Lynparza tablet to be prescribed at Big 5 hospitals

Severance Hospital last among the Big 5 hospitals to clear Lynparza… passed DC reviews in 45 medical institutions in Korea

Passed DREC as maintenance therapy for ovarian cancer… prescription amount expected to be stable when listed

The tablet formulation of the anticancer drug ‘Lynparza’ can now be prescribed at the Big-5 tertiary hospitals.

 

Industry sources reported that AstraZeneca’s poly ADP ribose polymerase (PARP) inhibitor Lynparza (olaparib) passed the review of drug committees (DC) in the five major hospitals, the ‘Big-5s,’ which include the Samsung Medical Center, Seoul National University Hospital, Seoul St.

 

Mary’s Hospital, Asan Medical Center, and Severance Hospital.

 

With Severance Hospital’s DC giving the last nod, Lynparza has now landed in all five hospitals as well as 25 other medical institutions nationwide.

 

As the company received approval from HIRA's Drug Review Evaluation Committee (DREC) to reimburse Lynparza for the ‘first- and second-line maintenance treatment of patients with BRCA-mutated ovarian cancer,’ prescriptions are expected to be made soon after being listed for reimbursement.

 

The company had submitted an application to expand Lynparza tablet's reimbursement to ▲first-line maintenance treatment for patients with BRCA-mutated advanced ovarian cancer; ▲second-line or higher maintenance monotherapy for patients with recurrent platinum-sensitive advanced epithelial ovarian cancer; and ▲HER-2 negative metastatic breast cancer; however, reimbursement for second-line treatment of mBRCA-negative ovarian cancer and breast cancer patients were rejected in the listing process.

 

The addition of the tablet formulation also signifies an improvement in the convenience of oral administration for patients.

 

In the SOLO-2 trial, which investigated the efficacy of the tablet formulation of Lynparza, the 300mg of the tablet formulation taken twice a day met the primary efficacy endpoint.

 

The recommended dose of the Lynparza tablet is two 150mg tablets (300 mg) taken orally twice daily, while the dose for the Lynparza capsule is eight 50mg capsules (400mg) taken orally twice daily.

 

The total number of pills to take is reduced from 16 to 4 per day with the tablet formulation.

 

Lynparza was listed for ovarian cancer in October 2017 as an expenditure cap type under the Risk Sharing Agreement (RSA) through the PE exemption policy.

 

However, the coverage only applied for its use as maintenance therapy for 15 months following chemotherapy.

 

Due to the period limit, cases of patients being discontinued reimbursement started to arise from January 2019.

 

To resolve the issue, the government and AstraZeneca discussed expanding the reimbursement and lifted the period limit set on the drug.