Zejula for ovarian cancer gets close to 4th-line coverage

Initiates drug pricing with NHIS, expanding PARP inhibitor indication

Also retrying 1st-line maintenance therapy for all-comers, expecting Cancer Deliberation Committee next year

An anticancer therapy for ovarian cancer Zejula is at the last threshold to win the reimbursement expansion.

 

According to pharmaceutical industry sources, Takeda Pharmaceutical has recently initiated the drug pricing negotiation with the National Health Insurance Service (NHIS) on a poly ADP-ribose polymerase (PPARP) inhibitor Zejula’s (niraparib) expanded indication to treat patients with relapsed ovarian cancer, who have received more than four chemotherapies, as a single therapy.

 

A first PARP inhibitor to be used, regardless of BRCA mutation, Zejula was approved in South Korea in March last year as a monotherapy for the maintenance treatment of patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to second or later-line platinum-based chemotherapy.

 

Although it was listed for reimbursement last December, the first reimbursement standard was limited to patients with gBRCA mutation.

 

In last June, the Cancer Deliberation Committee reviewed using the drug as a single-agent maintenance therapy in patients with gBRCA-negative high-grade serous relapsed ovarian cancer who showed complete or partial response in platinum-based chemotherapy, and as a monotherapy in patients with relapsed ovarian cancer who previously received fourth-line or later chemotherapy.

 

Ultimately, only the fourth-line monotherapy indication was approved, while the gBRCA-negative indication failed.

 

But in August, Takeda immediately submitted an application for reimbursement on Zejula as a monotherapy for the patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first-line platinum-based chemotherapy, regardless of BRCA mutation.

 

Currently, the company awaits the decision by Cancer Deliberation Committee.

 

The fourth or later-line indication, currently in negotiation with NHIS, has been approved based on multicenter, open-label QUADRA study in adult patients with ovarian cancer, who have been treated with third or later-line therapy.

 

During the clinical study, Zejula reached its primary efficacy endpoint and demonstrated clinical efficacy with an object response rate (ORR).

 

The patient group with platinum-sensitive homologous repair deficiency (HRD) demonstrated ORR of 24 percent, where as BRCA-positive platinum-sensitive group, BRCA-positive platinum-resistant group and BRCA-positive platinum-refractory group recorded ORR of 39 percent, 29 percent and 19 percent, respectively.

 

And the median duration of response (mDOR), a secondary efficacy endpoint of the trial, in the HRD group was confirmed at 8.3 months.

 

The drug’s safety profile seems it could be under control by adjusting the dose.

 

Originally, Zejula’s reimbursed price was set at 76,400 won per capsule.

 

Compared to the alternative option, Lynparza (olaparib) by AstraZeneca, Takeda’s option was evaluated as more cost-effective.

 

But because Lynparza was listed with a pharmacoeconomic-analysis exemption through the risk sharing agreement (RSA), Zejula was also applied with the expenditure cap type RSA.