had been approved as a maintenance treatment in the BRCA-positive patient population from the start.

 

Zejula had applied for an ‘All-Comer’ indication regardless of the BRCA mutation status, however, HIRA’s Cancer Disease Deliberation Committee only approved the BRCA-positive indication.

 

Faced with the high barrier to reimbursement, Takeda Pharmaceuticals decided to take the safe road and be first listed for the BRCA-positive indication.

 

Lynparza and Zejula both own the BRCA-negative indication as a second-line or later maintenance therapy, however, reimbursement for these indications was not passed yet.

 

Professor Jae-won Kim of the Obstetrics and Gynecology Department at SNUH said, “Using a drug as maintenance therapy in the first-line and second-line or higher-line is very different, and using the drug earlier will increase the rate of survival.

 

Personally, I believe that coverage for the PARP inhibitors as maintenance treatment should be extended to benefit as many patients as possible in the first-line.” Zejula was first listed for insurance benefit at ₩76,400 under the Risk-sharing agreement (RSA) scheme, and was determined cost-effective over its substitute, Astrazeneca’s ‘Lynparza (olaparib).’ However, as Lynparza was listed through the PE exemption track, both were applied the RSA Expenditure cap type of reimbursement.